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 almos

Ciri produk

DescriptionDIQUAS ® 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, pot\
assium chloride, chlorhexidine gluconate, and dilute hydrochloric acid or sodiu\
m hydroxide as pH adjuster. Its pH is 7.2 - 7.8 and its osmolar ratio is 1.0 - 1.1.
IndicationsThe product should be used in patients diagnosed with dry eye, associated with keratoconjunctival epithelium disorders that accompany lacrimal fluid ab\
normality.
Dosage and AdministrationInstill 1 drop a time in the affected eye(s) 6 times daily.
ContraindicationsPatients with a history of hypersensitivity to any of the ingredients of \
this product.
Precautions1.Adverse ReactionsAdverse drug reactions (including abnormal changes in laboratory test values) were reported in 155 of 655 patients (23.7%) in clinical trials conduc\
ted 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 observational study in Japan. The major adverse reactions were eye irrit\
ation 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%) and blepharitis in 19 pati\
ents (0.6%), etc.If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken.
Incidence Type Incidence unknown ≧ 5% 0.1 - < 5%
Hypersensitivity − − Blepharitis
Ophthalmic
Corneal epithelium disorder (filamentary keratitis, keratitis superficial, corneal erosion, etc.) , conjunctivitis
Eye irritation Eye discharge, conjunctival hyperaemia,