Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Diazepam
Richter Pharma AG
QN05BA01
Diazepam
5 milligram(s)/millilitre
Solution for injection
VPO: Veterinary Practitioner Only as defined in relevant national legislation
Cats, Dogs
diazepam
Sedative
Authorised
2018-06-01
Health Products Regulatory Authority 08 June 2018 CRN000V58 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Diazedor 5 mg/ml solution for injection for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Diazepam 5.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless to greenish-yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cats and dogs: For the short term management of convulsive disorders and skeletal muscle spasms of central and peripheral origin. As part of a pre-anaesthetic or sedation protocol. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Do not use in cases of severe hepatic disease. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For strict intravenous use. Diazepam alone is less likely to be effective as a sedative when used in animals that are already excited. Health Products Regulatory Authority 08 June 2018 CRN000V58 Page 2 of 6 Diazepam can cause sedation and disorientation and should be used with caution in working animals, such as military, police or service dogs. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The product should be used with caution in animals with hepatic or renal disease and in debilitated, dehydrated, anaemic, obese, or geriatric animals. The product should be used with caution in animals in shock, coma, or with significant respiratory depression. The product should be used with caution in animals affected by glaucoma. It is not recommended to use diazepam for convulsive disorder control in cats in case of chronic chlorpyrifos toxicosis as organophosphate's toxicity may be potentiated. Special precautions to be taken by the person administering the veterinary medicinal product to animals This product is a CNS depressant. Av Perskaitykite visą dokumentą