BUSCOPANVET 20MG/ML SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

HYOSCINE BUTYLBROMIDE

Available from:

Boehringer Ingelheim Ltd

ATC code:

QA03BB01

INN (International Name):

HYOSCINE BUTYLBROMIDE

Dosage:

20 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Equine - Food

Therapeutic area:

Butylscopolamine

Therapeutic indications:

Neurological Preparations

Authorization status:

Authorised

Authorization date:

2003-09-05

Summary of Product characteristics

                                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
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_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
                                
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