Pharmasin 250 mg/g Oral Granules
País: Alemania
Idioma: inglés
Fuente: HMA (Heads of Medicines Agencies)
Ficha técnica
(SPC)
21-08-2013
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Ingredientes activos:
tylosin phosphate 250 mg/g
Disponible desde:
Huvepharma N.V.
Código ATC:
QJ01FA90
formulario farmacéutico:
Granules
Grupo terapéutico:
tylosin
Área terapéutica:
Pigs
Fecha de autorización:
2009-03-12
Ficha técnica
SUMMARY OF PRODUCT CHARACTERISTICS
PHARMASIN 250 MG/G ORAL GRANULES
Huvepharma NV
Page 1 of 13
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHARMASIN
250 MG/G ORAL GRANULES FOR PIGS (BE, CZ, DE, IT, PL, NL)
TYLMASIN GRANULAT (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance:
Tylosin (as tylosin phosphate) : 250 mg per g (equivalent to 250 000 IU)
Excipients:
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Oral granules
Light tan coloured, free flowing granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Pigs: Treatment and prevention of clinical signs of porcine proliferative enteritis (porcine
intestinal adenomatosis, proliferative hemorrhagic enteropathy, ileitis) associated with
_Lawsonia intracellularis _when the disease has been diagnosed at the group level._ _
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active substance and/or to any of
the excipients of the product.
Do not use in animals with known hypersensitivity to tylosin and other macrolides.
Do not use where cross-resistance to other macrolides (MLS resistance) is suspected.
SUMMARY OF PRODUCT CHARACTERISTICS
PHARMASIN 250 MG/G ORAL GRANULES
Huvepharma NV
Page 2 of 13
Do not use in animals vaccinated with tylosin-sensitive vaccines either at the same time or
within 1 week previously.
Do not use in animals with hepatic disorders.
Do not use in horses – danger of inflammation of the cecum.
SUMMARY OF PRODUCT CHARACTERISTICS
PHARMASIN 250 MG/G ORAL GRANULES
Huvepharma NV
Page 3 of 13
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