NEVANAC OPHTHALMIC SUSPENSION 0.1%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NEPAFENAC

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

NEPAFENAC

Unit dalam pakej:

5 ml

Dikeluarkan oleh:

ALCON COUVREUR N.V

Risalah maklumat

_Customer Medication Indication Leaflet (RiMUP) _
NEVANAC OPHTHALMIC SUSPENSION
Nepafenac 0.1% w/v
1
WHAT IS IN THIS LEAFLET
1.
What Nevanac is used for
2.
How Nevanac works
3.
Before you use Nevanac
4.
How to use Nevanac
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Nevanac
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NEVANAC IS USED FOR
Nevanac
contains
the
active
substance nepafenac, and belongs
to
a
group
of
medicines
called
nonsteroidal
anti-inflammatory
drugs (NSAIDs).
Nevanac
is
indicated
for
the
treatment
of
pain
and
inflammation
associated
with
cataract surgery.
Reduction
in
the
risk
of
after
operation
macular
oedema
(swelling in the macula, the central
part of the retina at the back of the
eye)
associated
with
cataract
surgery in diabetic patients.
HOW NEVANAC WORKS
Nevanac
reduces
pain
and
inflammation
associated
with
cataract surgery.
BEFORE YOU USE NEVANAC
-
_When you must not use it _
Do not use Nevanac
•
if
you
are
allergic
to
nepafenac or any of the other
ingredients of this medicine
•
if you are allergic to non-
steroidal
anti-
inflammatories (NSAIDs).
•
if
you
have
experienced
asthma,
skin
allergy,
or
intense inflammation in your
nose
when
using
other
NSAIDs.
Examples
of
NSAIDs are: acetylsalicylic
acid, ibuprofen, ketoprofen,
piroxicam, diclofenac.
-
_Before you start use it _
Talk to your doctor, pharmacist
or nurse before using Nevanac if
you
have
the
following
condition:
1.
bleeding tendency
2.
eye disorder
3.
eye infection
4.
diabetes
5.
rheumatoid arthritis
6.
eye surgery
Avoid sunlight during treatment
with Nevanac.
Wearing
contact
lenses
is
not
recommended
after
cataract
surgery. Your doctor will advise
you when you can use contact
lenses again.
_Pregnancy and breast-feeding _
If you are pregnant, or might get
pregnant,
talk
to
your
doctor
before you use Nevanac. Women
who may become pregnant are
advised
to
use
effective
contraception
during
Nevanac
treatment. The use of Nevanac is
not
recommended
during
pre

Ciri produk

Novartis
Malaysia Package Insert 19-Nov-2020 Nevanac
®
1.
NAME OF THE MEDICINAL PRODUCT
NEVANAC
1 mg/ml eye drops, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of suspension contains 1 mg nepafenac.
Excipient with known effect
Each ml of suspension contains 0.05 mg of benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension
Light yellow to light orange uniform suspension, pH 7.4
(approximately).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEVANAC
®
ophthalmic suspension is indicated for the treatment of pain and
inflammation
associated with cataract surgery. Reduction in the risk of
postoperative
macular
oedema
associated with cataract surgery in diabetic patients (see section
5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Recommended Dose and Dosage Adjustment _
Shake well before use. One drop of NEVANAC
®
ophthalmic suspension should be applied
to the affected eye(s) three-times-daily beginning 1 day prior to
cataract surgery, continued on
the day of surgery and through the first 2 weeks of the postoperative
period.
For the reduction in the risk of postoperative macular oedema
associated with cataract surgery
in diabetic patients, the dose is 1 drop of NEVANAC in the
conjunctival sac of the affected
eye(s) 3 times daily beginning 1 day prior to cataract surgery,
continued on the day of surgery
and up to 60 days of the postoperative period as directed by the
clinician. An additional drop
should be administered 30 to 120 minutes prior to surgery.
_Special populations_
_Patients with renal or hepatic impairment _
NEVANAC
has
not
been
studied
in
patients
with
hepatic
disease
or
renal impairment.
Nepafenac is eliminated primarily through biotransformation and
the
systemic
exposure is
Novartis
Malaysia Package Insert 19-Nov-2020 Nevanac
®
very low following topical ocular administration. No dose adjustment
is warranted in these
patients.
_Paediatric population _
The safety and efficacy of NEVANAC in children and adolesce