ALDARA CREAM 5%

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

IMIQUIMOD

Tilgængelig fra:

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

INN (International Name):

IMIQUIMOD

Enheder i pakken:

1Units Units

Fremstillet af:

3M HEALTH CARE LTD

Indlægsseddel

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALDARA
®
CREAM 5%
Imiquimod (5% w/w)
WHAT IS IN THIS LEAFLET
1.
What Aldara Cream 5% is used for
2.
How Aldara Cream 5% works
3.
Before you use Aldara Cream 5%
4.
How to use Aldara Cream 5%
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Aldara
Cream 5%
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ALDARA CREAM 5% IS USED FOR
Aldara Cream 5% 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% for another purpose. If you
are not sure why you are using this
medicine, ask your doctor.
HOW ALDARA CREAM 5% WORKS
Aldara Cream 5% 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% works is unknown, it
is believed to be due to its effects on
the immune system.
BEFORE YOU USE ALDARA CREAM 5%
_-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% 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% has
not been studied.
•
on areas that are sunburnt.
•
if the packaging is torn or shows
signs of tampering or after the
“use by” date shown on the box

Produktets egenskaber

ALD A RA ® C REA M
Name of The Drug
Imiquimod
Description
Imiquimod is 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4 -amine. It is a odourless, white t o o ff-whit e cryst alline solid.
Imiquimod has a molecular formula of C 14H16N4 and a molecular weight of 240. 3. It’s structural formula is
Aldara
® is the brand name for imiqui mod. Each gram of the 5% cream contains 50mg of imiquimod in an off-white oil-in-wate r
vanish ing cream base consist ing of isostearic a cid, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbat e 60, sorbit an
monostearate, glycerol, xanthan gum, purified wat er, benzyl alcohol, methyl-hydroxybenzoate and propyl-hydroxy-benzoate.
Pharmacolog y
Pharmacodynamics: Imiquimod is an immune response modifier. It has no direct antiviral activity in cell culture. A
mechanism of action study in 22 patien ts wit h genital/peria nal warts shows that imiquimod induces cytokines including
interferon-α at the treatment site. In ad dition, HPV E7 and L1mRNA as well as HPV DNA are significantly decreased f ollowing
tre atment. Ho wever, the clinica l relevance of these f indings is unknown.
Pharmacokinetics
Percutaneous absorptio n of [
14C] imiquimod was minimal in a study involving 6 healthy subjects tre ated with a s ingle t opical
applicat ion (5mg) of [ 14C] imiquimo d cream formulation. No radioactivity was det ected in the serum (lower limit of qua ntitation:
1ng/mL) and 50%) reduction was 91% for female and 74% for male. The median baseline wart area
was 69mm
2 (rang e 8 to 5525 mm 2). Visible w art changes occurred as early as 4 weeks and some patients required 16 weeks.
The median time to total wart clearance was 10 weeks. In anoth er st udy, Aldara 5% cream applied daily, 59% of the males
and 84% of the females achieved total clearance o f their genital/perianal warts. A low percent age (6-23%) of the pat ients wh o
achieved total clearan ce of their warts experienced a recur rence of their warts during the 12 week follow-up period. In two
studies, some patients achieved t o