Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Ketamine hydrochloride
Eurovet Animal Health B.V.
QN01AX03
Ketamine hydrochloride
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs, Horses
ketamine
Neurological Preparations
Authorised
2014-05-09
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses (AT, IE, IT, PL, PT, UK(NI)). Nimatek vet 100 mg/ml, Solution for injection for dogs, cats and horses (FI, SE). 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: 100 mg ketamine equivalent to 115.4 mg ketamine hydrochloride EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t Chlorocresol 1 mg Sodium hydroxide Hydrochloric acid Water for injections Clear, colourless liquid free from visible evidence of contamination. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Dogs, cats and horses 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES The veterinary medicinal product may be used to induce anaesthesia: a) in conjunction with butorphanol and medetomidine in the dog and cat, b) in conjunction with xylazine in the dog, cat and horse, c) in conjunction with detomidine in the horse, d) in conjunction with romifidine in the horse. Based on a benefit/risk assessment performed by the veterinarian the veterinary medicinal product may also be used as a sole agent for restraint and minor surgical procedures where muscle relaxation is not required in the domestic cat. 3.3 CONTRAINDICATIONS Do not use in animals with hepatic or renal failure. Do not use ketamine as a sole agent in the horse or the dog. Do not use in animals with severe cardiac de-compensation, apparent high blood pressure or glaucoma. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS 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 be achieved with ketamine alone, additional muscle-relaxants should be used concomitantly. For improvement of anaesthesia Izlasiet visu dokumentu