Land: Storbritannien
Sprog: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Ketamine
Eurovet Animal Health B.V.
QN01AX03
Ketamine
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs, Horses
Neurological Agent general anaesthetic
Authorized
2013-07-10
Revised: June 2018 AN: 01506/2017 Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ANESKETIN 100 mg/ml solution for injection for dogs, cats and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance: Ketamine 100 mg (corresponding to ketamine hydrochloride 115.4 mg) Excipient: Chlorocresol 1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless liquid free from visible evidence of contamination. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog, cat and horse. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To be used as a sole agent for restraint and minor surgical procedures in the cat, where muscle relaxation is not required. To be used to induce anaesthesia: a) in combination with butorphanol and medetomidine in the dog and cat, b) in combination with xylazine in the horse, dog and cat, c)in combination with detomidine in the horse, d) in combination with romifidine in the horse. 4.3 CONTRAINDICATIONS Do not use: • in animals with hepatic or renal failure. • ketamine as a sole agent in the horse or the dog. • in animals with severe cardiac de-compensation, suspected pulmonary disease, apparent high blood pressure or cerebrovascular insults. • in animals with eclampsia, pre-eclampsia, glaucoma and seizure disorders (e.g. epilepsy). • for surgical intervention on pharynx, larynx, trachea or bronchial tree, if sufficient relaxation is not ensured by administration of a muscle relaxant (intubation obligatory). • in animals undergoing a myelogram procedure. Revised: June 2018 AN: 01506/2017 Page 2 of 13 Do not use in known cases of hypersensitivity to the active substance or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For very painful and major surgical interventions, as well as for maintenance of anaesthesia, a combination with injectable or inhalation anaesthetics is necessary. As muscle relaxation required for surgical procedures cannot b Læs hele dokumentet