Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
Hyoscine butylbromide; Metamizole
Boehringer Ingelheim Vetmedica GmbH
QA03DB04
Hyoscine butylbromide; Metamizole
4/500 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
butylscopolamine and analgesics
Authorised
1991-10-01
BUSCOMP-SPC-B-16 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Buscopan Compositum Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Butylscopolamine bromide 4mg Metamizole 500mg Excipients Phenol (as preservative) 5mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection A slightly yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES_ _ Cattle (adult), horses and dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES_ _ As an aid in the control of pain associated with simple equine colic and as a diagnostic aid in more severe equine colics. For the control of diarrhoea in cattle, horses and dogs particularly when pain or abdominal discomfort is present. For the control of pain associated with urinary obstruction in horses and dogs. 4.3 CONTRAINDICATIONS _ _ _ _ _ _ Due to a risk of local reactions do not use the intramuscular route in horses. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in horses suffering from paralytic ileus. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None BUSCOMP-SPC-B-16 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE_ _ (I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to the risk of anaphylactic shock metamizole-containing solutions should be administered slowly when given intravenously. (II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS Take care to avoid self-injection. In a very small number of people, metamizole can cause reversible, but potentially serious agranulocytosis and other reactions such as skin allergy. Avoid use of the product if you are known to be sensitive to pyrazolones, or are sensitive to aspirin. Wash any splashes from the skin. If accidental self-injection occurs, seek medical advice and show the Doctor the product packaging. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In horses, a slight transient increase in heart rate may b Lue koko asiakirja