BUSCOPAN 20 MG/ML, solution for injection for horses and calves
Država: Italija
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
Uputa o lijeku
(PIL)
04-03-2012
Svojstava lijeka
(SPC)
04-03-2012
Aktivni sastojci:
hyoscine butylbromide 20 mg/ml
Dostupno od:
Boehringer Ingelheim B.V.
ATC koda:
QA03BB01
Farmaceutski oblik:
Solution for injection
Terapijska grupa:
butylscopolamine
Područje terapije:
Cattle Young, Horses Food
Datum autorizacije:
2012-02-19
Uputa o lijeku
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
Pročitajte cijeli dokument
Svojstava lijeka
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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