Vetmulin 20 g/kg Premix for Medicated Feedingstuff for Pigs

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

Authorization status:

Expired

Summary of Product characteristics

Revised: January 2014
AN: 00201/2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 20G/KG PREMIX for medicated feedingstuff for pigs (UK, IE,
NL, BE,
IT, HU, RO, CZ, BG, PL)
VETMULIN 20 G/KG MEDICATED PREMIX for pigs (ES)
VETMULIN 20 G/KG MEDICATED PREMIX (PT)
VETMULIN 20 G/KG MEDICATED PREMIX (DE, AT)
VETMULIN 20 G/KG PREMIX (EL)
VETMULIN 16.2g/kg MEDICATED PREMIX for pigs (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each kg contains: Tiamulin hydrogen fumarate: 20 g (equivalent to
tiamulin
16.2 g).
For a full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
A yellowish free-flowing granular material.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
For treatment and prevention, when the disease is present at herd
level, of
swine dysentery caused by _Brachyspira hyodysenteriae_ susceptible to
tiamulin.
The presence of disease in the herd should be established before use.
4.3
CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active substances
or any
of the excipients.
Do not use in case of resistance to tiamulin
Do not administer products containing ionophores such as monensin,
salinomycin or narasin during or for at least seven days before or
after
treatment with the product. See section 4.8.
Page 1 of 7
Revised: January 2014
AN: 00201/2013
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
The uptake of medication by animals can be altered as a consequence of
illness. For animals with a reduced feed intake, treat parenterally
using an
appropriate injectable product
Long term or repeated use should be avoided by improving management
practice and thorough cleansing and disinfection.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Do not use the product in liquid feed.
Due to the likely variability (time, geographical) in the occurrence
of
resistance of bacteria for tiamulin, the use of the product should be
based on bacteriologi