DEXA-GENTAMICIN EYE DROPS

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

DEXAMETHASONE SODIUM PHOSPHATE; GENTAMICIN SULPHATE

Verfügbar ab:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (Internationale Bezeichnung):

DEXAMETHASONE SODIUM PHOSPHATE; GENTAMICIN SULPHATE

Einheiten im Paket:

5ml mL

Hergestellt von:

Ursapharm Arzneimittel GmbH

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
DEXA-GENTAMICIN EYE DROPS
_ _
Dexamethasone Phosphate/ Gentamicin Sulphate (1mg/5mg per 1ml)
1
WHAT IS IN THIS LEAFLET
1. What Dexa-Gentamicin is used for
2. How Dexa-Gentamicin works
3. Before you use Dexa-Gentamicin
4. How to use Dexa-Gentamicin
5. While you are using it
6. Side effects
7.Storage
and
Disposal
of
Dexa-
Gentamicin
8. Product Description
9.Manufacturer
and
Product
Registration Holder
10. Date of revision
WHAT DEXA-GENTAMICIN IS USED FOR
Dexa-Gentamicin is used for bacterial
infections
associated
with
allergic
reaction or inflammation of the eyes
or eyelids.
HOW DEXA-GENTAMICIN WORKS
Dexa-Gentamicin
contains
active
ingredients
of
dexamethasone
and
gentamicin.
Dexamethasone
is
in
corticosteroid
group
which
help
to
reduce
inflammation, redness and itchiness,
while gentamicin is an antibiotic that
kills
certain
bacteria
that
caused
infections.
BEFORE YOU USE DEXA-GENTAMICIN
_- When you must not use it _
Do not use Dexa-Gentamicin if:
•
you
are
allergic
to
dexamethasone,
gentamicin
sulphate
or
any
ingredients
of
this medicine (listed in Product
Description)
•
you have viral, tuberculous or
fungal infection or ulceration of
the eyes
•
you have increased pressure in
the eyes (glaucoma)
Consult
your
doctor
before
using
Dexa-Gentamicin.
_- Before you start to use it _
Please tell your doctor if you have
any medical illness.
Not to be used in children below 8
years old.
_Pregnancy and lactation _
Please
consult
your
doctor
or
pharmacist
if
you
are
pregnant,
planning
for
pregnancy
or
breast-
feeding before using any medicine.
Dexa-Gentamicin must only be used
during
pregnancy
if
the
benefits
is
more
than
the
risks
to
the
fetus.
Dexamethasone is secreted into breast
milk and may affect your baby. Your
doctor
will
discuss
the
risk
and
benefits
of
breast
feeding
while
you’re using Dexa-Gentamicin.
_- Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you buy without a prescription from a
pharmacy, supe

Fachinformation

DEXA-GENTAMICIN™ EYE DROPS
DEXAMETHASONE SODIUM PHOSPHATE 1.00 MG/ML AND GENTAMICIN SULPHATE 5.00
MG/ML
ANTIALLERGIC, ANTI-INFLAMMATORY AND ANTI-INFECTIVE AGENT
PRODUCT DESCRIPTION
Dexa-Gentamicin™ eye drops (1.0 mg/ml Dexamethasone sodium phosphate
and 5.0 mg/ml Gentamicin
sulphate) is a clear, colourless solution available as 5 ml solution
filled in plastic bottles with dropping
inserts and caps.
PHARMACOLOGY
PHARMACODYNAMICS
_ANTIBIOTIC_
The bactericidal action of Gentamicin is based on an irreversible
inhibition of the bacterial protein
synthesis. Gentamicin elicits rapid bacterial action by acting
directly on the bacterial ribosome, where
it disrupts the normal cycle of ribosomal function. Additionally,
Gentamicin includes misreading of the
genetic code of the mRNA template, leading to incorporation of
incorrect amino acids into the growing
polypeptide chain.
_CORTICOSTEROID_
The corticosteroid’s method of action is not yet completely known.
The corticosteroids are thought
to act by controlling the rate of synthesis of proteins important for
chemotactic and immunologic
reactions. Modifications of the leukocyte’s and macrophage’s
functions seem to have an influence on the
suppression of inflammatory and allergic reactions.
PHARMACOKINETICS
_ANTIBIOTIC_
Systemically available Gentamicin has a half-life of plasma of 2 to 3
hours in healthy adults and is
excreted unchanged by the kidneys. Topically applied, Gentamicin is
absorbed by conjunctiva and cornea
and is detectable in the aqueous humour 15 minutes after application.
Using Gentamicin on intact mucous
membranes of the eye, no detectable amounts of Gentamicin are to be
expected in serum.
_CORTICOSTEROID_
Dexamethasone sodium phosphate and Dexamethasone poorly penetrate an
intact corneal epithelium.
The penetration is significantly elevated in eyes with inflamed or
lesioned mucosal membranes.
Systemically absorbed Dexamethasone is bound to proteins to 80 %. It
is excreted by the kidneys
(as glucuronid) with a half-life of 3 to 4 hours.
INDICATIONS