MYLAN ETOPOSIDE CONCENTRATE FOR SOLUTION FOR INJECTION 20MGML

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

ETOPOSIDE

متاح من:

MYLAN HEALTHCARE SDN. BHD.

INN (الاسم الدولي):

ETOPOSIDE

الوحدات في الحزمة:

1vial Vials

المصنعة من قبل:

Mylan Laboratories Limited (OTL)

خصائص المنتج

MYLAN ETOPOSIDE CONCENTRATE FOR SOLUTION FOR INJECTION 20MG/ML
COMPOSITION
Mylan Etoposide Concentrate for Solution for Injection 20 mg/mL - Each
mL contains Etoposide 20 mg
PRODUCT DESCRIPTION
Mylan Etoposide Concentrate for Solution for Injection 20 mg/mL is
nearly colourless to yellow liquid filled in type I flint vials with
20mm grey bromobutyl
omniflex plus coated rubber closures with 20mm flip off aluminium
seals. The reconstituted solution is a clear colourless liquid.
PHARMACODYNAMICS
Pharmacotherapeutic group: antineoplastic agent—podophyllotoxin
derivatives
ATC code: L01CB01
Etoposide is a semi-synthetic podophyllotoxin derivative. Its main
effect seems to occur during the G
2
phase of the cell cycle. Two dose-dependent reactions
occur: at high concentrations (> 10 µg/ml), lysis can be observed of
the cells entering mitosis; at low concentrations (0.3–10 µg/ml),
the cells are prevented
from entering the prophase. The main macromolecular effect appears to
be inhibition of DNA synthesis.
PHARMACOKINETICS
The concentration of etoposide in blood and organs is low with maximum
values in the liver and the kidneys. Protein binding could be as high
as 98%.
On intravenous administration, the disposition of etoposide is best
described as a biphasic process with an initial half-life of about 1.5
hours. After distribution,
half-life is about 40 hours. The terminal half-life is 6-8 hours.
Etoposide is cleared by both renal and nonrenal processes i.e.
metabolism and biliary excretion. In patients with renal dysfunction
plasma etoposide
clearance is decreased.
In adults, the total body clearance of etoposide is correlated with
creatinine clearance, serum albumin concentration and nonrenal
clearance. In children,
elevated serum ALT levels are associated with reduced drug total body
clearance. Prior use of cisplatin may result in a decrease of
etoposide total body
clearance.
Following a single intravenous dose etoposide is excreted in the urine
for about 63% and in the faeces for about 31% after 80 hours.
INDICATI