Tylan Soluble Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tylosin (as tylosin tartrate)

Available from:

Elanco GmbH

ATC code:

QJ01FA90

INN (International Name):

Tylosin (as 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 area:

tylosin

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
02 August 2018
CRN000YJT
Page 1 of 6
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.
Health Products Regulatory Authority
02 August 2018
CRN000YJT
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of this product should be based on susceptibility testing of the
bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional,
farm level) epidemiological information about susceptibility of the
target bacteria.
Whenever possible the product should only be used on the b