Tylolab tartrate 200,000 IU/ml solution for injection

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Tylosin tartrate

Saatavilla:

Labiana Life Sciences, S.A.

ATC-koodi:

QJ01FA90

INN (Kansainvälinen yleisnimi):

Tylosin tartrate

Lääkemuoto:

Solution for injection

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

tylosin

Valtuutus päivämäärä:

2023-09-22

Valmisteyhteenveto

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tylolab tartrate 200,000 IU/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Tylosin tartrate
200,000 IU
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Benzyl alcohol (E 1519)
5 mg
Propylene glycol
Sodium citrate
Water for injections
Clear, yellow or yellow-orangish solution, free from visible
particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle:
•
For the treatment of respiratory infections caused by
_Pasteurella multocida, Trueperella _
_pyogenes_
or
_Fusobacterium necrophorum._
•
For the treatment of foot infections caused by
_Fusobacterium necrophorum._
Pigs:
•
For the treatment of respiratory infections caused by
_Pasteurella multocida_
or
_Mycoplasma _
_hyopneumoniae_
.
•
For the treatment of mycoplasmal arthritis caused by
_Mycoplasma hyosynoviae_
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, other
macrolides or to any of the
excipients.
Do not use in animals with renal and /or liver failure.
Do not administer to horses or other equines in which injection of
tylosin may be fatal.
Do not use in suspected cases of cross-resistance to other macrolides
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Cross-resistance has been shown between tylosin and other macrolides
or lincosamides. Use of the
veterinary medicinal product should be carefully considered when
susceptibility testing has shown
resistance to macrolides or lincosamides because its effectiveness may
be reduced.
Use of the veterinary medicinal product should be based on
identification and susceptibility testing of
the target pathogen(s). If this is not possible, therapy should be
based on epidemiological information
a