Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Atipamezole Hydrochloride
Eurovet Animal Health B.V.
QV03AB90
Atipamezole Hydrochloride
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Neurological Agent
Authorized
2008-03-04
Revised: June 2013 AN. 00690/2012 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Atipam, 5.0 mg/ml, solution for injection for cats and dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active ingredients Atipamezole hydrochloride 5.0 mg (equivalent to 4.27 mg atipamezole base) Excipients Methyl parahydroxybenzoate (E 218) 1.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless sterile aqueous solution. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cats and dogs. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Atipamezole hydrochloride is a selective α2-antagonist and is indicated for reversal of the sedative effects of medetomidine and dexmedetomidine in cats and dogs. 4.3. CONTRAINDICATIONS The product should not be used in: - Breeding animals - Animals suffering from liver- or renal diseases See also section 4.7. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES Make sure the animal has regained a normal swallowing reflex before any food or drink is offered. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS After administration of the product, the animals should be allowed to rest in a quiet place. During recovery time animals should not be left unattended. Due to different dosing recommendations caution should be taken if using the product off-label in animals other than the target species. If sedatives other_ _than (dex)medetomidine are given, it must be kept in mind that the effects of those other agents may persist after reversal of (dex)medetomidine. Revised: June 2013 AN. 00690/2012 Page 2 of 5 Atipamezole does not reverse the effect of ketamine, which may cause seizures in dogs and elicit cramps in cats when used alone. Do not administer atipamezole within 30 – 40 minutes of prior administration of ketamine. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Due to the potent pharmacological activi Read the complete document