BAYTRIL 5% INJECTABLE SOLUTION VETERINARY

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

ENROFLOXACIN

Dostupno od:

LIDORR ELEMENTS LTD

Farmaceutski oblik:

SOLUTION FOR INJECTION

Sastav:

ENROFLOXACIN 50 MG/ML

Administracija rute:

S.C

Tip recepta:

Required

Proizveden od:

BAYER ANIMAL HEALTH GmbH, GERMANY

Terapijske indikacije:

In calves:Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of Pasteurellamultocida, Mannheimia haemolytica and Mycoplasma spp.Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of Escherichia coli.Treatment of septicaemia caused by enrofloxacin susceptible strains of Escherichia coli.Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of Mycoplasma bovis.only after the sensitivity of the bacteria has been proven and it has been found that there is no alternative treatment (proven resistance to other agents).

Datum autorizacije:

2022-06-30

Uputa o lijeku

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
Baytril 5%, injectable solution veterinary
2.
ACTIVE INGREDIENTS and quantity in a single dose:
Enrofloxacin 50 mg/ml
Excipients:
Butyl alcohol: 30 mg/ml.
For the full list of excipients, see section 13 in this leaflet.
3.
WHAT IS THE MEDICINE INTENDED FOR IN CALVES:
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible
strains of Pasteurella multocida, Mannheimia haemolytica and
Mycoplasma spp.
Treatment of infections of the alimentary tract caused by enrofloxacin
susceptible
strains of Escherichia coli.
Treatment of septicaemia caused by enrofloxacin susceptible strains of
Escherichia
coli.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin
susceptible
strains of Mycoplasma bovis.
Only after the sensitivity of the bacteria has been proven and it has
been found that
there is no alternative treatment (proven resistance to other agents).
Therapeutic group: Fluoroquinolone antibiotic for systemic use.
4.
CONTRA-INDICATIONS
Do not use in animals with known hypersensitivity to enrofloxacin or
other
fluoroquinolones or to any of the excipients.
Do
not
use
in
animals
that
are
epileptic
or
suffer
from
seizures
since
enrofloxacin may cause Central Nervous System stimulation.
5.
SIDE EFFECTS
In very rare cases (less than 1 in 10,000 animals) Digestive tract
disorders (e.g.
diarrhoea) may occur. These signs are generally mild and transient.
In very rare cases (less than 1 in 10,000 animals), transient local
tissue injection site
reactions may occur, and may be observed up to 14 days.
Side effects can be reported to the Ministry of Health by clicking on
the link
"Adverse Drug Reactions Report" 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

Svojstava lijeka

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BAYTRIL 5% INJECTABLE SOLUTION VETERINARY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin: 50 mg
EXCIPIENT:
Butyl alcohol:30 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear light-yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CALVES
Treatment of infections of the respiratory tract caused by
enrofloxacin
susceptible strains of _Pasteurella multocida, Mannheimia haemolytica
_and
_Mycoplasma _spp.
Treatment of infections of the alimentary tract caused by enrofloxacin
susceptible strains of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of
_Escherichia coli_.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin
susceptible strains of _Mycoplasma bovis_
_Only after the sensitivity of the bacteria has been proven and it has
been _
_found that there is no alternative treatment (proven resistance to
other _
_agents). _
_ _
Page 2 of 8
_ _
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to enrofloxacin or
other
fluoroquinolones or to any of the excipients listed in section 6.1.
Do not use in animals that are epileptic or suffer from seizures since
enrofloxacin may cause CNS stimulation.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account
when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded poorly, or are expected to respond
poorly, to other classes of antimicrobials.
fluoroquinolones should only be used based on susceptibility testing.
Use of the product including use deviating from the instructions given
in the SPC may increase the prevalence of b