Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Menbutone
V.M.D. n.v.,
QA05AX90
Menbutone
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
menbutone
Authorised
2017-03-24
Health Products Regulatory Authority 27 November 2020 CRN009TCW Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alvebuton 100 mg/ml Solution for injection for cattle, pigs, horses, sheep, goats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains: ACTIVE SUBSTANCE: Menbutone 100.00 mg EXCIPIENTS: Chlorocresol 2.00 mg Sodium metabisulfite (E 223) 2.00 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, pale yellow to yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs, horses, sheep, goats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle, pigs, horses, sheep, goats: Stimulation of hepato-digestive activity in case of digestive disorders and hepatic insufficiency. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals with cardiac disease or in the late stages of pregnancy. Please refer to section 4.7 "Use during pregnancy, lactation or lay". 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals For horses only slow intravenous administration. Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection can induce irritation. People with known hypersensitivity to menbutone should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Do not eat, drink or smoke while handling this product. Health Products Regulatory Authority 27 November 2020 CRN009TCW Page 2 of 4 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) After intravenous administration, salivation, lacrimation, tremors, spontaneous urination and defecation may occur. After intramuscular administration, reaction at the injection site (oedema, ha সম্পূর্ণ নথি পড়ুন