Buscopanvet 20 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Hyoscine butylbromide

Available from:

Boehringer Ingelheim Ltd

ATC code:

QA03BB01

INN (International Name):

Hyoscine butylbromide

Dosage:

20 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses

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.
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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 Withd