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:

100

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine, Equine - Food, Porcine

Therapeutic area:

Sulfadoxine and trimethoprim

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-02-13

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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/07/2015_
_CRN 7019646_
_page number: 1_
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) epidemiological information about susceptibility of the target
bacteria.
In order to avoid impairment of the kidneys by crystalluria during the treatment adequate drinking water should be
available at all times.
For intravenous administration. The injection solution should be approximately at body temperature. At the