BUSCOPAN COMPOSITUM SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-12-2014
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Active ingredient:
HYOSCINE BUTYLBROMIDE, METAMIZOLE
Available from:
Boehringer Ingelheim Ltd
ATC code:
QA03DB04
INN (International Name):
HYOSCINE BUTYLBROMIDE, METAMIZOLE
Dosage:
4
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Equine - Food
Therapeutic area:
Butylscopolamine and analgesics
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
1991-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Buscopan Compositum Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
A slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (adult), horses and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid in the control of pain associated with simple equine colic and as a diagnostic aid in more severe equine
colics.
For the control of diarrhoea in cattle, horses and dogs particularly when pain or abdominal discomfort is present.
For the control of pain associated with urinary obstruction in horses and dogs.
4.3 CONTRAINDICATIONS
Due to a risk of local reactions do not use the intramuscular route in horses.
Do not use in animals with known hypersensitivity to the active ingredients.
Do not use in horses suffering from paralytic ileus.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
ACTIVE SUBSTANCE
Butylscopolamine bromide
4 mg
Metamizole
500 mg
EXCIPIENTS
Phenol (as preservative)
5 mg
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 10/12/2014_
_CRN 7018576_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Take care to avoid self-injection. In a very small number of people, metamizole can cause reversible, but potentially
serious agranulocytosis and other reactions such as skin allergy. Avoid use of the product if you are known to be
sensitive to pyrazolones, or are sensitive to aspirin. Wash any sp
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