Kraj: Wielka Brytania
Język: angielski
Źródło: VMD (Veterinary Medicines Directorate)
Tiletamine, Zolazepam
Virbac
QN01AX99
Tiletamine, Zolazepam
Lyophilisate and solvent for solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Neurological Agent general anaesthetic
Authorized
2016-04-20
Revised: April 2023 AN: 00777/2022 & 00782/2022 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZOLETIL 100 (50 mg/ml+50 mg/ml) Lyophilisate and Solvent for Solution for Injection for Dogs and Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of 970 mg lyophilisate contains: Active substances: Tiletamine (as hydrochloride) 250.00 mg Zolazepam (as hydrochloride) 250.00 mg Each vial of 5 ml solvent contains: Benzyl alcohol (E1519) 0.100 g Water for injections 5.00 ml Each ml of reconstituted solution contains: Active substances: Tiletamine (as hydrochloride) 50.00 mg Zolazepam (as hydrochloride) 50.00 mg Excipient: Benzyl alcohol (E1519) 20.00 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection. Appearance of the lyophilisate: White to slightly yellow compact mass; Appearance of the solvent: Clear colourless liquid; Appearance of the reconstituted solution: Clear, colourless to slightly green-yellow solution, free from particles. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES General anaesthesia. Revised: April 2023 AN: 00777/2022 & 00782/2022 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Do not use in animals with severe cardiac or respiratory disease, or in animals with renal, pancreatic or hepatic insufficiency. Do not use in the event of severe hypertension. Do not use in rabbits. Do not use in animals with head trauma or intracranial tumours. Do not use for caesarean section. Do not use in pregnant bitches and queens. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In dogs, since zolazepam is eliminated more quickly than tiletamine, there is a shorter duration of tranquilisation than there is of anaesthesia. 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Animals should be fasted for 12 hours prior to anaesthesia. Re Przeczytaj cały dokument