Pharmasin 250 mg/g Oral Granules
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
tylosin phosphate 250 mg/g
Available from:
Huvepharma N.V.
ATC code:
QJ01FA90
Pharmaceutical form:
Granules
Therapeutic group:
tylosin
Therapeutic area:
Pigs
Authorization date:
2009-03-12
Summary of Product characteristics
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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