DIQUAS Ophthalmic Solution 3%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Diquafosol Sodium

Boleh didapati daripada:

SANTEN PHARMA MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

Diquafosol Sodium

Unit dalam pakej:

5mL Units

Dikeluarkan oleh:

SANTEN PHARMACEUTICALS CO LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DIQUAS OPHTHALMIC SOLUTION 3%
Diquafosol sodium (30mg/mL)
WHAT IS IN THIS LEAFLET
1.
What Diquas is used for
2.
How Diquas works
3.
Before you use Diquas
4.
How to use Diquas
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Diquas
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT DIQUAS IS USED FOR
This medicine should be used in patients
diagnosed with dry eye, associated with
keratoconjunctival
(corneal)
epithelium
disorders that accompany lacrimal fluid
abnormality.
HOW DIQUAS WORKS
This
medicine
improves
keratoconjunctival epithelial disorder by
promoting secretion of mucin and water
as
components
of
tears,
thereby
improving the tear film conditions.
BEFORE YOU USE DIQUAS
-
_When you must not use it_
Do not use Diquas if you are allergic to
any of the ingredients of this product.
Diquas
contains
chlorhedixine.
Inform
your healthcare provider if you have a
known allergy to chlorhexidine.
Stop
using
this
product
and
seek
immediate
medical
assistance
if
you
experience
rash,
itching,
swelling,
breathing difficulties, light headedness or
rapid heartbeat.
-
_Before you start to use it_
Before using this medicine, be sure to tell
your doctor or pharmacist:

If
you
have
previously
experienced
any
allergic
reactions (itch, rash, etc.) to any
medicines.

If you are pregnant or
breastfeeding
-
_Taking other medicines_
If you are taking any other medicinal
products, some medicines may interact to
enhance or diminish medicinal effects.
Beware
of
over-the-counter
medicines
and dietary supplements as well as other
prescription medicines.
HOW TO USE DIQUAS
-
_How much to use_
In general, instill 1 drop at a time, 6
times
a
day.
Strictly
follow
the
instructions.
-
_When to use it_
6 times a day.
-
_How long to use it_
Do not stop using this medicine unless
your doctor instructs you to do so.
-
_If you forget to use it_
If you miss a dose, instill the missed dose
as soon as possible. If it is almost time

Ciri produk

Santen PI Blue
PRINTABLE COLOURS:
Profile
Technical Info
NON PRINT:
DESCRIPTION:
GLAMS PART NUMBER:
TECHNICAL DRAWING NO:
2D MATRIX:
DATE:
MARKET:
MATERIAL CODE:
SGK is a Matthews International Corporation
COMMERCIAL
ARTWORK
754794
Diquas 3% (MY) 5 ml Leaflet
CAW-5806-02
N/A
DIMENSION:
420 X 120 mm
PHARMA CODE:
004680
N/A
10-05-2023
MY
ARTWORK VERSION NUMBER:
SCHAWK JOB NO.:
108673493/403290901
03
CMO SPEC NUMBER:
N/A
CMO ITEM NUMBER:
N/A
Description
DIQUAS
®
ophthalmic solution is a clear, colorless and sterile aqueous
ophthalmic
solution. Each mL contains 30 mg of diquafosol sodium. It also
contains dibasic
sodium phosphate hydrate, disodium edetate hydrate, sodium chloride,
potassium
chloride, chlorhexidine gluconate, and dilute hydrochloric acid or
sodium hydroxide
as pH adjuster. Its pH is 7.2 - 7.8 and its osmolar ratio is 1.0 -
1.1.
Indications
The product should be used in patients diagnosed with dry eye,
associated with
keratoconjunctival epithelium disorders that accompany lacrimal fluid
abnormality.
Dosage and Administration
Instill 1 drop a time in the affected eye(s) 6 times daily.
Contraindications
Patients with a history of hypersensitivity to any of the ingredients
of this product.
Precautions
1.Adverse Reactions
Adverse drug reactions (including abnormal changes in laboratory test
values)
were reported in 155 of 655 patients (23.7%) in clinical trials
conducted in Japan
before approval. The major adverse reactions were eye irritation in 44
patients
(6.7%), eye discharge in 31 patients (4.7%), conjunctival hyperaemia
in 24 patients
(3.7%), eye pain in 18 patients (2.7%), eye itching in 16 patients
(2.4%), foreign
body sensation in eyes in 14 patients (2.1%) and ocular discomfort in
7 patients
(1.1%), etc.
Adverse reactions were reported in 202 of 3,196 patients (6.3%) in
post marketing
obser
vational study in Japan. The major adverse reactions were eye
irritation in 30
patients (0.9%), eye discharge in 30 patients (0.9%), eye pain in 22
patients (0.7%),
lacrimation increased in 20 patients (0.6%)