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SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 40 G/KG PREMIX
Huvepharma NV
Page 1 of 3
PACKAGE LEAFLET
TILMOVET 40 G/KG PREMIX for medicated feeding stuff 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
Huvepharma NV, UItbreidingstraat 80, 2600 Antwerpen, Belgium
Manufacturer responsible for batch release
1. Biovet JSC, 39 Petar Rakov Str, 4550 Peshtera
– Bulgaria
2. Qalian, 34 Rue Jean Monnet,
Z.I. d’Étriché , 49500 SEGRÉ Cedex, France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET 40 G/KG PREMIX for medicated feeding stuff for pigs
tilmicosin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
_The product is a yellowish tan to reddish tan free-flowing granular material containing _40 g
tilmicosin per kg
4.
INDICATION(S)
Tilmovet Premix 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
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SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 40 G/KG PREMIX
Huvepharma NV
Page 1 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TILMOVET 40 G/KG PREMIX
for medicated feeding stuff for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: 40 g tilmicosin per kg
For a full list of excipients: see section 6.1
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
A yellowish tan to reddish tan free-flowing granular material.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Weaned fattening pigs
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Tilmovet Premix 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.
SUMMARY OF PRODUCT CHARACTERISTICS
TILMOVET 40 G/KG PREMIX
Huvepharma NV
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Cross-resistance between tilmicosin and other macrolide antibiotic has been
observed .Use of the product should b
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