ALDARA CREAM 5% ww

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

IMIQUIMOD

Tersedia dari:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (Nama Internasional):

IMIQUIMOD

Unit dalam paket:

2 gm; 12 Sachets

Diproduksi oleh:

Ensign Laboratories Pty Limited

Selebaran informasi

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALDARA
®
CREAM 5% W/W
Imiquimod (5% w/w)
WHAT IS IN THIS LEAFLET
1.
What Aldara® Cream 5% w/w is
used for
2.
How Aldara® Cream 5% w/w
works
3.
Before you use Aldara® Cream
5% w/w
4.
How to use Aldara® Cream 5%
w/w
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Aldara®
Cream 5% w/w
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ALDARA® CREAM 5% W/W IS
USED FOR
Aldara® Cream 5% w/w is used to
treat genital/perianal warts, actinic
keratoses on the face and scalp and
superficial basal cell carcinoma.
•
External genital/perianal warts
(condyloma acuminate) are warts
that appear on the surface of the
penis or vulva (external female
sexual organ) and around the anus
(back passage).
•
Actinic keratosis is thickened,
scaly patches of skin caused by too
much sun exposure.
•
Superficial basal cell carcinoma
(sBCC) is a common slow-
growing form of skin cancer.
Your doctor may prescribe Aldara®
Cream 5% w/w for another purpose. If
you are not sure why you are using this
medicine, ask your doctor.
HOW ALDARA® CREAM 5% W/W WORKS
Aldara® Cream 5% w/w contains an
active ingredient, imiquimod.
Imiquimod is an immune response
modifier. It activates immune cells in
the body. The immune cells then
proceed to kill and remove the virus
infected or cancer cells. Although the
exact way that Aldara® Cream 5%
w/w works is unknown, it is believed
to be due to its effects on the immune
system.
BEFORE YOU USE ALDARA® CREAM 5%
W/W
_-When you must not use it _
Do not use this medicine:
•
if you are allergic to imiquimod or
to any of the ingredients listed at
the end of this leaflet.
•
on skin where there are open sores
or wounds. Do not start using
Aldara® Cream 5% w/w until
after the area has healed.
•
on warts inside the vagina or
inside the anus or inside the
urethra (where you pass urine).
The use of Aldara® Cream 5%
w/w has not been studied.
•
on areas that are sunburnt.
•
if the packa

Karakteristik produk

ALDARA® CREAM 5% W/W
PRODUCT DESCRIPTION
White to faintly yellow cream with a uniform appearance.
COMPOSITION
Each sachet contains 12.5mg of Imiquimod in 250mg cream (5%w/w).
Each pump contains 1000mg of Imiquimod in 2g crem (5%w/w)
Excipients: Isostearic Acid, Cetyl Alcohol, Stearyl Alcohol, White
Soft Paraffin, Polysorbate
60, Sorbitan Stearate, Glycerol, Xanthan Gum, Purified Water, Benzyl
Alcohol, Methyl
Hydroxybenzoate and Propyl Hydroxybenzoate.
PHARMACODYNAMICS
Imiquimod is an immune response modifier. It has no direct antiviral
activity in cell culture.
A mechanism of action study in 22 patients with genital/perianal warts
shows that
imiquimod induces cytokines including interferon-α at the treatment
site. In addition, HPV
E7 and L1mRNA as well as HPV DNA are significantly decreased following
treatment.
However, the clinical relevance of these findings is unknown.
PHARMACOKINETICS
Percutaneous absorption of [
14
C] imiquimod was minimal in a study involving 6 healthy
subjects treated with a single topical application (5mg) of [
14
C] imiquimod cream
formulation. No radioactivity was detected in the serum (lower limit
of quantitation:
1ng/mL) and <0.9% of the radiolabelled dose was excreted in the urine
and faeces
following topical application.
CLINICAL STUDIES
In a double-blind, placebo-controlled clinical trial, Aldara® Cream
5% w/w applied three
times a week for treatment of genital and perianal warts had wart
clearance rates that were
statistically significantly greater than the placebo control. The
percentage of patients
achieving total clearance was 77% for females and 40% for males. The
percentage of
patients achieving partial wart area (>50%) reduction was 91% for
female and 74% for male.
The median baseline wart area was 69mm
2
(range 8 to 5525 mm
2
). Visible wart changes
occurred as early as 4 weeks and some patients required 16 weeks. The
median time to
total wart clearance was 10 weeks. In another study, Aldara® Cream 5%
w/w applied daily,
59% of the males and 84% of the females achieved t