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hameln pharmaceuticals ltd
Nexus, Gloucester Business Park, Gloucester, GL3 4AG
Telephone: +44 (0)1452 621 661
Fax: +44 (0)1452 632 732
WWW: http://www.hameln.co.uk
Medical Information e-mail: drugsafety@hameln.co.uk

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: 06/12/2010
SPC Ondansetron 2 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 06/12/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   15-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

  • Sections 4.1, 4.2, 4.4, 4.8, 5.1 & 5.2 have been updated with regard to the “Paediatric Population” following the EU-Worksharing Procedure - Paediatric public assessment report for Ondansetron.

 

  • Section 4.5 has been updated with regard to “Use of Ondansetron with QT prolonging drugs may result in additional QT prolongation. Concomitant use of Ondansetron with cardiotoxic drugs (e.g. anthracyclines) may increase the risk of arrhythmias (section 4.4).”
Updated on 02/12/2009 and displayed until 06/12/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   01-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.3, the shelf-life has been changed from 2 to 3 years
Updated on 13/03/2009 and displayed until 02/12/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  ondansetron hydrochloride dihydrate