Cerenia hund

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Read on to learn more about how CERENIA ® (maropitant citrate) can help.

TAKE CARE OF YOUR PET'S VOMITING

Th e Misadven tures

For any dog or cat, vomiting can be a painful, exhausting, anxiety-inducing experience. 1 Though there may be many causes, there is only one FDA-approved treatment.

CERENIA ® (maropitant citrate) is the first and only FDA-approved veterinary medication to safely and effectively treat vomiting in dogs and cats and prevent vomiting due to motion sickness in dogs.*

CERENIA Users 2

Th e Misadven tures o f Ralph

Car sickness affects as many as 20% of dogs. 3

Important Safety Information:

Use CERENIA Injectable for vomiting in cats 4 months and older; use subcutaneously for acute vomiting in dogs 2 to 4 months of age or either subcutaneously or intravenously in dogs 4 months of age and older. Use CERENIA Tablets for acute vomiting in dogs 2 months and older, and for prevention of vomiting due to motion sickness in dogs 4 months and older. Safe use has not been evaluated in cats and dogs with gastrointestinal obstruction, or those that have ingested toxins. Use with caution in cats and dogs with hepatic dysfunction. Pain/vocalization upon injection is a common side effect. In people, topical exposure may elicit localized allergic skin reactions, and repeated or prolonged exposure may lead to skin sensitization. See full Prescribing Information.

BarkBox is a registered trademark of BarkBox, Inc.
Benadryl® is a registered trademark of Johnson & Johnson Consumer Inc. or one of its affiliated companies. Dramamine® is a registred trademark of Prestige Brands Holdings, Inc. or its licensors. Bonine® is a registered trademark of Insight Pharmaceuticals LLC.
* Dramamine®, Bonine®, Benadryl® and herbal supplements have not been tested and approved by the FDA-CVM for use in dogs.
1 Conder GA, Sedlacek HS, Boucher JF, Clemence RG. Efficacy and safety of maropitant, a selective neurokinin 1 receptor antagonist, in two randomized clinical trials for prevention of vomiting due to motion sickness. J Vet Pharmacol Ther. 2008;31(6):528-532.
2 Data on file, Cerenia A&U Report June 2016. Zoetis Inc.
3 Data on file, Harris Interactive Pet Owner Market Research CERMS2012, 2012 Zoetis Inc.
4 Yates BJ, Miller AD, Lucot JB. Physiological basis and pharmacology of motion sickness: an update. Brain Res Bull. 1998;47(5):395-406.

Online Product Information Statement:

The product information provided in this site is intended only for residents of the United States. The products discussed herein may not have marketing authorization or may have different product labeling in different countries. The animal health information contained herein is provided for educational purposes only and is not intended to replace discussions with an animal healthcare professional. All decisions regarding the care of a veterinary patient must be made with an animal healthcare professional, considering the unique characteristics of the patient.

Treat or Prevent Vomiting

With Once-Daily CERENIA

CERENIA ® (maropitant citrate), the first and only FDA‑approved veterinary antiemetic, effectively treats or prevents canine and feline vomiting from multiple causes. 1,2

CERENIA Is the #1 Antiemetic Prescribed for Cats and Dogs

Rapid onset of action and 24-hour efficacy 3-6

Easy once-daily dosing

Unique mode of action

that treats or prevents vomiting from multiple causes 3, 7-9

Feline Vomiting

Vomiting can have various causes. Address your feline patients' immediate needs while diagnosing the underlying cause of the vomiting.

Perioperative Vomiting in Dogs

Prevent vomiting when using opioids in your canine preoperative protocol.

IMPORTANT SAFETY INFORMATION: Use CERENIA Injectable for vomiting in cats 4 months and older; use subcutaneously for acute vomiting in dogs 2 to 4 months of age or either subcutaneously or intravenously in dogs 4 months of age and older. Use CERENIA Tablets for acute vomiting in dogs 2 months and older, and for prevention of vomiting due to motion sickness in dogs 4 months and older. Safe use has not been evaluated in cats and dogs with gastrointestinal obstruction, or those that have ingested toxins. Use with caution in cats and dogs with hepatic dysfunction. Pain/vocalization upon injection is a common side effect. In people, topical exposure may elicit localized allergic skin reactions, and repeated or prolonged exposure may lead to skin sensitization. Please see full Prescribing Information.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different labeling in different countries. The animal health information contained herein is provided for educational purposes only and is not intended to replace discussions with an animal healthcare professional. All decisions regarding the care of a veterinary patient must be made with an animal healthcare professional, considering the unique characteristics of the patient.

All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.

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Cerenia hund

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Cerenia Tablets for dogs contain 16 mg, 24 mg, 60 mg or 160 mg maropitant as maropitant citrate monohydrate. The tablets also contain Sunset Yellow (E110) as a colourant. The tablets are pale orange and have a score line on both sides allowing the tablet to be halved. Each tablet is marked with the Pfizer logo on the reverse side. On the obverse side, each half is marked with the letters "MPT" and figures denoting the quantity of maropitant.

Cerenia 160mg Tablet

Cerenia tablets contain boxmaropitant citrate monohydrate. Indicated for the prevention of vomiting including that induced by chemotherapy, in conjunction with cerenia solution for. [More info]

Cerenia 16mg Tablet

Cerenia tablets contain boxmaropitant citrate monohydrate. Indicated for the prevention of vomiting including that induced by chemotherapy, in conjunction with cerenia solution for. [More info]

Cerenia 24mg Tablet

Cerenia tablets contain boxmaropitant citrate monohydrate. Indicated for the prevention of vomiting including that induced by chemotherapy, in conjunction with cerenia solution for. [More info]

Cerenia 60mg Tablet

Cerenia tablets contain boxmaropitant citrate monohydrate. Indicated for the prevention of vomiting including that induced by chemotherapy, in conjunction with cerenia solution for. [More info]

Cerenia tablets are indicated for the prevention of nausea induced by chemotherapy. For the treatment of vomiting, in conjunction with Cerenia Solution for Injection and in combination with other supportive measures. For the prevention of vomiting including that induced by motion sickness.Also the prevention of nausea induced by chemotherapy and treatment and prevention of vomiting (except motion sickness)

Cerenia tablets should be administered once daily, at a dose of 2 mg maropitant per kg bodyweight, using the number of tablets given in the table below. Tablets are breakable along the score line on the tablet.

To prevent vomiting, tablets should be given more than 1 hour in advance. The duration of the effect is approximately 24 hours and, therefore, tablets can be given the night before administration of an agent that may cause emesis (e.g. chemotherapy).

Cerenia can be used as either tablets or Solution for Injection once daily for up to five consecutive days to treat vomiting.

Cerenia tablets are effective in the treatment of vomiting, however in cases of frequent vomiting it is recommended to initiate treatment with Cerenia Solution for Injection.

Treatment and prevention of vomiting (except motion sickness)

Cerenia tablets should be administered once daily, at a dose of 8 mg maropitant per kg bodyweight, using the numbers of tablets given in the table below. Tablets are breakable along the score line on the tablet.

Tablets should be administered at least one hour before starting the journey. The anti-emetic effect persists for at least 12 hours, which for convenience may allow administration the night before early morning travel. Treatment may be repeated for a maximum of two consecutive days.

In some individual dogs and when repeating the treatment, lower doses than recommended might be sufficient.

Prevention of motion sickness only

Firstly, fold or cut along the perforation between each tablet as shown by the scissor symbol. Find the pull-back notch (or cut) as shown by the arrow symbol. Holding one side of the cut firmly, pull the other side towards the centre of the blister until the tablet is visible. Remove table from blister and administer as instructed.

Note: No attempt should be made to remove the tablet by pushing it through the blister backing as this will damage both the tablet and blister.

A light meal or snack before dosing is recommended; prolonged fasting before administration should be avoided. Cerenia tablets should not be administered wrapped or encapsulated in food as this may delay dissolution of the tablet and consequently the onset of the effect.

Dogs should be carefully observed following administration to ensure that each tablet is swallowed.

Vomiting can be associated with serious, severely debilitating conditions including gastrointestinal obstructions; therefore, appropriate diagnostic evaluations should be employed.

Administering Cerenia on a completely empty stomach may cause the dog to vomit. A light snack before dosing could help prevent this effect.

The safety of Cerenia has not been established in dogs less than 16 weeks of age and in pregnant or lactating bitches. Use only according to a risk benefit assessment by the responsible veterinary surgeon.

Cerenia should be used in conjunction with other supportive measures if appropriate.

Clinical signs including vomiting on first administration, excess salivation and watery faeces have been observed when the product has been overdosed in excess of 20 mg/kg.

Maropitant is metabolised in the liver and therefore should be used with caution in dogs with liver disease.

Cerenia should be used with caution in animals suffering from or with a predisposition for heart diseases. Cerenia should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.

Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.

Cerenia is not a sedative and some motion sick dogs may show nausea-like signs during travel such as salivation and lethargy. These signs are temporary and should resolve when the journey ends.

Incidents of pre-travel vomiting, usually within two hours post-dosing, were commonly reported after administration of the 8 mg/kg dose.

Wash hands after use. In case of accidental ingestion seek medical advice immediately and show the package leaflet or the label to the physician.

This veterinary medicinal product does not require any special storage conditions.

Half tablets should be stored for a maximum of two days after removal from the blister. Half-tablets should be returned to the opened blister and kept within the cardboard outer.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Keep out of the reach and sight of children. For animal treatment only.

Cerenia tablets are supplied in blister packs with four tablets per pack.

Cerenia ®

For subcutaneous injection in dogs and cats

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Maropitant is a neurokinin (NK1) receptor antagonist that blocks the pharmacological action of substance P in the central nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is C32H40N2O C6H8O7 H2O and the molecular weight 678.81. The chemical name is (2 S ,3 S) -2-benzhydryl- N -(5- tert -butyl-2- methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Each mL of CERENIA Injectable Solution contains 10 mg maropitant, 63 mg sulphobutylether-beta-cyclodextrin, 3.3 mg meta-cresol and water for injection.

The chemical structure of maropitant citrate is:

INDICATIONS

Dogs: CERENIA (maropitant citrate) Injectable Solution is indicated for the prevention and treatment of acute vomiting in dogs.

Cats : CERENIA (maropitant citrate) Injectable Solution is indicated for the treatment of vomiting in cats.

