Tyawalt 450 mg/g Granules for Use in Drinking Water for Pigs, Chicken and Turkeys

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Tiamulin Hydrogen Fumarate

Available from:

HCS bvba

ATC code:

QJ01XQ01

INN (International Name):

Tiamulin Hydrogen Fumarate

Pharmaceutical form:

Granules 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:

2018-01-16

Summary of Product characteristics

                                Revised: February 2018
AN: 01672/2014 (amended pages)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tyawalt 450 mg/g granules for use in drinking water for pigs, chickens
and
turkeys (DE, BE, DK, ES, NL, PL, PT, UK)
Tyawalt 364.28 mg/g granules for use in drinking water for pigs,
chickens and
turkeys (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Tiamulin hydrogen fumarate
450 mg (corresponds to 364.28 mg of
tiamulin base)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules for use in drinking water
White to almost white small granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs, chickens and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs

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.

Treatment of Porcine Colonic Spirochaetosis (colitis) caused by
_Brachyspira pilosicoli_ susceptible to tiamulin_. _The presence of
the disease
in the herd must be established before the product is used.

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.

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.
Page 1 of 9
Revised: February 2018
AN: 01672/2014 (amended pages)

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 Syn
                                
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