Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
KETAMINE HYDROCHLORIDE
Eurovet Animal Health B.V.
QN01AX03
KETAMINE HYDROCHLORIDE
100 Mg/Ml
Solution for Injection
VPO-Vet.Practitioner Only
Canine, Equine - Food, Feline
Ketamine
Neurological Preparations
Authorised
2014-05-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT NIMATEK 100 mg/ml, Solution for injection for dogs, cats and horses. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution contains: ACTIVE SUBSTANCE: Ketamine 100 mg (corresponding to ketamine hydrochloride 115.4 mg) EXCIPIENT(S): Chlorocresol (preservative) 1 mg For a 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 Dogs, cats and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The 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 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. 4.3 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 any of the excipients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/05/2014_ _CRN 7015018_ _page number: 1_ 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 a Read the complete document