Dosage and Administration

Use of refrigerated product may reduce the pain response associated with subcutaneous injection.

Dogs 4 months of Age and Older : Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/1 kg (1 mL/22 lb) of body weight once daily for up to 5 consecutive days.

In dogs that are actively vomiting, it is recommended to initiate treatment with CERENIA Injectable Solution. Thereafter, CERENIA Tablets may be used for the prevention of acute vomiting at 2 mg/kg once daily. (See CERENIA Tablets package insert for complete prescribing information).

For Prevention of Vomiting in Dogs 4 months of Age and Older Caused by Emetogenic Medications or Chemotherapeutic Agents: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) of body weight one time, 45-60 minutes prior to use of emetogenic medications or chemotherapeutic agents.

For Treatment of Vomiting in Cats 4 Months of Age and Older: Administer CERENIA Injectable Solution intravenously over 1-2 minutes or subcutaneously at 1 mg/kg (0.45 mg/lb) equal to 0.1 mL/kg (0.1 mL/2.2 lb) of body weight once daily for up to 5 consecutive days.

The underlying cause of acute vomiting should be identified and addressed in dogs and cats that receive CERENIA Injectable Solution. If vomiting persists despite treatment, the case should be re-evaluated.

Not for use in humans. Keep out of reach of children. In case of accidental injection or exposure, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. In case of accidental skin exposure, wash with soap and water. CERENIA is also an ocular irritant. In case of accidental eye exposure, flush with water for 15 minutes and seek medical attention.

In puppies younger than 11 weeks of age, histological evidence of bone marrow hypocellularity was observed at higher frequency and greater severity in puppies treated with CERENIA compared to control puppies. In puppies 16 weeks and older, bone marrow hypocellularity was not observed ( see ANIMAL SAFETY ).

PRECAUTIONS

The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats with gastrointestinal obstruction or that have ingested toxins.

Use with caution in patients with hepatic dysfunction because CERENIA Injectable Solution is metabolized by CYP3A, CYP2D15(dogs) and CYP1A (cats) enzymes (see Pharmacokinetics ). The influence of concomitant drugs that may inhibit the metabolism of CERENIA Injectable Solution has not been evaluated. CERENIA Injectable Solution is highly protein bound. Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA Injectable Solution with other protein bound drugs has not been studied in dogs or cats. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. Drug compatibility should be monitored in patients requiring adjunctive therapy.

The safe use of CERENIA Injectable Solution has not been evaluated in dogs or cats used for breeding, or in pregnant or lactating bitches or queens.

Adverse Reactions

In a US field study for the prevention and treatment of vomiting associated with administration of cisplatin for cancer chemotherapy, the following adverse reactions were reported in 77 dogs treated with CERENIA Injectable Solution at 1 mg/kg subcutaneously or 41 dogs treated with placebo:

The following adverse reactions were reported during the course of a US field study for the prevention and treatment of acute vomiting in dogs treated with 1 mg/kg CERENIA Injectable Solution subcutaneously and/or CERENIA Tablets at a minimum of 2 mg/kg orally once daily for up to 5 consecutive days:

Other clinical signs were reported but were <0.5% of dogs.

Adverse reactions seen in a European field study included ataxia, lethargy and injection site soreness in one dog treated with CERENIA Injectable Solution.

Post-Approval Experience (Rev. 2015)

The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.

The following adverse events reported for dogs are listed in decreasing order of reporting frequency for CERENIA Injectable Solution: Pain/vocalization upon injection, depression/lethargy, anorexia, anaphylaxis/anaphylactoid reactions (including swelling ofthe head/face), ataxia, convulsions, hypersalivation, tremors, fever, dyspnea, collapse/loss of consciousness, recumbency, injection site reactions (swelling, inflammation) and sedation.

Cases of death (including euthanasia) have been reported.

The following adverse reactions were reported during the course of a US field study for the treatment of vomiting in cats treated with 1 mg/kg CERENIA Injectable Solution subcutaneously once daily for up to five consecutive days:

The clinician observed and graded each cat’s response to injection.

2 Cat objected to the injection by retreating and vocalizing

3 Cat objected to the injection by retreating, hissing, scratching,

Post-Approval Experience (Rev. 2015)

The following adverse events reported for cats are listed in decreasing order of reporting frequency for CERENIA Injectable Solution: Depression/lethargy, anorexia, hypersalivation, pain/vocalization upon injection, dyspnea, ataxia, fever, recumbency, vomiting, panting, convulsion, and muscle tremor.

Cases of death (including euthanasia) have been reported.

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

CLINICAL PHARMACOLOGY:

Pharmacodynamics:

Vomiting is a complex process coordinated centrally by the emetic center which consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid. Maropitant is a neurokinin 1 (NK1) receptor antagonist which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family. Substance P is found in significant concentrations in the nuclei comprising the emetic center and is considered the key neurotransmitter involved in emesis.1 By inhibiting the binding of substance P within the emetic center, maropitant provides broad-spectrum effectiveness against neural (central) and humoral (peripheral) causes of vomiting. In vivo model studies in dogs have shown that maropitant has antiemetic effectiveness against both central and peripheral emetogens including apomorphine, cisplatin, and syrup of ipecac.

Pharmacokinetics

CERENIA Injectable Solution is formulated using sulphobutyletherß-cyclodextrin (SBECD), which exhibits enhanced binding to maropitant at refrigerated temperatures. The enhanced binding affinity reverses rapidly upon warming.

The pharmacokinetic (PK) characterization associated with maropitant after a single oral (PO), intravenous (IV), or subcutaneous (SC) dose administration in adult Beagle dogs is provided in the table below.

a Harmonic mean

The absolute bioavailability of maropitant was much higher following SC injection (91% at 1 mg/kg) than after PO administration (24% at 2 mg/kg). Oral bioavailability may be underestimated due to the presence of nonlinear kinetics and the resulting longer T1/2 seen after intravenous (IV) administration. Although hepatic firstpass metabolism contributed to the relatively low bioavailability after an oral dose, prandial status does not significantly affect the extent of oral bioavailability. Greater than dose-proportional drug exposure can be expected with an increase in dose (1–16 mg/kg PO). Systemic clearance of maropitant following IV administration was 1499.13 mL/hr/kg at a dose of 1 mg/kg. An accumulation ratio of 1.5 was observed following once-daily use of maropitant for five consecutive days at 1 (SC) or 2 mg/kg (PO). Urinary recovery of maropitant and its major metabolitewas minimal (<1% each). The hepatic metabolism of maropitant involves two cytochrome P-450 isoenzymes: CYP2D15 and CYP3A12. Based on in vitro enzyme kinetics data, it is believed that the non-linear kinetics may be partially associated with saturation of the low capacity enzyme (CYP2D15). However as doses increase (20–50 mg/kg PO), dose proportionality is re-established. Based upon in vitro enzyme kinetics, involvement of a high capacity enzyme (CYP3A12) may contribute to this return to dose linearity. Plasma protein binding of maropitant was high (99.5%).

Based on differences in plasma trough concentrations from a single study, the exposure of 10 week old puppies to maropitant may be lower than that observed in adult dogs, particularly after doses of 1 or 2 mg/kg.

The pharmacokinetic characterization associated with maropitant after a single subcutaneous (SC) or intravenous (IV) dose administration in cats is provided in the table below.

Pharmacokinetic Parameters for a Single Dose in 6-7 Month Old Cats (Mean±SD or Mean and Range)

There appears to be an age-related effect on the pharmacokinetics of maropitant in cats; kittens (4 months) have a higher clearance than adults. In multiple IV and SC studies, the mean maropitant half-life in kittens (4-7 months old) is 7.83 hours, compared to 17.2 hours in adults. The mean bioavailability of maropitant after subcutaneous administration in cats was 91.3%. The mean total body clearance (CL) and volume of distribution at steady-state (Vss) determined after IV administration of 1.0 mg/kg to 6 cats was 510 (388 to 603) mL/hr/kg and 2.3 (1.4 to 3.6) L/kg, respectively. Maropitant displays linear kinetics when administered SC within the 0.25–3 mg/kg dose range. Following SC administration of once daily doses of 1 mg/kg body weight for 5 consecutive days, accumulation was 250%. Maropitant undergoes cytochrome P450 (CYP) metabolism in the liver. CYP1A and CYP3A-related enzymes were identified as the feline isoforms involved in the hepatic biotransformation of maropitant. Renal and fecal clearances are minor routes of elimination for maropitant, with less than 1% of a 1 mg/kg SC dose appearing in the urine or feces as maropitant. For the major metabolite, 10.4% of the maropitant dose was recovered in urine and 9.3% in feces. Plasma protein binding of maropitant in cats was estimated to be 99.1%.

EFFECTIVENESS

In laboratory model studies, CERENIA Injectable Solution administered at 1 mg/kg in Beagle dogs reduced the number of emetic events associated with established neural (central) and humoral (peripheral) stimuli. Following administration of apomorphine (central emetic stimuli), vomiting was observed in 16.7% (2 of 12) of dogs treated with CERENIA Injectable Solution and 83.3% (10 of 12) of placebo-treated dogs. Following administration of syrup of ipecac (peripheral emetic stimuli) vomiting was observed in 25% (3 of 12) of dogs treated with CERENIA Injectable Solution and in 100% (12 of 12) of dogs treated with placebo.

In a study of veterinary cancer patients, dogs were treated with CERENIA Injectable Solution or placebo either 1 hour prior to cisplatin (prevention) or after the first vomiting episode following cisplatin (treatment) and monitored for 5 hours. In the groups evaluated for prevention of vomiting, 94.9% (37/39) of the dogs administered CERENIA Injectable Solution and 4.9% (2/41) of the dogs administered placebo did not vomit. In the groups evaluated for treatment, 21% (8/38) of the dogs administered CERENIA Injectable Solution and 5.1% (2/39) of the dogs administered placebo had no further episodes of vomiting following treatment.

