TS-ONE Capsule 20

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

Thành phần hoạt chất:

Gimeracil; Oteracil potassium; Tegafur

Sẵn có từ:

TAIHO PHARMA ASIA PACIFIC PTE. LTD.

Mã ATC:

L01BC53

Liều dùng:

5.8mg

Dạng dược phẩm:

CAPSULE

Thành phần:

Gimeracil 5.8mg; Oteracil potassium 19.6mg; Tegafur 20mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

Taiho Pharmaceutical Co., Ltd. (Tokushima Plant)

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2009-07-13

Tờ rơi thông tin

Revised: June 2013 
Taiho Pharmaceutical Co., Ltd. 
1

TS-ONE _CAPSULE 20_    TS-ONE _CAPSULE 25_ 
< Tegafur, Gimeracil and Oteracil potassium Capsule > 

WARNINGS 
1.  CANCER  CHEMOTHERAPY  WITH  TS-ONE  SHOULD  BE  AD-
MINISTERED ONLY TO PATIENTS FOR WHOM TREATMENT WITH 
TS-ONE  HAS  BEEN  JUDGED  APPROPRIATE,  UNDER  THE 
SUPERVISION  OF  EXPERIENCED  PHYSICIANS  WHO  ARE  FA-
MILIAR WITH CANCER CHEMOTHERAPY AND WHO ARE BASED 
IN  MEDICAL  INSTITUTIONS WITH ADEQUATE EMERGENCY FA-
CILITIES.  A  PATIENT  WHO  WILL  RECEIVE      CHEMOTHERAPY 
THAT  INCLUDES  TS-ONE  SHOULD  BE  CAREFULLY  SELECTED 
WITH  REFERENCE  TO  THE  PACKAGE  INSERT  OF  EACH  CON-
COMITANT DRUG. TS-ONE SHOULD ONLY BE ADMINISTERED 
AFTER  THE  EFFECTIVENESS  AND  RISKS  HAVE  BEEN  EX-
PLAINED,  AND  INFORMED  CONSENT  HAS  BEEN  GIVEN  BY 
THE  PATIENT  OR  BY  THE  PATIENT’S  GUARDIAN  BEFORE 
CHEMOTHERAPY IS STARTED. 
2.  SINCE  THE  DOSE-LIMITING  TOXICITY  (DLT)  OF  TS-ONE  IS 
BONE MARROW DEPRESSION (SEE ADVERSE REACTIONS), IN 
WHICH  it  IS  DIFFERENT  FROM  CONVENTIONAL  ORAL  FLUOR-
OURACIL-GROUP  DRUGS,  IT  IS  NECESSARY  TO  BE  ALERT  FOR 
CHANGES  IN  THE  LABORATORY  DATA.  LABORATORY  TESTS 
SHOULD BE PERFORMED FREQUENTLY. 
3.  INASMUCH  AS  THERE  MAY  OCCUR  SEVERE  HEPATIC  DISOR-
DERS,  SUCH  AS  FULMINANT  HEPATITIS,  THE  PATIENT'S  HE-
PATIC  FUNCTIONS  SHOULD  BE  MONITORED  CLOSELY  BY  PE-
RIODIC  HEPATIC  FUNCTION TESTS TO  DETECT  HEPATIC  DISOR-
DER  EARLY.  CLOSE  MONITORING  IS  NECESSARY  TO  DETECT 
POSSIBLE MALAISE ACCOMPANIED BY ANOREXIA, WHICH IS 
THOUGHT  TO  BE  A  SIGN  OR  SUBJECTIVE  SYMPTOM  OF  HE-
PATIC  DISORDER.  IF  JAUNDICE�

Đặc tính sản phẩm

1
Revised: March 2022
TS-ONE
® CAPSULE 20
TS-ONE
® CAPSULE 25
< TEGAFUR, GIMERACIL AND OTERACIL POTASSIUM CAPSULE >
DESCRIPTION
Brand name
TS-ONE
®
Capsule 20
TS-ONE
®
Capsule 25
Ingredient/
contents
Tegafur
20
mg,
Gimeracil
5.8
mg
and
Oteracil potassium 19.6
mg per capsule
Tegafur
25
mg,
Gimeracil 7.25 mg and
Oteracil
potassium 24.5
mg per capsule
Inactive
ingredients
Lactose
hydrate,
Magnesium
stearate,
Gelatin, Sodium lauryl
sulfate, Titanium oxide
Lactose
hydrate,
Magnesium
stearate,
Gelatin,
Sodium
lauryl
sulfate, Titanium oxide,
FD&C Yellow No.6
Description
TS-ONE
®
is an opaque,
hard-shell capsule with
a white cap and white
body
containing
white
powder and granules.
TS-ONE
®
is an opaque,
hard-shell
capsule
with
an orange cap and white
body
containing
white
powder and granules.
Appearance
No.4 capsule
No.4 capsule
Size
and
weight
Total length: 14.5 mm
Long diameter (cap): 5.2 mm
Short diameter (body): 5.0 mm
Weight: approx. 179 mg
Total length: 14.5 mm
Long diameter (cap): 5.2 mm
Short diameter (body): 5.0 mm
Weight: approx. 214 mg
Identification
code
TC442
TC443
INDICATIONS
-
Post-operative adjuvant chemotherapy for locally advanced (stage
II (excluding T1), IIIA or IIIB) gastric cancer
-
For
the
treatment
of
locally
advanced
or
metastatic
adenocarcinoma of the pancreas
-
For the treatment of locally advanced or metastatic non-small cell
lung cancer in patients who have been previously treated with
platinum-based chemotherapy
DOSAGE AND ADMINISTRATION
The standard doses in Table 1 below are the recommended initial
dose for adults according to body surface area. TS-ONE
®
should be
administered twice daily, after breakfast and after the evening meal,
for 28 consecutive days, followed by a 14-day rest. This is regarded
as one course of the regimen.
_Table 1: Standard dose calculations by body surface area (BSA) _
_(m_
_2_
_) _
Body surface area (m
2
)
Initial dose (tegafur equivalent)
< 1.25
40 mg twice daily
1.25 - < 1.5
50 mg twice daily
≥ 1.5
60 mg twice daily
WARNINGS
1.
CANCER
CHEMOTHERAPY
WITH