Pharmasin 25% Premix
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
tylosin tartrate 250 mg/g
Available from:
Huvepharma N.V.
ATC code:
QJ01FA90
Pharmaceutical form:
Premix for medicated feed
Therapeutic group:
tylosin
Therapeutic area:
Chicken Broilers, Chicken Young, Pigs
Authorization date:
2012-01-20
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
PHARMASIN 250 MG/G PREMIX
Huvepharma NV
Page 1 of 15
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PHARMASIN 250 MG/G PREMIX for medicated feeding stuff for pigs, broilers and pullets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tylosine (as tylosin phosphate) : 250 mg per g. (equivalent to 250 000 IU)
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Light tan coloured, free flowing granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs, broilers and pullets.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
Pigs
-
Treatment and prevention of Porcine Intestinal Adenomatosis (Ileitis)associated
with _Lawsonia intracellularis_ when the disease has been diagnosed at the group
or herd level,
-
Treatment and prevention of swine dysentery caused by _Brachyspira _
_hyodysenteria_e when the disease has been diagnosed in the herd.
Broilers and pullets:
-
Treatment and prevention of respiratory infections caused by _Mycoplasma _
_gallisepticum_ and _Mycoplasma synoviae, _when the disease has been diagnosed in
the flock_. _
-
Treatment and prevention of necrotic enteritis caused by _Clostridium _
_perfringens_, when the disease has been diagnosed in the flock.
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
PHARMASIN 250 MG/G PREMIX
Huvepharma NV
Page 2 of 15
4.3
CONTRAINDICATIONS
-
Do not use in animals with known sensitivity to the active substance and/or to any of the
excipients of the veterinary medicinal product,
-
Do not use in animals with known hyper sensitivity to tylosin and other macrolides,
-
Do not use where cross-resistance to other m
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