Vetmulin 100 mg/g Oral Granules for Pigs

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Tiamulin Hydrogen Fumarate

Disponibil de la:

Huvepharma N.V.

Codul ATC:

QJ01XQ01

INN (nume internaţional):

Tiamulin Hydrogen Fumarate

Forma farmaceutică:

Granules

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Pigs

Zonă Terapeutică:

Antimicrobial

Statutul autorizaţiei:

Authorized

Data de autorizare:

2009-10-28

Caracteristicilor produsului

Revised: August 2014
AN. 01176/2013
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VETMULIN 100 mg/g Oral Granules for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each gram contains: Tiamulin hydrogen fumarate 100 mg (equivalent to
tiamulin 81 mg)
Excipients: For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral granules
A yellowish granular material
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
For the treatment of swine dysentery caused by _Brachyspira
hyodysenteriae._
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient or
to any of the excipients
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.
Revised: August 2014
AN. 01176/2013
Page 2 of 8
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
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. Use of the product should be
based
on bacteriological sampling and susceptibility testing and take into
account official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may
increase the prevalence of bacteria resistant to tiamulin and may
decrease the effectiveness of treatment with other pleuromutilins due
to
the potential for cross-resistance.
If there is no response to treatment within 3 days, the diagnosis
should
be re-established.
Avoid concurrent administ