Country: United Kingdom
Bahasa: Inggeris
Sumber: VMD (Veterinary Medicines Directorate)
Acepromazine
Le Vet Beheer B.V.
QN05AA04
Acepromazine
Oral gel
POM-V - Prescription Only Medicine – Veterinarian
Dogs, Horses
Neurological Agent sedative
Authorized
2017-11-21
Unlimited Renewal: April 2022 AN: 03008/2021 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Tranquigel 35 mg/g oral gel for dogs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram contains: ACTIVE SUBSTANCES: Acepromazine (as acepromazine maleate) 35.0 mg EXCIPIENT(S): Methyl parahydroxybenzoate (E 218) 1.04 mg Propyl parahydroxybenzoate 0.104 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral gel. Clear, viscous, orange-yellow gel. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For sedation of dogs and horses 4.3 CONTRAINDICATIONS Do not use in cases of hypotension, post-traumatic shock or hypovolemia. Do not use in animals in a state of severe emotional excitation. Do not use in animals suffering from hypothermia. Do not use in animals with haematological disorders/coagulopathies or anaemia. Do not use in animals with heart and or lung failure. Do not use in animals with epilepsy. Do not use in neonates. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Unlimited Renewal: April 2022 AN: 03008/2021 Page 2 of 7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Dogs None Horses Sedation lasts for approximately six hours, although the actual time and depth of sedation are very dependent on the status of the individual animal. Increasing the dosage above that recommended results in prolonged action and side effects but no greater sedation. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: This veterinary medicinal product should be used with caution and with reduced dosage in the case of hepatic disease or in debilitated animals. Acepromazine has negligible analgesic effects. Painful activities should be avoided when handling tranquillized animals, unless treated with appropriate analgesics. After administration of this veterinary medicinal product, animals should be kept in a calm place and sensorial stimu Baca dokumen lengkap