Aranesp

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Darbepoetin alfa 500 µg/mL;  

Available from:

Amgen New Zealand Limited

INN (International Name):

Darbepoetin alfa 500 µg/mL

Dosage:

500 mcg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Darbepoetin alfa 500 µg/mL   Excipient: Dibasic sodium phosphate Monobasic sodium phosphate monohydrate Polysorbate 80 Sodium chloride Water for injection

Units in package:

Syringe, glass, 1 x 150 �g/0.3mL, 0.3 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Amgen Manufacturing Ltd

Product summary:

Package - Contents - Shelf Life: Syringe, glass, 1 x 150 ?g/0.3mL - 0.3 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 1 x 200 ?g/0.4mL - 0.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 1 x 300 ?g/0.6mL - 0.6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 1 x 500 ?g/1.0mL - 1 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 4 x 150 ?g/0.3mL - 1.2 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 4 x 200 ?g/0.4mL - 1.6 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 4 x 300 ?g/0.6mL - 2.4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 4 x 500 ?g/1.0mL - 4 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2000-01-26

Summary of Product characteristics

NEW ZEALAND DATA SHEET
ARANESP NZ DATA SHEET CDS V23
PAGE 1 OF 32
The medicine is not currently marketed in New Zealand
1.
ARANESP
ARANESP 15 microgram solution for injection vial
ARANESP 25 microgram solution for injection vial
ARANESP 40 microgram solution for injection vial
ARANESP 60 microgram solution for injection vial
ARANESP 100 microgram solution for injection vial
ARANESP 10 microgram solution for injection pre-filled syringe
ARANESP 15 microgram solution for injection pre-filled syringe
ARANESP 20 microgram solution for injection pre-filled syringe
ARANESP 30 microgram solution for injection pre-filled syringe
ARANESP 40 microgram solution for injection pre-filled syringe
ARANESP 50 microgram solution for injection pre-filled syringe
ARANESP 60 microgram solution for injection pre-filled syringe
ARANESP 80 microgram solution for injection pre-filled syringe
ARANESP 100 microgram solution for injection pre-filled syringe
ARANESP 150 microgram solution for injection pre-filled syringe
ARANESP 200 microgram solution for injection pre-filled syringe
ARANESP 300 microgram solution for injection pre-filled syringe
ARANESP 500 microgram solution for injection pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ARANESP 15 microgram solution for injection vial contains 15
micrograms of
darbepoetin alfa in 1 mL (15

g/mL)
ARANESP 25 microgram solution for injection vial contains 25
micrograms of
darbepoetin alfa in 1 mL (25

g/mL)
ARANESP 40 microgram solution for injection vial contains 40
micrograms of
darbepoetin alfa in 1 mL (40

g/mL)
NEW ZEALAND DATA SHEET
ARANESP NZ DATA SHEET CDS V23
PAGE 2 OF 32
ARANESP 60 microgram solution for injection vial contains 60
micrograms of
darbepoetin alfa in 1 mL (60

g/mL)
ARANESP 100 microgram solution for injection vial contains 100
micrograms of
darbepoetin alfa in 1 mL (100

g/mL)
ARANESP 10 microgram solution for injection pre-filled syringe
contains 10 micrograms
of darbepoetin alfa in 0.4 mL (25

g/mL)
ARANESP 15 microgram solution for