国: イギリス
言語: 英語
ソース: HMA (Heads of Medicines Agencies)
acepromazine 35 mg/ml
Floris Veterinaire Produkten BV
QN05AA04
Oral gel
Acepromazine
Horses
2012-12-21
Revised: May 2013 AN: 00075/2012 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Relaquine 35 mg/ml Oral Gel for Horses DE, FR, NL, UK Relaquine vet 35 mg/ml Oral Gel for Horses SE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per ml ACTIVE SUBSTANCE Acepromazine (as Acepromazine maleate) 35.00 mg (47.50 mg) EXCIPIENTS: Methyl parahydroxybenzoate 0.65 mg Propyl parahydroxybenzoate 0.35 mg For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Oral gel. Clear yellow gel for oral administration. 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Horse. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For sedation of horses. 4.3. CONTRAINDICATIONS Do not use in cases of post-traumatic shock or hypovolaemia. Do not use in animals in a state of severe emotional excitation. Do not use in animals with epilepsy. Do not use in pregnant or lactating mares. Do not use in animals with heart failure. _ _ Do not use in animals with haematological disorders/coagulopathies. _ _ Revised: May 2013 AN: 00075/2012 Page 2 of 6 Do not use in animals suffering from hypothermia. Do not use in the case of known hypersensitivity to the active substance or any of the excipients of the product. 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES 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 完全なドキュメントを読む