Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Carboplatin 10 mg/mL
Pfizer New Zealand Limited
Carboplatin 10 mg/mL
10 mg/mL
Solution for injection
Active: Carboplatin 10 mg/mL Excipient: Water for injection
Vial, 50 mg/5 mL, 5 mL
Prescription
Prescription
Johnson Matthey Pharmaceutical Materials
· advanced stage ovarian cancer of epithelial origin.
Package - Contents - Shelf Life: Vial, 50 mg/5 mL - 5 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light - Vial, 150 mg/15 mL - 15 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light - Vial, 450 mg/45 mL - 45 mL - 18 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at or below 25°C protect from light
1989-07-21
Version: pfdcarpi10823 Supersedes: pfdcarpi10223 Page 1 of 14 NEW ZEALAND DATA SHEET 1. PRODUCT NAME_ _ DBL ™ Carboplatin Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION DBL Carboplatin Injection (all presentations) is a sterile solution of carboplatin in Water for Injections. The vials contain 5, 15 or 45 mL of 10 mg/mL carboplatin. The solution does not contain any preservatives. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Carboplatin Injection is a solution for injection. It is clear, colourless or slightly yellow solution free from particulates and is presented in vials. The pH of the injection ranges between 4.0 to 7.0. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carboplatin is indicated in the treatment of: • advanced stage ovarian cancer of epithelial origin • small cell lung carcinoma • carcinoma of the head and neck • carcinoma of the testis • paediatric cerebral tumours • soft tissue sarcoma • neuroblastoma 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE CONTAINS NO ANTIMICROBIAL AGENT. PRODUCT IS FOR SINGLE USE IN ONE PATIENT ONLY. DISCARD ANY RESIDUE. Version: pfdcarpi10823 Supersedes: pfdcarpi10223 Page 2 of 14 Adults: The recommended dose of carboplatin in previously untreated adults with normal renal function is 400 mg/m 2 given as a single intravenous infusion over 15 to 60 minutes. Therapy should not be repeated until four weeks after the previous carboplatin course. It is recommended that according to clinical circumstances the initial dosage may require reduction by 20 to 25% in patients with risk factors such as increasing age, previous myelosuppressive therapy and poor performance status. Dosage modification may be required when carboplatin is used in combination with other myelosuppressive drugs or radiation therapy, to minimise additive myelosuppressive effects. Determination of haematologic nadir by weekly blood counts during initial courses is recommended for future dosage adjustment and scheduling of carboplatin. Impaired Renal Fu Pročitajte cijeli dokument