Država: Velika Britanija
Jezik: angleščina
Source: HMA (Heads of Medicines Agencies)
hyoscine butylbromide 20 mg/ml
Boehringer Ingelheim B.V.
QA03BB01
Solution for injection
butylscopolamine
Cattle Young, Horses Food
2012-02-19
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 17 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Buscopan 20 mg/ml solution for injection for horses and calves Buscopanvet 20 mg/ml solution for injection (Ireland) Buscopanvet (Italy) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Page 3 of 17 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 ANIMA Preberite celoten dokument
Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 17 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Buscopan 20 mg/ml solution for injection for horses and calves Buscopanvet 20 mg/ml solution for injection (Ireland) Buscopanvet (Italy) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Page 3 of 17 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 ANIMA Preberite celoten dokument