Tialin 125 mg/ml Solution for Use in Drinking Water for Pigs, Chickens and Turkeys

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tiamulin Hydrogen Fumarate

Available from:

Dechra Limited

ATC code:

QJ01XQ01

INN (International Name):

Tiamulin Hydrogen Fumarate

Pharmaceutical form:

Solution for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Pigs, Turkeys

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2018-07-20

Summary of Product characteristics

Revised: December 2023
AN: 02624/2022
Page 1 of 10
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
Each ml contains:
ACTIVE SUBSTANCE:
101.2 mg of tiamulin, equivalent to 125.0 mg of tiamulin hydrogen
fumarate.
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Ethanol 96%
100.0 mg
Methyl parahydroxybenzoate (E218)
0.9 mg
Propyl parahydroxybenzoate
0.1 mg
Citric acid monohydrate
Disodium phosphate dihydrate
Water purified
Clear, colourless to pale yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs, chickens (pullets, breeders, layer hens) and turkeys (breeders,
layer hens).
3.2
INDICATIONS FOR USE FOR EACH 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.
Revised: December 2023
AN: 02624/2022
Page 2 of 10
-
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
veterinary
medicinal 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 flock must be established before
the veterinary
medicinal product is used.
Turke