ALDIQ imiquimod 50 mg/g cream sachet

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

imiquimod, Quantity: 12.5 mg

Disponível em:

Strides Pharma Science Pty Ltd

DCI (Denominação Comum Internacional):

Imiquimod

Forma farmacêutica:

Cream

Composição:

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

Via de administração:

Topical

Unidades em pacote:

6 and 12 sachets per carton

Classe:

Medicine Registered

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

? treatment of solar (actinic) keratosis on the face and scalp (see Precautions), 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 Precautions).

Resumo do produto:

Visual Identification: A white to off white, oil in water vanishing cream; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2013-07-19

Folheto informativo - Bula

ALDIQ
_imiquimod_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALDIQ. 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 using ALDIQ against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALDIQ IS USED
FOR
ALDIQ is used to treat:
•
Solar keratosis (SK) on the face
and Superficial Basal Cell
Carcinoma (sBCC)
Solar keratoses are thickened, scaly
patches of skin caused by too much
sun exposure. Solar keratosis is also
known as actinic keratosis.
Basal cell carcinoma is a type of skin
cancer.
•
Genital/perianal warts
External genital/perianal warts
(condyloma acuminata) are warts that
appear on the surface of the penis or
vulva (external female sexual organ)
and around the anus.
ALDIQ is not recommended for use
in patients under the age of 18 years
as there have been no studies of its
effects in this age group.
ALDIQ cream contains the 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 ALDIQ works is unknown, it is
believed to be due to its effects on
the immune system.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE USING IT
_WHEN YOU MUST NOT USE IT_
DO NOT USE ALDIQ IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
imiquimod
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash

Características técnicas

AUSTRALIAN PRODUCT INFORMATION
ALDIQ
_imiquimod cream _
1
NAME OF THE MEDICINE
Imiquimod
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 250 mg sachet of ALDIQ contains 12.5 mg of imiquimod as the
active ingredient.
Excipients of known effect: hydroxybenzoates.
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ALDIQ is a white to off-white, oil in water vanishing cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ALDIQ is indicated for:
•
treatment of solar (actinic) keratosis on the face and scalp (see
section 4.4 Special Warnings and
Precautions for Use)
•
primary treatment of confirmed superficial basal cell carcinoma where
surgery is considered
inappropriate
•
treatment of external genital and perianal warts/condyloma acuminata
in adults (see section 4.4
Special Warnings and Precautions for Use)
4.2
DOSE AND METHOD OF ADMINISTRATION
Before applying ALDIQ, the patient should wash the treatment area with
mild soap and water and allow the
area to dry thoroughly. ALDIQ 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 to 10 hours). The
cream should be rubbed in until it is no
longer visible. Following the treatment period, the cream should be
removed by washing the treated area with
mild soap and water. During the 6 to 10 hour treatment period
showering or bathing should be avoided. Hand
washing before and after cream application is recommended.
Local skin reactions (erythema) at the treatment area are common.
These reactions may be due to the
pharmacological response of the body’s immune system to imiquimod.
In clinical studies in patients with
superficial basal cell carcinoma (sBCC) the histological clearance
following imiquimod therapy was
statistically (p < 0.001) higher (91%) in patients with moderate to
severe local skin reactions compared to
those patients who experienced no or mild skin reactions (54%).
Similarly, there was a significant association
between the intensity o