Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
BUTORPHANOL TARTRATE
aniMedica GmbH
QN02AF01
BUTORPHANOL TARTRATE
10 Mg/Ml
Solution for Injection
POM
Equine - Food
Butorphanol
Neurological Preparations
Authorised
2010-10-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Morphasol 10 mg/ml solution for injection for horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Butorphanol 10 mg (as Butorphanol tartrate 14.7 mg/ml) Excipients Benzethonium chloride 0.1 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 Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For short term relief of pain associated with colic of gastrointestinal tract origin. For information on the onset and duration of analgesia that can be expected following treatment, see section 5.1. For sedation in combination with certain 2-adrenoceptor agonists (see section 4.9). HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/06/2015_ _CRN 7019644_ _page number: 1_ 4.3 CONTRAINDICATIONS _Butorphanol – as a sole agent and in any combination:_ Do not use in horses with a history of liver or kidney disease. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. Do not use in cases of cerebral injury or organic brain lesions (e.g. lesions following cranial trauma) and in animals with obstructive respiratory diseases, heart dysfunction or spastic convulsions. _Butorphanol / detomidine hydrochloride combination_: The combination should not be used in pregnant animals. Do not use the combination in horses with a pre-existing cardiac dysrhythmia or bradycardia. Do not use in horses with emphysema due to a possible depressive effect in the respiratory system. _Butorphanol / romifidine combination:_ Do not use during the Aqra d-dokument sħiħ