Pharmasin 250000 IU/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Tylosin

Available from:

Huvepharma N.V.

ATC code:

Pharmaco

INN (International Name):

Tylosin

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2009-10-20

Summary of Product characteristics

                                Revised: July 2020
AN: 01504/2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pharmasin 250 000 IU/g Premix for medicated feeding stuff for pigs,
broilers
and pullets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance:
Tylosine (as tylosin phosphate): 250 000 IU
Excipients:
For the 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 metaphylaxis of Porcine Intestinal Adenomatosis
(Ileitis)associated with Lawsonia intracellularis when the disease has
been diagnosed at the group or herd level.
Broilers and pullets:
-
Treatment and metaphylaxis of respiratory infections caused by
Mycoplasma gallisepticum and Mycoplasma synoviae, when the disease
has been diagnosed in the flock.
-
Treatment and metaphylaxis of necrotic enteritis caused by Clostridium
perfringens, when the disease has been diagnosed in the flock.
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.
Revised: July 2020
AN: 01504/2019
Page 2 of 6
Do not use in animals with known hyper sensitivity to tylosin and
other
macrolides.
Do not use where cross-resistance to other macrolides
(MLS-resistance)is
suspected.
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.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Animals with acute infections may have a reduced feed intake and
should be treated with a suitable injectable product first.
‘Due to likely variability (time, geographical) in susceptibilit
                                
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