情報リーフレット
MUPHORAN
®
_fotemustine (pronounced fo-te-mus-teen )_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
MUPHORAN. It does not contain all
the available information. Reading
this leaflet 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 being treated with
MUPHORAN against the expected
benefits for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING TREATED WITH THIS MEDICINE,
ASK YOUR DOCTOR, PHARMACIST, OR
ONCOLOGY NURSE.
KEEP THIS LEAFLET IN A SAFE PLACE.
You may need to read it again.
WHAT MUPHORAN IS
The name of your medicine is
MUPHORAN. The active ingredient
of MUPHORAN is called
fotemustine. Fotemustine is a type of
chemotherapy that belongs to a group
of anti-cancer agents called
nitrosoureas (pronounced ni-tro-so-u-
ree-as).
WHAT MUPHORAN IS
USED FOR
YOU HAVE BEEN PRESCRIBED
MUPHORAN FOR MELANOMA (ALSO
KNOWN AS MALIGNANT MELANOMA).
MUPHORAN is available only with
a prescription - usually from an
experienced cancer specialist (also
known as an oncologist).
WHY MUPHORAN IS
USED FOR MELANOMA
Melanoma is a type of skin cancer.
Sometimes melanoma spreads from
the skin to the lung, liver, bowel, or
brain.
MUPHORAN works by stopping the
rapid growth of some types of cancer
cells.
MUPHORAN treatment can shrink
and slow the growth of melanoma
tumours for some patients. Other
patients may not have a useful
treatment response from
MUPHORAN.
Ask your doctor if you have any
questions about why you are being
treated with MUPHORAN.
BEFORE YOU ARE TREATED
WITH MUPHORAN
There are some people who shouldn't
be treated with MUPHORAN. Please
read the following lists. If you think
any of these situations apply to you
or you have any questions, please
consult your doctor, pharmacist, or
oncology nurse.
WHEN YOU MUST NOT BE
TREATED WITH
MUPHORAN
•
YOU ARE ALLERGIC TO FOTEMUSTINE
OR ANY OTHER NITROSOUREA.
Symptoms of an allergic reaction
to MUPHORAN may include
short
完全なドキュメントを読む
製品の特徴
MUPHORAN
®
(FOTEMUSTINE)
– Product Information
1 (8)
Version: 2k
_MUPHORAN_
_®_
PRODUCT INFORMATION
NAME OF THE MEDICINE
Registered tradename: _MUPHORAN _
DESCRIPTION
Chemical name: Diethyl 1-[3-(2-chloroethyl)-3-nitrosureido] ethylphosphonate RS
INN (recommended): fotemustine
Formulae:
Structural Formula:
Molecular formula:
C
9
H
19
CIN
3
O
5
P
Molecular weight (relative): 315.7
Physicochemical properties:
Physical form:
pale yellow powder
Solubility:
results obtained show that fotemustine, in accordance with the
standards of the European pharmacopoeia is slightly soluble
in
water and soluble in 95% ethanol
pH:
6.3 (03% aqueous solution)
pKa:
10.4 for the acid group
Polymorphism:
an infrared spectrophotometric study carried out on several batches
shows no polymorphism
Partition coefficient: octanol/water of 15.7-17.9
(pH 2.1- 7.4)
_ _
PHARMACOLOGY
Fotemustine
is a cytostatic anticancer agent of the nitrosourea family with an alkylating and
carbamoylating effect with
a wide spectrum of experimental antitumoral activity.
PHARMACODYNAMICS
Fotemustine is a cytostatic antineoplastic agent whose chemical formula includes a bioiostere of
alanine (1-amino ethylphosphonic acid) in order to facilitate cellular penetration and passage
across the blood-brain barrier.
In animal pharmacology, its spectrum of anticancer activity is very wide and is exerted on tumours
of various histological types and
in various anatomical sites, particularly cerebral and visceral.
MUPHORAN
®
(FOTEMUSTINE)
– Product Information
2 (8)
Version: 2k
As a
result of its
完全なドキュメントを読む