Epoetin Alfa Hexal

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

epoetin alfa

MAH:

Hexal AG

ATC_code:

B03XA01

INN:

epoetin alfa

therapeutic_group:

Antianemic preparations

therapeutic_area:

Anemia; Kidney Failure, Chronic; Cancer

therapeutic_indication:

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. , Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).,

leaflet_short:

Revision: 24

authorization_status:

Authorised

authorization_date:

2007-08-27

PIL

75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPOETIN ALFA HEXAL 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 2,000 IU/1 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 3,000 IU/0.3 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 4,000 IU/0.4 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 6,000 IU/0.6 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 7,000 IU/0.7 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 8,000 IU/0.8 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 9,000 IU/0.9 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 10,000 IU/1 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 20,000 IU/0.5 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 30,000 IU/0.75 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
EPOETIN ALFA HEXAL 40,000 IU/1 ML SOLUTION FOR INJECTION IN A
PRE-FILLED SYRINGE
Epoetin 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 Epoetin alfa HEXAL is and what it is used for
2.
What you need to know before you use Epoetin alfa HEXAL
3.
How to use Epoetin alfa HEXAL
4.
Possible side effects
5.
How to store Epoetin alfa HEXAL
6.
Contents of the pack and other information
1.
WHAT EPOETIN ALFA HEXAL IS AND WHAT IT IS USED FOR
Epoetin alfa

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 30,000 IU/0.75 mL solution for injection in a
pre-filled syringe
Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a
pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a
pre-filled syringe
Each mL of solution contains 2,000 IU of epoetin alfa
*
corresponding to 16.8 micrograms per mL
A pre-filled syringe of 0.5 mL contains 1,000 international units (IU)
corresponding to 8.4 micrograms
epoetin alfa. *
Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a
pre-filled syringe
Each mL of solution contains 2,000 IU of epoetin alfa
*
corresponding to 16.8 micrograms per mL
A pre-filled syringe of 1 mL contains 2,000 international units (IU)
corresponding to 16.8 micrograms
epoetin alfa. *
Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a
pre-filled syringe
Each mL of solution contains 10,000 IU of epoetin alfa
*
corresponding to 84.0 micrograms per mL
A pre-filled syringe of 0.3 mL contains 3,000 international units (IU)
corresponding
to 2