Ducressa (Dexamethasone 1mgml + Levofloxacin 5mgml) eye drops solution

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXAMETHASONE SODIUM PHOSPHATE; Levofloxacin hemihydrate

Boleh didapati daripada:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

DEXAMETHASONE SODIUM PHOSPHATE; Levofloxacin hemihydrate

Unit dalam pakej:

1 x 5 ml

Dikeluarkan oleh:

Tubilux Pharma S.p.A.

Risalah maklumat

DUCRESSA
® 1MG/ML + 5MG/ML EYE DROPS
SOLUTION
Dexamethasone/Levofloxacin
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DUCRESSA is used for
2.
How DUCRESSA works
3.
Before you use DUCRESSA
4.
How to use DUCRESSA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DUCRESSA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DUCRESSA IS USED FOR
Ducressa is an eye drops solution that
contains
levofloxacin
and
dexamethasone.
Ducressa
is
used
to
prevent
and
treat
inflammation
and
prevent
possible
infection of the eye after cataract surgery
in adults.
HOW DUCRESSA WORKS
Levofloxacin is an antibiotic of the type
called
fluoroquinolones
(sometimes
shortened
to
quinolones).
It
works
by
killing some types of bacteria that can
cause infections.
Dexamethasone is a corticosteroid, it has
an
anti-inflammatory
action
(stopping
symptoms like pain, heat, swelling and
redness).
BEFORE YOU USE DUCRESSA
-
_When you must not use it_
-
if you are allergic to levofloxacin (or
other quinolones) or dexamethasone
(or other corsticosteroids) or any of
the
other
ingredients
of
this
medicine.
-
if
you
are
suffering
from
an
eye
infection
that
you
are
not
using
medicine
for
including
viral
(like
herpes
simplex
keratitis
or
varicella),
fungal
infections
and
tuberculosis of the eye.
You could have an infection if you have
a sticky discharge from your eye or if
you have a red eye that has not been seen
by a doctor.
-
_Before you start use it_
Talk
to
your
doctor
before
using
Ducressa:
•
If you are using any other antibiotic
treatment, including oral antibiotics.
As
with
other
anti-infectives,
prolonged use may induce antibiotic
resistance
with
the
result
of
overgrowth
of
pathogenic
microrganisms.
•
If you suffer from high pressure in
the eye or if you have already had
high pressure in the eye after using an
eye steroid medicine. You are at risk
of
having
this
again
if
you
use
Ducressa.
If
you
suffer
from
high
pressure in the eye tell your doc

Ciri produk

1. NAME OF THE MEDICINAL PRODUCT
Ducressa 1 mg/ml + 5 mg/ml, eye drops, solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml of eye drops solution contains dexamethasone sodium phosphate
equivalent to 1 mg of dexamethasone
and levofloxacin hemihydrate equivalent to 5 mg of levofloxacin.
One drop (about 30 microliter) contains about 0.03 mg of dexamethasone
and 0.150 mg of levofloxacin.
3. PHARMACEUTICAL FORM
Eye drops solution (eye drops).
A clear, greenish-yellow, sterile aqueous ophthalmic solution
practically free from particles with a pH of 7.0-
7.6 and osmolality of 270-330 mOsm/Kg. The expelled drops appear clear
and colorless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ducressa eye drops solution is indicated for prevention and treatment
of inflammation, and prevention of
infection associated with cataract surgery in adults.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One drop instilled into the conjunctival sac after surgery every 6
hours. Duration of treatment is 7 days. Care
should be taken not to discontinue therapy prematurely.
If one dose is missed, treatment should continue with the next dose as
planned.
Re-evaluation of the patient to assess the need to continue the
administration of corticosteroid eye drops as
monotherapy is recommended after the completion of one week of therapy
with Ducressa eye drops. The length
of this treatment can depend on the patient’s risk factors and
outcome of surgery and must be determined by
the doctor according to slit-lamp microscopic findings and depending
on the severity of the clinical picture. A
follow-up treatment with steroid eye drops should not normally exceed
2 weeks. However, care should be
taken not to discontinue therapy prematurely._ _
_ _
_Paediatric population: _
The safety and efficacy of Ducressa in children and adolescents below
the age of 18 years have not been
established. No data are available.
Ducressa is not recommended f