Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: VMD (Veterinary Medicines Directorate)
Medetomidine Hydrochloride
Eurovet Animal Health B.V.
QN05CM91
Medetomidine Hydrochloride
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Neurological Agent sedative
Authorized
2007-03-21
Revised: April 2019 AN: 01582/2018 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SEDATOR, 1.0 mg/ml, solution for injection for cats and dogs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: Active substance Medetomidine hydrochloride 1.0 mg Excipients Methyl parahydroxybenzoate (E 218) 1.0 mg Propyl parahydroxybenzoate 0.2 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless solution 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Dogs, cats. 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES _Dogs_: for restraint, sedation and analgesia associated with clinical examinations and procedures, minor surgery, pre-anaesthesia and as a premedication before thiopentone-halothane general anaesthesia and as a premedicant before general anaesthesia with propofol. In combination with butorphanol for sedation, analgesia and as a premedicant to thiopentone anaesthesia. _Cats_: for restraint and sedation. In combination with ketamine for induction of general anaesthesia prior to surgical procedures in the cat. In combination with butorphanol for sedation and analgesia, and combined with both butorphanol and ketamine for general anaesthesia. As a premedication before alphaxalone/alphadolone for general anaesthesia. 4.3. CONTRAINDICATIONS Do not use in conjunction with sympathomimetic amines. Care should be taken with the use of medetomidine in animals with cardiovascular disease or in poor general health. Before using any combinations consult the contraindications and warnings that appear on the other products’ data sheet. Medetomidine should not be used with thiopentone or propofol in animals with cardiac or respiratory disease (see also section 4.10). Revised: April 2019 AN: 01582/2018 Page 2 of 10 4.4. SPECIAL WARNINGS FOR EACH TARGET SPECIES An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting sm Perskaitykite visą dokumentą