Aranesp

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Nopērc to tagad

Lejuplādēt Produkta apraksts (SPC)
05-09-2017

Aktīvā sastāvdaļa:

Darbepoetin alfa 500 µg/mL;  

Pieejams no:

Amgen New Zealand Limited

SNN (starptautisko nepatentēto nosaukumu):

Darbepoetin alfa 500 µg/mL

Deva:

500 mcg/mL

Zāļu forma:

Solution for injection

Kompozīcija:

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

Vienības iepakojumā:

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

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Amgen Manufacturing Ltd

Produktu pārskats:

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

Autorizācija datums:

2000-01-26

Produkta apraksts

                                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 
                                
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