Vetmulin 125 mg/ml Oral Solution for use in drinking water for pigs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Tiamulin hydrogen fumarate

Commercializzato da:

Huvepharma NV

Codice ATC:

QJ01XQ01

INN (Nome Internazionale):

Tiamulin hydrogen fumarate

Dosaggio:

125 milligram(s)/millilitre

Forma farmaceutica:

Oral solution

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Pigs

Area terapeutica:

tiamulin

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-02-05

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmulin 125 mg/ml Oral
Solution for use in drinking water for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Tiamulin hydrogen fumarate
125 mg (equivalent to 101.2 mg tiamulin)
EXCIPIENTS
Methyl parahydroxybenzoate (E218)
0.90 mg
Propyl parahydroxybenzoate
0.10 mg
For the full list of excipients: see section 6.1
3 PHARMACEUTICAL FORM
Oral solution for use in drinking water.
Clear colourless to slightly yellow liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In pigs
For the treatment of swine dysentery caused by or further complicated
by tiamulin-susceptible_ Brachyspira_
_hyodysenteriae._
For the treatment of enzootic pneumonia and the reduction of lesions
caused by tiamulin-susceptible_ Mycoplasma_
_hyopneumoniae._
The presence of the disease in the herd should be established before
use.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any of the excipient.
Do not use in the case of resistance to tiamulin.
Do not administer products containing monensin, salinomycin, narasin,
maduramicin or other ionophores during or for
at least seven days before or after treatment with the product. See
also section 5.1. and 4.8.
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