Moxifcin Eye Drops 0.5% wv

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

MOXIFLOXACIN HCL

Διαθέσιμο από:

Y.S.P. INDUSTRIES (M) SDN. BHD.

INN (Διεθνής Όνομα):

MOXIFLOXACIN HCL

Μονάδες σε πακέτο:

5 ml

Κατασκευάζεται από:

Y.S.P. INDUSTRIES (M) SDN. BHD.

Φύλλο οδηγιών χρήσης

_Consumer Medication Information Leaflet (RiMUP)_
MOXIFCIN EYE DROPS 0.5% W/V
Moxifloxacin 5mg/ml
1
WHAT IS IN THIS LEAFLET
1.
What MOXIFCIN is used for
2.
How MOXIFCIN works
3.
Before you use MOXIFCIN
4.
How to use MOXIFCIN
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of MOXIFCIN
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MOXIFCIN IS USED FOR
MOXIFCIN
_ _
is
used
for
treatment
of
bacterial infections of the external part of
the eye.
HOW MOXIFCIN WORKS
MOXIFCIN contains moxifloxacin which
is a “fluoroquinolone” antibiotic.
BEFORE YOU USE MOXIFCIN
-
_When you must not use it _
Do not take MOXIFCIN if:
• You have known hypersensitivity to
any component of MOXIFCIN.
• You have allergy to any other similar
medicines.
• The seal around the cap is broken.
• The bottle/packaging shows signs of
tampering.
• The expiry date on the bottle/carton
has passed.
Do not put MOXIFCIN into your eye(s)
while you are wearing contact lenses.
_Pregnancy and lactation _
Do not take MOXIFCIN if you are
pregnant, trying to get pregnant or think
you
may be pregnant, or are breast
feeding.
Ask
your
doctor
or
pharmacist
for
advice before taking any medicine.
_ _
-
_Before you start to use it _
Tell your doctor or pharmacist if you
are allergic to any medicines or if you
have any other medical conditions.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
HOW TO USE MOXIFCIN
-
_How much to use _
The recommended dose is to instill one
drop in the affected eye 3 times a day
for 7 days. Any necessary dose change
should
be
according
to
doctor’s
recommendation(s) and supervision.
Follow these steps to use the eye drops:
1. Wash your hands thoroughly with
soap and water.
2. Remove the cap from the bottle.
3. Hold the bottle upside down in one
hand between your thumb and middle
finger (see Diagram 1).
_Diagram 1_
4. While tiltin

Αρχείο Π.Χ.Π.

PAGE 1
MOXIFCIN
EYE DROPS 0.5% W/V
INGREDIENT(S):
Each ml contains:
Moxifloxacin Hydrochloride (eq. to Moxifloxacin 5mg/ml) .........
5.45mg
PHARMACODYNAMIC:
Moxifloxacin has _ in vitro_ activity against a wide range of
Gram-positive
and
Gram-negative
microorganisms.
Moxifloxacin
inhibits
the
topoisomerase
II
(DNA
gyrase)
and
topoisomerase
IV
required
for
bacterial DNA replication, transcription, repair and recombination.
The
C8-methoxy moiety of moxifloxacin also 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.
Fluoroquinolones, including moxifloxacin, differ in chemical structure
and
mode
of
action
from
β-lactam
antibiotics,
macrolides
and
aminoglycosides, and therefore may be active against bacteria
resistant
to 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
following microorganisms, 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,
gentamicin, ofloxacin, tetra