Carboplatin 150mg/15 mL Solution for injection/concentrate for solution for infusion 150mg/15ml

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Carboplatin

Available from:

Sandoz GmbH, Kundl, AUSTRIA

ATC code:

Other antineoplastic agents

INN (International Name):

Carboplatin

Dosage:

150mg/15ml

Pharmaceutical form:

Solution for injection/concentrate for solution for infusion

Manufactured by:

Fareva Unterach GmbH Company, AUSTRIA

Product summary:

Physical description: Clear, colourless or almost colourless solution; Local technical representative: phillips pharmaceuticals Tanzania (51625)

Authorization status:

Registered/Compliant

Authorization date:

2022-09-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carboplatin 10 mg / ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml vial contains 50 mg Carboplatin.
Each 15 ml vial contains 150 mg Carboplatin.
Each 45 ml vial contains 450 mg Carboplatin.
Each 60 ml vial contains 600 mg Carboplatin.
Each 100 ml vial contains 1000 mg Carboplatin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Carboplatin 5 ml vial: A clear, colourless solution.
Carboplatin 15 ml vial: A clear, colourless solution.
Carboplatin 45 ml vial: A clear, colourless solution.
Carboplatin 60 ml vial: A clear, colourless solution.
Carboplatin 100 ml vial: A clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Carboplatin is used alone or in combination with other antineoplastic
agents in
the treatment of advanced ovarian carcinoma and small cell (SCLC) and
non-
small cell lung carcinoma (NSCLC).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Carboplatin injection should be used by the intravenous route only.
The recommended dosage of carboplatin injection in previously
untreated adult
patients with normal kidney function is 400 mg/m
2
as a single intravenous dose
administered by a 15- to 60- minute infusion.
Therapy should not be repeated until 4 weeks after the previous
carboplatin
injection 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
.
Reduction of the initial dosage by 20-25% is recommended for those
patients who
present
with
risk
factors
such
as
prior
myelosuppressive
treatment
and
low
performance status (ECOG- Zubrod 2-4 or Karnofsky below 80).
Determination of the hematologic nadir by weekly blood count during
the initial
courses
of
treatment
with
carboplatin
injection
is
recommended
for
dosage
adjustment for subsequent courses of therapy.
Needles or intravenous sets containing aluminum parts that may come in
contact wit