RESTASIS 0.05% ww OPHTHALMIC EMULSION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

cyclosporine

Boleh didapati daripada:

ABBVIE SDN BHD

INN (Nama Antarabangsa):

cyclosporine

Unit dalam pakej:

0.4ml mL; 0.9ml mL; 0.4 ml 30 Units mL; 0.9 ml 30 Units mL

Dikeluarkan oleh:

Allergan Sales, LLC

Risalah maklumat

1
RESTASIS
TM
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
cyclosporine (0.05% w/v) Ophthalmic Emulsion
WHAT IS IN THIS LEAFLET
1.
What
RESTASIS
TM
is used for
2.
How
RESTASIS
TM
works
3.
Before you use
RESTASIS
TM
4.
How to use
RESTASIS
TM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
RESTASIS
TM
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
1.
WHAT RESTASIS
TM
IS USED FOR
RESTASIS
TM
is
used
to
increase
tear
production in patients whose eyes are not
producing
enough
tears
due
to
eye
inflammation associated with dry eye
2.
HOW RESTASIS
TM
WORKS
R E S T A S I S
T M
a c t s a s a t o p i c a l
immunomodulator
with
anti-
inflammatory effects.
3.
BEFORE YOU USE RESTASIS
TM
−
_ _
_When you must not use it _
Do not use
RESTASIS
TM
:
−
_ _
If you are allergic (hypersensitive to
cyclosporine,
or
any
of
the
other
ingredients of
RESTASIS
TM
. (for a
full list of ingredients, see section 8
“PRODUCT DESCRIPTION”).
−
_ _
If you have an active eye infection
−
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
think
you
may
be
pregnant
or
are
planning
to
have
a
baby,
ask
your
doctor or pharmacist for advice before
taking
this
medicine.
Do
not
use
RESTASIS
TM
if
you
are
pregnant
unless your doctor still recommends it.
Do not use
RESTASIS
TM
if you are
breast-feeding. It is not known whether or
not
cyclosporine
is
passed
into
breast
milk. Ask your doctor for advice
before taking any medicine during breast-
feeding.
−
_ _
_Children: _
The safety and efficacy of
RESTASIS
TM
have not been studied
in children below the age of 16.
_Herpes keratitis: _
RESTASIS
TM
has not been studied in
patients with a history of herpes keratitis.
Therefore,
before
you
use
RESTASIS
TM
, talk to your doctor or
pharmacist
if
you
have
a
history
of
herpes keratitis.
−
_ _
_Before you start use it _
Take special care with
RESTASIS
TM
.
The
emulsion
from
one
individual
single-use
vial
is
to
be
used
immediately
after
opening
for
administration
to one

Ciri produk

- Artwork is actual size
- Drop dieline and notes before processing
- Perforation required: No
Part number
Drawing number
Code 128 C
Page
20073490
0120001
5492
1 of 2
Global Label Management JAPAC
Black
Dieline
RESTASIS®
Cyclosporine Ophthalmic
Emulsion 0.05%
Sterile, Preservative-Free
5492
5492
20073490
DESCRIPTION
RESTASIS
®
(cyclosporine ophthalmic emulsion) 0.05% contains a topical
immunomodulator
with anti-inflammatory effects. Cyclosporine’s chemical name is
Cyclo[[(E)-(2S,3R,4R)-
3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-
N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-
methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure:
Structural Formula
Formula: C
62
H
111
N
11
O
12
Mol. Wt.: 1202.6
Cyclosporine is a fine white powder. RESTASIS
®
appears as a white opaque to slightly
translucent homogeneous emulsion. It has an osmolality of 230 to 320
mOsmol/kg and
a pH of 6.5-8.0.
Each mL of RESTASIS
®
contains:
Active:
cyclosporine 0.05%.
Inactive:
glycerin;
castor oil; polysorbate 80; carbomer 1342; purified water and sodium
hydroxide to adjust
the pH.
CLINICAL PHARMACOLOGY
Mechanism of action:
Cyclosporine
is
an
immunosuppressive
agent
when
administered systemically. In patients whose tear production
is presumed to be suppressed due to ocular inflammation
associated with keratoconjunctivitis sicca, cyclosporine
emulsion is thought to act as a partial immunomodulator.
The exact mechanism of action is not known.
Pharmacokinetics:
Blood cyclosporine A concentrations were measured using a specific
high pressure liquid
chromatography-mass spectrometry assay. Blood concentrations of
cyclosporine, in all
the samples collected, after topical administration of RESTASIS
®
0.05%, BID, in humans
for up to 12 months, were below the quantitation limit of 0.1 ng/mL.
There was no
detectable drug accumulation in blood during 12 months of treatment
with RESTASIS
®
.
Clinical Evaluations:
Four
multicenter,
randomized,
adequate
and
well-con