In a study of 275 canine patients presented to veterinary hospitals with a history of acute vomiting, dogs were initially administered CERENIA Injectable Solution or placebo on Day 0. Following the initial dose, dogs allocated to the CERENIA group were treated with either CERENIA Tablets at a minimum of 2 mg/kg orally or Injectable Solution at 1 mg/kg subcutaneously once daily at the discretion of the clinician. Dogs allocated to the placebo group were treated using either an injectable placebo solution or placebo tablets once daily at the discretion of the clinician. Of the 199 dogs included in the analysis for effectiveness, 27 of 54 dogs (50%) in the placebo group displayed vomiting at some time during the study and 31 of 145 dogs (21.4%) in the CERENIA-treated group displayed vomiting during the study period.

In US field studies in veterinary patients, CERENIA Injectable Solution and Tablets were well tolerated in dogs presenting with various clinical conditions including parvovirus, gastroenteritis, and renal disease. There were no notable differences in mean laboratory values between CERENIA-treated and placebo-treated patients.

CERENIA Injectable Solution was used safely in dogs receiving other frequently used veterinary products such as fluid and electrolyte replacement solutions, antimicrobial agents, vaccines, antacids, and antiparasitic agents.

In a laboratory study, thirty-one dogs were subcutaneously administered CERENIA Injectable Solution or saline, at 1 mL/10 kg body weight, 45 minutes prior to administration of an opioid analgesic. Following administration of the opioid analgesic, none of the CERENIA Injectable Solution treated dogs vomited and 93.8% (15/16) of placebo-treated dogs vomited.

The effectiveness of CERENIA administered at 1 mg/kg IV was demonstrated by bridging the results of a PK study to clinical data supporting effectiveness of 1 mg/kg administered SC. The IV and SC administration of a single dose of 1 mg/kg maropitant are equivalent, based on the bioequivalence of the IV and SC AUClast and justification for the therapeutic equivalence of the IV and SC Cmax.

In a field study, 195 cats were presented to veterinary hospitals with a history of vomiting associated with various clinical conditions including gastroenteritis, gastritis, pancreatitis, inflammatory bowel disease, neoplasia, and hepatic lipidosis. Cats were treated with CERENIA Injectable Solution or placebo (in a ratio of 2:1) and observed in the veterinary hospital for 24 hours for the presence of an emetic event(s) defined as the observation of the act of vomiting or the presence of vomitus. Cats could continue antiemetic treatment every 24 hours for up to 5 consecutive days at the discretion of the clinician. Of 165 cats included in the analysis for effectiveness, 2 CERENIA-treated cats (1.8%) vomited 1 time each and 10 placebo-treated cats (18.5%) vomited a total of 15 times in the first 24 hours post treatment.

Percent of Cats Vomiting for Each Study Day by Treatment

The effectiveness of CERENIA administered at 1 mg/kg IV was demonstrated by bridging the results of a PK study to clinical data supporting effectiveness of 1 mg/kg administered SC. The IV and SC administration of a single dose of 1 mg/kg maropitant are equivalent, based on the bioequivalence of the IV and SC AUC last and justification for the therapeutic equivalence of the IV and SC Cmax

ANIMAL SAFETY

Laboratory and field studies have demonstrated that CERENIA Injectable Solution is well tolerated in dogs after subcutaneous administration.

Fifty six Beagle dogs (28 males and 28 females) approximately 16 weeks of age were administered CERENIA Injectable Solution subcutaneously once daily for 15 days at 0, 1, 3, and 5 mg/kg. There were 8 dogs (4 males and 4 females) in the 1 mg/kg group and 16 dogs (8 males and 8 females) in all other groups. The primary treatment-related findings were injection site reactions. Swelling, thickened skin, or pain at one or more of the injection sites on one or more days of the study were observed in 6 of 16 animals treated with 3 mg/kg/day and 5 of 16 animals treated with 5 mg/kg/day. Additionally, the activated partial thromboplastin time (APTT) was prolonged (67.5 seconds, reference range 9-15 seconds) in one male dog in the 1 mg/kg group on study day 15. Relationship of the prolonged APTT to drug administration could not be determined.

Beagle dogs approximately 8 weeks of age were administered CERENIA Injectable Solution subcutaneously once daily for 15 days at 0, 1, 3, and 5 mg/kg using a protocol similar to the previous study. A dose dependent increase in frequency and severity of bone marrow hypoplasia was observed histologically. One placebo-treated dog died on day 14 of the study and was diagnosed with suppurative pancreatitis and esophagitis. Interpretation of the study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, and many of the dogs in the study tested positive for coccidia.

Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA Tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA Injectable Solution at 1 mg/kg SC for 5 days, or CERENIA Tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimatization period. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the reference range for reticulocyte counts. Decreases in reticulocyte counts were also seen in 4 (of 8) placebo treated dogs (SC saline for 5 days). Hypocellular femoral bone marrow described as "minimal" was seen in 1 male that received 1 mg/kg maropitant SC for 5 days; reticulocyte counts were not available for this dog.

Twenty four Beagle dogs approximately 16 weeks of age were administered CERENIA Injectable Solution intravenously once daily for 5 days at 0, 1, and 3 mg/kg (4 females and 4 males per group). CERENIA Injectable Solution was administered at room temperature over 1-2 minutes. Reaction to injection was not specifically recorded. One male dog in the 1 mg/kg group had low hematocrit and white blood cell count on study day 5. One female dog in the 3 mg/kg group had an increased fibrinogen on study day 5. There were no other clinically relevant findings during the study, at necropsy or in histopathology.

Thirty-two domestic short hair cats (16 males and 16 females) approximately 16 weeks of age were administered CERENIA Injectable Solution subcutaneously once daily for 15 days at 0, 1, 3, and 5 mg/kg. There were 8 cats (4 males and 4 females) in each group. Treatment-related, dose dependent findings included pain associated with injection of CERENIA and injection site heat, pain, redness, and firmness. Pain on injection was observed in 5% of cats at 0 mg/kg, 50% of cats at 1 mg/kg, and 75% of cats at 3 and 5 mg/kg. Injection site firmness >10 mm in diameter was observed at one or more of the injection sites, on one or more days of the study, in 1 of 8 cats at 1 mg/kg, 7 of 8 cats at 3 mg/kg, and 7 of 8 cats at 5 mg/kg. There was a statistically significant reduction (p=0.0171) in food intake at 5 mg/kg compared to cats at 0 mg/kg. One cat at 5 mg/kg was lethargic on Days 12, 13, and 14 of the study. Increased skin turgor was observed in 1 cat at 3 mg/kg on Days 10 and 11, 1 cat at 3 mg/kg on Day 12, and 1 cat at 5 mg/kg on Day 12. At gross necropsy, there were no treatment-related findings. Histopathologic evaluation of injection sites revealed a dose dependent inflammatory response.

Twenty-four healthy domestic shorthair cats (12 males and 12 females) approximately 16 weeks of age were administered maropitant at 1 or 3 mg/kg, or saline at 0.1 mL/kg intravenously once daily for 5 days. CERENIA Injectable Solution was administered at room temperature over 1-2 minutes. Reaction to injection was not specifically recorded, but one cat experienced discomfort with accidental extravascular administration. There were no clinically relevant findings during the study, at necropsy or in histopathology.

STORAGE CONDITIONS

CERENIA Injectable Solution should be stored at controlled room temperature 20-25°C (68-77°F) with excursions between 15-30°C (59-86°F). After first vial puncture, CERENIA Injectable Solution should be stored at refrigerated temperature 2-8°C (36-46°F). Use within 90 days of first vial puncture. Stopper may be punctured a maximum of 25 times.

HOW SUPPLIED

CERENIA Injectable Solution is supplied in 20 mL amber glass vials. Each mL contains 10 mg of maropitant as maropitant citrate.

NADA #141-263, Approved by FDA

1. Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. [Review] [60 refs]. Drugs. 2000;60:533-46.

NADA #141-263, Approved by FDA

Kalamazoo, MI 49007

Revised: October 2015 Made in France

PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton Made in France

10 mg of maropitant/mL

For subcutaneous injection in

CAUTION: Federal (USA) law

restricts this drug to use by or

on the order of a licensed

NET CONTENTS: 20 mL

NADA #141-263, Approved by FDA

PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton Made in Brazil

Cerenia

Generic Name: maropitant citrate

Dosage Form: FOR ANIMAL USE ONLY

For oral use in dogs only

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Cerenia Description

Maropitant is a neurokinin (NK 1 ) receptor antagonist that blocks the pharmacological action of substance P in the central nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is C 32 H 40 N 2 O C 6 H 8 O 7 H 2 O and the molecular weight 678.81. The chemical name is (2 S ,3 S )-2-benzhydryl- N -(5- tert -butyl-2-methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Each peach-colored oval tablet is scored and contains 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet.

The chemical structure of maropitant citrate is:

INDICATIONS

Cerenia (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.

Cerenia Dosage and Administration

Cerenia Tablets are recommended for use in dogs 16 weeks and older.

For Prevention of Acute Vomiting

Administer Cerenia Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days.

Cerenia Tablets may be used interchangeably with Cerenia Injectable Solution for once daily dosing for the prevention of acute vomiting.

For Prevention of Vomiting Due to Motion Sickness

Administer Cerenia Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days. Dogs should be fasted 1 hour prior to administration of Cerenia Tablets. Administer Cerenia Tablets 2 hours prior to travel.

Not for use in humans. Keep out of the reach of children. In case of accidental ingestion, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. Wash hands with soap and water after administering drug. Cerenia is also an ocular irritant. In case of accidental eye exposure, flush with water for 15 minutes and seek medical attention.

In puppies younger than 11 weeks of age, histological evidence of bone marrow hypoplasia was seen at higher frequency and greater severity in puppies treated with Cerenia than in control puppies. In puppies 16 weeks and older, bone marrow hypoplasia was not seen (See Animal Safety Section).

Precautions

The safe use of Cerenia Tablets has not been evaluated in dogs used for breeding, pregnant or lactating bitches, dogs with gastrointestinal obstruction, or dogs that have ingested toxins. Use with caution in dogs with hepatic dysfunction. Use with caution with other medications that are highly protein bound. The concomitant use of Cerenia with other protein bound drugs has not been studied in dogs. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Cerenia has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

Adverse Reactions

Prevention of Acute Vomiting (minimum of 2 mg/kg)

The following adverse reactions were reported during the course of a US field study for the prevention of acute vomiting in dogs treated with Cerenia Tablets at a minimum of 2 mg/kg orally and/or Injectable Solution at 1.0 mg/kg subcutaneously once daily for up to 5 consecutive days:

Other clinical signs were reported but were <0.5% of dogs.

