Buscopan Compositum Solution for Injection

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: VMD (Veterinary Medicines Directorate)

Thành phần hoạt chất:

Hyoscine Butylbromide, Metamizole

Sẵn có từ:

Boehringer Ingelheim Limited

Mã ATC:

QA03DB04

INN (Tên quốc tế):

Hyoscine Butylbromide, Metamizole

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM-V - Prescription Only Medicine – Veterinarian

Nhóm trị liệu:

Cattle, Dogs, Horses

Khu trị liệu:

Neurological Agent

Tình trạng ủy quyền:

Authorized

Ngày ủy quyền:

2001-01-29

Đặc tính sản phẩm

Revised: August 2011
AN: 00284/2011
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
Page 1 of 5
Revised: August 2011
AN: 00284/2011
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).
4.7
USE DURING