Clobex Shampoo

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Clobetasol propionate 0.5 mg/g;  ;  ;  

Boleh didapati daripada:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Nama Antarabangsa):

Clobetasol propionate 0.5 mg/g

Dos:

0.5 mg/g

Borang farmaseutikal:

Shampoo

Komposisi:

Active: Clobetasol propionate 0.5 mg/g       Excipient: Citric acid monohydrate Coco-betaine Ethanol Polyquaternium-10 Purified water Sodium citrate dihydrate Sodium laureth sulfate

Unit dalam pakej:

Bottle, plastic, HDPE with polypropylene snap cap, 60 mL

Kelas:

Prescription

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Symbiotec Pharmalab Limited

Tanda-tanda terapeutik:

The topical treatment of moderate to severe scalp psoriasis.

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with polypropylene snap cap - 30 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, plastic, HDPE with polypropylene snap cap - 60 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C - Bottle, plastic, HDPE with polypropylene snap cap - 125 mL - 24 months from date of manufacture stored at or below 25°C 4 weeks opened stored at or below 25°C

Tarikh kebenaran:

2005-08-16

Risalah maklumat

CLOBEX

SHAMPOO _(500mcg/mL clobetasol propionate) Ver2 _
1
CONSUMER MEDICINE INFORMATION
CLOBEX
 SHAMPOO
_500mcg/mL clobetasol propionate _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
CLOBEX SHAMPOO. It does
not contain all the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
CLOBEX SHAMPOO against
the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to
read it again.
WHAT CLOBEX
SHAMPOO IS USED
FOR
CLOBEX SHAMPOO is used
as
a
topical
treatment
for
moderate
to
severe
scalp
psoriasis in adults.
It belongs to a group of
medicines called
corticosteroids.
CLOBEX SHAMPOO is used
on the scalp to relieve the
redness, swelling, itching and
discomfort of scalp psoriasis.
Your doctor, however, may
have prescribed CLOBEX
SHAMPOO for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CLOBEX SHAMPOO HAS
BEEN PRESCRIBED FOR YOU.
There is no evidence that
CLOBEX SHAMPOO is
addictive.
CLOBEX SHAMPOO is
available only with a doctor's
prescription.
BEFORE YOU USE
CLOBEX SHAMPOO
_WHEN YOU MUST NOT USE IT_
DO NOT USE CLOBEX
SHAMPOO IF:
1. YOU HAVE EVER HAD AN
ALLERGIC REACTION TO :
•
MEDICINES CONTAINING
_CLOBETASOL PROPIONATE_
•
ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS
LEAFLET
2. YOU HAVE SKIN AREAS
AFFECTED BY BACTERIAL,
MYCOBACTERIAL OR VIRAL SKIN
INFECTIONS (SUCH AS COLD
SORES, SHINGLES OR CHICKEN
POX)
3. YOU HAVE SKIN AREAS
AFFECTED BY FUNGAL OR
PARASITIC SKIN INFECTIONS
(SUCH AS THRUSH, TINEA OR
RINGWORM)
4. YOU HAVE SKIN AREAS
AFFECTED BY SPECIFIC SKIN
DISEASES (SUCH AS SKIN
TUBERCULOSIS OR SKIN
DISEASE CAUSED BY LUES)
5. YOU HAVE SKIN AREAS WITH
ULCEROUS WOUNDS
IF YOU ARE NOT SURE WHETHER
YOU SHOULD BE USING CLOBEX
SHAMPOO, TALK TO YOUR
DOCTOR.
DO NOT USE CLOBEX
SHA

Ciri produk

NEW ZEALAND DATASHEET
1 PRODUCT NAME
CLOBEX
®
Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Clobetasol propionate 0.05% w/w
3 PHARMACEUTICAL FORM
CLOBEX Shampoo contains 0.05% w/w clobetasol propionate. CLOBEX
Shampoo is a
viscous, translucent, colourless to pale yellow liquid shampoo with an
alcoholic odour.
One millilitre of CLOBEX Shampoo contains 500 micrograms of clobetasol
propionate.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Topical treatment of moderate to severe scalp psoriasis.
4.2 Dosage and method of administration
CLOBEX Shampoo should be applied to the dry (not wet) scalp once daily
taking care to
cover and massage the lesions well. Using the measuring cup included,
measure out 7.5
mL which is sufficient to cover all the scalp and is the maximum daily
dosage. CLOBEX
Shampoo should be then left in place without covering for 15 minutes
before rinsing. As
with any topical medication, patients should wash their hands
carefully after application.
After 15 minutes, the product must be rinsed with water and / or hair
can be washed by
using an additional amount of regular shampoo if needed to facilitate
washing. In order
to avoid
interaction
with hair colour
dying
product,
such
as
hair colour
changes,
CLOBEX Shampoo should be thoroughly rinsed. Then, hair can be dried as
usual.
Avoid contact with the eyes. If the shampoo accidentally comes in
contact with the eyes,
rinse out the eyes with water immediately.
The treatment duration should be limited to a maximum of 4 weeks. The
total dosage
should not exceed 50mL per week.
As soon as clinical results are observed, applications
should
be
spaced
out
or
replaced,
if
needed,
by
an
alternative
treatment.
If
no
improvement
is
seen
within
four
weeks,
reassessment
of
the
diagnosis
may
be
necessary.
Chronic over dosage may occur in the case of continuous use of large
quantities for long
periods of time.
Clobetasol propionate belongs to the most potent class of topical
corticosteroids (class
IV/class
I)
and
prolonged
use
may
result
in
serious
undesirable