Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
MAROPITANT AS MAROPITANT CITRATE
ZOETIS AUSTRALIA PTY LTD
maropitant as citrate(60mg/Tb)
ORAL TABLET
MAROPITANT AS MAROPITANT CITRATE AMINO-ACID Active 60.0 mg/Tb
4 Tablets
VM - Veterinary Medicine
ZOETIS AUSTRALIA
DOG | PUPPY - OVER 8 WEEKS OLD | BITCH | CASTRATE | PUPPY
CENTRAL NERVOUS SYSTEM
PREVENT NAUSEA | TRAVEL SICKNESS | VOMITING
Poison schedule: 4; Withholding period: WHP: NIL; Host/pest details: DOG: [PREVENT NAUSEA, TRAVEL SICKNESS, VOMITING]; PUPPY - OVER 8 WEEKS OLD: [PREVENT NAUSEA, TRAVEL SICKNESS, VOMITING]; For the prevention of nauseas & acute vomiting in dogs & puppies (8+ weeks) and the prevention of vomiting due to motion sickness in dogs (16+ weeks).NOT TO BE USED in food producing species of animals. The safety of this product has NOT been established during pregnancy and lactation, and in puppies less than 8 weeks of age. Use with caution in animals suffering from a predisposition to heart disease
Registered
2023-07-01
Copy in the header and footer will not appear on the final printed label CERENIA Tabs 60 mg Label Prepared: 30/07/2013 Page 1 of 10 BLISTER FOIL MAIN PANEL _ _ RLP APPROVED Copy in the header and footer will not appear on the final printed label CERENIA Tabs 60 mg Label Prepared: 30/07/2013 Page 2 of 10 LEAFLET PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY CERENIA ® TABLETS FOR DOGS DESCRIPTION Tablets containing 16, 24, 60 or 160 mg of maropitant as maropitant citrate per tablet. Maropitant is a neurokinin (NK 1 ) receptor antagonist that blocks the pharmacological action of substance P in the CNS. INDICATIONS DOGS: For the prevention of nausea and acute vomiting in dogs and puppies 8 weeks of age or older and the prevention of vomiting due to motion sickness in dogs 16 weeks of age or older. PHARMACOLOGY Pharmacokinetics The pharmacokinetic characterisation associated with maropitant after oral (PO) or subcutaneous (SC) administration in adult beagle dogs is provided in the table below. PHARMACOKINETIC PARAMETERS IN BEAGLE DOGS (MEAN ± SD OR RANGE) SC at 1 mg/kg (n=6) PO at 2 mg/kg (n=8) PO at 8 mg/kg (n=8) AUC 0-inf (hr*ng/mL) 860±137 561±322 7840±5600 C max (ng/mL) 92±34 81±32 776±604 T 1/2 (hr) 8.84 (6.07-17.7) 4.03 (2.48-7.09) 5.46 (3.39-7.65) T max (hr) 0.75±1.11 1.9±0.5 1.7±0.7 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 1/2 seen after 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. Systemic clearance of maropitant following intravenous (IV) administration was 970, 995 and 533 mL/hr/kg at doses of 1, 2 Read the complete document
PRODUCT NAME: CERENIA® TABLETS FOR DOGS PAGE: 1 OF 7 THIS VERSION ISSUED: 19 NOVEMBER, 2015 SAFETY DATA SHEET Issued by: Zoetis Australia Pty Ltd Phone: 1800 814 883 POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA SECTION 1 - IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND SUPPLIER ZOETIS AUSTRALIA PTY LTD ABN 94 156 476 425 Level 6, 5 Rider Blvd Rhodes NSW 2138 AUSTRALIA Tel: 1800 814 883 Fax: (02) 8876 0444 Email: australia.animalhealth@zoetis.com PRODUCT IDENTIFIER: CERENIA® TABLETS FOR DOGS APVMA APPROVAL NUMBERS: 62421, 62422, 62422, 62424. OTHER NAMES: This product is sold in several sizes, suited to different varieties and sizes of dogs. OTHER NAMES: None. CHEMICAL FAMILY: Maropitant, is a neurokinin (NK 1 ) receptor antagonist. RECOMMENDED USE: For the prevention of nausea and acute vomiting in dogs and puppies 8 weeks of age or older and the prevention of vomiting due to motion sickness in dogs 16 weeks of age or older. RESTRICTIONS ON USE For veterinary use only. EMERGENCY PHONE: 1800 814 883 (ALL HOURS) SECTION 2 - HAZARDS IDENTIFICATION STATEMENT OF HAZARDOUS NATURE This product is classified as: Xn, Harmful. Xi, Irritating. N, Dangerous to the environment. Hazardous according to the criteria of SWA. Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code. RISK PHRASES: R36, R43, R51, R48/22. Irritating to eyes. May cause sensitisation by skin contact. Toxic to aquatic organisms. Harmful: danger of serious damage to health by prolonged exposure if swallowed. SAFETY PHRASES: S22, S28, S36, S60, S24/25. Do not breathe dust. After contact with skin, wash immediately with plenty of soap and water. Wear suitable protective clothing. This material and its container must be disposed of as hazardous waste. Avoid contact with skin and eyes. ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the ADG Code. GHS CLASSIFICATION: HAZARDOUS. GHS LABEL ELEMENTS: SIGNAL WORD: WARNING PRECAUTIONARY STATEMENTS H317: May cause an allergic skin reaction. H320: Causes eye irritat Read the complete document