DP-Fluorouracil

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Fluorouracil 5%{relative};  ;  

Inapatikana kutoka:

Douglas Pharmaceuticals Limited

INN (Jina la Kimataifa):

Fluorouracil 5% w/w

Kipimo:

5% w/w

Dawa fomu:

Topical cream

Tungo:

Active: Fluorouracil 5%{relative}     Excipient: Methyl hydroxybenzoate Polysorbate 60 Propyl hydroxybenzoate Propylene glycol Purified water Stearyl alcohol White soft paraffin

Dawa ya aina:

Prescription

Viwandani na:

Sicor de Mexico SA de CV

Matibabu dalili:

DP-Fluorouracil is used for the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms, keratoa canthoma; Bowen's disease; superficial basal-cell carcinoma.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Tube, aluminium, White plain aluminium tube with white fez plastic cap - 5 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, White plain aluminium tube with white fez plastic cap - 20 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, White plain aluminium tube with white fez plastic cap - 25 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, White plain aluminium tube with reverse fez plastic cap - 40 g - 24 months from date of manufacture stored at or below 25°C

Idhini ya tarehe:

2014-03-31

Taarifa za kipeperushi

NEW ZEALAND CONSUMER MEDICINE INFORMATION
DP-FLUOROURACIL
_FLUOROURACIL 5% W/W CREAM _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about DP-Fluorouracil.
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 DP-Fluorouracil 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 DP-FLUOROURACIL IS USED FOR
DP-Fluorouracil is used to treat:
•
Superficial pre-malignant and malignant skin lesions
•
Keratoses including senile, actinic and arsenical forms
•
Bowens disease (type of skin cancer); and
•
Superficial Basal-Cell Carcinoma.
It contains the active ingredient fluorouracil. DP-Fluorouracil
belongs to a group
of medicines called topical anti-cancer (also called antineoplastic or
cytotoxic)
medicines.
Topical anti-cancer medicines are used on the skin to treat conditions
caused by
ageing or exposure to sunlight (solar keratoses). If left untreated,
these
conditions may develop into skin cancer.
DP-Fluorouracil is also used to treat Bowen's disease and superficial
Basal Cell
Carcinomas, which are types of skin cancer.
YOU SHOULD BE AWARE THAT YOU MAY LOOK WORSE WHILE TREATMENT IS IN
PROGRESS BEFORE YOU SEE ANY IMPROVEMENT IN YOUR CONDITION.
When DP-Fluorouracil is applied to the skin, the following usually
happens: a
redness of the affected area (generally within 3 to 5 days) followed
by blistering,
peeling, and cracking (within 11 to 14 days) with occasional open
sores and
some discomfort.
Although the skin seems to be worse, it is a sign that the medication
is working.
The treated skin will flake away. Some redness of the skin will
continue for some
time after the medicine is stopped. Scarring would not be expected.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DP-FLUOROURACI

Tabia za bidhaa

DATA SHEET
DP-FLUOROURACIL
Fluorouracil 5% w/w Topical Cream
PRESENTATION
DP-Fluorouracil is a homogenous, opaque, white cream containing
fluorouracil 5%
w/w.
_ _
_ACTIONS _
Fluorouracil is a competitive antagonist for uracil in the formation
of RNA and inhibits
the incorporation of uracil into RNA. DNA may be inhibited indirectly
because of its
dependence for synthesis on RNA.
When applied topically to keratoses and preneoplastic skin lesions,
fluorouracil
produced the following pattern of response: erythema, usually followed
by scaling,
tenderness, erosion, ulceration, necrosis and re-epithelialisation.
Responses may
sometimes occur in areas which appear clinically normal. These may be
sites of
subclinical actinic (solar) keratoses which the medication is
affecting.
_ _
_PHARMACOKINETICS _
Little is absorbed when fluorouracil is applied to healthy skin but up
to 20% of a dose
applied to diseased skin may be excreted in the urine over 24 hours.
It is also
absorbed to a small extent through serous membranes. Fluorouracil is
converted to
active nucleotide metabolites within the target cells. Fluorouracil is
excreted
unchanged in the urine, or inactivated in the liver or excreted as
respiratory carbon
dioxide (with the production of urea).
_ _
_INDICATIONS _
DP-FLUOROURACIL is used for the topical treatment of superficial
pre-malignant
and malignant skin lesions; keratoses including senile, actinic and
arsenical forms;
keratoa canthoma; Bowen’s disease; superficial basal-cell carcinoma.
Deep,
penetrating or nodular basal cell and squamous cell carcinomas do not
usually
respond to fluorouracil therapy. It should be used only as a
palliative therapy in such
cases where no other form of treatment is possible.
DOSAGE AND ADMINISTRATION
DP-FLUOROURACIL cream is for topical application and should not be
diluted.
_ _
_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 _
1
The cream should be applied onc