Tylan G250 Premix for medicated feeding stuff

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Tylosin phosphate

Disponible desde:

Elanco GmbH

Código ATC:

QJ01FA90

Designación común internacional (DCI):

Tylosin phosphate

Dosis:

250 gram(s)/kilogram(s)

formulario farmacéutico:

Premix for medicated feeding stuff

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

tylosin

Estado de Autorización:

Authorised

Fecha de autorización:

1999-05-14

Ficha técnica

Health Products Regulatory Authority
27 July 2018
CRN008DD8
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylan G250 Premix for medicated feeding stuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tylosin activity (as tylosin phosphate) 250 g per kg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Light tan coloured, free flowing granular material.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs, broilers and pullets.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
For the prevention and control of enzootic pneumonia.
For the treatment and control of _Lawsonia intracellularis_, the
organism associated
with Porcine Intestinal Adenomatosis (Ileitis) and Porcine
Haemorrhagic Enteropathy.
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.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity.
Do not use in animals vaccinated with tylosin-sensitive vaccines
either at the same time or
within one week previously
Health Products Regulatory Authority
27 July 2018
CRN008DD8
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For incorporation into medicated feedingstuffs only.
To ensure thorough dispersion of the product it should first be mixed
with a small
quantity of feed ingredients before incorporation into the final mix.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Tylosin may induce irritation. Macrolides, such as tylosin, may also
cause
hypersensitivity (alle