Vetmulin 450 mg/g granules 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:

Huvepharma NV

ATC code:

QJ01XQ01

INN (International Name):

Tiamulin hydrogen fumarate

Dosage:

450 milligram(s)/gram

Pharmaceutical form:

Granules

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Pigs, Turkeys

Therapeutic area:

tiamulin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2009-03-20

Summary of Product characteristics

Health Products Regulatory Authority
24 September 2018
CRN000YD1
Page 1 of 10
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)
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.
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.
Health Products Regulatory Authority
24 September 2018
CRN000YD1
Page 2 of 10
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
flock must be
e