Buscopan Compositum Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Hyoscine Butylbromide, Metamizole

Available from:

Kernfarm B.V.

ATC code:

QA03DB04

INN (International Name):

Hyoscine Butylbromide, Metamizole

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Dogs, Horses

Therapeutic area:

Neurological Agent

Authorization status:

Expired

Authorization date:

2016-02-29

Summary of Product characteristics

Issued: February 2016
AN: 00894/2015
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buscopan Compositum Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Butylscopolamine bromide 4mg
Metamizole 500mg
Excipients
Phenol (as preservative) 5mg
For a full list of excipients, see section 6.1
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 case of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in horses suffering from paralytic ileus.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Issued: February 2016
AN: 00894/2015
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None
ii.
Special Precautions to be taken by the person administering the
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 splashes from the skin.
If accidental self-injection occurs, seek medical advice and show the
Doctor the product packaging.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In horses, a slight transient increase in heart rate may be observed
due to
the parasympatholytic activity of butylscopolaminiumbromide (hyoscine
butylbromide).
4