COMPOSITION:
Each vial contains:
Carboplatin U.S.P. 150 mg
Mannitol U.S.P. q.s

PREPARATION OF SOLUTION:
The lyophilised powder is reconstituted with 15 ml sterile water for injection to produce a concentration of 10 mg / ml of Carboplatin.

STORAGE:
Store in a cool, dark and dry place.

PRESENTATION:
Vial containing 150 mg.

ACTIONS:
Carboplatin is a second generation platinum compound that reacts with nucleophilic sites of DNA, RNA and protein synthesis.

INDICATION:
Advanced ovarian cancer, small cell lung cancer, nonsmall cell lung cancer, head and neck cancer and in genitourinary cancer, particularly in testicular, bladder and cervical cancers. pediatric brain tumor. ( meduloblastoma).

CONTRAINDICATIONS:
History of severe allergic reactions to platinum containing compounds or mannitol, severe bone marrow depression or significant bleeding.

WARNING:
Bone marrow suppression (leukopenia, neutropenia and thromobocytopenia) is dose dependent and is also the dose limiting toxicity.

Pregnancy :
Carboplatin may cause fetal harm when administered to a pregnant woman.

DRUG INTERACTIONS :
The renal effects of nephrotoxic compounds may be potentiated.

ADVERSE REACTIONS :
Haematologic toxicity, gastointestinal toxicity, neurotoxicity, nephrotoxicity, hepatoxicity, serum electrolyte disturbances, allergic reactions, pain asthenia, alopecia, cardiovascular, respiratory, genitourinary and mucosal side effects have been reported.

OVERDOSAGE:
There is no known antidote for Carboplatin overdosage. The anticipated complications of overdosage would be secondary to bone marrow suppression and /or hepatic toxicity.

DOSAGE AND ADMINISTRATION :
Doses of 400 mg / m² body surface area by intravenous infusion over 15 minutes to 1 hour. Doses should not be given more frequently than every 4 weeks and should be reduced in patients at risk of myelosuppression . Lower doses may also be given as part of combination regimens.

Note : Needles or intravenous administration sets containing aluminum parts that may come in contact with Carboplatin should not be used for the preparation or administration of the drug. Aluminum can react with Carboplatin causing precipitate formation and loss of potency.