ZANAFLOX EYE DROPS 0.5% WV

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

MOXIFLOXACIN HCL

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

MOXIFLOXACIN HCL

Unit dalam pakej:

5ml mL

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ZANAFLOX EYE DROPS 0.5%W/V
Moxifloxacin 0.5% w/v (as Moxifloxacin Hydrochloride)
Each ml contains 5mg of Moxifloxacin (as 5.45mg of Moxifloxacin HCl)
1
WHAT IS IN THIS LEAFLET:
1.
What is Zanaflox used for
2.
How Zanaflox works
3.
Before you use Zanaflox
4.
How to use Zanaflox
5.
While you are using Zanaflox
6.
Side effects
7.
Storage and disposal of Zanaflox
8.
Product Description
9.
Manufacturer and Product Registration Holder
10.
Date of Revision_ _
WHAT IS ZANAFLOX USED FOR
It
is
used
to
treat
inflammation
of
conjunctiva
(thin
membrane
that
covers
inner surface of eyelid and the white part
of eyeball) caused by susceptible strains of
microorganisms in patient 1 year of age
and older.
HOW ZANAFLOX WORKS
Moxifloxacin
is
a
bactericidal
which
inhibits the reproduction of bacteria.
BEFORE YOU USE ZANAFLOX
_When you must not use it _
Do not use Zanaflox if you are:

allergic
to
quinolones
including
moxifloxacin or any other ingredients
in this medicine.

going
to
drive
or
operate
any
machinery.
Do
not
drive
or
operate
machinery unless vision is clear upon
use.
_ _
_Before you start to use it _
Tell your doctor or pharmacist before using
Zanaflox if you:

are taking quinolones.

have a history of myasthenia gravis (a
condition causing abnormal weakness
of certain muscles).

have
any
other
infections
caused
by
fungus or virus.

are using other eye medicament.

wearing contact lenses.

are pregnant or plan to pregnant.

are
breast-feeding
or
plan
to
start
breast-feeding.
_ _
_Using other medicines _
Tell your doctor or pharmacist if you are
taking or having recently taken any other
medicines including other eye drops or
ointment and any other medicines which
you have bought without a prescription.
HOW TO USE ZANAFLOX
_How much to use _
For topical eye use only.
Instill one drop in the affected eye(s), 3
times a day for 7 days.
Not to be used for children below 1 year
old.
_ _
_When to use it _
Follow the prescription from your doctor
or phar

Ciri produk

Important information. Please read carefully.
_ ZANAFLOX EYE DROPS 0.5%W/V _
_ _
OPTHALMIC SOLUTION
COMPOSITION
Moxifloxacin 0.5% w/v (as Moxifloxacin Hydrochloride)
Each ml contains 5mg of Moxifloxacin (as 5.45mg of Moxifloxacin HCl)
PHARMACODYNAMICS
Moxifloxacin is a fluoroquinolone bactericidal and acts by inhibiting
the topoisomerase II
(DNA gyrase) and topoisomerase IV, which are essential enzymes in the
reproduction of
bacterial DNA.
PHARMACOKINETICS
_Absorption:_ Moxifloxacin is readily absorbed form the
gastrointestinal tract after oral doses
with an absolute bioavailability of about 90%.
_Distribution:_ Moxifloxacin is widely distributed throughout the body
tissues and is about 30
to 50% bound to plasma proteins.
_Metabolism:_ Moxifloxacin has an elimination half-life of about 12
hours, allowing once-daily
dosing. It is metabolized mainly via sulfate and glucuronide
conjugation.
_Elimination:_ Moxifloxacin is excreted in the urine and the faeces as
unchanged drug and as
metabolites, the sulfate conjugate primarily in the faeces and the
glucuronide exclusively in
the urine.
_ _
INDICATIONS
Zanaflox is indicated for the treatment of patients 1 year of age and
older with bacterial
conjunctivitis caused by susceptible strains of the following
organisms:
GRAM-POSITIVE BACTERIA:
_Corynebacterium species*_
_Microbacterium species_
_Micrococcus luteus* _[including erythromycin, gentamicin,
tetracycline, and/or trimethoprim
resistant strains]
_Staphylococcus _
_aureus_
[including
methicillin,
erythromycin,
gentamicin,
ofloxacin,
tetracycline and/or trimethoprim resistant strains]
_Staphylococcus _
_epidermidis_
[including
methicillin,
erythromycin,
gentamicin,
ofloxacin,
tetracycline and/or trimethoprim resistant strains]
_Staphylococcus haemolyticus_ [including methicillin, erythromycin,
gentamicin, ofloxacin,
tetracycline and/or trimethoprim resistant strains]
_Staphylococcus _
_hominis_
[including
methicillin,
erythromycin,
gentamicin,
ofloxacin,
tetracycline and/or trimethoprim resistant strains]
_Staphylococ