País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
GIMERACIL; OTERACIL POTASSIUM; TEGAFUR
SYDNA FARMA - Indonesia
GIMERACIL; OTERACIL POTASSIUM; TEGAFUR
25/7.25/24.5 MG
TABLET CEPAT LARUT
BOX @ 2 SAHCETS FOIL@ 2 BLISTERS @ 14 TABLETS
TAIHO PHARMACEUTICAL - Japan
2019-07-02
1 TS-ONE ® OD TABLET 20 AND TS-ONE ® OD TABLET 25 TEGAFUR + GIMERACIL + OTERACIL POTASSIUM 20 mg and 25 mg Orally Disintegrating Tablet WARNINGS 1. Cancer chemotherapy with TS-ONE ® , as a single drug or in combination, should be administered only to patients for whom treatment with TS-ONE ® has been judged appropriate, under the supervision of experienced physicians who are familiar with cancer chemotherapy and who are based in medical institutions with adequate emergency facilities. A patient who will receive chemotherapy that includes TS-ONE ® should be carefully selected with reference to the package insert of each concomitant drug. TS-ONE ® should only be administered after the effectiveness and risks have been explained, 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 fluorouracil-group drugs, it is necessary to pay attention to changes in the laboratory data. Laboratory tests should be performed frequently. 3. In as much as there may occur severe hepatic disorders, such as fulminant hepatitis, the patient’s hepatic functions should be monitored closely by periodic hepatic function tests to detect hepatic disorder early. Close monitoring should be given to detect possible malaise accompanied by anorexia, in which is thought to be a sign or subjective symptom of hepatic disorder. If jaundice (yellow ocular coloring) appears, TS-ONE ® should be discontinued immediately, and appropriate measures should be taken. 4. TS-ONE ® should not be combined with other fluoropyrimidine-group anti-cancer drugs, combination therapies with them (such as folinate plus Tegafur-Uracil combination therapy), or the antifungal agent flucytosine because there is a possibility that combination with these drugs may cause adverse reactions such as serious blood dyscrasia (See Drug Interactions). 5. Read this Leer el documento completo