Vetmulin 450 mg/g Granules 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:

Huvepharma N.V.

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:

2009-03-19

Summary of Product characteristics

Revised: August 2018
AN. 00077/2018
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vetmulin 450 mg/g granules for use in drinking water for pigs,
chickens and
turkeys.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each gram contains Tiamulin hydrogen fumarate 450.0 mg (equivalent to
tiamulin 364.2 mg) (All MS except FR)
Each gram contains 364.2 mg tiamulin as 450.0 mg Tiamulin hydrogen
fumarate (FR only)
EXCIPIENTS:
For a full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Granules for use in drinking water.
White to pale yellow granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs, chickens and turkeys.
Revised: August 2018
AN. 00077/2018
Page 2 of 11
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.
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. T