MICROMOX EYE DROPS (Moxifloxacin Ophthalmic Solution 0.5 % wv)

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

MOXIFLOXACIN HCL

Dostupno od:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International ime):

MOXIFLOXACIN HCL

Jedinice u paketu:

1 x 5 ml

Proizveden od:

Micro Labs Limited

Uputa o lijeku

MICROMOX EYE DROPS
Moxifloxacin Ophthalmic Solution 0.5% w/v
_Consumer Medication Information Leaflet (RiMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What Micromox is used for
2.
How Micromox works
3.
Before you use Micromox
4.
How to use Micromox
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Micromox
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT
IS
MICROMOX
USED
FOR
Moxifloxacin eye drops are used for the
treatment
of
infections
of
the
eye
(conjunctivitis) when caused by bacteria.
The active ingredient is moxifloxacin an
ophthalmological anti-infective.
HOW MICROMOX WORKS
Moxifloxacin,
a
fourth-generation
fluoroquinolone, inhibits the DNA gyrase
and
topoisomerase
IV
required
for
bacterial
DNA
replication,
repair,
and
recombination.
BEFORE YOU USE MICROMOX
_-When you must not use it _
Do not use Moxifloxacin
•
If you are allergic (hypersensitive) to
moxifloxacin, to other quinolones, or any
of the other ingredients of this medicine
_-Taking other medications _
Tell your doctor or pharmacist if you are
taking, have recently taken, or might take
any other medicines, including medicines
obtained without a prescription.
HOW TO USE MICROMOX
Always use this medicine exactly as your
doctor or pharmacist has told you.
Check with your doctor or pharmacist if
you are not sure.
_-How much to use _
Adults, including the older, and children:
1 drop in the affected eye or eyes
_-When to use it _
3 times a day (in the morning, in the
afternoon and at night)
_-How long to use it _
4 days
_-If you forget to use it _
If
you
forget
to
use
the
medicine,
continue with the next dose as planned.
Do not use a double dose to make up for
a forgotten dose.
_-If you use too much (overdose) _
If
you
use
more
medicine
than
you
should, rinse it all out with warm water.
Do not put in any more drops until it is
time for your next regular dose.
WHILE YOU ARE USING IT
_-Things you must do _
Wash your hands
-
Twist off the cap
-
After cap is removed, if tamper evid

Svojstava lijeka

1
MOXIFLOXACIN OPHTHALMIC SOLUTION 0.5% W/V
MICROMOX EYE DROPS
BRAND OR PRODUCT NAME
MICROMOX EYE DROPS
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Moxifloxacin 0.5% w/v
PRODUCT DESCRIPTION
Clear, greenish- yellow solution practically free from particles
_PHARMACODYNAMICS:_
Pharmacotherapeutic group: Ophthalmologicals; anti-infective, other
anti-infective, ATC code: S01A E07
_MODE OF ACTION: _
Moxifloxacin, a fourth-generation fluoroquinolones, inhibits the DNA
gyrase and topoisomerase IV required for bacterial DNA
replication, repair, and recombination.
Resistance:
Resistance to fluoroquinolones, including moxifloxacin generally
occurs by chromosomal mutations in genes encoding DNA gyrase
and topoisomerase IV. In Gram-negative bacteria, moxifloxacin
resistance can be due to mutations in _ mar_ (multiple antibiotic
resistances) and the _ qnr_ (quinolone resistance) gene systems.
Resistance is also associated with expression of bacteria efflux
proteins and inactivating enzymes. Cross-resistance with beta-lactams,
macrolides and aminoglycosides is not expected due to
differences in mode of action.
SUSCEPTIBILITY TESTING BREAKPOINTS
There are no pharmacological data correlated with clinical outcome for
moxifloxacin administered as a topical agent. As a result, the
European Committee on Antimicrobial Susceptibility Testing (EUCAST)
suggests the following epidemiological cut-off values (ECOFF
mg/l) derived from MIC distribution curves to indicate susceptibility
to topical moxifloxacin:
Corynebacterium: ND
Staphylococcus aureus: 0.25 mg/l
Staphylococcus, coag-neg.: 0.25 mg/l
Streptococcus pneumonia: 0.5 mg/l
Streptococcus pyogenes: 0.5 mg/l
Streptococcus, viridans group: 0.5 mg/l
Enterobacter spp.: 0.25 mg/l
Haemophilus influenza: 0.125 mg/l
Klebsiella spp.: 0.25 mg/l
Moraxella catarrhalis: 0.25 mg/l
Morganella morganii: 0.25 mg/l
Neisseria gonorrhoeae: 0.032 mg/l
Pseudomonas aeruginosa: 4 mg/l
Serratia marcescens: 1 mg/l
The prevalence of acquired resistance may vary geographically and with
time for selected species and