BUSCOPAN 20 MG/ML, solution for injection for horses and calves
Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: HMA (Heads of Medicines Agencies)
Tờ rơi thông tin
(PIL)
04-03-2012
Đặc tính sản phẩm
(SPC)
04-03-2012
Thành phần hoạt chất:
hyoscine butylbromide 20 mg/ml
Sẵn có từ:
Boehringer Ingelheim B.V.
Mã ATC:
QA03BB01
Dạng dược phẩm:
Solution for injection
Nhóm trị liệu:
butylscopolamine
Khu trị liệu:
Cattle Young, Horses Food
Ngày ủy quyền:
2012-02-19
Tờ rơi thông tin
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 17
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buscopan 20 mg/ml solution for injection for horses and calves
Buscopanvet 20 mg/ml solution for injection (Ireland)
Buscopanvet (Italy)
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
Page 3 of 17
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 ANIMA
Đọc toàn bộ tài liệu
Đặc tính sản phẩm
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 17
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Buscopan 20 mg/ml solution for injection for horses and calves
Buscopanvet 20 mg/ml solution for injection (Ireland)
Buscopanvet (Italy)
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
Page 3 of 17
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 ANIMA
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