APO-Imiquimod

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Imiquimod 12.5mg

Mevcut itibaren:

Apotex NZ Ltd

INN (International Adı):

Imiquimod 12.5 mg

Doz:

5% w/w

Farmasötik formu:

Topical cream

Kompozisyon:

Active: Imiquimod 12.5mg Excipient: Benzyl alcohol Cetyl alcohol Glycerol Isostearic acid Methyl hydroxybenzoate Polysorbate 60 Propyl hydroxybenzoate Purified water Sorbitan stearate Stearyl alcohol White soft paraffin Xanthan gum

Paketteki üniteler:

Sachet, aluminium foil, Al/Al, 1 dose unit

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

USV Private Limited

Terapötik endikasyonlar:

Indicated for the topical treatment of actinic keratosis on the face and scalp in immunocompetent adults.

Ürün özeti:

Package - Contents - Shelf Life: Sachet, aluminium foil, Al/Al - 1 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Sachet, aluminium foil, Al/Al - 3 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Sachet, aluminium foil, Al/Al - 6 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Sachet, aluminium foil, Al/Al - 12 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze - Sachet, aluminium foil, Al/Al - 30 dose units - 24 months from date of manufacture stored at or below 25°C. Do not freeze

Yetkilendirme tarihi:

2011-03-25

Bilgilendirme broşürü

New Zealand Consumer Medicine Information
APO-IMIQUIMOD
_IMIQUIMOD _
5% w/w cream
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using
Apo-Imiqumod.
This leaflet answers some common questions about Apo-Imiqumod. 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
Apo-Imiqumod 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 APO-IMIQUMOD IS USED FOR
The name of your medicine is Apo-Imiqumod. It 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 imiquimod works is unknown, it is believed
to be due to
its effects on the immune system.
Apo-Imiquimod is used to treat solar keratosis
(SK) on the face and scalp, superficial
basal cell carcinoma
(sBCC), and genital/perianal warts.
•
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.
•
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.
Your doctor may have prescribed Apo-Imiqumod for another reason.
Ask your doctor if you have any questions about why Apo-Imiqumod has
been
prescribed for you.
Apo-Imiquimod 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.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
BEFORE YOU USE APO-IMIQUIMOD
_ _
_WHEN YOU MUST NOT USE I

Ürün özellikleri

NEW ZEALAND DATA SHEET
APO-IMIQUIMOD
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1 of 14
1. PRODUCT NAME
APO-IMIQUIMOD 5% w/w topical cream
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Imiquimod 5% w/w
EXCIPIENT(S) WITH KNOWN EFFECT
Nil.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
APO-IMIQUIMOD is a white cream with a uniform appearance. Each sachet
contains 250 mg of cream
for use as a single application.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
APO-IMIQUIMOD cream is indicated for the topical treatment of:
•
actinic keratosis on the face and scalp in immunocompetent adults.
•
superficial basal cell carcinoma where surgical excision is considered
inappropriate.
•
external genital and perianal warts (condyloma acuminata).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
The dosing frequency of imiquimod cream is different for each
indication.
ACTINIC KERATOSIS
Treatment should be initiated and monitored by a physician. Imiquimod
cream should be applied 3 times
per week (example: Monday, Wednesday and Friday) for four weeks prior
to normal sleeping hours and
left on the skin for approximately 8 hours. Sufficient cream should be
applied to cover the treatment
area. After a 4-week treatment-free period, clearance of AKs should be
assessed. If any lesions persist,
treatment should be repeated for another four weeks.
The maximum recommended dose is one sachet. The maximum recommended
treatment duration is 8
weeks.
An interruption of dosing should be considered if intense local
inflammatory reactions occur (see section
4.4) or if infection is observed at the treatment site. In this latter
case, appropriate other measures should
be taken. Each treatment period should not be extended beyond 4 weeks
due to missed doses or rest
periods.
If the treated lesion(s) show an incomplete response at the follow-up
examination at 4-8 weeks after the
second treatment period, a different therapy should be used.
SUPERFICIAL BASAL CELL CARCINOMA
Imiquimod