Tialin 250 mg/ml solution for use in drinking water for pigs, chickens and turkeys

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Tiamulin hydrogen fumarate

Fáanlegur frá:

Dechra Regulatory B.V.

ATC númer:

QJ01XQ01

INN (Alþjóðlegt nafn):

Tiamulin hydrogen fumarate

Skammtar:

250 milligram(s)/millilitre

Lyfjaform:

Solution for use in drinking water

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

tiamulin

Leyfisstaða:

Authorised

Leyfisdagur:

2018-07-20

Vara einkenni

Health Products Regulatory Authority
28 January 2022
CRN00CPMT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tialin 250 mg/ml solution for use in drinking water for pigs, chickens
and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ML OF SOLUTION CONTAINS:
​
​
ACTIVE SUBSTANCE:
​
​
Tiamulin hydrogen fumarate
​250.0 mg
​
equivalent to 202.4 mg of tiamulin
​
​
EXCIPIENTS:
​
​
Ethanol 96%
​200.0 mg
​
For the full list of excipients, see section 6.1.
​
3 PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs, chickens (pullets, breeders, layer hen) and turkeys (breeders,
layer hen).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs

Treatment of Swine Dysentery caused by _Brachyspira hyodysenteriae_
susceptible to tiamulin.

Treatment of Porcine Colonic Spirochaetosis (colitis) caused by
_Brachyspira pilosicoli_ susceptible to tiamulin.

Treatment of Porcine Proliferative Enteropathy (ileitis) caused by
_Lawsonia intracellularis_ susceptible to tiamulin.

Treatment and metaphylaxis of Enzootic Pneumonia caused by _Mycoplasma
hyopneumoniae_, including infections
complicated by _Pasteurella multocida_ susceptible to tiamulin.

Treatment of Pleuropneumonia caused by _Actinobacillus
pleuropneumoniae_ susceptible to tiamulin.
The presence of the disease in the herd must be established before the
product is used.
Chickens
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 herd must be established before the
product is used.
Turkeys
Treatment and metaphylaxis of Infectious Sinusitis and Airsacculitis
caused by _Mycoplasma gallisepticum_, _Mycoplasma synoviae_
and _Mycoplasma meleagridis_ susceptible to tiamulin.
The presence of the disease in the herd must