Tilmovet 100 mg/g Oral Granules for Pigs

Summary of Product characteristics

                                Revised: July 2014
AN: 01175/2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET 100 mg/g oral granules for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains
ACTIVE SUBSTANCE:
Tilmicosin: 100 mg
EXCIPIENTS
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral granules.
A brown granulated powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (weaned piglets and fattening pigs)
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
The product is indicated for the treatment of pneumonia in weaned
piglets
and fattening pigs, caused by _Actinobacillus pleuropneumoniae,
Mycoplasma _
_hyopneumoniae, Pasteurella multocida_ sensitive to tilmicosin.
4.3
CONTRAINDICATIONS
Do
not
use
in
animals
hypersensitive
to
tilmicosin
and
when
there
is
resistance to tilmicosin or cross resistance to other macrolides like
tylosin,
erythromycin or lincomycin.
Tilmicosin is known to be toxic for horses. Do not allow horses or
other
equines access to feeds containing tilmicosin.
Revised: July 2014
AN: 01175/2013
Page 2 of 6
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
If for an individual animal, feed intake is such that the recommended
dosage
is not realized, medication should be carried out by parenteral
treatment.
4.5
SPECIAL PRECAUTIONS FOR USE
4.5I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Cross-resistance between tilmicosin and other macrolide antibiotic has
been observed. Use of the product should be based on susceptibility
testing and take into account official and local antimicrobial
policies.
Due to likely variability (time, geographical) in the occurrence of
the
resistance
of
bacteria
for
tilmicosin,
bacteriological
sampling
and
susceptibility
testing
are
recommended.
Inappropriate
use
of
the
product may increase the prevalence of bacteria resistant to
tilmicosin
and may decrease the effectiveness of treatment with tilmicosin
related
substances.
4.5II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICI
                                
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