Tylan 200, 200 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tylosin

Available from:

Elanco GmbH

ATC code:

QJ01FA90

INN (International Name):

Tylosin

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

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
12 June 2020
CRN009RCS
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylan 200, 200 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Tylosin (as the base) 200 mg/ml
Excipient
Benzyl Alcohol 40 mg/ml
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A sterile yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Tylan 200 mg/ml Solution for Injection is indicated for use in cattle
and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
TYLAN 200 mg/ml Solution for Injection is indicated in all conditions
associated with bacteria sensitive to tylosin which includes
organisms in the following genera:
​
Streptococcus
​Campylobacter
​
Bacillus
​Spirochaetes
​
Staphylococcus
​Fusiformis
​
Corynebacterium ​Pasteurella
​
Clostridium
​Chlamydia
​
Erysipelothrix
​
TYLAN 200 mg/ml Solution for Injection has been successfully used in
respiratory and genito-urinary tract infections, otitis,
cellulitis and secondary bacterial conditions associated with virus
disease or post-operative infections. Specific disease entities
treated successfully with TYLAN include Swine Dysentery, Erysipelas
and Enzootic Pneumonia in pigs, foul in the foot, mastitis
and calf pneumonia in cattle.
For the prevention and control of enzootic pneumonia, swine dysentery
and other scours caused by organisms sensitive to
tylosin, in pigs.
For the control of pneumonia in cattle associated with mycoplasmata
and _Pasteurella multocida _sensitive to tylosin.
4.3 CONTRAINDICATIONS
Tylan 200 should not be given to chickens or turkeys.
Do not use in animals with known hypersensitivity to the active
ingredients.
Do not use in equine animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
12 June 2020
CRN009RCS
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of this product should be base