ENROFLOXACIN MEDIMARKET 5% VETERINAY

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

ENROFLOXACIN

Διαθέσιμο από:

A.L. MEDI-MARKET LTD.

Φαρμακοτεχνική μορφή:

SOLUTION FOR INJECTION

Σύνθεση:

ENROFLOXACIN 50 MG / 1 ML

Οδός χορήγησης:

S.C

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

CHANELLE PHARMACEUTICALS MANUFACTURING LTD., IRELAND

Θεραπευτικές ενδείξεις:

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).

Ημερομηνία της άδειας:

2023-12-31

Αρχείο Π.Χ.Π.

THIS LEAFLET FORMAT HAS BEEN DETERMINED BY THE MINISTRY OF HEALTH AND
THE CONTENT
HAS BEEN CHECKED AND APPROVED IN JANUARY 2019
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrofloxacin Medimarket 5% Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin: 50 mg
EXCIPIENT(S):
n-Butyl alcohol: 30 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Yellow Clear solution free from particulate matter.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
Enrofloxacin Medimarket 5% Veterinary should be used 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).
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
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.
Whenever possible fluoroquinolones should only be used based on