Prevention of Vomiting Due to Motion Sickness (minimum of 8 mg/kg)

The following adverse reactions were reported during US studies for the prevention of vomiting due to motion sickness in dogs treated with Cerenia Tablets at a minimum of 8 mg/kg orally one time. Dogs may have experienced more than one of the observed adverse reactions.

The following adverse reactions were reported during a European field study for the prevention of vomiting due to motion sickness in dogs treated with Cerenia Tablets at a minimum of 8 mg/kg orally once daily for 2 consecutive days. Dogs may have experienced more than one of the observed adverse reactions.

For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call Pfizer Animal Health at 1-800-366-5288.

Cerenia - Clinical Pharmacology

Pharmacokinetics

The pharmacokinetic characterization associated with maropitant after oral (PO) or subcutaneous (SC) administration in adult Beagle dogs is provided in the table below.

The absolute bioavailability of maropitant was much higher following SC injection (91% at 1 mg/kg) than after PO administration (24% at 2 mg/kg). Oral bioavailability may be underestimated due to the presence of nonlinear kinetics and the resulting longer T ½ seen after intravenous (IV) administration. Although hepatic first-pass metabolism contributed to the relatively low bioavailability after an oral dose, prandial status does not significantly affect the extent of oral bioavailability. Greater than dose-proportional drug exposure can be expected with an increase in dose (1-16 mg/kg PO). Systemic clearance of maropitant following IV administration was 970, 995, and 533 mL/hr/kg at doses of 1, 2 and 8 mg/kg, respectively. An accumulation ratio of 1.5 was observed following once-daily use of maropitant for five consecutive days at 1 mg/kg (SC) or 2 mg/kg (PO). Urinary recovery of maropitant and its major metabolite was minimal (<1% each). The hepatic metabolism of maropitant involves two cytochrome P-450 isoenzymes: CYP2D15 and CYP3A12. Based on in vitro enzyme kinetics data, it is believed that the non-linear kinetics may be partially associated with saturation of the low capacity enzyme (CYP2D15). However as doses increase (20-50 mg/kg PO), dose proportionality is re-established. Based upon in vitro enzyme kinetics, involvement of a high capacity enzyme (CYP3A12) may contribute to this return to dose linearity. Plasma protein binding of maropitant was high (99.5%).

Pharmacodynamics

Vomiting is a complex process coordinated centrally by the emetic center which consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid. Maropitant is a neurokinin 1 (NK 1 ) receptor antagonist which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family. Substance P is found in significant concentrations in the nuclei comprising the emetic center and is considered the key neurotransmitter involved in emesis.1 By inhibiting the binding of substance P within the emetic center, maropitant provides broad-spectrum effectiveness against neural (central) and humoral (peripheral) causes of vomiting. In vivo model studies in dogs have shown that maropitant has antiemetic effectiveness against both central and peripheral emetogens including apomorphine, and syrup of ipecac.

1 Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. [Review] [60 refs]. Drugs. 2000;60:533-46.

EFFECTIVENESS

Prevention of Acute Vomiting

In laboratory model studies, Cerenia Tablets dosed at a minimum of 2 mg/kg BW reduced the number of emetic events associated with established neural (central) and humoral (peripheral) stimuli. Following administration of apomorphine (central emetic stimuli), vomiting was observed in 33% (4 of 12) of Beagle dogs treated with Cerenia Tablets and 100% (12 of 12) of Beagle dogs treated with placebo tablets. Following administration of syrup of ipecac (peripheral emetic stimuli) vomiting was observed in 33% (4 of 12) of Beagle dogs treated with Cerenia Tablets and in 83% (10 of 12) of Beagle dogs treated with placebo tablets.

In a study of 275 canine patients presented to veterinary hospitals with a history of acute vomiting, dogs were initially administered Cerenia Injectable Solution or placebo on Day 0. Following the initial dose, dogs allocated to the Cerenia group were treated with either Cerenia Tablets at a minimum of 2 mg/kg orally or Injectable Solution at 1 mg/kg subcutaneously once daily at the discretion of the clinician. Dogs allocated to the placebo group were treated using either an injectable placebo solution or placebo tablets once daily at the discretion of the clinician. Of the 199 dogs included in the analysis for effectiveness, 27 of 54 dogs (50%) in the placebo group displayed vomiting at some time during the study and 31 of 145 dogs (21.4%) in the treated group displayed vomiting during the study period.

Prevention of Vomiting due to Motion Sickness

In a study of canine veterinary patients taken on a one-hour car journey and treated with either Cerenia Tablets at a minimum dose of 8 mg/kg BW or placebo tablets 2 hours prior to the journey, 67 of 122 (55%) of dogs vomited during the journey when treated with placebo while 8 of 122 (7%) vomited during the journey after treatment with Cerenia Tablets. The probability that a dog in this study, prone to motion sickness would NOT vomit during a journey if treated with Cerenia Tablets was 93%, while the probability was 48% if treated with placebo.

ANIMAL SAFETY

Laboratory and field studies have demonstrated that Cerenia Tablets are well tolerated in dogs after oral administration.

Target Animal Safety Study for Acute Vomiting

Fifty six Beagle dogs (28 males and 28 females) approximately 16 weeks of age were administered Cerenia Tablets orally once daily for 15 days at 0, 2, 6, and 10 mg/kg. There were 8 dogs (4 males and 4 females) in the 2 mg/kg group and 16 dogs (8 males and 8 females) in all other groups. Cerenia Tablets caused decreases in food consumption and body weight that were not dose-dependent and did not persist after cessation of treatment.

Beagle dogs approximately 8 weeks of age were administered Cerenia Tablets orally once daily for 15 days at 0, 2, 6, and 10 mg/kg using a protocol similar to the previous study. A dose dependent increase in severity of bone marrow hypoplasia was observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, many of the dogs in the study tested positive for coccidia and some tested positive for canine parvovirus.

Target Animal Safety Study for Motion Sickness

Forty Beagle dogs (20 males and 20 females) between 16 – 18 weeks of age were administered Cerenia Tablets orally once daily for 6 days at 0, 8 and 24 mg/kg. There were 16 dogs (8 males and 8 females) in the 0 and 24 mg/kg groups and 8 dogs (4 males and 4 females) in the 8 mg/kg group. At 24 mg/kg, Cerenia Tablets caused decreases in food consumption, with decreases in body weight, liver and testis weight; and an increase in RBC count indicating hemoconcentration, but the effects on feed consumption, body weight, and RBCs did not persist in the post-treatment recovery period (beyond Day 5).

Beagle dogs approximately 8 weeks of age were administered Cerenia Tablets orally once daily for 6 days at 0, 8, and 24 mg/kg using a protocol similar to the previous study. One dog in the 24 mg/kg/day group died of unknown causes on study day 2 and a dose dependent increase in occurrence and severity of bone marrow hypoplasia and lymphoid depletion was observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, and many of the dogs in the study tested positive for coccidia. Additionally, some dogs in the study tested positive for canine parvovirus, however, clinical parvoviral disease was not definitively diagnosed.

Tolerance Study

Twenty four Beagle dogs (14 males and 10 females) between 11 and 25 weeks of age were administered Cerenia Tablets in 2 phases with 8 dogs per group. In the first phase the dogs were administered 0, 20 or 30 mg/kg orally once daily for 7 days and in the second phase 0, 40, or 50 mg/kg once daily for 7 days. Cerenia Tablets administered at 20 and 30 mg/kg caused occasional vomiting. Cerenia Tablets administered at 40 mg/kg and 50 mg/kg caused clinically relevant signs of weight loss, vomiting, soft stools, weakness, lethargy, salivation and hypokalemia. Additionally, leukopenia characterized by a neutropenia and a trend toward decreasing plasma phosphorus values was seen. Decreased heart rate and prolonged corrected QT intervals were seen in all treatment groups in a dose dependent manner.

In US field studies in veterinary patients, Cerenia Tablets and Injectable Solution were well tolerated in dogs presenting with various conditions including parvovirus, gastroenteritis, and renal disease. There were no notable differences in mean laboratory values between Cerenia-treated and placebo-treated patients.

Cerenia Tablets were used safely in dogs receiving other frequently used veterinary products such as fluid and electrolyte replacement solutions, antimicrobial agents, vaccines, antacids, and antiparasitic agents.

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Cerenia (maropitant citrate) – Indlægsseddel - QA04AD90

Updated on site: 09-Feb-2018

Indhold af artikel

Cerenia tabletter til hunde

1. NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA

Indehaver af markedsføringstilladelsen: Zoetis Belgium SA

Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIEN

Fremstiller ansvarlig for batchfrigivelse: FAREVA AMBOISE

29 route des Industries

37530 Pocé-sur-Cisse FRANKRIG

2. VETERINÆRLÆGEMIDLETS NAVN

Cerenia 16 mg tabletter til hunde

Cerenia 24 mg tabletter til hunde

Cerenia 60 mg tabletter til hunde

Cerenia 160 mg tabletter til hunde

3. ANGIVELSE AF DET AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER

Hver tablet indeholder 16 mg, 24 mg, 60 mg eller 160 mg maropitant som maropitant citrat monohydrat.

Tabletterne indeholder også Sunset Yellow (E110) som farvestof.

Tabletterne er svagt orange og har delekærv som gør, at tabletten kan deles i to halvdele. Hver tablet er mærket med bogstaverne ”MPT” og tal, der angiver mængden af maropitant på den ene side og glat på den anden side.

4. INDIKATIONER

• Til forebyggelse af kvalme forårsaget af kemoterapi.

• Til forebyggelse af opkastning forårsaget af transportsyge.

• Til forebyggelse og behandling af opkastning i forbindelse med behandling med Cerenia- injektionsvæske, opløsning og i kombination med anden støttebehandling.

5. KONTRAINDIKATIONER

6. BIVIRKNINGER

Hvis hunden får Cerenia på en fuldstændig tom mave, kan det fremkalde opkastning hos hunden. Hvis hunden får et let måltid eller en godbid inden dosering har det vist sig at hjælpe til at begrænse denne virkning.

Faste før dosering bør undgås.

Cerenia er ikke et beroligende middel og nogle hunde, som lider af transportsyge, kan vise tegn på kvalme under rejsen i form af savlen og døsighed. Disse symptomer er forbigående og ophører, når transporten er slut.

Kontakt din dyrlæge, hvis du observerer bivirkninger. Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.

7. DYREARTER

8. DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ

Til oral anvendelse.

Til forebyggelse af kvalme forårsaget af kemoterapi og til behandling og forebyggelse af opkastning (undtagen transportsyge), kun til hunde, der er 8 uger eller ældre.

For at behandle eller forebygge opkastning, som ikke skyldes køre- eller søsyge, gives Cerenia tabletter en gang daglig med en dosis på 2 mg pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel. Tabletterne kan deles via delekærven på tabletten.

For at forebygge opkastning bør tabletterne gives mere end 1 time på forhånd. Virkningen varer ca. 24 timer, og derfor kan tabletterne gives aftenen før administrationen af et stof, der kan forårsage opkastning (f.eks. kemoterapi).

Cerenia kan bruges til at behandle eller forebygge opkastning, enten som tabletter eller som injektionsvæske, opløsning givet én gang dagligt. Cerenia injektionsvæske, opløsning kan gives i op til 5 dage og Cerenia tabletter i op til 14 dage.

Til forebyggelse af kvalme forårsaget af kemoterapi

Behandling og forebyggelse af opkastning (undtagen transportsyge)

Hundens vægt (kg)

* Til hunde under 3 kg kan præcis dosering ikke opnås.

Til forebyggelse af opkastning, forårsaget af køre- og søsyge, kun til hunde, der er 16 uger eller ældre.

For at forebygge opkastning forårsaget af køre- og søsyge gives Cerenia tabletter en gang daglig med en dosis på 8 mg maropitant pr. kg. legemsvægt med det antal tabletter, som er angivet i nedenstående tabel. Tabletter kan deles via delekærven på tabletten.

Tabletterne bør gives mindst én time før rejsens påbegyndelse. Den kvalmestillende effekt varer i mindst 12 timer, hvilket muliggør dosering aftenen før en tidlig afrejse. Behandling kan gentages i højst 2 på hinanden følgende dage.

Ved gentagen behandling kan lavere dosis end den anbefalede være tilstrækkeligt hos nogle hunde.

Forebyggelse af køre- og søsyge

Hundens vægt (kg)

9. OPLYSNINGER OM KORREKT ANVENDELSE

Tabletterne udtages fra blisterpakningen på følgende måde:

• Fold eller skær først langs den stiplede linie mellem hver tablet angivet ved saksesymbolet 

• Find afrivningsslippen eller skær som vist ved pilesymbolet

• Mens der holdes fast på den ene side ved snittet, trækkes den anden side mod midten af blisterpakningen til tabletten kan ses.

• Fjern tabletten fra pakningen og giv tabletten som anvist.

OBS: Man bør ikke forsøge at trykke tabletten gennem bagsiden af blister pakningen, da dette både vil beskadige tabletten og blisterpakningen.

Mod transportsyge anbefales at give et let måltid eller en godbid før dosering. Lang faste inden administrationen bør undgås.

Cerenia tabletter bør ikke gives ”indpakket” i foder, da dette kan forsinke opløsningen af tabletten og dermed tidspunktet for tablettens virkning.

Hunden bør observeres omhyggeligt efter indgiften for at sikre, at hver tablet er slugt.

10. TILBAGEHOLDELSESTID

11. EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING

Opbevares utilgængeligt for børn.

Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.

Halve tabletter bør højst opbevares i 2 dage efter de er trykket ud af blisterpakken. Ubrugte halve tabletter lægges tilbage i den åbnede blister og opbevares i æsken.

Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på blisterpakken efter EXP.

12. SÆRLIGE ADVARSLER

Særlige advarsler for hver dyreart :

Opkastninger kan skyldes alvorlige, stærkt svækkende lidelser og årsagen skal undersøges. Lægemidler som Cerenia bør bruges sammen med andre forholdsregler som kontrol med foderet og væsketerapi, som anbefalet af din dyrlæge. Maropitants sikkerhed ved behandling af målpopulationen (dvs. unge hunde der lider af viral enterititis) i mere end 5 dage er ikke undersøgt. Hvis det vurderes, at det er nødvendigt at behandle i mere en 5 dage, bør der iværksættes omhyggelig monitorering af potentielle bivirkninger.

Maropitant nedbrydes i leveren og skal derfor bruges med forsigtighed til patienter med leverlidelse. Da maropitant akkumuleres i kroppen under en 14-dages behandlingsperiode på grund af en metabolisk mætning, bør der ved langtidsbehandling iværksættes omhyggelig overvågning af leverfunktionen og bivirkninger.

Special forholdsregler til brug hos dyr:

Sikkerheden af det veterinærmedicinske lægemiddel er ikke undersøgt i hunde yngre end 16 uger for dosen 8 mg/kg (transportsyge), hos hunde yngre end 8 uger for dosen 2 mg/kg (opkastning) eller hos drægtige eller diegivende tæver. Den ansvarlige dyrlæge bør foretage en risikovurdering før brug af Cerenia til hunde under 8 respektive 16 uger eller til drægtige eller diegivende tæver.

Efter overdosering højere end 20 mg/kg er set spredte kliniske symptomer som opkastning efter første indgift, forøget spytsekretion og vandig afføring.

Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr :

Personer med kendt overfølsomhed over for maropitant bør administrere veterinærlægemidlet med forsigtighed.

Vask hænderne efter håndtering. I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges læge, og indlægssedlen eller etiketten bør vises til lægen.

13. EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT

Kontakt din dyrlæge eller apotekspersonalet vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for. Disse foranstaltninger skal bidrage til at beskytte miljøet.

14. DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN

Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).

15. ANDRE OPLYSNINGER

Cerenia tabletter findes i blisterpakninger med 4 tabletter i hver pakke.

Receptpligtig medicin oplistet. Producent: "Zoetis Belgium SA"

Du bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis du ønsker yderligere oplysninger om dette lægemiddel.

Zoetis Belgium SA

Oriola Vilnius UAB

Tél/Tel.: +32 (0) 800 99 189

Tel: +370 610 05088

Zoetis Belgium SA

Teл: +359 2 4775791

Tél/Tel.: +352 8002 4026

Zoetis Česká republika, s.r.o.

Zoetis Hungary Kft.

Tel: +420 257 101 111

Tel: +361 224 5222

Orion Pharma Animal Health

Tlf: +45 86 14 00 00

Tel: +356 21 465 797

Zoetis Deutschland GmbH

Tel: +49 30 330063 0

Tel: +31 (0)10 714 0900

Oriola Vilnius UAB

Orion Pharma Animal Health

Tel: +370 610 05088

Tlf: +47 40 00 41 90

Zoetis Hellas S.A.

Zoetis Österreich GmbH

Τηλ.: +30 210 6791900

Tel: + 43 1 2701100 110

Zoetis Spain, S.L.

Zoetis Polska Sp. z o.o.

Tel: +34 91 4191900

Tel: +48 22 2234800

Zoetis Portugal, Lda.

Tél: +33 (0)810 734 937

Tel: +351 21 042 72 00

Zoetis B.V., Podružnica Zagreb za promidžbu

Zoetis România SRL

Tel: +385 1 644 1460

Tel: +40 21 202 3083

Zoetis Belgium SA

Zoetis B.V., Podružnica Zagreb za promidžbu

Tel: +353 (0) 1 256 9800

Tel: +385 1 644 1460

Zoetis Česká republika, s.r.o.

Sími: +354 540 80 00

Tel: +420 257 101 111

Zoetis Italia S.r.l.

Zoetis Finland Oy

Tel: +39 06 3366 8133

Puh/Tel: +358 (0)9 4300 40

Zoetis Hellas S.A.

Orion Pharma Animal Health

Τηλ.: +30 210 6791900

Tel: +46 (0)8 623 64 40

Oriola Vilnius UAB

Zoetis UK Limited

Tel: +370 610 05088

Tel: +44 (0) 845 300 8034

Cerenia 10 mg/ml injektionsvæske, opløsning til hunde og katte

1. NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN SAMT PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA

Indehaver af markedsføringstilladelsen: Zoetis Belgium SA

Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIEN

Fremstiller ansvarlig for batchfrigivelse: FAREVA AMBOISE

29 route des Industries

37530 Pocé-sur-Cisse FRANKRIG

2. VETERINÆRLÆGEMIDLETS NAVN

Cerenia 10 mg/ml injektionsvæske, opløsning til hunde og katte

3. ANGIVELSE AF DET AKTIVE STOF OG ANDRE INDHOLDSSTOFFER

Injektionsvæsken indeholder 10 mg maropitant pr. ml som maropitant citrat monohydrat, som en klar, farveløs til svagt gul opløsning.

Den indeholder også metakresol som konserveringsmiddel.

• Til behandling og forebyggelse af kvalme forårsaget af kemoterapi.

• Til forebyggelse af opkastning, undtagen opkastning forårsaget af transportsyge.

• Til forebyggelse og behandling af opkastning i kombination med anden veterinær- og støttende terapi.

• Til forebyggelse af perioperativ kvalme og opkastning samt forbedring af rekonvalescens efter universel anæstesi efter anvendelse af µ-opiatreceptoragonisten morphin.

• Til forebyggelse af opkastning og reduktion af kvalme, undtagen opkastning forårsaget af transportsyge.

• Til behandling af opkastning i kombination med anden støttende terapi.

Smerte på injektionsstedet kan forekomme under subkutan injektion.

Det er meget almindeligt at der hos katte observeres moderat til alvorligt respons over for injektion (hos cirka en tredjedel af kattene).

I meget sjældne tilfælde kan anafylaktiske reaktioner (allergisk ødem, urticaria, erytem, kollaps, dyspnø, blege slimhinder) forekomme.

Hyppigheden af bivirkninger er defineret som:

- Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling)

- Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr)

- Ikke almindelige (flere end 1, men færre end 10 dyr af 1.000 behandlede dyr)

- Sjældne (flere end 1, men færre end 10 dyr ud af 10.000 behandlede dyr)

- Meget sjælden (færre end 1 dyr ud af 10.000 behandlede dyr, herunder isolerede rapporter).

8. DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ

Til subkutan eller intravenøs injektion hos hunde og katte.

