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Pharmacia Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 31/08/2011
SPC Refolinon Injection 3mg/ml

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 31/08/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 27/11/2009 and displayed until 31/08/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in posology and Administration of Refolinon Injection. Inclusion of trimetrexate toxicity, trimethoprime toxicity, pyrimethamine toxicity and therapy after high-dose methotrexate.
Updated on 16/10/2009 and displayed until 27/11/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 5.1 – addition of ATC code, update info about calcium folinate and pharmacodynamic properties.

Section 5.2 – addition of AMDE properties of calcium folinate

Section 6.6 – addition of information re: handling and disposal Refolinon injection
Updated on 15/09/2009 and displayed until 16/10/2009
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.6:

Clarification to information regarding the studies carried out in pregnant or breast feeding women whilst taking Refolinon.

The information is mainly administrative changes.

Section 4.9:

Administrative changes to provide clarification on the contents of the section.
No new information added.
Updated on 06/02/2008 and displayed until 15/09/2009
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:   01/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 7.0 : change of MAH holder address

Section 10: change of revision date
Updated on 01/06/2006 and displayed until 06/02/2008
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 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   01/02/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.2: Warning that calcium leucovorin should not be administered intrathecally.

 

Section 4.3: Section updated to include known sensitivity to calcium folinate or any of the excipients.

 

Section 4.4: Lactose warning deleted and warning that calcium folinate should only be given by intramuscular or intravenous injection added.

 

Section 4.5: Update with potential interactions with antiepileptics, phenobarbitone, phenytoin and primidone.

 

Section 4.6: Update section with caution use due to a lack of human data.

 

Section 4.8: Update section and add additional allergic reactions (anaphylactoid and urticaria).

 

Furthermore, the information in Section 4.4 and Section 4.3 has been re-arranged.
Updated on 17/06/2005 and displayed until 01/06/2006
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 20/02/2003 and displayed until 17/06/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 13/07/2001 and displayed until 20/02/2003
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 03/01/2001 and displayed until 13/07/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  calcium folinate