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 Vetmedica GmbH

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 area:

butylscopolamine

Authorization status:

Authorised

Authorization date:

2003-09-05

Summary of Product characteristics

Health Products Regulatory Authority
06 July 2018
CRN000YHT
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Buscopanvet 20 mg/ml solution for injection
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.
Health Products Regulatory Authority
06 July 2018
CRN000YHT
Page 2 of 5
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
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 intervention should be
considered, as the
product does not mask symptoms of surgical cases.
In cases of mechanical obstruction of the gut, concomitant therapy
with polyionic
fluids, laxatives and analgetics should be considered.
In animals with cardiac dysfunction the produ