Pharmasin 100000 IU/g Premix for Medicated Feeding Stuff for Pigs, Broilers and Pullets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: VMD (Veterinary Medicines Directorate)

Werkstoffen:

Tylosin

Beschikbaar vanaf:

Huvepharma N.V.

ATC-code:

Pharmaco

INN (Algemene Internationale Benaming):

Tylosin

farmaceutische vorm:

Premix for medicated feeding stuff

Prescription-type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutische categorie:

Chickens, Pigs

Therapeutisch gebied:

Antimicrobial

Autorisatie-status:

Authorized

Autorisatie datum:

2009-11-04

Productkenmerken

Revised: July 2020
AN: 01504/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Pharmasin 100 000 IU/g Premix for medicated feeding stuff for pigs,
broilers
and pullets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
Active substance:
Tylosin (as tylosin phosphate) : 100 000 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 (PIA)
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.
Revised: July 2020
AN: 01504/2019
Page 2 of 7
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 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 suscept