EFUDIX CREAM 5%

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

FLUOROURACIL

可用日期:

MEGAPHARM LTD

ATC代码:

L01BC

药物剂型:

CREAM

组成:

FLUOROURACIL 50 MG / 1 G

给药途径:

DERMAL

处方类型:

Required

厂商:

ICN POLFA RZESZOW S.A., POLAND

治疗组:

PYRIMIDINE ANALOGUES

疗效迹象:

Antineoplastic agent to treat actinic keratosis multiple and superfacial basel cell carcinoma.

授权日期:

2016-11-30

资料单张

Page 1 of 5
PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS)
– 1986
THIS MEDICINE IS DISPENSED WITH A PHYSICIAN’S PRESCRIPTION ONLY
EFUDIX CREAM 5%
COMPOSITION:
ACTIVE INGREDIENT:
EACH GRAM OF CREAM CONTAINS 50 MG OF FLUOROURACIL
FOR A LIST OF INACTIVE AND ALLERGENIC INGREDIENTS IN THE MEDICINE, SEE
SECTION 2 - "BEFORE USING
THE MEDICINE" AND SECTION 6-
“ADDITIONAL INFORMATION”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise
information about the medicine. If you have further questions, consult
your physician or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm them even
if it seems to you that their illness is similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
EFUDIX CREAM 5% is used for the treatment of skin problems, such as
keratosis and basal cell carcinoma
(BCC). The active ingredient Fluorouracil.
THERAPEUTIC GROUP: Belongs to a group of anti-cancer medicines.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient FLUOROURACIL or
to any of the additional
ingredients
that the medicine contains (please see section 6, “Additional
information”).
•
You are pregnant, you think you may be pregnant or you are
breastfeeding.
•
You are using any medicines known as antiviral nucleosides (e.g.,
brivudine, sorivudine). These
medicines are usually used to treat chickenpox or shingles.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE:
BEFORE TREATMENT WITH EFUDIX CREAM 5%, TELL YOUR PHYSICIAN IF:
•
You suffer from inactivity or deficiency of the enzyme DPD
(dihydropyrimidine dehydrogenase)
(complete or partial deficiency of the enzyme).
PARTICULAR CAUTION USING EFUDIX CREAM 5% IS REQUIRED IN THE FOLLOWING
INSTANCES:
•
When using the medicine, do not smoke or go near open flames
–
there is a risk of severe burns.
Fabric (e.g., clothing, bedding, dressings, etc.) that comes in
contact with th

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE MEDICINAL PRODUCT
EFUDIX CREAM 5%
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Efudix Cream 5% contains 50 MG/ 1G fluorouracil.
For the full list of excipients, see section 6.1.
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3. PHARMACEUTICAL FORM
White, opaque cream.
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4. CLINICAL PARTICULARS top of the page
4.1 THERAPEUTIC INDICATIONS
Antineoplastic agent to treat actinic keratosis multiple and
superfacial
basal cell carcinoma.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
EFUDIX CREAM 5% is for topical application.
_Pre-malignant conditions_
The cream should be applied thinly to the affected area once or twice
daily; an occlusive dressing is not essential.
_Malignant conditions_
The cream should be applied once or twice daily under an occlusive
dressing where this is practicable.
The cream should not harm healthy skin. Treatment should be continued
until there is marked inflammatory response from the treated area,
preferably with some erosion in the case of pre-malignant conditions.
Severe discomfort may be alleviated by the use of topical steroid
cream.
The usual duration of treatment for an initial course of therapy is
three to
four weeks, but this may be prolonged. Lesions on the face usually
respond more quickly than those on the trunk or lower limbs whilst
lesions
on the hands and forearms respond more slowly. Healing may not be
complete until one or two months after therapy is stopped.
_Elderly_
Many of the conditions for which EFUDIX CREAM 5% is indicated are
common in the elderly. No special precautions are necessary. _ _
_Children_
In view of the lack of clinical data available, EFUDIX CREAM 5% is not
recommended for use in children.
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4.3 CONTRAINDICATIONS
EFUDIX CREAM 5% is contraindicated in patients with known
hypersensitivity to fluorouracil or any of the excipients listed in
section 6.1.
Coadministration of EFUDIX CREAM 5% with antiviral nucleoside drugs
(e.g.
brivudine and analogues)