מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
BUTORPHANOL TARTRATE
Richter Pharma AG
QN02AF01
10 Mg/Ml
Solution for Injection
Neurological Preparations
Equine - Food
2006-12-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Butorphanol "Richter" 10 mg/ml Solution for Injection for Horses. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: 10 mg butorphanol as tartrate EXCIPIENT: 0.1 mg benzethonium chloride 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 Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Monotherapy _AS AN ANALGESIC_ For the short term relief of moderate to severe abdominal pain such as colic associated with intestinal impaction and hypermotility. For information on the duration of analgesia that can be expected following treatment, see section 5.1. Combination-therapy: _AS A SEDATIVE_ In combination with 2 -adrenoceptor agonists (detomidine, romifidine, xylazine): Standing chemical restraint for therapeutic and diagnostic procedures such as minor standing surgery and restraint of intractable patients. _AS A PRE-ANAESTHETIC_ Premedication to general anaesthesia. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/01/2012_ _CRN 7010945_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, or to any of the excipients. Do not use in horses with severe dysfunction of liver and kidneys. For combination use with detomidine: The combination should not used in horses with a pre-existing cardiac dysrhythmia. The combination will cause a reduction in gastrointestinal motility and consequently should not be used in cases of colic associated with impaction. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR קרא את המסמך השלם