VETMULIN 125 mg/ml Solution for use in drinking water for pigs and chickens

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:

Solution for use in drinking water

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapi:

tiamulin

Status otorisasi:

Authorised

Tanggal Otorisasi:

2019-04-04

Karakteristik produk

Health Products Regulatory Authority
17 April 2019
CRN000WHT
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 125 mg/ml Solution for use in drinking water for pigs and
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
Active substance
​
​
Tiamulin hydrogen fumarate
​125 mg
​
(equivalent to Tiamulin
​101.2 mg)
​
​
​
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
Solution for use in drinking water.
Clear, colorless to slightly yellow liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs. Chickens (Laying hens).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
i) Treatment of Swine dysentery caused by _Brachyspira hyodysenteriae_
susceptible to tiamulin. The presence of the disease in
the herd must be established before the product is used.
ii) Treatment of Porcine Colonic Spirochaetosis (spirochaetal
diarrhoea or colitis) caused by _Brachyspira pilosicoli_ susceptible
to
tiamulin. The presence of the disease in the herd must be established
before the product is used.
iii) Treatment of Porcine Proliferative Enteropathy (ileitis) caused
by _Lawsonia intracellularis,_ susceptible to tiamulin. The
presence of the disease in the herd must be established before the
product is used.
iv) Treatment and metaphylaxis of Enzootic pneumonia caused by
_Mycoplasma hyopneumoniae_, including infections
complicated by _Pasteurella multocida_ susceptible to tiamulin. The
presence of the disease in the herd must be established
before the product is used.
Laying hens:
Treatment and metaphylaxis of Chronic Respiratory Disease caused by
_Mycoplasma gallisepticum_ and Airsacculitis and
Infectious Synovitis caused by _Mycoplasma synoviae_ susceptible to
tiamulin. The presence of the disease in the flock must be
established before the product is used.
4.3 CONTRAINDICATIONS
Do not use in anima