Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
BUTORPHANOL TARTRATE
aniMedica GmbH
QN02AF01
BUTORPHANOL TARTRATE
4 Mg/Ml
Solution for Injection
POM
Canine, Feline
Butorphanol
Neurological Preparations
Authorised
2009-12-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Morphasol 4 mg/ml solution for injection for dogs and cats. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Butorphanol 4 mg (as Butorphanol tartrate 5.83 mg) Excipients Benzethonium chloride 0.1 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES DOGS: As an analgesic: for the relief of mild to moderate visceral pain. As a sedative: in combination with medetomidine. CATS: As an analgesic: for the relief of mild to moderate visceral pain. 4.3 CONTRAINDICATIONS Do not use in case of known hypersensitivity to the active substance or to any of the excipients in the product. Do not use in animals with known or suspected liver or kidney disease. Use of butorphanol is contraindicated in case of cerebral injury or organic brain lesions and in animals with obstructive respiratory diseases, heart dysfunction or spastic conditions. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 19/12/2014_ _CRN 7019497_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Butorphanol is intended for use where short (dog) and short to medium (cat) analgesia is required. For information on the duration of analgesia that can be expected following treatment, see section 5.1. However, repeat treatments of butorphanol may be administered. For cases where longer duration analgesia is likely to be required, an alternative therapeutic agent should be used. The safety of the product in young puppies and kittens has Lugege kogu dokumenti