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medac GmbH
Fehlandtstrasse 3, 20354 Hamburg, Germany
Telephone: +44 (0)1786 458086
Fax: +44 (0)1786 458032
Medical Information e-mail: info@medac-uk.co.uk

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Summary of Product Characteristics last updated on the eMC: 26/02/2010
SPC Fluorouracil Injection, 25 mg / ml, solution for injection

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 26/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The SPC was revised due to changes in recent renewal (approval April 2009) and two subsequent Type II variations (approval September 2009):

The scope of one was to include safety information into the SPC on potential side effects, namely cerebral ischaemia, intestinal ischaemia, peripheral ischaemia, thromboembolism in the SPC under rare vascular disorders.
The scope of the other was to include safety information into the SPC on the interaction of fluorouracil with brivudin and on the interaction of fluorouracil with phenytoin based on the "Stufenplanverfahren Stufe II" for 5-fluorouracil-containing drugs initiated by the German Regulatory Authority, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) on September 1st, 2006.

At the same time the SPC has completely been updated with regard to QRD and MedDRA requirements as well as formal corrections.
Updated on 09/02/2007 and displayed until 26/02/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/09/2003 and displayed until 09/02/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  fluorouracil