Tylan G50 Premix for medicated feedingstuff

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Tylosin phosphate

Dostępny od:

Elanco GmbH

Kod ATC:

QJ01FA90

INN (International Nazwa):

Tylosin phosphate

Dawkowanie:

50 gram(s)/kilogram(s)

Forma farmaceutyczna:

Premix for medicated feeding stuff

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

tylosin

Status autoryzacji:

Authorised

Data autoryzacji:

1999-11-26

Charakterystyka produktu

Health Products Regulatory Authority
27 July 2018
CRN008DD8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylan G50 Premix for medicated feedingstuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tylosin activity (as tylosin phosphate) 50 g per kg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feedingstuff.
Light tan coloured, free flowing granular material.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
For use in pig feeds 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.
Health Products Regulatory Authority
27 July 2018
CRN008DD8
Page 2 of 5
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
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 (allergy) following injection, inhalation, ingestion
or contact with skin
or eye. Hypersensitivity to tylosin may lead to cross reactions to
other macrolides
and vice versa. Allergic reactions to these substances may
occasionally be serious
and therefore direct contact should be avoided.
To avoid exposure during preparation of the medicated feed, wear
overalls, safety
glasses, impervious gloves and wear either a disposable half mask
respirator
conforming to European Standard EN149 or a non-disposable re