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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 14/10/2011
SPC Eprex 2000, 4000 and 10000 IU/ml solution for injection in pre-filled syringe

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 14/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   29-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to traceability and identification statement:

In order to improve the traceability of erythropoiesis-stimulating agents (ESAs), the trade name of the administered ESA should be clearly recorded (or stated) in the patient file.

 

Patients should only be switched from one ESA to another under appropriate supervision.

Updated on 10/09/2010 and displayed until 14/10/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 6.5: and a needle safety device (copolyester and polycarbonate) attached to the syringe

Change to section 10: 27 August 2010.
Updated on 01/07/2010 and displayed until 10/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 - Special warnings and precautions for Use

Amend Section 4.4 to update the existing Pure Red Cell Aplasia (PRCA) related warnings and to advise physicians of the observed risks associated with the unapproved use of erythropoiesis stimulating agents (ESAs) to treat anaemia related to ribavirin/interferon therapy for chronic hepatitis C.

Change to section 5.1 - Pharmacodynamic Properties

Revision of section 5.1 (Pharmacodynamic Properties) in accordance with the recommendations of the Committee for Human Medicinal Products’ (CHMP) and the Pharmacovigilance Working Party’s (PhVWP) safety review of epoetins, concluded in September 2009

Change to section 10 - Date of revision of the text

Changed to 2nd April 2010
Updated on 12/08/2009 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.4:

  • Hyperkalaemia.  Revisions to the existing text.
  • Porphyria.  Addition of a warning regarding the possibility of an exacerbation of porphyria during treatment in patients with chronic renal failure.

Change to section 4.6:

  • Addition of advise that, as erythropoetin is present in human milk, EPREX should be used in caution with nursing women.

Change to section 10:
Updated to 29th April 2009
Updated on 18/02/2009 and displayed until 12/08/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   09-Feb-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 9 - Updated to 04 August 2008
Change to section 10 - Updated to 09 February 2009
Updated on 27/10/2008 and displayed until 18/02/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 7 - Updated to 50-100 Holmers Farm Way
Change to section 10 - Updated to 14th October 2008
Updated on 22/07/2008 and displayed until 27/10/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change due to harmonisation of SPC
  • Change to section 4.1 - Therapeutic indications
Date of revision of text on the SPC:   01-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Change to section 4.1 – Therapeutic Indications

Addition of sub heading - Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients

Change to section 4.2 – Posology and Method of Administration

Additional information for caregivers administering Eprex.

 

Change of sub heading from Chronic renal failure patients to Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients.

Update to section regarding haemoglobin concentration - aim for between 10 and 12g/dl. Eprex should be administered in order to increase haemoglobin to not greater than 12g/dl. Plus additional text on the administration of Eprex and monitoring of the patient.

 

Change of sub heading from Adult cancer patients with symptomatic anaemia receiving chemotherapy to Treatment of patients with chemotherapy induced anaemia.

Update to section regarding desired haemoglobin level.

 

Change to section 4.4 – Special Warnings and Precautions for Use

Addition of - In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the target for the indication of use.

 

Change of sub heading from Chronic renal failure patients to Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients. Additional information on the maintenance of the haemoglobin level.

Paragraph added on shunt thromboses.

 

Change of sub heading from Adult cancer patients with symptomatic anaemia receiving chemotherapy to Treatment of patients with chemotherapy induced anaemia.

Paragraph added on clinical studies and additional information on tumour progression.

 

Addition of - This medicinal product contains less than 1 mmol sodium (23 mg) per dose i.e. essentially “sodium free”.

 

Addition of - In order to improve the traceability of the ESA all measures necessary and possible to ensure it should be taken (e.g. exact information on the product used should be documented in an appropriate way).  Furthermore, patients should only be switched from one ESA to another under appropriate supervision.

 

Change to section 4.8 – Undesirable effects

Reclassified according to the MedDRA system organ classes.

Change to section 5.1 - Pharmacodynamic properties

Addition of information on studies regarding survival and tumour progression.

Change to section 6.4 – Special Precautions for Storage

Addition of - For the purpose of ambulatory use, the patient may remove EPREX from the refrigerator and store it not above 25°C for one single period of up to 3 days.

 

Change to section 6.5 – Nature and Contents of Container

Addition of information regarding needle safety device.

Change to section 6.6 –  Instructions for use, handling and disposal

Addition of - Before use, leave the EPREX syringe to stand until it reaches room temperature. This usually takes between 15 and 30 minutes.

