TELADO

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE, DOLUTEGRAVIR SODIUM

Tillgänglig från:

SAMPHARINDO RETROVIRAL INDONESIA - Indonesia

INN (International namn):

TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE, DOLUTEGRAVIR SODIUM

Dos:

300 MG /300 MG /52.6 MG

Läkemedelsform:

TABLET SALUT SELAPUT

Enheter i paketet:

DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT

Tillverkad av:

SAMPHARINDO RETROVIRAL INDONESIA - Indonesia

Tillstånd datum:

2021-10-21

Produktens egenskaper

TEMODAL
Â
COMPOSITION
Each Temodal capsule contains 5 mg, 20 mg, 100 mg or 250 mg
temozolomide.
DESCRIPTION
Temodal
in
an imidazotetrazene alkylating
agent
with antitumor activity. It undergoes rapid
chemical conversion in the systemic circulation at physiologic pH to
the active compound, MTIC
(monomethyl triazeno imidazole carboxamide). The cytotoxicity of MTIC
is thought to be due
primarily to alkylation at the O
6
position of guanine with additional alkylation also occurring at the
N
7
position. Cytotoxic lesions that develop subsequently are thought to
involve aberrant repair of
the methyl adduct.
From preclinical safety data, Temozolomide knows as an embryotoxic,
teratogenic and genotoxic
alkylating agent.
INDICATIONS
TEMODAL Capsules are indicated in treatment of patients with reccurent
malignant glioma, such
as glioblastoma multiforme or anaplastic astrocytoma.
DOSAGE AND ADMINISTRATION
Adult patients : In patients previously untreated with chemotherapy,
TEMODAL is administered
orally at a dose of 200 mg/m
2
once daily for 5 days per 28-day cycle. For patients previously
treated with chemotherapy, the initial dose is 150 mg/m
2
once daily, to be increased in the
second cycle to the 20 mg/m
2
daily providing the absolute neutrophil count (ANC) is ³ 1.5 x 10
9
/L
and the thrombocyte count is ³ 100 x 10
9
/L on Day 1 of the next cycle.
Pediatric patients : In patients 3 years of age older, TEMODAL is
administered orally at dose of
200
mg/m
2
once
daily
for
5
days
per
28-day
cycle.
Pediatric
previously
treated
with
chemotherapy should receive an initial dose of 160 mg/m
2
once daily for 5 days, with excalation
to200 mg/m
2
once daily at the next cycle if there is no hematologic toxicity.
Use in patients with hepatic or renal dysfunction
The pharmacokinetics of temozolomide were comparable in patients with
normal hepatic function
and
in
those
with
mild
or
moderate
hepatic
dysfunction.
No
data
are
available
on
the
administration of Temodal in patients with severe hepatic dysfunction
(Child’s Class III) or w