EPREX 2,000 IU/mL solution for injection in pre-filled syringe

Valsts: Malta

Valoda: angļu

Klimata pārmaiņas: Medicines Authority

Aktīvā sastāvdaļa:

EPOETIN ALFA

Pieejams no:

Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, Belgium

ATĶ kods:

B03XA01

SNN (starptautisko nepatentēto nosaukumu):

EPOETIN ALFA 2000 IU/ml

Zāļu forma:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Kompozīcija:

EPOETIN ALFA 2000 IU/ml

Receptes veids:

POM

Ārstniecības joma:

ANTIANEMIC PREPARATIONS

Autorizācija statuss:

Withdrawn

Autorizācija datums:

2008-01-22

Lietošanas instrukcija

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPREX 2,000 IU/ML, 4,000 IU/ML AND 10,000 IU/ML
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES
(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, nurse or
pharmacist.
-
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, nurse, or
pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What EPREX is and what it is used for
2.
What you need to know before you use EPREX
3.
How to use EPREX
4.
Possible side effects
5.
How to store EPREX
6.
Contents of the pack and other information
1.
WHAT EPREX IS AND WHAT IT IS USED FOR
EPREX 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). Epoetin
alfa is a copy of the human protein erythropoietin
(ee-rith-roe-po-eh-tin) and acts in the same way.
•
EPREX IS USED TO TREAT SYMPTOMATIC ANAEMIA CAUSED BY KIDNEY DISEASE
•
in children on haemodialysis
•
in adults on haemodialysis or peritoneal dialysis
•
in severely anaemic adults not yet undergoing dialysis.
If you have kidney disease, you may be short of red blood cells if
your kidney does not produce
enough erythropoietin (necessary for red cell production). EPREX is
prescribed to stimulate
your bone marrow to produce more red blood cells.
•
EPREX IS USED TO TREAT ANAEMIA IN ADULTS RECEIVING CHEMOTHERAPY FOR
SOLID TUMOURS,
malignant lymphoma or multiple myeloma (bone marrow cancer) who may
have a need for a
blood transfusion. EPREX can reduce the need for a blood transfusion
in these patients.
•
EPREX IS USED IN MODERATELY ANAEMIC ADULTS WHO DONATE

Produkta apraksts

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
EPREX 2,000 IU/mL solution for injection in pre-filled syringe.
EPREX 4,000 IU/mL solution for injection in pre-filled syringe.
EPREX 10,000 IU/mL solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EPREX 2,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 2,000 IU/mL (16.8 micrograms per mL), produced in Chinese
Hamster Ovary (CHO)
cells by recombinant DNA technology
A pre-filled syringe of 0.5 mL contains 1,000 IU (8.4 micrograms) of
epoetin alfa.
EPREX 4,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 4,000 IU/mL (33.6 micrograms per mL), produced in Chinese
Hamster Ovary (CHO)
cells by recombinant DNA technology
A pre-filled syringe of 0.5 mL contains 2,000 IU (16.8 micrograms) of
epoetin alfa.
EPREX 10,000 IU/mL solution for injection in pre-filled syringe
Epoetin alfa 10,000 IU/mL (84.0 micrograms per mL), produced in
Chinese Hamster Ovary (CHO)
cells by recombinant DNA technology
A pre-filled syringe of 0.3 mL contains 3,000 IU (25.2 micrograms) of
epoetin alfa
A pre-filled syringe of 0.4 mL contains 4,000 IU (33.6 micrograms) of
epoetin alfa
A pre-filled syringe of 0.5 mL contains 5,000 IU (42.0 micrograms) of
epoetin alfa
A pre-filled syringe of 0.6 mL contains 6,000 IU (50.4 micrograms) of
epoetin alfa
A pre-filled syringe of 0.8 mL contains 8,000 IU (67.2 micrograms) of
epoetin alfa
A pre-filled syringe of 1.0 mL contains 10,000 IU (84.0 micrograms) of
epoetin alfa
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPREX is indicated for the treatment of symptomatic anaemia associated
with chronic renal failure
(CRF):
•
in adults and paediatrics aged 1 to 18 years on haemodialysis and
adult patients on peritoneal
dialysis.
•
in adults with renal insufficiency not yet undergoing dialysis for the
treatment of se