Deriva MS Aqueous Gel 0.1% ww

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ADAPALENE

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

ADAPALENE

Unit dalam pakej:

15gm mcg/mL

Dikeluarkan oleh:

GLENMARK PHARMACEUTICALS LTD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
_ _
1
DERIVA MS AQUEOUS GEL
Adapalene Gel Microspheres 0.1% w/w
WHAT IS IN THIS LEAFLET
1. What Deriva MS Aqueous
Gel is used for
2. How Deriva MS Aqueous
Gelworks
3. Before you use Adapalene
Gel Microspheres 0.1 w/w
4. How to use Deriva MS
Aqueous Gel
5. While you are using it
6. Side effects
7. Storage and Disposal of
Adapalene Gel Microspheres
0.1 w/w
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT DERIVA MS AQUEOUS
GELIS USED FOR
Deriva MS Aqueous Gel is a
prescription medicine for skin
use only (topical) used to treat
acne vulgaris in people 12 years
of age and older.
Acne vulgaris is a condition in
which the skin has blackheads,
whiteheads and pimples.
It is not known if Deriva MS
Aqueous Gel is safe and
effective in children younger
than 12 years of age
HOW DERIVA MS AQUEOUS GEL
WORKS
The active substance in Deriva
MS Aqueous Gel is adapalene
which has an anti-inflammatory
effect
reducing
soreness
and
irritation.
BEFORE YOU USE ADAPALENE
GEL MICROSPHERES 0.1 W/W
-
_When you must not use it _
Do not use Deriva MS Aqueous
Gel
if
you
are
allergic
to
adapalene
or
any
of
the
ingredients in this product. See
the
end
of
this
Consumer
Information
Leaflet
for
a
complete list of ingredients in
Deriva MS Aqueous Gel.
-
_Before you start to use it _
Tell your doctor if you:

have other skin problems,
including
eczema,
seborrhoeic
skin
inflammation

have
any
other
medical
conditions

have severe forms of acne
_Pregnancy, breast-feeding and _
_fertility _
It is not known if Deriva MS
Aqueous
Gel
can
harm
your
unborn
baby.
The
use
of
Adapalene is not recommended
during pregnancy. Talk to your
doctor if you are pregnant or
plan to become pregnant.
It is not known if Deriva MS
Aqueous Gel passes into your
breast milk and if it can harm
your baby. Talk to your doctor
about the best way to feed your
baby
if
you
use
Deriva
MS
Aqueous Gel.
To avoid contact exposure of
the infant, application of Deriva
MS Aqueous Gel to t

Ciri produk

PE00000 MY
PRODUCT REGISTRATION HOLDER
Glenmark Pharmaceuticals (Malaysia)
Sdn Bhn (660397-W)
D-31-02. Menara Suezcap 1,
No. 2, Jalan Kerinchi,
59200 Kuala Lumpur, Malaysia
SAME SIZE ARTWORK
LEAFLET SIZE: 140 mm x 352 mm
COMPOSITION:
Adapalene 0.1% w/w (As Microspheres)
In a aqueous gel base
PRESERVATIVES:
Methyl Hydroxybenzoate BP
0.1% w/w
Phenoxyethanol BP
0.25% w/w
PRODUCT DESCRIPTION:
A printed carton containing an insert &
printed lami tube containing opaque white
smooth homogenous gel.
GENERAL INFORMATION:
Adapalene Gel microspheres, containing
Adapalene
in
a
MICROSPONGE
DELIVERY
SYSTEM, is used for the topical treatment of
acne vulgaris. Each gram of Adapalene Gel
microspheres
contains
adapalene
0.1%
(1 mg), a retinoid analogue for the topical
treatment of acne vulgaris, as microspheres
a n d
p r e s e r v a t i v e s ,
v i z .
M e t h y l
Hydroxybenzoate and phenoxyethanol.
The chemical name of adapalene is 6-[3-(1-
adamantyl)-4 methoxyphenyl]-2-naphthoic
acid. Adapalene is a white to off- white
powder which is soluble in tetrahydrofuran,
sparingly soluble in ethanol, and practically
insoluble in water. The molecular formula of
adapalene is C H O , and its molecular
28
28
3
weight
is
412.52.
Adapalene
has
the
following structural formula:
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS:
Adapalene is a retinoid analogue for the
treatment of acne vulgaris. It is a naphthoic
acid Adapalenetive with a methoxyphenyl
adamantyl
side
chain.
Biochemical
and
pharmacological
profile
studies
have
demonstrated
that
adapalene
is
a
modulator
of
cellular
differentiation,
keratinization,
and
inflammatory
processes, all of which represent important
features in the pathology of acne vulgaris.
Adapalene is a chemically stable derivatice
of naphthoic acid that binds selectively to
the nuclear retinoic acid receptor (RAR)
subtypes
RAR
γ
(found
in
dermal
fibroblasts), activating genes responsible
for cellular differentiation; it does not bind to
cytosolic
retinoid
acid
binding
proteins.
Adapalene
is
thought
to
modulate
keratinisation