Glanatec Ophthalmic Solution 0.4%

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

Ripasudil hydrochloride hydrate

Verfügbar ab:

DKSH MALAYSIA SDN. BHD.

INN (Internationale Bezeichnung):

Ripasudil hydrochloride hydrate

Einheiten im Paket:

5 ml

Hergestellt von:

Teika Pharmaceutical Co., Ltd. Shinjo Factory

Gebrauchsinformation

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
GLANATEC
_®_ OPHTHALMIC SOLUTION 0.4%
Ripasudil hydrochloride hydrate 4.896 mg/mL (4.0 mg as ripasudil)
1
WHAT IS IN THIS LEAFLET
1.
What GLANATEC
®
is used for
2.
How GLANATEC
®
works
3.
Before you use GLANATEC
®
4.
How to use GLANATEC
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GLANATEC
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT GLANATEC
® IS USED FOR
GLANATEC
®
is used for
reduction
of intraocular pressure (lOP) in
patients with glaucoma and ocular
hypertension in whom other
antiglaucoma drugs are not
sufficiently effective or cannot be
used.
HOW GLANATEC
® WORKS
GLANATEC
®
contains Ripasudil
hydrochloride hydrate that belongs to
a group of medicines known as Rho
kinase inhibitor. Ripasudil
hydrochloride hydrate lowers IOP by
facilitating the outflow of fluid
(aqueous humor) from the major
pathway.
GLANATEC
®
is used to reduce the
pressure in your eye if you have
conditions known as glaucoma or
ocular hypertension. Both these
conditions are linked to an increase in
the pressure within your eye,
eventually affecting your eyesight.
Your doctor will prescribe you
GLANATEC
®
when other medicines
have not worked adequately.
BEFORE YOU USE GLANATEC
®
GLANATEC
®
can be used in adult
(including the elderly).
GLANATEC
®
is not recommended
for children or adolescents because
the safety and efficacy have not been
established.
_- When you must not use it _
Do not use GLANATEC
®
:
-
if you are allergic
(hypersensitive) to Ripasudil
hydrochloride hydrate, or any of
the components of
GLANATEC
®
(see “Product
Description”).
-
if you are pregnant (or trying to
become pregnant)
-
if you are breastfeeding
_- Before you start to use it _
_ _
Talk to your doctor or pharmacist
before using GLANATEC
®
if you
have now or have had in the past:
-
You wear contact lenses. Follow
the instructions for contact lens
wearers (see “Contact lenses
wearers”)
Tell you

Fachinformation

KOWA COMPANY, LTD.
GLANATEC OPHTHALMIC SOLUTION 0.4%
1.
NAME OF THE MEDICINAL PRODUCT
GLANATEC ophthalmic solution 0.4%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of the ophthalmic solution contains 4.896 mg of ripasudil
hydrochloride
hydrate equivalent to 4.0 mg of ripasudil.
Each bottle of 5 mL of the ophthalmic solution contains 24.48 mg of
ripasudil
hydrochloride hydrate equivalent to 20.0 mg of ripasudil.
Excipients with known effect
Each mL of the ophthalmic solution contains 0.04 mg of benzalkonium
chloride
concentrated solution 50.
For a full list of excipients see Section 6.1.
3.
PHARMACEUTICAL FORM
Sterile aqueous ophthalmic solution
Colorless to clear light yellow
pH 5.0 to 7.0
Osmotic pressure ratio of approximately 1 (ratio to isotonic sodium
chloride solution)
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GLANATEC is indicated to decrease elevated intraocular pressure in
patients with
ocular hypertension or open-angle glaucoma as adjunctive therapy in
patients who are
insufficiently responsive to topical beta-blockers or prostaglandin
analogues, or as
monotherapy in patients who are intolerant or contraindicated to other
intraocular
pressure lowering medications.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Use in adults
(aged 20 years or older), including the elderly
Instill one drop into the affected eye(s) twice daily.
Use in paediatric population
Safety in low birth weight infants, newborns, infants, and children
has not been
established.
METHOD OF ADMINISTRATION
(1) Route of administration: Instillation only.
(2) When dispensing the drug: Instruct patients on the following:
1) In the instillation, the patient should tilt the head backwards,
open the affected
eye, instill the drug into the conjunctival sac, close the eyelid for
1 to 5 minutes
while compressing the lacrimal part, and open the eye.
2) Be careful during the instillation to avoid direct contact of the
tip of the container
with the eye in order to prevent contamination of the drug.
3) Instill with an interval of