Cerenia injektionsvæske, opløsning skal injiceres subkutant eller intravenøst, en gang daglig med en dosis på 1 mg pr. kg legemsvægt (1 ml pr.10 kg legemsvægt). Behandlingen kan gentages i op til fem på hinanden følgende dage. Ved intravenøs anvendelse Cerenia bør gives som en enkelt bolus uden at blande produktet med andre væsker.

Hos hunde kan Cerenia bruges til at behandle eller forebygge opkastning en gang daglig i op til 5 dage.

9. OPLYSNINGER OM KORREKT ANVENDELSE

For at forebygge opkastning bør Cerenia gives mere end 1 time på forhånd. Varigheden af effekten er omkring 24 timer og derfor kan behandlingen gives aftenen før behandlingen med et brækningsfremkaldende middel, f.eks. kemoterapi.

På grund af den hyppige forekomst af forbigående smerte under subkutan injektion, skal dyret eventuelt fastholdes på en passende måde. Smerte ved injektion kan reduceres ved at produktet injiceres i kold tilstand.

11. EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING

Opbevares utilgængeligt for børn.

Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen. Opbevaringstid efter åbning af hætteglasset: 28 dage.

Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på hætteglassets etiket efter EXP.

12. SÆRLIGE ADVARSLER

Særlige advarsler for hver dyreart :

Maropitant nedbrydes i leveren og skal derfor bruges med forsigtighed til patienter med leverlidelse. Cerenia bør bruges med forsigtighed til dyr, der lider af, eller er prædisponerede for hjertelidelser

Brug af Cerenia-injektionsvæske, opløsning mod opkastning forårsaget af køresyge anbefales ikke.

Cerenias reducerende virkning på kvalme blev vist i studier, hvor der blev anvendt en model (kvalme forårsaget af xylazin).

Special forholdsregler til brug hos dyr:

Sikkerheden af Cerenia er ikke undersøgt i hunde yngre end 8 uger eller hos katte yngre end 16 uger og hos drægtige eller diegivende hunde og katte. Den ansvarlige dyrlæge bør foretage en risikovurdering før brug af Cerenia til hunde under 8 uger, hos katte mindre end 16 uger eller til drægtige eller diegivende katte og hunde.

Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr :

Personer med kendt overfølsomhed over for maropitant bør administrere veterinærlægemidlet med forsigtighed.

Vask hænderne efter håndtering. I tilfælde af selvindgivelse ved hændeligt uheld skal der straks søges læge, og indlægssedlen eller etiketten bør vises til lægen. Maropitant har vist sig at være et muligt øjenirriterende stof. I tilfælde af at stoffet ved et uheld kommer i øjet, skyl øjet med masser af vand og der søges læge.

Drægtighed og laktation:

Må kun bruges efter risikovurdering af den ansvarlige dyrlæge, da der for ingen dyrearters vedkommende er gennemført konklusive reproduktionstoksikologiske undersøgelser.

Interaktion med andre lægemidler og andre former for interaktion:

Cerenia bør ikke bruges samtidig med Ca-kanal antagonister, da maropitant har affinitet til Ca- kanaler.

Maropitant er stærkt bundet til plasmaproteiner og kan konkurrere med andre stærkt bundne stoffer.

Overdosis (symptomer, nødforanstaltninger, modgift):

Bortset fra forbigående reaktioner ved injektionsstedet under subkutan injektion, var Cerenia veltålt af hunde og unge katte, der fik daglige injektioner med Cerenia injektionsvæske, opløsning op til 5 mg/kg (5 gange den anbefalede dosis) i 15 på hinanden følgende dage (3 gange den anbefalede doseringsvarighed). Der er ikke blevet udarbejdet data for overdoseringer hos voksne katte.

Da der ikke er foretaget forligelighedsstudier, må dette veterinære lægemiddel ikke blandes med andre veterinære lægemidler i samme sprøjte.

13. EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE, OM NØDVENDIGT

Kontakt din dyrlæge eller apotekspersonalet vedrørende bortskaffelse af lægemidler, der ikke længere findes anvendelse for. Disse foranstaltninger skal bidrage til at beskytte miljøet.

14. DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN

Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu).

15. ANDRE OPLYSNINGER

Receptpligtig medicin oplistet:

Cerenia 10 mg/ml injektionsvæske, opløsning til hunde og katte findes i 20 ml ravfarvet hætteglas. Hver æske indeholder 1 hætteglas.

Du bedes kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen, hvis du ønsker yderligere oplysninger om dette lægemiddel.

Zoetis Belgium SA

Oriola Vilnius UAB

Tél/Tel.: +32 (0) 800 99 189

Tel: +370 610 05088

Zoetis Belgium SA

Teл: +359 2 4775791

Tél/Tel.: +352 8002 4026

Zoetis Česká republika, s.r.o.

Zoetis Hungary Kft.

Tel: +420 257 101 111

Tel: +361 224 5222

Orion Pharma Animal Health

Tlf: +45 86 14 00 00

Tel: +356 21 465 797

Zoetis Deutschland GmbH

Tel: +49 30 330063 0

Tel: +31 (0)10 714 0900

Oriola Vilnius UAB

Orion Pharma Animal Health

Tel: +370 610 05088

Tlf: +47 40 00 41 90

Zoetis Hellas S.A.

Zoetis Österreich GmbH

Τηλ.: +30 210 6791900

Tel: + 43 1 2701100 110

Zoetis Spain, S.L.

Zoetis Polska Sp. z o.o.

Tel: +34 91 4191900

Tel: +48 22 2234800

Zoetis Portugal, Lda.

Tél: +33 (0)810 734 937

Tel: +351 21 042 72 00

Zoetis B.V., Podružnica Zagreb za promidžbu

Zoetis România SRL

Tel: +385 1 644 1460

Tel: +40 21 202 3083

Zoetis Belgium SA

Zoetis B.V., Podružnica Zagreb za promidžbu

Tel: +353 (0) 1 256 9800

Tel: +385 1 644 1460

Zoetis Česká republika, s.r.o.

Sími: +354 540 80 00

Tel: +420 257 101 111

Zoetis Italia S.r.l.

Zoetis Finland Oy

Tel: +39 06 3366 8133

Puh/Tel: +358 (0)9 4300 40

Zoetis Hellas S.A.

Orion Pharma Animal Health

Τηλ.: +30 210 6791900

Tel: +46 (0)8 623 64 40

Oriola Vilnius UAB

Zoetis UK Limited

Tel: +370 610 05088

Tel: +44 (0) 845 300 8034

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Cerenia Tablets

The information provided typically includes the following:

Cerenia Tablets Indications
Warnings and cautions for Cerenia Tablets
Direction and dosage information for Cerenia Tablets

Cerenia Tablets

For oral use in dogs only

Cerenia Tablets Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Maropitant is a neurokinin (NK₁) receptor antagonist that blocks the pharmacological action of substance P in the central nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is C₃₂H₄₀N₂O C₆H₈O₇ H₂O and the molecular weight 678.81. The chemical name is (2S,3S)-2-benzhydryl-N-(5-tert-butyl-2-methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Each peach-colored oval tablet is scored and contains 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet.

The chemical structure of maropitant citrate is:

Cerenia Tablets Indications

CERENIA (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.

Dosage and Administration

For Prevention of Acute Vomiting

For Prevention of Acute Vomiting in dogs 2-7 months of age: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days (see WARNINGS and Animal Safety).

For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.

If vomiting persists despite treatment, the case should be re-evaluated. CERENIA is most effective in preventing acute vomiting associated with chemotherapy if administered prior to the chemotherapeutic agent.

For prevention of acute vomiting, dispense whole or half tablets in strength(s) that most closely result in a 2 mg/kg dose:

Dog body weight

Number of Tablets

Interchangeable use with CERENIA Injectable Solution for Prevention of Acute Vomiting:

In dogs that are actively vomiting, to ensure that the full initial dose is administered, CERENIA Injectable Solution is recommended at a dose of 1 mg/kg once daily. (See package insert for CERENIA injectable solution.) Thereafter, for the prevention of acute vomiting, CERENIA Tablets at a dose of 2 mg/kg once daily may be used interchangeably with CERENIA Injectable Solution for up to 5 days.

For Prevention of Vomiting Due to Motion Sickness in dogs 4 months and older

Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days (see WARNINGS and Animal Safety).

Administer CERENIA Tablets a minimum of two hours prior to travel with a small amount of food to mitigate vomiting associated with administration of the dose on an empty stomach; however, refrain from feeding a full meal prior to travel.

Prevention of Vomiting Due to Motion Sickness in Dogs 4 months of age and older:

Dispense whole or half tablets in strengths that most closely result in an 8 mg/kg dose once daily for up to 2 consecutive days:

Dog body weight

Number of Tablets

CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg).

Precautions

The safe use of CERENIA has not been evaluated in dogs with gastrointestinal obstruction, or dogs that have ingested toxins.

Use with caution in dogs with hepatic dysfunction because CERENIA is metabolized by CYP3A enzymes (see Pharmacokinetics). Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA with other protein bound drugs has not been studied in dogs. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit the metabolism of CERENIA has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

CERENIA causes dose related decreases in appetite and body weight (see ANIMAL SAFETY). To maximize therapeutic potential of CERENIA, the underlying cause of vomiting should be identified and addressed in dogs receiving CERENIA.

Adverse Reactions

Prevention of Acute Vomiting (minimum of 2 mg/kg)

The following adverse reactions were reported during the course of a US field study for the prevention of acute vomiting in dogs treated with CERENIA Tablets at a minimum of 2 mg/kg orally and/or Injectable Solution at 1 mg/kg subcutaneously once daily for up to 5 consecutive days:

Frequency of Adverse Reactions by Treatment

Death during study

Euthanized during study

Other clinical signs were reported but were <0.5% of dogs.

Prevention of Vomiting Due to Motion Sickness (minimum of 8 mg/kg)

The following adverse reactions were reported during US studies for the prevention of vomiting due to motion sickness in dogs treated with CERENIA Tablets at a minimum of 8 mg/kg orally one time. Dogs may have experienced more than one of the observed adverse reactions.

Frequency of Adverse Reactions by Treatment

1 Not associated with motion sickness

The following adverse reactions were reported during a European field study for the prevention of vomiting due to motion sickness in dogs treated with CERENIA Tablets at a minimum of 8 mg/kg orally once daily for 2 consecutive days. Dogs may have experienced more than one of the observed adverse reactions.

