Buscopan Compositum Solution for Injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Hyoscine butylbromide; Metamizole

Dostupné s:

Boehringer Ingelheim Vetmedica GmbH

ATC kód:

QA03DB04

INN (Mezinárodní Name):

Hyoscine butylbromide; Metamizole

Dávkování:

4/500 milligram(s)/millilitre

Léková forma:

Solution for injection

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické oblasti:

butylscopolamine and analgesics

Stav Autorizace:

Authorised

Datum autorizace:

1991-10-01

Charakteristika produktu

BUSCOMP-SPC-B-16
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
BUSCOMP-SPC-B-16
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE_ _
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to the risk of anaphylactic shock metamizole-containing solutions
should
be administered slowly when given intravenously.
(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 b