CLOBEX SHAMPOO 0.05%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Clobetasol propionate

Available from:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC code:

D07AD01

Dosage:

0.05%

Pharmaceutical form:

SHAMPOO

Composition:

Clobetasol propionate 0.05%

Administration route:

TOPICAL

Prescription type:

Prescription Only

Manufactured by:

LABORATOIRES GALDERMA (125ml, 60ml,30ml)

Authorization status:

ACTIVE

Authorization date:

2007-03-14

Patient Information leaflet

NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
S H A M P O O
C L O B E X
®
( c l
o b e t a s o l
p r o p i
o n a t e )
S h a m p o o ,
0 .
0 5 %
Product code: P24538-2
Product description: CLOBEX SHA
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 8 pt
Fold size: 180x26,25
Pharmacode: 2194
DIELINES
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_INDUSTRIALIZATION DEPARTMENT_
_LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE_
PMS 432U
CLOBEX
®
(CLOBETASOL PROPIONATE) SHAMPOO, 0.05%
Rx Only
For External Use Only. Not for Ophthalmic Use.
DESCRIPTION:
CLOBEX
®
(clobetasol
propionate)
Shampoo,
0.05%,
contains
clobetasol
propionate, a synthetic fluorinated corticosteroid, for topical
dermatologic use.
The corticosteroids constitute a class of primarily synthetic steroids
used topically as anti-
inflammatory and antipruritic agents.
The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11ß,
17-dihydroxy-16ß-
methylpregna-1, 4-diene-3, 20-dione 17-propionate.
It has the following structural formula:
Clobetasol propionate has a molecular weight of 466.97 (CAS Registry
Number 25122-46-7).
The molecular formula is C
25
H
32
CIFO5. Clobetasol propionate is a white to practically white
crystalline, odorless powder insoluble in water.
Each
mL
of
CLOBEX
®
(clobetasol
propionate)
Shampoo,
0.05%,
contains
clobetasol
propionate, 0.05%, in a shampoo base consisting of alcohol, citric
acid, coco-betaine,
polyquaternium-10, purified water, sodium citrate, and sodium laureth
sulfate. It is a
translucent, colourless to pale yellow viscous liquid, with alcoholic
odour.
CLINICAL
PHARMACOLOGY:
Like
other
topical
corticosteroids,
CLOBEX
®
(clobetasol
propionate) Shampoo, 0.05%, has anti-inflammatory, antipruritic, and
vasoconstrictive
properties. The mechanism of the anti-inflammatory activity of the
topical steroids, in general,
is unclear. However, corticosteroids are thought to act by the
induction of phospholipase
A2 inhibitory proteins, collectively called lipocortins. It is
postulated tha

Summary of Product characteristics

NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
S H A M P O O
C L O B E X
®
(
c l
o b e t a s o l
p r o p i
o n a t e )
S h a m p o o ,
0 .
0 5 %
Product code: MOCK UP
Product description: CLOBEX SHA
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 8 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
GRAPHIC DESIGNER: Bérangère BLANCO
INDUSTRIALIZATION DEPARTMENT
LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE
PMS 432U
CLOBEX
®
(CLOBETASOL PROPIONATE) SHAMPOO, 0.05%
Rx Only
For External Use Only. Not for Ophthalmic Use.
DESCRIPTION:
CLOBEX
®
(clobetasol
propionate)
Shampoo,
0.05%,
contains
clobetasol
propionate, a synthetic fluorinated corticosteroid, for topical
dermatologic use.
The corticosteroids constitute a class of primarily synthetic steroids
used topically as anti-
inflammatory and antipruritic agents.
The chemical name of clobetasol propionate is 21-chloro-9-fluoro-11ß,
17-dihydroxy-16ß-
methylpregna-1, 4-diene-3, 20-dione 17-propionate.
It has the following structural formula:
Clobetasol propionate has a molecular weight of 466.97 (CAS Registry
Number 25122-46-7).
The molecular formula is C
25
H
32
CIFO5. Clobetasol propionate is a white to practically white
crystalline, odorless powder insoluble in water.
Each
mL
of
CLOBEX
®
(clobetasol
propionate)
Shampoo,
0.05%,
contains
clobetasol
propionate, 0.05%, in a shampoo base consisting of alcohol, citric
acid, coco-betaine,
polyquaternium-10, purified water, sodium citrate, and sodium laureth
sulfate. It is a
translucent, colourless to pale yellow viscous liquid, with alcoholic
odour.
CLINICAL
PHARMACOLOGY:
Like
other
topical
corticosteroids,
CLOBEX
®
(clobetasol
propionate) Shampoo, 0.05%, has anti-inflammatory, antipruritic, and
vasoconstrictive
properties. The mechanism of the anti-inflammatory activity of the
topical steroids, in general,
is unclear. However, corticosteroids are thought to act by the
induction of phospholipase
A2 inhibitory proteins, collectively called lipocortins. It is
postulated that thes