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

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Tiamulin hydrogen fumarate

Tersedia dari:

Huvepharma NV

Kode ATC:

QJ01XQ01

INN (Nama Internasional):

Tiamulin hydrogen fumarate

Dosis:

125 milligram(s)/millilitre

Bentuk farmasi:

Oral solution

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Pigs

Area terapi:

tiamulin

Indikasi Terapi:

Antibacterial

Status otorisasi:

Authorised

Tanggal Otorisasi:

2010-02-05

Karakteristik produk

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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