CARBOPLATIN SERVYCAL

Carboplatin 150 and 450 mg

Lyophilized powder for injection

Sale under filed prescription

Made in Argentina

QUALI-QUANTITATIVE COMPOSITION:
Each vial of Carboplatino Servycal 150 mg contains:
Carboplatin 150 mg
Mannitol 150 mg

Each vial of Carboplatino Servycal 450 mg contains:
Carboplatin 450 mg
Mannitol 450 mg

THERAPEUTIC ACTION:
Antineoplastic.

INDICATIONS:
Initial treatment of advanced ovarian carcinoma.

Carboplatino Servycal is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other chemotherapeutic agents. One established combination regime consists of Carboplatino Servycal and cyclophosphamide. Two randomized controlled studies carried out by the NCI and the SWOG using carboplatin vs. cisplatin, both in combination with cyclophosphamide, have shown similar survival rates between the two groups.

There is limited statistical power to demonstrate overall equivalence in pathologic response and long-term survival (≥ 3 years) due to the small number of patients with these characteristics: the small number of patients with residual tumors < 2 cm after initial surgery also limits the statistical power to demonstrate equivalence in this subgroup.

Secondary treatment of advanced ovarian carcinoma.

Carboplatin is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients previously treated with cisplatin.

Within the group of patients treated with cisplatin, those who developed progressive health decline during cisplatin therapy may show lower response rates.

PRESENTATION:
Carboplatino Servycal 150 mg x 1 vial containing lyophilized powder.
Carboplatino Servycal 450 mg x 1 vial containing lyophilized powder.

Keep between 15 °C and 30 °C, protected from light.