TS ONE OD Tablet 25

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

GIMERACIL; OTERACIL POTASSIUM; TEGAFUR

Disponible depuis:

SYDNA FARMA - Indonesia

DCI (Dénomination commune internationale):

GIMERACIL; OTERACIL POTASSIUM; TEGAFUR

Dosage:

25/7.25/24.5 MG

forme pharmaceutique:

TABLET CEPAT LARUT

Unités en paquet:

BOX @ 2 SAHCETS FOIL@ 2 BLISTERS @ 14 TABLETS

Fabriqué par:

TAIHO PHARMACEUTICAL - Japan

Date de l'autorisation:

2019-07-02

Résumé des caractéristiques du produit

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.
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