TS-ONE OD Tablet 25

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

Oteracil potassium; TEGAFUR; Gimeracil

Dostopno od:

ZUELLIG PHARMA SDN BHD

INN (mednarodno ime):

Oteracil potassium; TEGAFUR; Gimeracil

Enote v paketu:

2 x 2 X 14tablet Tablets

Izdeluje:

Taiho Pharmaceutical Co.,Ltd.

Navodilo za uporabo

_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.
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 other fluoropyrimidine anti-
cancer medicine such as fluorouracil
and capecitabine, or have

Lastnosti izdelka

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 15.8mg oteracil f ree acid)
TS -ONE ® OD Tablet 25
Each tablet contains 25 mg tegafur, 7.25 mg gimeracil and 24.5 mg oteracil potassium
(equivalent to 19.7mg oteracil free acid)
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
TS -ONE ® OD Tablet 20: an orally disintegrating , p ale 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 charact eristic odor.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
TS -ONE ® is indic ated 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.
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.