Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: VMD (Veterinary Medicines Directorate)
Butorphanol
VetViva Richter GmbH
QN02AF01
Butorphanol
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs, Horses
Neurological Agent analgesic
Authorized
2011-01-17
Revised: January 2023 AN: 02966/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Butador 10 mg/ml solution for injection for horses, dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Butorphanol 10 mg (as butorphanol tartrate 14.58 mg) EXCIPIENT: Benzethonium chloride 0.1 mg For the 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. Revised: January 2023 AN: 02966/2022 Page 2 of 8 AS A SEDATIVE In combination with α 2 --adrenoceptor agonists (medetomidine). AS A PRE-ANAESTHETIC Part of anaesthetic regime (medetomidine, ketamine). 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use for treatment of animals with severe dysfunction of the liver and kidneys, in case of cerebral injury or organic brain lesions and in animals with obstructive respiratory diseases, heart dysfunctions or spastic conditions. For combination use with α 2 --agonists in horses: Do not use in horses with a pre-existing cardiac dysrhythmia or bradycardia. The combination will cause a reduction in gastrointestinal motility and consequently should not be used in cases of colic associated with impaction. Do not use combination during pregnancy. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The precautionary measures required for contact with an Lesen Sie das vollständige Dokument