UFUR Capsule

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

TEGAFUR; Uracil

Boleh didapati daripada:

PHARM-D SDN. BHD.

INN (Nama Antarabangsa):

TEGAFUR; Uracil

Unit dalam pakej:

70Capsule Capsules

Dikeluarkan oleh:

TTY BIOPHARM CO LTD

Risalah maklumat

UFUR CAPSULE
®
Tegafur, Uracil (100mg, 224mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_UFUR Capsule_
is used for
2.
How
_UFUR Capsule_
works
3.
Before you use
_UFUR Capsule_
4.
How to use
_UFUR Capsule_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_UFUR_
_Capsule_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT_ UFUR CAPSULE_ IS USED FOR
_UFUR capsule_
is used in remission of
symptoms of the following cancers: head
and neck, gastric, bowel, liver,
gallbladder or bile-duct, pancreatic, lung,
breast, bladder, prostatic, and lower part
of the womb.
It is used in combination with another
medicine containing folinate for bowel
cancer.
HOW_ UFUR CAPSULE_ WORKS
_UFUR capsule_
has two medicines in it.
One is called tegafur and the other uracil.
Tegafur is a medicine to treat cancer by
blocking the cancer cell growth and
division (cytostatic). Uracil helps the
tegafur to work better. It does this by
slowing the rate that tegafur is passed out
of the body.
BEFORE YOU USE_ UFUR CAPSULE_
-
_When you must not use it_
1)
You are allergic to the ingredients
of this product.
2)
You are taking the antiviral
medicine sorivudine. The
concomitant use of
_UFUR Capsule_
with the antiviral medicine
sorivudine may cause fatal side
effect.
3)
You are pregnant; trying to get
pregnant or think you may be
pregnant.
4)
You are breast-feeding.
-
_Before you start to use it_
Please make sure you have understood
the explanation given by your doctor
or pharmacist before taking this
medicine. Speak to your doctor /
pharmacist if you have one of
following conditions:
1)
Liver problem.
2)
Bone marrow damage from
previous radiotherapy or treatment
with other anticancer medicines
3)
Bone marrow depression
4)
Liver dysfunction
5)
Kidney dysfunction
6)
Infectious diseases
7)
Infections and bleeding tendencies,
gastric/intestinal symptoms such as
abdominal pain, diarrhea
8)
Dehydration
9)
Sugar intolerance
10)
Heart disease or a history

Ciri produk

UFUR Capsule
UFUR contains tegafur and uracil
in a molar ration of
1:4,
and is an
antimalignant tumor agent with antimetablolic effect.
Tegafur is an antitumor agent synthesized in 1966 by Dr. Hiller,S.A.
et
al. It is gradually converted to 5-fluorouracil
(5-FU) in vivo to show it’s
efficacy, and is a prodrug of 5-FU. Conversely, uracil
is a compound of
nucleic acids and shows hardly any pharmacological
and toxic effects
when singly administered.
It
was confirmed in basic studies that
tegafur
and uracil
in a molar
ration of
1:4 suppressed the catabolism of
5-FU (a metabolite of
tegafur),
increased
selectively
the
levels
of
active
antitumor
compounds in tumors,
thereby enhancing its effects.
In clinical
trials
the product
was confirmed to have an optimal
combination ratio,
with
long lasting characteristics and a high concentration of
5-FU levels in
tumor. It shows efficacy as an antitumor agents in the treatment of
the
following cancers: gastric cancer, colorectal
cancer and breast cancer.
【
COMPOSITION
】
UFUR
：
Each capsule contains 100mg of tegafur and 224mg of uracil.
【
INDICATIONS
】
UFUR capsule is indicated to remission of
subjective and objective
symptoms in the following cancers: head and neck, gastric, colorectal,
liver,
gallbladder
or
bile-duct,
pancreatic,
lung,
breast,
bladder,
prostatic, and uterine cervical.
Folinate plus Tegafur-Uracil combination therapy is indicated for
colorectal cancer.
Under physician's prescription
【
DOSAGE AND ADMINISTRATION
】
UFUR capsules
are
administered
orally.
The
usual
dosage
is
(Tegafur
:
300 – 600mg) 3 – 6 capsules daily in 2 -3 divided doses.
For
patients with cervical
cancer,
the usual
dosage in 6 capsules
(Tegafur
600mg)
daily in 2 -3 divided doses.
Even in combination
chemotherapy
with
other
antineoplastics,
the
drug
is
given
as
described above.
[Dose Calculation Table]
Typical daily dose
Tegafur-equivalent dose
300~600mg
Uterine cervical
cancer: 600mg
Number of UFUR capsule
3~6 capsules
6 capsules
Folinate plus Tegafur-Uracil combination therap