Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
HYOSCINE BUTYLBROMIDE
Boehringer Ingelheim Ltd
QA03BB01
HYOSCINE BUTYLBROMIDE
20 Mg/Ml
Solution for Injection
POM
Bovine, Equine - Food
Butylscopolamine
Neurological Preparations
Authorised
2003-09-05
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Buscopanvet 20 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Colourless solution for injection 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and calves 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES HORSE: The product is indicated for antispasmodic treatment in case of equine colic. CALF: The product is indicated for its antispasmodic effect, as an aid to the symptomatic treatment of calf scour. Oral re- hydration and other appropriate therapy must also be administered as required. 4.3 CONTRAINDICATIONS Do not use in horses suffering from paralytic ileus. Do not use in horses less than 6 weeks of age. See also section 4.11 Withdrawal periods and section 4.7 for use during pregnancy. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Each ml contains: ACTIVE SUBSTANCE Hyoscine butylbromide 20 mg (Equivalent to 16.32 mg butylhyoscine) EXCIPIENTS Methyl parahydroxybenzoate (E 218) 1.8 mg Propyl parahydroxybenzoate (E 216) 0.2 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/02/2011_ _CRN 7010045_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In case of no clinical response the necessity for surgical intervention should be taken into consideration. See also section 4.11 Withdrawal periods. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Horses should be monitored carefully following treatment. If the response to treatment with the product is poor, careful re-evaluation of the diagnosis should be made and the possibility of surgical inter Read the complete document