Bimastat Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Neomycin sulphate; Sulfadiazine

Available from:

Bimeda Animal Health Limited

ATC code:

QJ01RA02

INN (International Name):

Neomycin sulphate; Sulfadiazine

Dosage:

25/150 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

sulfonamides, combinations with other antibacterials excl. trimethoprim

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2019
CRN008M62
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimastat Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Concurrent intravenous fluid therapy should be considered in
dehydrated calves. Parenteral antibiotic treatment should be
considered if a clinical response is not seen after 48 hours
treatment.
Health Products Regulatory Authority
03 May 2019
CRN008M62
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTION(S) 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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Avoid contact with skin. Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSN