Imiquad Cream (Imiquimod Cream USP 5% ww)

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

IMIQUIMOD

Pieejams no:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

SNN (starptautisko nepatentēto nosaukumu):

IMIQUIMOD

Vienības iepakojumā:

3 Sachets

Ražojis:

GLENMARK PHARMACEUTICALS LTD

Lietošanas instrukcija

1
IMIQUAD CREAM
Imiquimod Cream USP 5% W/W
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Imiquimod cream is used for
2.
How Imiquimod cream works
3.
Before you use Imiquimod cream
4.
How to use Imiquimod cream
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Imiquimod
cream
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT IMIQUIMOD CREAM IS USED FOR
Imiquimod cream may be used for
three different conditions. Your doctor
may prescribe Imiquimod cream for
the treatment of:
WARTS (CONDYLOMATA ACUMINATA)
on
the
surface
of
the
genitals
(sexual
organs)
and
around
the
anus
(back
passage).
SUPERFICIAL BASAL CELL CARCINOMA-
This is a common slow-growing form
of skin cancer with a very small
likelihood of spread to other parts of
the body. It usually occurs in middle-
aged and elderly people, especially
those who are fair-skinned and is
caused by too much sun exposure.
ACTINIC KERATOSIS-
Actinic keratoses are rough areas of skin
found in people who have been exposed
to a lot of sunshine over the course of
their lifetime. Some are skin coloured,
others are greyish, pink, red or brown.
They can be flat and scaly, or raised,
rough,
hard
and
warty.
Imiquimod
cream should only be used for flat actinic
keratoses
on
the
face
and
scalp
in
patients with a healthy immune system
where
your
doctor
has
decided
that
Imiquimod
cream
is
the
most
appropriate treatment for you.
HOW IMIQUIMOD CREAM WORKS
Imiquimod cream helps your body´s
own immune system to produce natural
substances which help fight your basal
cell carcinoma, actinic keratosis or the
virus that has caused your warts.
BEFORE YOU USE IMIQUIMOD CREAM
_-When you must not use it _
-If you are allergic to Imiquimod or any
of the other ingredients of this medicine.
_-Before you start to use it _
Talk to your doctor or pharmacist before
using Imiquimod creams
If you have previously used Imiquimod
cream or other similar preparations tell
your
doctor
be

Produkta apraksts

_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory _
_ _
Imiquimod Cream USP 5% w/w
IMIQUAD CREAM
COMPOSITION
Each 0.25 gm single use sachet contains:
Imiquimod USP….12.5mg (5.00% w/w)
Cream base……….q.s.
Preservatives:
Methyl Paraben 0.20% w/w
Propyl
Paraben
0.02%
w/w
Benzyl alcohol 2.00% w/w
PRODUCT DESCRIPTION:
White to off-white soft cream
PHARMACODYNAMICS:
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Chemotherapeutics for topical use,
antivirals: ATC Code: D06BB10.
Imiquimod is an immune response modifier. Saturable binding studies
suggest a membrane
receptor for imiquimod exists on responding immune cells. Imiquimod
has no direct antiviral
activity. In animal models imiquimod is effective against viral
infections and acts as an anti-tumour
agent principally by induction of alpha interferon and other
cytokines.
The induction of alpha interferon and other cytokines following
imiquimod cream application to
genital wart tissue has also been demonstrated. Increases in systemic
levels of alpha interferon and
other
cytokines
following
topical
application
of
imiquimod
were
demonstrated
in
a
pharmacokinetic study.
PHARMACOKINETICS:
External genital warts, superficial basal cell carcinoma and actinic
keratosis:
Less than 0.9% of a topically applied single dose of radiolabelled
imiquimod was absorbed through
the skin of human subjects. The small amount of drug which was
absorbed into the systemic
circulation was promptly excreted by both urinary and fecal routes at
a mean ratio of approximately
3 to 1.
No quantifiable levels (>5 ng/ml) of drug were detected in serum after
single or multiple topical
doses.
Systemic exposure (percutaneous penetration) was calculated from
recovery of carbon-14 from [
C] imiquimod in urine and faeces.
Minimal systemic absorption of imiquimod 5% cream across the skin of
patients with actinic
keratosis was observed with 3 times per week dosing for
16 weeks. The extent of percutaneous absorption did not change
significantly between the first