Land: Spanien
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
menbutone 100 mg/ml
AniMedica GmbH
QA05AX90
Solution for injection
menbutone
Cattle, Goats, Horses, Pigs, Sheep
2011-11-03
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Menbutil 100 mg/ml Solution for Injection for Cattle, Pigs, Horses, Sheep and Goats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance: Menbutone 100.0 mg Excipient(s): Chlorocresol 2.0 mg Sodium metabisulphite (E223) 2.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, Pigs, Horses, Sheep and Goats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle, pigs, horses, sheep and goats: - Stimulation of hepato-digestive activity in case of digestive disorders and hepatic insufficiency. 4.3 CONTRAINDICATIONS Do not use in case 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Only slow intravenous administration is advised for horses. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The intravenous administration should be done slowly (not less than 1 minute) to avoid the side effects described below in section 4.6. It is recommended not to inject intramuscularly more than 20 ml on one application site. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Do not eat, drink or smoke while handling the product. In case of accidental self-injection, seek medical advise immediately and show the package leaflet or the label to the physician.. 4.6 ADVERSE R Läs hela dokumentet