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SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 100 MG/G ORAL GRANULES
HUVEPHARMA NV
Page 1 of 3
PACKAGE LEAFLET
TILMOVET
100 MG/G GRANULES FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE
FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder
Huvepharma NV, UItbreidingstraat 80, 2600 Antwerpen, Belgium
Manufacturer
Biovet JSC, 39 Petar Rakov Str, 4550 Peshtera – Bulgaria
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET
100 MG/G OAL GRANULES for pigs
tilmicosin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each g contains 100 mg of Tilmicosin.
A Brown granulated powder
4.
INDICATION(S)
TILMOVET
100 mg/g Granules is indicated for the treatment of pneumonia in weaned
fattening pigs, caused by _Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae, _
_Pasteurella multocida_ and other organisms sensitive to tilmicosin.
5.
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.
6.
ADVERSE REACTIONS
Occasionally, feed intake may decrease (including feed refusal) in animals receiving
medicated feed. This effect is transient
If you notice any serious effects or other effects not mentioned in this leaflet, please inform
your veterinary surgeon.
7.
TARGET SPECIES
Weaned fattening pigs
SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 100 MG/G ORAL GRANULES
H
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产品特点
SKP
–EN Versie
TILMOVET 100 MG/G
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET 100 MG/G GRANULES for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains 100 mg of Tilmicosin.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules.
A brown granulated powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Weaned fattening pigs.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
TILMOVET 100 mg/g Granules is indicated for the treatment of pneumonia in
weaned 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.
SKP
–EN Versie
TILMOVET 100 MG/G
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. Inappropriate use
of the product may increase the prevalence of bacteria resistant to tilmicosin
and may decrease the effectiv
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