TYLOGAL POWDER VETERINARY

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

TYLOSIN AS TARTRATE

Tilgjengelig fra:

BIOVAC LTD., ISRAEL

Legemiddelform:

POWDER SOLUBLE

Sammensetning:

TYLOSIN AS TARTRATE 90.9 %W/W

Administreringsrute:

PER OS IN DRINKING WATER

Resept typen:

Required

Produsert av:

BIOVAC LTD., ISRAEL

Indikasjoner:

Chickens: Treatment and prevention of chronic respiratory diseases (CRD) caused by Mycoplasma gallisepticum and Mycoplasma synoviae when the disease has been established in the flock.Treatment and prevention of necrotic enteritis caused by Clostridium perfringens when the disease has been established in the flockTurkeys: Treatment and prevention of infectious sinusitis caused by Mycoplasma gallisepticum. when the disease has been established in the flock

Autorisasjon dato:

2022-12-31

Informasjon til brukeren

Page 1 of 4
CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
TYLOGAL POWDER VETERINARY, soluble powder for dissolution in drinking
water, containing TYLOSIN (AS TARTRATE salt) 90.9% W/W
2.
ACTIVE INGREDIENT AND QUANTITY IN A SINGLE DOSE
TYLOSIN (AS TARTRATE) 90.9 %W/W
Equivalent to 100% tylosin tartrate
3.
WHAT IS THE MEDICINE INTENDED FOR
Chickens:
- Treatment and prevention of chronic respiratory diseases (CRD)
caused by _Mycoplasma _
_gallisepticum_ and _Mycoplasma synoviae _when the disease has been
established in the flock.
- Treatment and prevention of necrotic enteritis caused by
_Clostridium perfringens_ when
the disease has been established in the flock.
_ _
Turkeys:
Treatment and prevention of infectious sinusitis caused by _Mycoplasma
gallisepticum_ when
the disease has been established in the flock.
Therapeutic group: Antibiotic of the macrolide group.
4.
CONTRA-INDICATIONS
Do not use in in case of known hypersensitivity to tylosin or other
macrolides.
Do not use in cases of known resistance to tylosin or cross-resistance
to other macrolides.
Do not use in animals vaccinated with tylosin-sensitive vaccines
either at the same time or
within 1 week previously.
Do not use in animals with hepatic disorders.
5.
SIDE EFFECTS
Side effects can be reported to the Ministry of Health by clicking on
the link "Adverse
Drug Reactions Repot" that appears on the home page of the Ministry of
Health web site
(www.health.gov.il), which leads to an online form for reporting side
effects. Alternatively
you can use the following link:
HTTPS://SIDEEFFECTS.HEALTH.GOV.IL/
6.
TARGET ANIMALS: Chickens, turkeys
7.
DOSAGE AND ADMINISTRATION
Administration through the drinking water.
1.1 gram of the product corresponds to 1 gram of tylosin. The
Dosages:
Turkeys:
75 – 100 mg tylosin per kg BW per day (corresponding to 82.5 – 110
mg of the product per
Page 2 of 4
kg BW) for 3 – 5 days.

Preparatomtale

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TYLOGAL POWDER VETERINARY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TYLOSIN AS TARTRATE 90.9 %W/W
Equivalent to 100% tylosin tartrate
3.
PHARMACEUTICAL FORM
POWDER SOLUBLE IN DRINKING WATER
.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens, turkeys
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Chickens: Treatment and prevention of chronic respiratory diseases
(CRD) caused by
_Mycoplasma _
_gallisepticum_
and
_Mycoplasma _
_synoviae _
when
the
disease
has
been
established in the flock.
Treatment and prevention of necrotic enteritis caused by _Clostridium
perfringens_ when the
disease has been established in the flock
_ _
Turkeys:
Treatment
and
prevention
of
infectious
sinusitis
caused
by
_Mycoplasma _
_gallisepticum. _when the disease has been established in the flock
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to tylosin or other
macrolides.
Do not use in cases of known resistance to tylosin or cross-resistance
to other macrolides
(MLS-resistance).
Do not use in animals vaccinated with tylosin-sensitive vaccines
either at the same time or
within 1 week previously.
Do not use in animals with hepatic disorders.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Page 2 of 5
Due
to
likely
variability
(time,
geographical)
in
susceptibility
of
bacteria
to
tylosin,
bacteriological sampling and susceptibility testing are recommended.
Under-dosing and/or treating for an insufficient length of time are
considered to promote
the development of resistance in bacteria and should be avoided.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Animals with acute infections may have a reduced water and feed
consumption and
should be treated with a suitable injectable veterinary medicinal
product first.
Do not leave or dispose of water containing tylosin tartrate where it
may be accessible to
either animals not under treatment or wildlife.
Special precautions for the person administeri