Frequency of Adverse Reactions by Treatment

The following Adverse Reactions were reported during the conduct of a US clinical field trial where CERENIA Tablets were administered once daily for 28 consecutive days to 32 dogs: lethargy, vomiting, inappetence, corneal edema, and enlarged lymph nodes.

The following adverse events are listed in decreasing order of reporting frequency in dogs: depression/lethargy, anorexia, hypersalivation, vomiting, diarrhea, ataxia, and trembling.

Cases of ineffectiveness have been reported.

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Clinical Pharmacology

Pharmacokinetics

Mean (±SD) Plasma Pharmacokinetic Parameters for Maropitant in Beagle Dogs after single dose and repeat oral doses of Maropitant:

2 mg/kg Single Dose

2 mg/kg repeat Doses 1

8 mg/kg Single Dose

8 mg/kg repeat Doses 1

1 Following once daily doses of maropitant for 14 days.

3 Ratio=Multiple Dose AUC_(0-24)/Single Dose AUC_(0-24), Least square means (95% Confidence Interval)

NA= Not Applicable

NC= Not Calculated

Following oral administration, median time to reach Cmax was within 2.5 hr. The absolute bioavailability of maropitant was low (24%) following oral administration of 2 mg/kg maropitant. After an oral dose, prandial status does not significantly affect the extent of oral bioavailability. Greater than dose-proportional drug exposure can be expected with an increase in dose (1-16 mg/kg PO). However as doses increase (20-50 mg/kg PO), the dose proportionality is re-established. Based upon in vitro enzyme kinetics, involvement of a high capacity enzyme (CYP3A12) may contribute to this return to dose linearity. Due to dose dependent pharmacokinetics, the maropitant concentrations reached steady state approximately after 4 and 8 days following 2 and 8 mg/kg, respectively. The observed drug accumulation ratios were 2.46 and 4.81, after oral administration of 2 and 8 mg/kg, respectively. The exposure of 10 week old puppies to maropitant was lower than that observed in adult dogs, particularly after repeat doses of 1 or 2 mg/kg. Systemic clearance of maropitant following IV administration was 970, 995, and 533 mL/hr/kg at doses of 1, 2 and 8 mg/kg, respectively.

Urinary recovery of maropitant and its major metabolite was minimal (<1% each). The hepatic metabolism of maropitant involves two cytochrome P-450 isoenzymes: CYP2D15 and CYP3A12. In in vitro enzyme kinetics data suggest that the non-linear kinetics may be partially associated with saturation of the low capacity enzyme (CYP2D15). Plasma protein binding of maropitant was high (99.5%).

Vomiting is a complex process coordinated centrally by the emetic center which consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid. Maropitant is a neurokininn 1 (NK₁) receptor antagonist which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family. Substance P is found in significant concentrations in the nuclei comprising the emetic center and is considered the key neurotransmitter involved in emesis. 1 By inhibiting the binding of substance P within the emetic center, maropitant provides broad-spectrum effectiveness against neural (central) and humoral (peripheral) causes of vomiting. In vivo model studies in dogs have shown that maropitant has antiemetic effectiveness against both central and peripheral emetogens including apomorphine, and syrup of ipecac.

1 Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. [Review] [60 refs]. Drugs. 2000;60:533-46.

Effectiveness

Prevention of Acute Vomiting

In laboratory model studies, CERENIA Tablets dosed at a minimum of 2 mg/kg BW reduced the number of emetic events associated with established neural (central) and humoral (peripheral) stimuli. Following administration of apomorphine (central emetic stimuli), vomiting was observed in 33% (4 of 12) of Beagle dogs treated with CERENIA Tablets and 100% (12 of 12) of Beagle dogs treated with placebo tablets. Following administration of syrup of ipecac (peripheral emetic stimuli) vomiting was observed in 33% (4 of 12) of Beagle dogs treated with CERENIA Tablets and in 83% (10 of 12) of Beagle dogs treated with placebo tablets.

In a study of 275 canine patients presented to veterinary hospitals with a history of acute vomiting, dogs were initially administered CERENIA Injectable Solution or placebo on Day 0. Following the initial dose, dogs allocated to the CERENIA group were treated with either CERENIA Tablets at a minimum of 2 mg/kg orally or Injectable Solution at 1 mg/kg subcutaneously once daily at the discretion of the clinician. Dogs allocated to the placebo group were treated using either an injectable placebo solution or placebo tablets once daily at the discretion of the clinician. Of the 199 dogs included in the analysis for effectiveness, 27 of 54 dogs (50%) in the placebo group displayed vomiting at some time during the study and 31 of 145 dogs (21.4%) in the treated group displayed vomiting during the study period.

Percent Of Vomiting For Each Study Day, Based Upon Treatment And Route Of Administration.

*2 dogs administered CERENIA were not observed on Day 0. Their vomiting status was unknown. 143 was used in the denominator for % vomited.

In US field studies in veterinary patients, CERENIA Tablets and Injectable Solution were well tolerated in dogs presenting with various conditions including parvovirus, gastroenteritis, and renal disease. There were no notable differences in mean laboratory values between CERENIA-treated and placebo-treated patients.

CERENIA Tablets were used safely in dogs receiving other frequently used veterinary products such as fluid and electrolyte replacement solutions, antimicrobial agents, vaccines, antacids, and antiparasitic agents.

Prevention of Vomiting due to Motion Sickness

In a study of canine veterinary patients taken on a one-hour car journey and treated with either CERENIA Tablets at a minimum dose of 8 mg/kg BW or placebo tablets 2 hours prior to the journey, 67 of 122 (55%) of dogs vomited during the journey when treated with placebo while 8 of 122 (7%) vomited during the journey after treatment with CERENIA Tablets. The probability that a dog in this study, prone to motion sickness would NOT vomit during a journey if treated with CERENIA Tablets was 93%, while the probability was 48% if treated with placebo.

ANIMAL SAFETY: Laboratory and field studies have demonstrated that CERENIA Tablets are well tolerated in dogs after oral administration.

Target Animal Safety Study for Acute Vomiting

Fifty six Beagle dogs (28 males and 28 females) approximately 16 weeks of age were administered CERENIA Tablets orally once daily for 15 days at 0, 2, 6, and 10 mg/kg. There were 8 dogs (4 males and 4 females) in the 2 mg/kg group and 16 dogs (8 males and 8 females) in all other groups. CERENIA Tablets caused decreases in food consumption and body weight that were not dose-dependent and did not persist after cessation of treatment.

Beagle dogs approximately 8 weeks of age were administered CERENIA Tablets orally once daily for 15 days at 0, 2, 6, and 10 mg/kg using a protocol similar to the previous study. A dose dependent increase in severity of bone marrow hypoplasia was observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, many of the dogs in the study tested positive for coccidia and some tested positive for canine parvovirus.

Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA Tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA Injectable Solution at 1 mg/kg SC for 5 days, or CERENIA Tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimation period. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the reference range for reticulocyte counts. Decreases in reticulocyte counts were also seen in 4 (of 8) placebo treated dogs (SC saline for 5 days). Hypocellular femoral bone marrow described as “minimal” was seen in 1 male that received 1 mg/kg maropitant SC for 5 days; reticulocyte counts were not available for this dog.

Twenty four Beagle dogs (12 males and 12 females) 7 months of age were administered maropitant at doses of 0, 1, 5, and 20 mg/kg orally once daily for 93 consecutive days. Maropitant produced sporadic clinical signs (salivation, emesis), body weight loss, and lower serum albumin levels at 20 mg/kg/day. Maropitant increased P-R interval, P wave duration, and QRS amplitude in the 20 mg/kg /day dose group. One female in the 20 mg/kg/day group had increased cellularity of the bone marrow. This female was noted to have lower mean red cell parameters (red blood cell count, hemoglobin, hematocrit) and higher platelet counts and reticulocytes.

Target Animal Safety Study for Motion Sickness

Forty Beagle dogs (20 males and 20 females) between 16 - 18 weeks of age were administered CERENIA Tablets orally once daily for 6 days at 0, 8 and 24 mg/kg. There were 16 dogs (8 males and 8 females) in the 0 and 24 mg/kg groups and 8 dogs (4 males and 4 females) in the 8 mg/kg group. At 24 mg/kg, CERENIA Tablets caused decreases in food consumption, with decreases in body weight, liver and testis weight; and an increase in RBC count indicating hemoconcentration, but the effects on feed consumption, body weight, and RBCs did not persist in the post-treatment recovery period (beyond Day 5).

Beagle dogs approximately 8 weeks of age were administered CERENIA Tablets orally once daily for 6 days at 0, 8, and 24 mg/kg using a protocol similar to the previous study. One dog in the 24 mg/kg/day group died of unknown causes on study day 2 and a dose dependent increase in occurrence and severity of bone marrow hypoplasia and lymphoid depletion was observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were weaned early, minimally acclimated to the test facility, and many of the dogs in the study tested positive for coccidia. Additionally, some dogs in the study tested positive for canine parvovirus, however, clinical parvoviral disease was not definitively diagnosed.

Twenty four Beagle dogs (14 males and 10 females) between 11 and 25 weeks of age were administered CERENIA Tablets in 2 phases with 8 dogs per group. In the first phase the dogs were administered 0, 20 or 30 mg/kg orally once daily for 7 days and in the second phase 0, 40, or 50 mg/kg once daily for 7 days. CERENIA Tablets administered at 20 and 30 mg/kg caused occasional vomiting. CERENIA Tablets administered at 40 mg/kg and 50 mg/kg caused clinically relevant signs of weight loss, vomiting, soft stools, weakness, lethargy, salivation and hypokalemia. Additionally, leukopenia characterized by a neutropenia and a trend toward decreasing plasma phosphorus values was seen. Decreased heart rate and prolonged corrected QT intervals were seen in all treatment groups in a dose dependent manner.

Twenty-four Beagle dogs (12 males and 12 females) approximately 28 weeks of age were administered maropitant (mesylate salt) orally once daily for 90 days at 0, 1, 5, and 20 mg/kg. End of study body weights in the 20 mg/kg group were 8-15% lower than baseline body weights.

STORAGE CONDITIONS: CERENIA Tablets should be stored at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F).