 

Addition of - The product is for single use only. Only take one dose of EPREX from each syringe removing unwanted solution before injection. Refer to section 3. How to use EPREX (instructions on how to inject EPREX) of the package leaflet.

 

Deletion of - if you know or suspect that the product has been left at room temperature for more than 60 minutes before injection

Change due to harmonisation of SPC

Change from Epoetinum alfa to Epoetin alfa throughout SmPC
Updated on 27/07/2006 and displayed until 22/07/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

4.2  Posology and method of administration

 

Chronic renal failure patients:

 

Text deleted

 

In patients with chronic renal failure the product must only be administered by the intravenous route (see Sections 4.3 and 4.4 – Pure Red Cell Aplasia).

 

Text inserted

 

In patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration by the intravenous route is preferable. Where intravenous access is not readily available (patients not yet undergoing dialysis and peritoneal dialysis patients) EPREX may be administered subcutaneously.

 

Adult haemodialysis patients:

 

In patients on haemodialysis the product must only be administered by the intravenous route (see Sections 4.3 and 4.4 – Pure Red Cell Aplasia).

 

Text replaced with

 

In patients on haemodialysis where intravenous access is readily available, administration by the intravenous route is preferable.

 

Paediatric haemodialysis patients:

 

Text deleted

 

In paediatric patients on haemodialysis, the product must only be administered by the intravenous route (see Sections 4.3 and 4.4 – Pure Red Cell Aplasia).

 

Adult patients with renal insufficiency not yet undergoing dialysis:

 

EPREX must only be given by the intravenous route (see Sections 4.3 and 4.4 – Pure Red Cell Aplasia).

 

Text replaced with

 

Where intravenous access is not readily available EPREX may be administered subcutaneously.

 

Adult peritoneal dialysis patients:

 

EPREX must only be given by the intravenous route (see Sections 4.3 and 4.4 – Pure Red Cell Aplasia).

 

Text replaced with

 

Where intravenous access is not readily available EPREX may be administered subcutaneously.
 

4.3 Contraindications

 

Text deleted

 

The subcutaneous route of administration is contraindicated only in patients with chronic renal failure (see Sections 4.4 – Pure Red Cell Aplasia and 4.8).
 

4.4 Special warnings and precautions for use

 

Pure Red Cell Aplasia text moved from under “Chronic renal failure patients” heading to “General” heading.
 

4.8 Undesirable effects

 

General

 

Text inserted

 

Antibody-mediated pure red cell aplasia (erythroblastopenia) has been reported after months to years of treatment with EPREX. (See Sections 4.3 and 4.4 – Pure Red Cell Aplasia).

 

Adult and paediatric haemodialysis patients, adult peritoneal dialysis and adult patients with renal insufficiency not yet undergoing dialysis

 

Text deleted

 

Pure red cell aplasia (erythroblastopenia) has rarely been reported in chronic renal failure patients after months to years of treatment with EPREX or other erythropoietins.  In most of these patients, antibodies to erythropoietins have been observed (See Sections 4.3 and 4.4 – Pure Red Cell Aplasia).
 

10. DATE OF (PARTIAL) REVISION OF THE TEXT

 

17 July 2006
 
 
Updated on 20/06/2006 and displayed until 27/07/2006
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:   08/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Eprex SPC split into two,  40,000 units now a separate SPC
Updated on 10/11/2005 and displayed until 20/06/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 06/06/2005 and displayed until 10/11/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/09/2004 and displayed until 06/06/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instruction for Use/Handling
Updated on 29/03/2004 and displayed until 30/09/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/03/2004 and displayed until 29/03/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/03/2004 and displayed until 29/03/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 08/07/2003 and displayed until 29/03/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 17/04/2003 and displayed until 08/07/2003
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 11/04/2003 and displayed until 17/04/2003
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 19/12/2002 and displayed until 11/04/2003
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/12/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 20/09/2002 and displayed until 13/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 11/09/2002 and displayed until 20/09/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 04/09/2002 and displayed until 11/09/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 29/08/2002 and displayed until 04/09/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 21/08/2002 and displayed until 29/08/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 16/08/2002 and displayed until 21/08/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 14/08/2002 and displayed until 16/08/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 21/11/2001 and displayed until 14/08/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 30/08/2001 and displayed until 21/11/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 29/08/2001 and displayed until 30/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 11/04/2001 and displayed until 29/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 02/03/2001 and displayed until 11/04/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/12/2000 and displayed until 02/03/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/07/2000 and displayed until 12/12/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 12/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  epoetin alfa