Borgal 24% Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sulfadoxine; Trimethoprim

Available from:

Virbac S.A.

ATC code:

QJ01EW13

INN (International Name):

Sulfadoxine; Trimethoprim

Dosage:

200, 40 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

sulfadoxine and trimethoprim

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1998-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Borgal 24% Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A light brownish yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of primary bacterial infections and bacterial
infections secondary to viral diseases in cattle, pigs and
horses.
4.3 CONTRAINDICATIONS
Do not administer in pregnant animals.
Potentiated sulphonamides are contraindicated in animals with known
sulphonamide hypersensitivity, severe liver or
kidney parenchymal damage or blood dyscrasias.
The intravenous route of administration is contra-indicated in the
case of previous or concurrent administration of central
nervous system depressants (e.g. anaesthetics, neuroleptics).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCES
Sulfadoxine
200.0 mg/ml
Trimethoprim
40.0 mg/ml
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing of the
bacteria isolated from the animal. If this is not possible,
therapy should be based on local (regional, farm level)