How Supplied

NADA #141-262, Approved by FDA

Manufactured by: Farvera, Amboise, France

Distributed by: Zoetis Inc., Kalamazoo, MI 49007

Revised: March 2016

333 PORTAGE STREET, KALAMAZOO, MI, 49007

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Cerenia ®

For oral use in dogs only

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Maropitant is a neurokinin (NK 1 ) receptor antagonist that blocks the pharmacological action of substance P in the central nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is C 32 H 40 N 2 O C 6 H 8 O 7 H 2 O and the molecular weight 678.81. The chemical name is (2 S ,3 S )-2-benzhydryl- N -(5- tert -butyl-2-methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Each peach-colored oval tablet is scored and contains 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet.

The chemical structure of maropitant citrate is:

INDICATIONS

CERENIA (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of vomiting due to motion sickness in dogs.

DOSAGE AND ADMINISTRATION:

For Prevention of Acute Vomiting

For Prevention of Acute Vomiting in dogs 2 -7 months of age: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days (see WARNINGS and Animal Safety).

For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer CERENIA Tablets orally at a minimum dose of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.

For prevention of acute vomiting, dispense whole or half tablets in strength(s) that most closely result in a 2 mg/kg dose:

Interchangeable use with CERENIA Injectable Solution for Prevention of Acute Vomiting:

In dogs that are actively vomiting, to ensure that the full initial dose is administered, CERENIA Injectable Solution is recommended at a dose of 1 mg/kg once daily. (See package insert for CERENIA injectable solution.) Thereafter, for the prevention of acute vomiting, CERENIA Tablets at a dose of 2 mg/kg once daily may be used interchangeably with CERENIA Injectable Solution for up to 5 days.

For Prevention of Vomiting Due to Motion Sickness

For Prevention of Vomiting Due to Motion Sickness in dogs 4 months and older

For Prevention of Vomiting due to motion sickness in dogs 4 months of age and older: Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days (see WARNINGS and Animal Safety).

Prevention of Vomiting Due to Motion Sickness in Dogs 4 months of age and older:

Dispense whole or half tablets in strengths that most closely result in an 8 mg/kg dose once daily for up to 2 consecutive days :

Dog body weight

Number of Tablets

CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion sickness (8mg/kg).

Not for use in humans. Keep out of the reach of children. In case of accidental ingestion, seek medical advice. Topical exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin sensitization. Wash hands with soap and water after administering drug. CERENIA is also an ocular irritant. In case of accidental eye exposure, flush with water for 15 minutes and seek medical attention.

PRECAUTIONS

PRECAUTIONS: The safe use of CERENIA Tablets has not been evaluated in dogs used for breeding, or in pregnant or lactating bitches.

The safe use of CERENIA has not been evaluated in dogs with gastrointestinal obstruction, or dogs that have ingested toxins.

Use with caution in dogs with hepatic dysfunction because CERENIA is metabolized by CYP3A enzymes (see Pharmacokinetics ). Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA with other protein bound drugs has not been studied in dogs. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral medications. The influence of concomitant drugs that may inhibit the metabolism of CERENIA has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.

CERENIA causes dose related decreases in appetite and body weight (see ANIMAL SAFETY ). To maximize therapeutic potential of CERENIA, the underlying cause of vomiting should be identified and addressed in dogs receiving CERENIA.

ADVERSE REACTIONS

Prevention of Acute Vomiting (minimum of 2 mg/kg)

Other clinical signs were reported but were <0.5% of dogs.

Prevention of Vomiting Due to Motion Sickness (minimum of 8 mg/kg)

Frequency of Adverse Reactions by Treatment

Post-Approval Experience

The following adverse events are listed in decreasing order of reporting frequency in dogs: depression/lethargy, anorexia, hypersalivation, vomiting, diarrhea, ataxia, and trembling.

Cases of ineffectiveness have been reported.

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Mean (±SD) Plasma Pharmacokinetic Parameters for Maropitant in Beagle Dogs after single dose and repeat oral doses of Maropitant:

2 mg/kg repeat Doses1

Accumulation Ratio (Rac)3

1 Following once daily doses of maropitant for 14 days.

3 Ratio=Multiple Dose AUC(0-24)/Single Dose AUC(0-24), Least square means (95% Confidence Interval)

NA= Not Applicable

NC= Not Calculated

Following oral administration, median time to reach Cmax was within 2.5 hr. The absolute bioavailability of maropitant was low (24%) following oral administration of 2 mg/kg maropitant. After an oral dose, prandial status does not significantly affect the extent of oral bioavailability. Greater than dose-proportional drug exposure can be expected with an increase in dose (1-16 mg/kg PO). However as doses increase (20-50 mg/kg PO), the dose proportionality is re-established. Based upon in vitro enzyme kinetics, involvement of a high capacity enzyme (CYP3A12) may contribute to this return to dose linearity. Due to dose dependent pharmacokinetics, the maropitant concentrations reached steady state approximately after 4 and 8 days following 2 and 8 mg/kg, respectively. The observed drug accumulation ratios were 2.46 and 4.81, after oral administration of 2 and 8 mg/kg, respectively. The exposure of 10 week old puppies to maropitant was lower than that observed in adult dogs, particularly after repeat doses of 1 or 2 mg/kg. Systemic clearance of maropitant following IV administration was 970, 995, and 533 mL/hr/kg at doses of 1, 2 and 8 mg/kg, respectively.

Urinary recovery of maropitant and its major metabolite was minimal (<1% each). The hepatic metabolism of maropitant involves two cytochrome P-450 isoenzymes: CYP2D15 and CYP3A12. In in vitro enzyme kinetics data suggest that the non-linear kinetics may be partially associated with saturation of the low capacity enzyme (CYP2D15). Plasma protein binding of maropitant was high (99.5%).

Pharmacodynamics

EFFECTIVENESS

Prevention of Acute Vomiting

In a study of 275 canine patients presented to veterinary hospitals with a history of acute vomiting, dogs were initially administered CERENIA Injectable Solution or placebo on Day 0. Following the initial dose, dogs allocated to the CERENIA group were treated with either CERENIA Tablets at a minimum of 2 mg/kg orally or Injectable Solution at 1 mg/kg subcutaneously once daily at the discretion of the clinician. Dogs allocated to the placebo group were treated using either an injectable placebo solution or placebo tablets once daily at the discretion of the clinician. Of the 199 dogs included in the analysis for effectiveness, 27 of 54 dogs (50%) in the placebo group displayed vomiting at some time during the study and 31 of 145 dogs (21.4%) in the treated group displayed vomiting during the study period.

*2 dogs administered CERENIA were not observed on Day 0. Their vomiting status was unknown. 143 was used in the denominator for % vomited.

Prevention of Vomiting due to Motion Sickness

ANIMAL SAFETY

Laboratory and field studies have demonstrated that CERENIA Tablets are well tolerated in dogs after oral administration.

Target Animal Safety Study for Acute Vomiting

Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA Tablets at 8 mg/kg for 2 days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA Injectable Solution at 1 mg/kg SC for 5 days, or CERENIA Tablets at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimation period. Two dogs that received 8 mg/kg maropitant orally for 2 days were below the reference range for reticulocyte counts. Decreases in reticulocyte counts were also seen in 4 (of 8) placebo treated dogs (SC saline for 5 days). Hypocellular femoral bone marrow described as "minimal" was seen in 1 male that received 1 mg/kg maropitant SC for 5 days; reticulocyte counts were not available for this dog.

Maropitant increased P-R interval, P wave duration, and QRS amplitude in the 20 mg/kg /day dose group.

One female in the 20 mg/kg/day group had increased cellularity of the bone marrow. This female was noted to have lower mean red cell parameters (red blood cell count, hemoglobin, hematocrit) and higher platelet counts and reticulocytes.

Target Animal Safety Study for Motion Sickness

Forty Beagle dogs (20 males and 20 females) between 16 – 18 weeks of age were administered CERENIA Tablets orally once daily for 6 days at 0, 8 and 24 mg/kg. There were 16 dogs (8 males and 8 females) in the 0 and 24 mg/kg groups and 8 dogs (4 males and 4 females) in the 8 mg/kg group. At 24 mg/kg, CERENIA Tablets caused decreases in food consumption, with decreases in body weight, liver and testis weight; and an increase in RBC count indicating hemoconcentration, but the effects on feed consumption, body weight, and RBCs did not persist in the post-treatment recovery period (beyond Day 5).

Tolerance Study

STORAGE CONDITIONS

CERENIA Tablets should be stored at controlled room temperature 20°–25°C (68°–77°F) with excursions between 15°–30°C (59°–86°F).

HOW SUPPLIED

CERENIA peach-colored tablets are scored with a break line, and contain 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet. Each tablet is marked with "MPT" and the tablet strength. Each tablet size is packaged in a bottle containing 60 tablets and packaged in blister packs containing 4 tablets per perforated sheet.

NADA #141-262, Approved by FDA

Kalamazoo MI 49007

Revised: March 2016

PRINCIPAL DISPLAY PANEL - 16 mg Tablet Bottle Label

For oral use in dogs only

NET CONTENTS: 60 tablets

NADA # 141-262, Approved by FDA

Kalamazoo, MI 49007

PRINCIPAL DISPLAY PANEL - 24 mg Tablet Bottle Label

For oral use in dogs only

NET CONTENTS: 60 tablets

Approved by FDA

Kalamazoo, MI 49007

PRINCIPAL DISPLAY PANEL - 60 mg Tablet Bottle Label

NET CONTENTS: 60 tablets

Approved by FDA

Kalamazoo, MI 49007

PRINCIPAL DISPLAY PANEL - 160 mg Tablet Bottle Label

For oral use in dogs only

NET CONTENTS: 60 tablets

Approved by FDA

Kalamazoo, MI 49007

PRINCIPAL DISPLAY PANEL - 16 mg Tablet Foil

(maropitant citrate) 7oetis

See package insert for complete product information. 16 mg

PRINCIPAL DISPLAY PANEL - 24 mg Tablet foil

(maropitant citrate) 7oetis

See package insert for complete product information. 24mg

PRINCIPAL DISPLAY PANEL - 60 mg Tablet foil

(maropitant citrate) 7oetis

See package insert for complete product information. 60 mg

PRINCIPAL DISPLAY PANEL - 160 mg Tablet Foil

(maropitant citrate) 7oetis

See package insert for complete product information. 160 mg