Aranesp

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
05-09-2017

Viambatanisho vya kazi:

Darbepoetin alfa 500 µg/mL;  

Inapatikana kutoka:

Amgen New Zealand Limited

INN (Jina la Kimataifa):

Darbepoetin alfa 500 µg/mL

Kipimo:

500 mcg/mL

Dawa fomu:

Solution for injection

Tungo:

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

Vitengo katika mfuko:

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

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

Amgen Manufacturing Ltd

Bidhaa muhtasari:

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

Idhini ya tarehe:

2000-01-26

Tabia za bidhaa

                                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 
                                
                                Soma hati kamili
                                
                            

Tazama historia ya hati