VETMULIN 162 mg/ml Solution for Injection for pigs

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Tiamulin

Disponible desde:

Huvepharma NV

Código ATC:

QJ01XQ01

Designación común internacional (DCI):

Tiamulin

Dosis:

162 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Porcine

Área terapéutica:

tiamulin

indicaciones terapéuticas:

Antibacterial

Estado de Autorización:

Authorised

Fecha de autorización:

2009-10-30

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 162 mg/ml Solution for Injection for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Pale yellow oily solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment and metaphylaxis of swine dysentery caused by_
Brachyspira hyodysenteriae_.
For the treatment of enzootic pneumonia caused by
tiamulin-susceptible_ Mycoplasma_
_hyopneumoniae_ and mycoplasmal arthritis caused by
tiamulin-susceptible_ Mycoplasma hyosynoviae._
4.3 CONTRAINDICATIONS
Do not use in cases of
known hypersensitivity to the active ingredient or any of the
excipients.
Do not use in cases of known resistance to tiamulin.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Inflammation/scarring may occur at the site of injection. For this
reason, it is recommended that the product should be
administered into the muscle of the neck.
Each ml contains:
ACTIVE SUBSTANCE
Tiamulin
162
mg/ml
EXCIPIENTS
Butyl parahydroxybenzoate
0.324 mg/ml
Propyl gallate (E310)
0.163 mg/ml
For a full list of excipients, see section 6.1.
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4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Due to the likely variability (time, geographical) in the