国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Apomorphine hydrochloride hemihydrate
Dechra Regulatory B.V.
QN04BC07
Apomorphine hydrochloride hemihydrate
3 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
apomorphine
Authorised
2018-03-16
Health Products Regulatory Authority 01 March 2019 CRN000YX0 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Apovomin 3 mg/ml solution for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Apomorphine hydrochloride hemihydrate 3.00 mg (equivalent to apomorphine 2.56 mg) EXCIPIENTS: Benzyl alcohol (E1519) 10 mg Sodium metabisulfite (E223) 1.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless aqueous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Induction of emesis. 4.3 CONTRAINDICATIONS Do not use in cats. Do not use in case of depression of the Central Nervous System (CNS). Do not use in cases of ingestion of caustic agents (acids or alkalis), foamy products, volatile substances, organic solvents and non-blunt objects (e.g. glass). Do not use in animals which are hypoxic, dyspnoeic, seizuring, in hyperexcitation, extremely weak, ataxic, comatose, lacking normal pharyngeal reflexes, or suffering other marked neurologic impairments that could lead to aspiration pneumonia. Do not use in cases of circulatory failure, shock and anaesthesia. Do not use in animals which are previously treated with Dopamine-Antagonists (Neuroleptics). Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Expulsive efforts with or without vomiting are likely to be seen from 2 to 15 minutes after the injection of the product and may last from 2 minutes to 2.5 hours. If emesis is not induced following a single injection, do not repeat the injection as it will not be effective and may provoke clinical signs of toxicity. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Health Products Regulatory Authority 01 March 2019 CRN000YX0 Page 2 of 4 In dogs with known severe hepatic failure, the benefit/risk balance for use of the 阅读完整的文件