TYLAN SOLUBLE POWDER FOR ORAL SOLUTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TYLOSIN TARTRATE

Available from:

Elanco Animal Health, Eli Lilly and Company Limited

ATC code:

QJ01FA90

INN (International Name):

TYLOSIN TARTRATE

Dosage:

100 Grams

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

POM

Therapeutic group:

Bovine, Fowl - Chicken, Fowl - Turkey, Porcine

Therapeutic area:

Tylosin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylan Soluble Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Tylosin 100g activity per bottle as Tylosin Tartrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
A white to medium yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Tylan Soluble is indicated for use in calves, pigs and poultry.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of _Mycoplasma synoviae _airsacculitis in chickens and _Mycoplasma gallisepticum _S6 in chickens and
turkeys. In the field tylosin has also proved useful in reducing the level of infection following stress associated with
live vaccination.
As an aid in the control of outbreaks of necrotic enteritis in chickens caused by _Clostridium perfringens._
For the prevention and control of enzootic pneumonia, and scours caused by organisms (e.g. _Lawsonia intracellularis_)
sensitive to tylosin, in pigs.
For the control of pneumonia in cattle associated with mycoplasmata and _Pasteurella multocida _sensitive to tylosin.
For information regarding swine dysentery see section 4.5.
4.3 CONTRAINDICATIONS
Do not leave or dispose of water containing tylosin tartrate where it may be accessible to either animals not under treatment
or wildlife.
Do not use in animals with known hypersensitivity to tylosin or other macrolides.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 18/11/2014_
_CRN 7019358_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of this product should be based on su