Buscopan 20 mg/ml Solution for Injection for Horses and Calves
Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Summary of Product characteristics
(SPC)
06-01-2009
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
Hyoscine Butylbromide
Available from:
Boehringer Ingelheim Ltd
ATC code:
QA03BB01
INN (International Name):
Hyoscine Butylbromide
Pharmaceutical form:
Solution for injection
Prescription type:
POM-V - Prescription Only Medicine – Veterinarian
Therapeutic group:
Cattle, Horses
Therapeutic area:
Neurological Agent
Authorization status:
Authorized
Authorization date:
2004-02-02
Summary of Product characteristics
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buscopan 20 mg/ml solution for injection for horses and calves
[Estocelan
Mono (France)
Buscopanvet 20 mg/ml solution for injection (Ireland)
Buscopanvet (Italy)
Buscapina
(Portugal)
Buscapina
uso veterinario 20 mg/ml solución inyectable (Spain)
The name "the product" will be used in the SPC].
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
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] i
Read the complete document
