Tialin 125 mg/ml solution for use in drinking water for pigs, chickens and turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tiamulin hydrogen fumarate

Available from:

Dechra Regulatory B.V.

ATC code:

QJ01XQ01

INN (International Name):

Tiamulin hydrogen fumarate

Dosage:

125 milligram(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

tiamulin

Authorization status:

Authorised

Authorization date:

2018-07-20

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2022
CRN00CPMT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tialin 125 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
​125.0 mg
equivalent to 101.2 mg of tiamulin
​
​
EXCIPIENTS:
​
​
Methyl parahydroxybenzoate (E218)
​0.9 mg
​
Propyl parahydroxybenzoate
​0.1 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 tiamul