TS-ONE OD Tablet 20

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TEGAFUR; Gimeracil; Oteracil potassium

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

TEGAFUR; Gimeracil; Oteracil potassium

Unit dalam pakej:

2 x 2 x 14tablet Tablets

Dikeluarkan oleh:

Taiho Pharmaceutical Co.,Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
TS-ONE
® OD TABLET
Tegafur/Gimeracil/Oteracil Potassium (20mg/5.8mg/19.6mg,
25mg/7.25mg/24.5mg)
1
WHAT IS IN THIS LEAFLET
1.
What TS-ONE
®
OD Tablet is used
for
2.
How TS-ONE
®
OD Tablet works
3.
Before
you
use
TS-ONE
®
OD
Tablet
4.
How to use TS-ONE
®
OD Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of TS-ONE
®
OD Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
IF YOU HAVE ANY CONCERNS ABOUT TAKING
THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET
. You may need to
read it again.
WHAT TS-ONE
® OD TABLET IS USED FOR
This medicine is used to treat adults
with:
•
Advanced gastric (stomach) cancer
when
given
in
combination
with
cisplatin
(another
anticancer
medicine).
•
Locally advanced (stage II (excluding
T1), IIIA or IIIB) gastric (stomach)
cancer
as
post
operative
adjuvant
chemotherapy.
•
Locally
advanced
or
metastatic
pancreatic
cancer
when
given
as
monotherapy.
•
Locally advanced or metastatic non-
small cell lung cancer when given in
combination
with
carboplatin
(another anticancer medicine).
•
Metastatic colorectal cancer when
given
in
combination
with
oxaliplatin
(another
anticancer
medicine) as first-line treatment or in
combination
with
irinotecan
(another
anticancer
medicine)
as
second-line treatment
.
•
For the treatment of HER2-negative
metastatic breast cancer when given
as monotherapy.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS BEEN PRESCRIBED FOR YOU
.
Your doctor may have prescribed it for
another reason.
HOW TS-ONE
® OD TABLET WORKS
TS-ONE
®
OD
Tablet
belongs
to
the
fluoropyrimidine
class
of
medicine
known as “antineoplastic agents” which
stop the growth of cancer cells.
BEFORE YOU USE TS-ONE
® OD TABLET
-
_When you must not use it _
Do not take TS-ONE
®
OD Tablet if
you:
•
are
allergic
(hypersensitive)
to
tegafur, gimeracil, oteracil or any of
the other ingredients of TS-ONE
®
OD Tablet
•
are
taking

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
TS-ONE
®
OD Tablet 20
TS-ONE
®
OD Tablet 25
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TS-ONE
®
OD Tablet 20
Each tablet contains 20 mg tegafur, 5.8 mg gimeracil and 19.6 mg
oteracil potassium
(equivalent to 15.8 mg oteracil free acid).
TS-ONE
®
OD Tablet 25
Each tablet contains 25 mg tegafur, 7.25 mg gimeracil and 24.5 mg
oteracil potassium
(equivalent to 19.7 mg oteracil free acid).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
TS-ONE
®
OD Tablet 20: an orally disintegrating, pale blue-green tablet with a
white disc
inset centrally in one face, having a characteristic odor.
TS-ONE
®
OD Tablet 25: an orally disintegrating, pale orange tablet with a
white disc inset
centrally in one face, having a characteristic odor.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TS-ONE
®
is indicated in adults
•
For the treatment of advanced gastric cancer when given in combination
with
cisplatin.
•
For post-operative adjuvant chemotherapy for locally advanced (stage
II (excluding
T1), IIIA or IIIB) gastric cancer_._
•
For the treatment of locally advanced or metastatic pancreatic cancer
when given as
monotherapy.
•
For the treatment of locally advanced or metastatic non-small cell
lung cancer when
given in combination with carboplatin.
•
For the treatment of metastatic colorectal cancer when given in
combination with
oxaliplatin as first-line treatment or in combination with irinotecan
as second-line
treatment.
•
For
the
treatment
of HER2-negative metastatic
breast
cancer
when
given
as
monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TS-ONE
®
should only be prescribed by a qualified physician experienced in
treating cancer
patients with anti-neoplastic medicinal products.
POSOLOGY
The recommended standard dose is based on studies performed in an
Asian population
and differs from the dosing recommended in Caucasian patients.
2
The standard TS-ONE
®
doses when given as monotherapy or combination therapy are
provided in Table 1.
_Table 1: