Bimastat Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Neomycin ; Sulfadiazine

Available from:

Cross Vetpharm Group Limited

ATC code:

QJ01RA02

INN (International Name):

Neomycin ; Sulfadiazine

Dosage:

25/150/105 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

sulfonamides, combinations with other antibacterials excl. trimethoprim

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimastat Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pre-ruminant calves.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of diarrhoea in pre-ruminant calves associated with
infections caused by organisms known to be, or
suspected of being, susceptible to the combination of sulfadiazine and
neomycin.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredients.
Do not exceed the recommended dosage or the period of treatment.
Do not
use local
anaesthetics of the procaine group during treatment
as they are antagonistic to the sulphonamide
component.
Do not use in calves with functional rumens.
Do not use in lactating cows.
Do not use in foals and horses.
ACTIVE SUBSTANCE
Sulfadiazine
150.0
mg/ml
Neomycin (as neomycin sulphate)
25.0
mg/ml
EXCIPIENTS
Methyl parahydroxybenzoate
2.0
mg/ml
Propyl parahydroxybenzoate
0.2
mg/ml
Carmoisine E122
0.05 mg/ml
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Concurrent intravenous fluid therapy should be considered in
dehydrated calves.
Parenteral antibiotic treatment should
be considered