Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: VMD (Veterinary Medicines Directorate)
Diazepam
Dechra Regulatory BV
QN05BA01
Diazepam
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Neurological Agent sedative
Authorized
2019-02-20
Revised: June 2023 AN: 01597/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Solupam 5 mg/ml solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Diazepam 5.0 mg EXCIPIENT: Benzyl Alcohol (E1519) 15.7 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, yellow-green solution, pH 6.2-7.2 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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 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 Diazepam alone is less likely to be effective as a sedative when used in animals that are already excited. Diazepam can cause sedation and disorientation and should be used with caution in working animals, such as military, police or service dogs. Revised: June 2023 AN: 01597/2022 Page 2 of 6 4.5 SPECIAL PRECAUTIONS FOR USE i). 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 poisoning by pesticides (chlorpyrifos) as the toxicity of these organophosphates may be potentiated. Paradoxical reactions (including excitation, a disinhibiting effect and aggression) may be observed if diazepam is used as a sole agent, therefore avoid the use of diazepam alone in potentially aggressiv Perskaitykite visą dokumentą