Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Menbutone
aniMedica GmbH
QA05AX90
Menbutone
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
menbutone
Authorised
2018-12-14
Health Products Regulatory Authority 20 March 2020 CRN0099JD Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 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 Excipients: Chlorocresol 2.0 mg Sodium metabisulphite (E 223) 2.0 mg For the 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 Stimulation of hepato-digestive activity in case of digestive disorders and hepatic insufficiency. 4.3 CONTRAINDICATIONS Do not use in 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 Slow intravenous administration is advised (not less than 1 minute) to avoid the side effects described 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. People with known hypersensitivity to menbutone should avoid contact with the veterinary medicinal product. Accidental self-injection can induce irritation. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Health Products Regulatory Authority 20 March 2020 CRN0099JD Page 2 of 4 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) After intraveno Przeczytaj cały dokument