Aranesp

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

darbepoetin alfa

Διαθέσιμο από:

Amgen Europe B.V.

Φαρμακολογική κατηγορία (ATC):

B03XA02

INN (Διεθνής Όνομα):

darbepoetin alfa

Θεραπευτική ομάδα:

Other antianemic preparations

Θεραπευτική περιοχή:

Anemia; Cancer; Kidney Failure, Chronic

Θεραπευτικές ενδείξεις:

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Περίληψη προϊόντος:

Revision: 45

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2001-06-08

Φύλλο οδηγιών χρήσης

191
B. PACKAGE LEAFLET
192
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARANESP 10 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 15 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 20 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 30 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 40 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 50 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 60 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 80 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 100 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 130 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 150 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 300 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
ARANESP 500 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
darbepoetin alfa
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet (see section 4).
WHAT IS IN THIS LEAFLET
1.
What Aranesp is and what it is used for
2.
What you need to know before you use Aranesp
3.
How to use Aranesp
4.
Possible side effects
5.
How to store Aranesp
6.
Contents of the pack and other information
7.
Instructions for injecting with the Aranesp pre-filled syringe
1.
WHAT ARANESP IS AND WHAT IT IS USED FOR
Your doctor has given you Aranesp (an anti-anaemic) to treat your
anaemia. Anaemia is when your
blood does not contain enough red blood cells and the symptoms may be
fatigue, weakness and

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aranesp 10 micrograms solution for injection in pre-filled syringe.
Aranesp 15 micrograms solution for injection in pre-filled syringe.
Aranesp 20 micrograms solution for injection in pre-filled syringe.
Aranesp 30 micrograms solution for injection in pre-filled syringe.
Aranesp 40 micrograms solution for injection in pre-filled syringe.
Aranesp 50 micrograms solution for injection in pre-filled syringe.
Aranesp 60 micrograms solution for injection in pre-filled syringe.
Aranesp 80 micrograms solution for injection in pre-filled syringe.
Aranesp 100 micrograms solution for injection in pre-filled syringe.
Aranesp 130 micrograms solution for injection in pre-filled syringe.
Aranesp 150 micrograms solution for injection in pre-filled syringe.
Aranesp 300 micrograms solution for injection in pre-filled syringe.
Aranesp 500 micrograms solution for injection in pre-filled syringe.
Aranesp 10 micrograms solution for injection in pre-filled pen.
Aranesp 15 micrograms solution for injection in pre-filled pen.
Aranesp 20 micrograms solution for injection in pre-filled pen.
Aranesp 30 micrograms solution for injection in pre-filled pen.
Aranesp 40 micrograms solution for injection in pre-filled pen.
Aranesp 50 micrograms solution for injection in pre-filled pen.
Aranesp 60 micrograms solution for injection in pre-filled pen.
Aranesp 80 micrograms solution for injection in pre-filled pen.
Aranesp 100 micrograms solution for injection in pre-filled pen.
Aranesp 130 micrograms solution for injection in pre-filled pen.
Aranesp 150 micrograms solution for injection in pre-filled pen.
Aranesp 300 micrograms solution for injection in pre-filled pen.
Aranesp 500 micrograms solution for injection in pre-filled pen.
Aranesp 25 micrograms solution for injection in vial.
Aranesp 40 micrograms solution for injection in vial.
Aranesp 60 micrograms solution for injection in vial.
Aranesp 100 micrograms solution for injection in vial.
Aranesp 200 micrograms so