Tylan G20 Premix for Medicated Feedingstuff

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Tylosin

Available from:

Eli Lilly and Company Limited

ATC code:

QJ01FA90

INN (International Name):

Tylosin

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1993-04-23

Summary of Product characteristics

Revised: October 2014
AN: 00702/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylan G20 Premix for medicated feedingstuff
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Tylosin activity (as tylosin phosphate) 20 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
For use in pig feeds only.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in known cases of hypersensitivity.
Revised: October 2014
AN: 00702/2014
4.5SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into
account when the product is used.
ii)
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 respirator to European Standard EN140 with a filter to
EN143.
Wash hands after use.
In the event of accidental skin contact, wash thoroughly with soap and
water. In case of accidental eye contact, flush the eyes with plent