Maa: Irlanti
Kieli: englanti
Lähde: HMA (Heads of Medicines Agencies)
romifidine hypochloride 1 mg
Virbac S.A.
QN
Solution for injection
NERVOUS SYSTEM
Cats Non Food, Dogs Non Food
2011-02-25
Revised: February 2011 AN: 01019/2010 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Romidys 1 mg/ml solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of Romidys 1 mg/ml solution for injection contains: ACTIVE INGREDIENT Romifidine hydrochloride 1 mg equivalent to 0.876 mg romifidine PRESERVATIVES Methyl parahydroxybenzoate (E218) 1.8 mg Propyl parahydroxybenzoate (E216) 0.2 mg 3. PHARMACEUTICAL FORM Solution for injection. Clear almost colorless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sedative for use in dogs and cats for restraint; to facilitate handling, clinical examinations, minor surgical interventions and manipulations. Premedicati on agent prior to the induction of general anaesthesia. For profound sedation/analgesia in dogs it may also be used with an opioid analgesic. In cats combination with ketamine provides surgical anaesthesia. 4.3 CONTRAINDICATIONS Do not use in pregnant animals. Do not use in animals suffering from diabetes mellitus. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES As a dose-dependent increase in blood urea may occur in cats, sufficient fluid intake should be ensured. Revised: February 2011 AN: 01019/2010 Page 2 of 7 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Sedated animals should be restrained to prevent injury. Care should be taken to ensure that animals have sufficient fluid Lue koko asiakirja