Aranesp

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Darbepoetin alfa 500 µg/mL;  

متاح من:

Amgen New Zealand Limited

INN (الاسم الدولي):

Darbepoetin alfa 500 µg/mL

جرعة:

500 mcg/mL

الشكل الصيدلاني:

Solution for injection

تركيب:

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

الوحدات في الحزمة:

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

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Amgen Manufacturing Ltd

ملخص المنتج:

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

تاريخ الترخيص:

2000-01-26

خصائص المنتج

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