Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Acepromazine maleate
Ecuphar NV
QN05AA04
Acepromazine maleate
2 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
acepromazine
Authorised
2016-07-15
Health Products Regulatory Authority 30 August 2021 CRN00CH1L Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Acecare 2 mg/ml Solution for Injection for Dogs and Cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution contains ACTIVE SUBSTANCE: Acepromazine 2 mg (as acepromazine maleate 2.71 mg) EXCIPIENTS: Phenol (as preservative) 3 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Pale yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Anaesthetic Premedication: Following acepromazine administration, the amount of anaesthetic necessary to induce anaesthesia is considerably reduced. This reduction is approximately one-third of a suitable induction agent. Tranquilisation: Acepromazine tranquilisation (ataraxy) involves a modification of temperament which is not associated with hypnosis, narcosis or marked sedation. This is achieved with low doses of acepromazine. Sedation: At higher dose rates acepromazine is a sedative. 4.3 CONTRAINDICATIONS Do not use in pregnant animals. Do not use on a long term basis in individual animals. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Acepromazine is hypotensive. Particular care should therefore be taken in hypovolaemic animals; rehydration should precede acepromazine administration. Acepromazine may cause hypothermia due to depression of the thermoregulatory centre and peripheral vasodilation. In some dogs, particularly Boxers and other short-nosed breeds, spontaneous fainting or syncope may occur due to sinoatrial block caused by excessive vagal tone. An attack may be precipitated by an injection of acepromazine, so a low dose should be used. Where there is a history of this type of syncope, or if it is suspected because of excessive sinus arrhythmia, it may be advantageous to control the Read the complete document