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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 19/08/2011
SPC Ecalta 100 mg powder for concentrate for solution for infusion

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

Updated on 19/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Change to section 4.4 and section 5.3
Updated on 18/03/2011 and displayed until 19/08/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
6.3 Shelf life
6.4 Special precautions for storage
Updated on 05/11/2010 and displayed until 18/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Changes in storage of the powder, the reconstituted solution and the infusion solution
excursions on storage of the powder of up to 48 hours at up to 25ºC
storage of the reconstitute solution at  25ºC for up to one hour
infusion of the diluted solution into patients at room temperature when stored at 25ºC for up to 4 hours
Removal of the ‘Do not freeze’ text for the powder as this applies to the alcohol diluent only and was inadvertently left in the labelling of the WFI product

- amendment of Section 4.4.to clarify the description of hepatic failure
- update of Section 4.8. to include infusion-related reactions and tabulation of AEs
- Section 5.1. microbiology
Updated on 16/04/2010 and displayed until 05/11/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

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

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Active Ingredients

 
  Anidulafungin