ALDARA PUMP imiquimod 50 mg/g cream pump

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

imiquimod, Quantity: 50 mg/g

Disponibbli minn:

iNova Pharmaceuticals (Australia) Pty Ltd

INN (Isem Internazzjonali):

Imiquimod

Għamla farmaċewtika:

Cream

Kompożizzjoni:

Excipient Ingredients: benzyl alcohol; glycerol; white soft paraffin; stearyl alcohol; isostearic acid; sorbitan monostearate; propyl hydroxybenzoate; xanthan gum; polysorbate 60; purified water; methyl hydroxybenzoate; cetyl alcohol

Rotta amministrattiva:

Topical

Unitajiet fil-pakkett:

2 x 2g, 1 x 2g

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

Aldara 5% cream is indicated for treatment of solar (actinic) keratosis on the face and the scalp (see Precautions), and primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and the treatment of external genital and peri-anal warts (Condyloma acuminata) in adults (see Precautions).

Sommarju tal-prodott:

Visual Identification: White to faintly yellow cream with a uniform appearance.; Container Type: Bottle, with integral pump - manual actuated; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2012-01-10

Fuljett ta 'informazzjoni

ALDARA
®
A
l
d
a
r
a
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ALDARA?
Aldara contains the active ingredient imiquimod. Aldara is used to
treat solar keratosis (also known as actinic keratoses), superficial
basal cell carcinoma and external genital/perianal warts (also known
as condyloma acuminata).
For more information, see Section 1. Why am I using Aldara? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ALDARA?
Do not use if you have ever had an allergic reaction to Aldara or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Aldara? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Aldara and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ALDARA?
Your doctor will tell you where to apply Aldara, how often and for how
long to apply it. Apply Aldara just before bedtime and leave on
the skin for 6-10 hours. Sufficient cream should be applied to cover
the treatment area.
More instructions can be found in Section 4. How do I use Aldara? in
the full CMI and in the instruction leaflet provided in the carton.
5.
WHAT SHOULD I KNOW WHILE USING ALDARA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Aldara
•
Call you doctor straight away if you become pregnant .
THINGS YOU
SHOULD NOT DO
•
Do not use more than the recommended amount of Aldara
•
Do not cover the treatment area with bandages or other dressings after
you have applied Aldara
•
Do not use sunlamps or tanning beds, and avoid going into the sun as
much as possible
•
Do not apply on the eyes, lips, nostrils

Karatteristiċi tal-prodott

1
AUSTRALIAN PRODUCT INFORMATION – ALDARA
® (IMIQUIMOD) CREAM &
ALDARA
®
PUMP (IMIQUIMOD) CREAM
1
NAME OF THE MEDICINE
Imiquimod.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imiquimod is 1-(2-methylpropyl)-1_H_-imidazo
[4,5-_c_]quinolin-4-amine. It is an odourless, white to off-
white crystalline solid.
Each gram of the 5% cream contains 50 mg of imiquimod in an off-white
oil-in-water vanishing cream
base consisting of isostearic acid, cetyl alcohol, stearyl alcohol,
white soft paraffin, polysorbate 60,
sorbitan monostearate, glycerol, xanthan gum, purified water, benzyl
alcohol, methyl hydroxybenzoate
and propyl hydroxybenzoate.
Excipients with known effects: methyl hydroxybenzoate, propyl
hydroxybenzoate.
3
PHARMACEUTICAL FORM
ALDARA Imiquimod 50mg/g cream sachet: White to faintly yellow cream
with a uniform appearance.
ALDARA
®
PUMP** Imiquimod 50mg/g cream pump: White to faintly yellow cream with
a uniform
appearance.
Each 250mg of Aldara contains 12.5mg of imiquimod. This is equivalent
to four actuations of the
pump. Each pump contains 2 g of Aldara. Usually a total of 1.5 g is
delivered due to the operation of the
airless pump system.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Aldara is indicated for:

treatment of solar (actinic) keratosis on the face and scalp (_see
Section 4.4 SPECIAL WARNINGS _
_AND PRECAUTIONS FOR USE_), and

primary treatment of confirmed superficial basal cell carcinoma where
surgery is considered
inappropriate, and

treatment of external genital and perianal warts/condyloma acuminata
in adults (_see Section _
_4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE)_
4.2
D
OSE AND METHOD OF ADMINISTRATION
Before applying Aldara, the patient should wash the treatment area
with mild soap and water and
allow the area to dry thoroughly. Aldara is to be applied to the
affected area prior to normal sleeping
hours and should be left on the skin for approximately 8 hours (6-10
hours). The cream should be
rubbed in until it is no longer visible. Following the treatment
period the