Bimamix Oral Suspension for Calves

Summary of Product characteristics

                                Revised: January 2016
AN: 01377/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Bimamix, Oral Suspension for Calves
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Sulfadiazine
150 mg/ml
Neomycin (as neomycin sulphate)
25 mg/ml
EXCIPIENTS:
Methyl Parahydroxybenzoate
2.0 mg/ml
Propyl Parahydroxybenzoate
0.2 mg/ml
Carmoisine E122
0.05 mg/ml
For the 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
ingredient.
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 a functional rumen.
Do not use in lactating cows
Do not use in foals and horses.
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Revised: January 2016
AN: 01377/2015
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.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account
when the
product is used.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Care should be taken to avoid contact with the skin. Wash hands after
use.
Sulphonamides may cause hypersensitivity (allergy) following
injection, inhalation,
ingestion or skin contact. Hypersensitivity to sulphonamides may lead
to cross reaction
with other antibiotics. Allergic re
                                
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