国: シンガポール
言語: 英語
ソース: HSA (Health Sciences Authority)
Gimeracil; Oteracil potassium; Tegafur
TAIHO PHARMA ASIA PACIFIC PTE. LTD.
L01BC53
5.8mg
CAPSULE
Gimeracil 5.8mg; Oteracil potassium 19.6mg; Tegafur 20mg
ORAL
Prescription Only
Taiho Pharmaceutical Co., Ltd. (Tokushima Plant)
ACTIVE
2009-07-13
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 完全なドキュメントを読む
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 完全なドキュメントを読む