Last Updated on eMC 04-09-2017 View medicine  | Pfizer Limited Contact details

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.

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:01-08-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 4.2      Posology and method of administration – Section updated in line with QRD. No new updates made.

 4.4    Special warnings and precautions for use – Section updated in line with QRD.

 4.6              Fertility, pregnancy and lactation Section reworded and updated in line with QRD.

 

4.7   Effects on ability to drive and use machines - Section reworded.

 4.8    Undesirable effects – Section updated in line with QRD.

Reasons for adding or updating:

  • Change to section 6.5 - Nature and contents of container

Date of revision of text on the SPC:01-06-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

6.5   Nature and Content of Container – new description added for alternate stopper

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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Date of revision of text on the SPC:01-08-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.1    Therapeutic indications – Section updated to reflect new indication.

 

4.2    Posology and method of administration – Section updated in line with QRD.

 

4.4    Special warnings and precautions for use – Section re-worded.

 

4.5    Interaction with other medicinal products and other forms of interaction – Section updated to include statement on paediatric population.

 

4.8    Undesirable effects – Section updated with data and changes made to frequency grouping. Also Section on reporting of adverse events updated in line with new name and contact details for HPRA.

5.1    Pharmacodynamic properties – Section updated for activity in vitro and inclusion of additional data in neutropenic patients and patients with deep tissue infections.

 

6.6    Special precautions for disposal and other handling – Section updated in line with QRD.

Reasons for adding or updating:

  • Improved electronic presentation

Date of revision of text on the SPC:01-08-2012

Legal Category:POM

Black Triangle (CHM): NO

Reasons for adding or updating:

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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 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:01-08-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Administrative changes to sections: 2, 4.2, 4.3, 4.6, 4.8, 5.1, 6.3, 6.4, 6.6, 9 & 10

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-06-2012

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Update of sections 4.2 to refer to section 4.4 

Update of
sections 4.4 and 4.8 to include statements on anaphylactic reactions including shock.

A
warning regarding infusion-related adverse events was also introduced in section 4.4 and sections 4.2 and 6.6 were updated regarding infusion rate.

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:01-08-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Changes to section 4.4 and 5.3

Reasons for adding or updating:

  • 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 10 date of revision of the text

Date of revision of text on the SPC:01-03-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Variation to update the storage conditions for Ecalta

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC:01-09-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:


- 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 

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

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES