Carboplatin injection, solution

Ingredients and appearance - Product information

Carboplatin injection, solution- Carboplatin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0703-4244
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Carboplatin ( UNII: BG3F62OND5)( Carboplatin - UNII: BG3F62OND5 ) 10 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Mannitol ( UNII: 3OWL53L36A)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077269 USA

Carboplatin injection, solution- Carboplatin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0703-4246
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Carboplatin ( UNII: BG3F62OND5)( Carboplatin - UNII: BG3F62OND5 ) 10 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Mannitol ( UNII: 3OWL53L36A)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077269 USA

Carboplatin injection, solution- Carboplatin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0703-4248
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Carboplatin ( UNII: BG3F62OND5)( Carboplatin - UNII: BG3F62OND5 ) 10 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Mannitol ( UNII: 3OWL53L36A)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077269 USA

Carboplatin injection, solution- Carboplatin

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0703-4239
Route of Administration Intravenous

Active Ingredient/Active Moiety

Ingredient Name Strength
Carboplatin ( UNII: BG3F62OND5)( Carboplatin - UNII: BG3F62OND5 ) 10 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Mannitol ( UNII: 3OWL53L36A)
Water ( UNII: 059QF0KO0R)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077269 USA

Labeler - Teva Parenteral Medicines, Inc.( 794362533)

114 Carboplatin and 109 Cisplatin patients did not undergo second look surgery in NCIC study.

90 Carboplatin and 106 Cisplatin patients did not undergo second look surgery in SWOG study.
Kaplan-Meier Estimates

Unrelated deaths occurring in the absence of progression were counted as events (progression) in this analysis.
Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis.
Kaplan-Meier Estimates
Analysis adjusted for factors found to be of prognostic significance were consistent with unadjusted analysis.
Values are in percent of evaluable patients
ns = not significant, p > 0.05
May have been affected by cyclophosphamide dosage delivered
Values are in percent of evaluable patients
ns = not significant, p > 0.05
May have been affected by cyclophosphamide dosage delivered
Use with Cyclophosphamide for Initial Treatment of Ovarian Cancer: Data are based on the experience of 393 patients with ovarian cancer (regardless of baseline status) who received initial combination therapy with carboplatin and cyclophosphamide in two randomized controlled studies conducted by SWOG and NCIC (see CLINICAL STUDIES ).

Combination with cyclophosphamide as well as duration of treatment may be responsible for the differences that can be noted in the adverse experience table.
Single Agent Use for the Secondary Treatment of Ovarian Cancer: Data are based on the experience of 553 patients with previously treated ovarian carcinoma (regardless of baseline status) who received single agent carboplatin.
Percentages apply to carboplatin injection as a single agent or to both carboplatin and cyclophosphamide in combination. In the controlled studies, dosages were also adjusted at a lower level (50% to 60%) for severe myelosuppression. Escalations above 125% were not recommended for these studies.