BIMASTAT ORAL SUSPENSION

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Compra

Scarica Scheda tecnica (SPC)
29-01-2016

Principio attivo:

NEOMYCIN SULFATE, SULFADIAZINE

Commercializzato da:

Cross Vetpharm Group Limited

Codice ATC:

QJ01RA02

INN (Nome Internazionale):

NEOMYCIN SULFATE, SULFADIAZINE

Dosaggio:

Unknown

Forma farmaceutica:

Oral Suspension

Tipo di ricetta:

POM

Gruppo terapeutico:

Bovine

Area terapeutica:

Sulfonamides, combinations with other antibacterials excl. trimethoprim

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

1988-10-01

Scheda tecnica

                                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
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 13/01/2016_
_CRN 7022820_
_page number: 1_
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 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 
                                
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