CLOBEX SPRAY 0.05% ww

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

CLOBETASOL PROPIONATE 0.05%

Prieinama:

GALDERMA SINGAPORE PRIVATE LIMITED

ATC kodas:

D07AD01

Vaisto forma:

SOLUTION

Sudėtis:

CLOBETASOL PROPIONATE 0.05% 0.05% w/w

Vartojimo būdas:

CUTANEOUS

Recepto tipas:

Prescription Only

Pagaminta:

LABORATOIRES GALDERMA

Autorizacija statusas:

ACTIVE

Leidimo data:

2017-02-28

Pakuotės lapelis

S P R A Y
NOTICE RECTO 180x315
PLAN n° MT.09.DRA.0352.R02.2
Product code: MOCK UP
Product description: CLOBEX SPRAY
Market: EX2
Article: Leaflet
Flat size: 180x315
Font size: 8 pt
Fold size: 180x26,25
Pharmacode: TBD
DIELINES
_GRAPHIC DESIGNER: Guillaume ANDRÉ_
_INDUSTRIALIZATION DEPARTMENT_
_LABORATOIRES GALDERMA - Z.I. Galderma - 74540 ALBY-SUR-CHÉRAN -
FRANCE_
PMS 432U
c l
o b e t a s o l
p r o p i
o n a t e
5 0 0
m i
c r o g r a m s /
g r a m
®
COMPOSITION
DRUG SUBSTANCE:
Clobetasol propionate 500µg/g
EXCIPIENTS:
Ethanol, sodium lauryl sulfate, undecenoic acid and isopropyl
myristate.
PHARMACEUTICAL FORM AND AMOUNT IN DRUG SUBSTANCE PER UNIT
Solution as a spray to be used on the skin.
1 g solution contains 0.5 mg of clobetasol propionate.
INDICATIONS / POSSIBILITIES OF USE
Topical treatment of moderate to severe plaque-type psoriasis, from 18
years of age on.
POSOLOGY / METHOD OF ADMINISTRATION
Clobex cutaneous spray is intended for use on the skin, the solution
should be sprayed directly onto the affected areas twice daily and
then rubbed in gently until completely absorbed.
Hands should be washed carefully after application. Each cycle of
treatment should be limited to 4 consecutive weeks. Treatment of a
lesion has to be stopped as soon as disease control
is achieved; the diagnostic is to be re-evaluated if there is no
improvement observed after 2 weeks.
Not more than 50g of spray-solution should be used per week. No more
than 35 sprays should be involved in one application, i.e. not more
than 70 sprays per day.
Clobex cutaneous spray should be used neither on the face nor on
intertriginous areas (axillae and genitoanal regions, see “Warnings
and precautions”).
The safety and efficacy of Clobex cutaneous spray in children and
adolescents under 18 years of age have not been established so far. No
data are available in this context.
CONTRA-INDICATIONS
• Hypersensitivity to the active substance or to any of the excipients.
• Skin areas affected by bacterial, viral (varicella, herpes simplex,
herpe

Prekės savybės

COMPOSITION
Each gram contains: Clobetasol
propionate....................................... 0.5 mg
Vehicle (ethanol, isopropyl myristate, sodium laurilsulfate, and
undecylenic acid)
q.s………………………………………..............1 gram
Excipient with known effect: One gram of Clobex spray contains 492.5
mg alcohol (ethanol 96 percent) which is equivalent to
49.25% w/w.
PHARMACEUTICAL FORM AND AMOUNT IN DRUG SUBSTANCE PER UNIT
Solution as a spray to be used on the skin.
1 g solution contains 0.5 mg of clobetasol propionate.
Cutaneous spray, solution. Clear colourless solution
INDICATIONS / POSSIBILITIES OF USE
Topical treatment of moderate to severe plaque-type psoriasis, from 18
years of age on.
POSOLOGY / METHOD OF ADMINISTRATION
Clobex cutaneous spray is intended for use on the skin, the solution
should be sprayed directly onto the affected areas twice daily
and then rubbed in gently until completely absorbed. Hands should be
washed carefully after application. Each cycle of treatment
should be limited to 4 consecutive weeks. Treatment of a lesion has to
be stopped as soon as disease control is achieved; the
diagnostic is to be re-evaluated if there is no improvement observed
after 2 weeks.
Not more than 50g of spray-solution should be used per week. No more
than 35 sprays should be involved in one application, i.e.
not more than 70 sprays per day. Clobetasol propionate belongs to the
most potent class of topical corticosteroids (class IV/class I)
and prolonged use may result in serious undesirable effects (see
Warnings and Precautions). If treatment with a local corticosteroid
is clinically justified beyond 4 weeks, a less potent corticosteroid
preparation should be considered. Repeated but short courses of
clobetasol propionate may be used to control exacerbations.
Clobex cutaneous spray should be used neither on the face nor on
intertriginous areas (axillae and genitoanal regions, see “Warnings
and precautions”).
The safety and efficacy of Clobex cutaneous spray in children and
adolescent