Proleukin

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Aldesleukin 18 MIU (Interleukin-2 (recombinant human));  

Tillgänglig från:

Novartis New Zealand Ltd

INN (International namn):

Aldesleukin 18 MIU (Interleukin-2 (recombinant human))

Dos:

18 MIU

Läkemedelsform:

Powder for injection

Sammansättning:

Active: Aldesleukin 18 MIU (Interleukin-2 (recombinant human))   Excipient: Dibasic sodium phosphate dihydrate Mannitol Monobasic sodium phosphate dihydrate Sodium laurilsulfate

Enheter i paketet:

Vial, glass, 18 MIU

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Bayer HealthCare Pharmaceuticals Inc

Terapeutiska indikationer:

Proleukin is indicated for the treatment of metastatic renal cell carcinoma (MRCC).

Produktsammanfattning:

Package - Contents - Shelf Life: Vial, glass, - 18 MIU - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Tillstånd datum:

1998-11-13

Produktens egenskaper

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