Tylan 200, 200mg/ml Solution for Injection

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Tylosin

Dostępny od:

Elanco Animal Health, Eli Lilly and Company Limited

Kod ATC:

QJ01FA90

INN (International Nazwa):

Tylosin

Dawkowanie:

200 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Cattle, Pigs

Dziedzina terapeutyczna:

tylosin

Wskazania:

Antibacterial

Status autoryzacji:

Authorised

Data autoryzacji:

1988-10-01

Charakterystyka produktu

Health Products Regulatory Authority
28 September 2017
CRN000VVX
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylan 200, 200mg/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.
Health Products Regulatory Authority
28 September 2017
CRN000VVX
Page 2 of 5
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of this product should be based on susceptibility test