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 gram(s)

Pharmaceutical form:

Powder for oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

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.
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