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Pharmacosmos UK Limited
Chiltern House, Unit P, Howland Road, Thame, Oxfordshire, OX9 3GQ
Telephone: +44 (0)1844 269007
Fax: +44 (0)1844 269005
Medical Information Direct Line: +44 (0)1844 269 007
Medical Information e-mail: info@pharmacosmos.co.uk
Medical Information Fax: +44 (0)1844 269005

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: 28/03/2012
SPC CosmoFer

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 28/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 8 Marketing Authorisation Number has changed from PL 18328/0001 to PL 18380/0002.
In section 10 Date of Revision of Text has changed to 07/2010
Updated on 27/01/2010 and displayed until 28/03/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 10 date of revision of the text has changed to 07/2009.
Updated on 09/06/2008 and displayed until 27/01/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Introduction of new pack/pack size
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 2 a 10ml ampoule containing 500mg iron (III) has been added.
In Section 6.5 packs of 2 x 10ml and 5 x 10ml have been added.
In Section 9 the Renewal of the Authorisation has changed to 08/2007.
In Section 10 the Date of Revision of the Text has changed to 08/2007. 
Updated on 25/06/2007 and displayed until 09/06/2008
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

Black Triangle removed as no longer applicable.

Section 4.1  Minor change to wording.

Section 4.2  Repositioning of text to highlight Test dose.

                    (Dosage)  Warning concerning not administering Cosmofer concomitantly with oral iron.

Section 4.4  Repositioning of text to highlight allergic reactions in patients with immune or inflammatory conditions.

Section 4.6  Expansion of the use of Cosmofer in pregnancy.

Section 4.8  Repositioning of text to highlight anaphylactoid reactions. Expansion of undesirable effect table to include sections on the
                      following organ classes: Blood and lymphatic system, Immune system, Psychiatric disorders, Vascular system.

Section 5.3  Change in units, update to in vitro/vivo genotoxicity.

Section 6.6  Addition of intravenous dilution solutions to this section.

Section 10.  Date of revision changed to June 6, 2007.
Updated on 10/04/2007 and displayed until 25/06/2007
Reasons for adding or updating:
  • Addition of Black Triangle
  • 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:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Black Triangle Added
Section 7 MA Holder Pharmacosmos A/S
Section 10 Date of Revision August 14, 2006
Updated on 04/04/2007 and displayed until 10/04/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Pending awaiting re-submission
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 MA Holder now Pharmacosmos A/S
Updated on 04/04/2007 and displayed until 04/04/2007
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Addition of Black Triangle
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Black triangle added
Section 10 - date of revision changed
Updated on 01/11/2006 and displayed until 04/04/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 4.2 – Posology and Method of Administration, -   Addition of highlighted text under Intravenous drip infusion section: On each occasion the first 25 mg of iron should be infused over a period of 15 minutes.
Addition of highlighted text under Intravenous injection section: On each occasion before administering a slow intravenous injection, 25 mg of iron should be injected slowly over a period of 1 to 2 minutes. Insertion of the following text at the start of the Intramuscular injection section: Following a test dose prior to the first injection the entire dose is administered at once for subsequent intramuscular injections.
Clarification of symbols in Calculation of dose section: x replaces • in calculations.

Change to Section 4.8 – Undesirable Effects, -   Addition of Tachycardia to the Rare section of Cardiovascular System undesirable effects.Deletion of percentages under Common, Uncommon and Rare classifications.
Change to Section 7 – MA Holder, - Change of MA Holder address. Address is now: Nebo a/s, Roervangsvej 30, DK-4300 Holbaek, Denmark.
Change to Section 8 MA Numbers, - Removal of PA Number. SPC now refers only to the UK.
Change to Section 9 – Date of First Authorisation/Renewal of Authorisation, - Date of renewal of authorization changed to March 8 2005
Change to Section 10 – Date of Revision of Text.- Date of revision of text changed to March 10 2005
Updated on 25/10/2006 and displayed until 01/11/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Pending awaiting re-submission
Date of revision of text on the SPC:   03/2005
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2
Addition of the bold text to the Intravenous Drip Infusion section:
On each occasion the first 25mg of iron should be infused over a period of 15 minutes.
 
Addition of the bold text to the Intravenous Injection section:
On each occasion before administering a slow intravenous injection, 25mg of iron should be injected over a period of 1 to 2 minutes.
 
Addition of the following sentence to the Intramuscular Injection section:
Following a test dose prior to the first injection the entire dose is administered at once for subsequent intramuscular injections.
 
Clarification of symbols in the Calculation of dose section.
x replaces • in calculations. 
 
Section 4.8
Addition of Tachycardia as an undesirable effect to the Cardiovascular Organ System.
Percentages removed from common, uncommon and rare effect headings.
 
Section 7
MA holder address change to:
Nebo a/s
Roervangsvej 30
DK-4300 Holbaek
Denmark
 
Section 8
Removal of PA number. Separate SPC's now exist for the UK and Ireland.
 
Section 9
Date of renewal changed to March 8 2005.
 
Section 10
Date of revision of text changed to March 10 2005.
 
Updated on 09/03/2004 and displayed until 25/10/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  iron dextran