国家: 英国
语言: 英文
来源: HMA (Heads of Medicines Agencies)
butorphanol tartrate 10 mg/ml
Richter Pharma AG
QN02AF01
Solution for injection
butorphanol
Cats, Dogs, Horses Food
2010-08-10
BUTOMIDOR 10 MG/ML - S OLUTION FOR INJECTION FOR HORSES, DOGS AND CATS S PC_LABELLING_PIL 22 DECEMBER 2011 1 _[Version 7.2, 12/2008] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AT, BE, DE, EL, ES, LT, NL, PT, SI: Butomidor 10 mg/ml solution for injection for horses, dogs and cats FI: Torpudor vet 10 mg/ml solution for injection for horses, dogs and cats SE, NO: Butomidor vet. 10 mg/ml solution for injection for horses, dogs and cats IE, UK: Butador 10 mg/ml solution for injection for horses, dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Butorphanol as tartrate 10 mg EXCIPIENT: Benzethonium chloride 0.1 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to almost colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horse, dog, cat 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES HORSE AS AN ANALGESIC For the short term relief of pain such as colic of gastrointestinal tract origin. AS A SEDATIVE AND PRE -ANAESTHETIC In combination with α 2 -adrenoceptor agonists (detomidine, romifidine, xylazine): For therapeutic and diagnostic procedures such as minor standing surgery and sedation of intractable patients. DOG/CAT AS AN ANALGESIC For relief of moderate visceral pain e.g. pre- and post-surgical as well as post-traumatic pain. _ _ AS A SEDATIVE In combination with 2 -adrenoceptor agonists (medetomidine). 3 AS A PRE -ANAESTHETIC Part of anaesthetic regime (medetomidine, ketamine). 4.3 CONTRAIN 阅读完整的文件