Binocrit
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
21-11-2023
Produktets egenskaber
(SPC)
21-11-2023
Offentlige vurderingsrapport
(PAR)
04-10-2018
Aktiv bestanddel:
epoetin alfa
Tilgængelig fra:
Sandoz GmbH
ATC-kode:
B03XA01
INN (International Name):
epoetin alfa
Terapeutisk gruppe:
Antianemic preparations
Terapeutisk område:
Anemia; Kidney Failure, Chronic
Terapeutiske indikationer:
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).
Produkt oversigt:
Revision: 22
Autorisation status:
Authorised
Autorisation dato:
2007-08-28
Indlægsseddel
75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BINOCRIT 1,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 2,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
BINOCRIT 3,000 IU/0.3 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 4,000 IU/0.4 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 5,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 6,000 IU/0.6 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 7,000 IU/0.7 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 8,000 IU/0.8 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 9,000 IU/0.9 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 10,000 IU/1 ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE BINOCRIT 20,000 IU/0.5 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE BINOCRIT 30,000 IU/0.75 ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
BINOCRIT 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 Binocrit is and what it is used for
2.
What you need to know before you use Binocrit
3.
How to use Binocrit
4.
Possible side effects
5.
How to store Binocrit
6.
Contents of the pack and other information
1.
WHAT BINOCRIT IS AND WHAT IT IS USED FOR
Binocrit contains the active substance epoetin alfa, a protein that
stimulates the bone marrow to
produce more red blood cells which carry haemoglobin (a substance that
transports oxygen). Epoe
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Binocrit 1,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Binocrit 2,000 IU/1 mL solution for injection in a pre-filled syringe
Binocrit 3,000 IU/0.3 mL solution for injection in a pre-filled
syringe
Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled
syringe
Binocrit 5,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Binocrit 6,000 IU/0.6 mL solution for injection in a pre-filled
syringe
Binocrit 7,000 IU/0.7 mL solution for injection in a pre-filled
syringe
Binocrit 8,000 IU/0.8 mL solution for injection in a pre-filled
syringe
Binocrit 9,000 IU/0.9 mL solution for injection in a pre-filled
syringe
Binocrit 10,000 IU/1 mL solution for injection in a pre-filled syringe
Binocrit 20,000 IU/0.5 mL solution for injection in a pre-filled
syringe
Binocrit 30,000 IU/0.75 mL solution for injection in a pre-filled
syringe
Binocrit 40,000 IU/1 mL solution for injection in a pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Binocrit 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. *
Binocrit 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. *
Binocrit 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 25.2 micrograms epoetin alfa. *
Binocrit 4,000 IU/0.4 mL solution for injection in a pre-filled
syringe
Each mL of solution contains 10,000 IU of epoetin alfa
*
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