Megaplatin

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

carboplatin

Available from:

Genepharm S.A.

INN (International Name):

carboplatin

Dosage:

10mg/ml

Pharmaceutical form:

solution for i/v infusion

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
CARBOPLATIN
1.
NAME OF THE MEDICINAL PRODUCT
MEGAPLATIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of 15ml contains 150mg carboplatin.
3.
PHARMACEUTICAL FORM
Solution for infusion
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS:
Carboplatin is indicated in the treatment of the following neoplasms:
-
Advanced ovarian carcinoma of epithelial origin in: a) first line
therapy, b)
second line therapy, after other treatments have failed.
-
Small cell carcinoma of the lung
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Carboplatin is administered intravenously only.
The recommended dose of carboplatin in previously untreated adults
with normal
renal function is 400mg/m
2
, given as a single intravenous infusion over 15 to 60
minutes.
For adult patients with normal renal function, previously untreated,
the recommended
dose is 400mg/m
2
of body surface in a single dose, administered as intravenous
infusion (duration 15 to 60 minutes).
Therapy should not be repeated until 4 weeks after the previous
carboplatin course
and/or until the neutrophil count is at least 2,000 cells/mm
3
and the platelet count is
at least 100,000 cells/mm
3
. Initial dosage should be reduced by 20-25% in patients
with
risk
factors
such
as
previous
myelosuppressive
therapy
and/or
poor
performance status (Performance status scale ECOG- Zubrod 2-4 or
Karnofsky
below 80). To patients over 65 years, initial or subsequent dose
adjustment may be
necessary depending on the patient's condition.
Determination of haematologic nadir by weekly blood counts during
initial courses is
recommended for future dosage adjustment and scheduling of
carboplatin.
Impairment
of
renal
function:
Patients
with
creatinine
clearance
values
below
60m1/min are at greater risk of severe myelosuppression. The rate of
severe
leukopenia, neutropenia or thrombopenia was maintained at 25% with the
following
dose regimens:
- 250mg/m
2
of carboplatin intravenously on the 1st day in patients with initial
creatinine clearance values between 41-5