Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Aldesleukin 18 MIU (Interleukin-2 (recombinant human));
Novartis New Zealand Ltd
Aldesleukin 18 MIU (Interleukin-2 (recombinant human))
18 MIU
Powder for injection
Active: Aldesleukin 18 MIU (Interleukin-2 (recombinant human)) Excipient: Dibasic sodium phosphate dihydrate Mannitol Monobasic sodium phosphate dihydrate Sodium laurilsulfate
Vial, glass, 18 MIU
Prescription
Prescription
Bayer HealthCare Pharmaceuticals Inc
Proleukin is indicated for the treatment of metastatic renal cell carcinoma (MRCC).
Package - Contents - Shelf Life: Vial, glass, - 18 MIU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
1998-11-13
1 NEW ZEALAND DATA SHEET 1. NAME OF THE MEDICINAL PRODUCT PROLEUKIN ® 18 x 10 6 IU, powder for solution for injection or infusion Aldesleukin powder for injection 18 million International Units (1.1mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Proleukin ® powder for solution for injection or infusion contains 22 x 10 6 International Units (IU) aldesleukin. Aldesleukin is produced by recombinant DNA technology using an _ Escherichia coli_ strain which contains a genetically engineered modification of the human Interleukin-2 (IL-2) gene. After reconstitution with 1.2 mL water for injections, according to the instructions (see Instructions for use), each 1 mL solution contains 18 x 10 6 IU (1.1 mg) aldesleukin. 3. PHARMACEUTICAL FORM One glass vial contains 22 x 10 6 IU sterile freeze-dried, white powder for solution for injection or infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Proleukin is indicated for: The treatment of metastatic melanoma (MM). The treatment of metastatic renal cell carcinoma (MRCC). Risk factors associated with decreased response rates and median survival have been identified and should be taken into consideration when selecting appropriate patients for therapy (see Contraindications). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY For MRCC, Proleukin should be administered by high dose intravenous (i.v.) bolus infusion, by continuous i.v. infusion or by subcutaneous injection. For MM, Proleukin should be administered by high dose i.v. bolus infusion or by continuous i.v. infusion. HIGH DOSE BOLUS INFUSION 0.6 x 10 6 IU/kg (0.037 mg//kg) is administered every 8 hours by a 15-minute intravenous infusion for a maximum of 14 doses. Following 5 to 9 days without Proleukin therapy, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated. During clinical trials, doses were frequently withheld for toxicity Metastatic RCC patients treated with this schedule received a median of 20 of the 28 doses during the first cou Olvassa el a teljes dokumentumot