SVOZ (0.5%wv OPHTHALMIC SOLUTION)

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

MOXIFLOXACIN HCL

Disponibil de la:

SPG PHARMA (MALAYSIA) SDN BHD

INN (nume internaţional):

MOXIFLOXACIN HCL

Unități în pachet:

1 x 5 mL BOTTLE

Produs de:

SIAM BHEASACH CO LTD

Prospect

_ _
_ _
_ _
_ Consumer Medication Information Leaflet (RiMUP)_
SVOZ (0.5% OPHTHALMIC SOLUTION)
Moxifloxacin 5 mg/mL
1
WHAT IS IN THIS LEAFLET
1.
What SVOZ is used for
2.
How SVOZ works
3.
Before you use SVOZ
4.
How to use SVOZ
5.
While you are using SVOZ
6.
Side effects
7.
Storage and Disposal of SVOZ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT SVOZ IS USED FOR
SVOZ is an ophthalmic solution
used to treat bacterial conjunctivitis
(infection of the eye) caused by
bacteria.
HOW SVOZ WORKS
SVOZ belongs to a class of
medicines known as fourth-
generation fluoroquinolone.
It works by preventing the growth
of bacteria organisms which causes
your infection.
BEFORE YOU USE SVOZ
_When you must not use it _
Do not use SVOZ if you are:
▪
allergic to quinolones,
moxifloxacin or any other
ingredients in this product
▪
going to drive or operate
machinery, wait until vision is
clear before use
_Before you start to use it _
Tell your doctor or pharmacist
before using SVOZ if you:
▪
are taking quinolones
▪
have any other infections caused
by fungus or virus
▪
are using other eye medications
▪
are pregnant or plan to get
pregnant
▪
are breast-feeding or plan to start
breast-feeding
_Taking other medicines _
Tell your doctor or pharmacist if
you are taking or have recently
taken any medicines, including
traditional products bought without
a prescription.
HOW TO USE SVOZ
_How much to use _
For topical eye use only.
Instill 1 drop in the affected eye 3
times a day for 7 days.
If you are using other eye
medications, wait at least 5 minutes
apart. Eye ointments should be
applied last.
Not to be used in infant below 1
year of age.
(See
DIAGRAM 1-3 _Instructions for _
_use_
on the next page)
_When to use it _
Use as directed by your doctor or
pharmacist.
_How long to use it _
Follow the prescription from your
doctor.
_If you forget to use it _
Take your next scheduled dose at
the correct time. Do not double the
dose to make up for the missed
dose.
_If you use too much (ov

Caracteristicilor produsului

PRODUCT NAME
SVOZ (0.5% OPHTHALMIC SOLUTION)
NAME AND STRENGTH OF ACTIVE SUBSTANCE
1 mL of solution contains: 5.45 mg moxifloxacin hydrochloride
(equivalent to 5 mg moxifloxacin)
PRODUCT DESCRIPTION
Clear greenish-yellow solution
PHARMACODYNAMICS
Pharmacotherapeutic group: ophthalmologicals, anti-infectives, other
anti-infectives
Mechanism of Action
Moxifloxacin, a fourth-generation fluoroquinolone, inhibits the DNA
gyrase and topoisomerase
IV required for bacterial DNA replication, repair, and recombination.
The C8-methoxy moiety
of moxifloxacin lessens the selection of resistant mutants of
Gram-positive bacteria compared
to the C8-H moiety found in older fluoroquinolones. Moxifloxacin’s
bulky C-7 substituent
group interferes with the quinolone efflux pump mechanism of bacteria.
Moxifloxacin is
often bactericidal at concentrations equal to or slightly greater than
inhibitory concentrations.
Microbiological Susceptibility
Fluoroquinolones, including moxifloxacin, differ in chemical structure
and mode of action
from
β
-lactam antibiotics, macrolides and aminoglycosides. Therefore,
organisms resistant
to these drugs may be susceptible to moxifloxacin. In vitro resistance
to moxifloxacin develops
slowly via multiple-step mutations and occurs at a general frequency
between 10-9 to 10-11
for Gram-positive bacteria.
Moxifloxacin has been shown to be active against most strains of the
microorganisms as
tabulated in FIGURE 1 below, both in vitro and in clinical infections.
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, genta