Vetmulin 125 mg/ml Solution for Use in Drinking Water for Pigs and Chickens

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:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2019-02-05

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 125 mg/ml Solution for use in drinking water for pigs and
chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Tiamulin hydrogen fumarate
125 mg
(equivalent to Tiamulin
101.2 mg)
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
0.90 mg
Propyl parahydroxybenzoate
0.10 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear, colorless to slightly yellow liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs. Chickens (Laying hens).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
i)
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.
ii) Treatment of Porcine Colonic Spirochaetosis (spirochaetal
diarrhoea or
colitis) caused by _Brachyspira pilosicoli_ susceptible to tiamulin.
The presence of
the disease in the herd must be established before the product is
used.
iii) 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.
iv) 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.
Unlimited renewal: July 2023
AN: 00712/2023
Page 2 of 8
Laying hens:
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 product is used.
4.3
CONTRAINDICATIONS
Do not use in animals that could receive products containing monensin,
narasin o