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Ecalta 100 mg powder for concentrate for solution for infusion

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Pharmacy Only: Prescription

Updated on 29 June 2023

File name

Adv PIL ECW 23_0_IE NI clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 February 2023

File name

AdvSPCECW171IEClean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 December 2022

File name

Adv PIL ECW 22_0 IE NI clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 February 2022

File name

AdvSPCECW171IEClean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 February 2022

File name

AdvPILECW210IENIClean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 30 November 2021

File name

Adv SPC ECW 17_0 IE (2).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC NI has been updated as follows:

Section 4.8 ADR reporting updated to United Kingdom (Northern Ireland)

Updated on 17 November 2021

File name

Adv SPC ECW 18_0 NI clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 ADR reporting updated to United Kingdom (Northern Ireland)

Updated on 17 November 2021

File name

Adv PIL ECW 20_0 IE & NI clean.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Updated on 18 November 2020

File name

Adv SPC ECW 17_0 IE Clean (002).pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 November 2020

File name

Adv PIL ECW 19_0 IE Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 20 October 2020

File name

DEC202069779_Adv SPC ECW 16_0 UK & IE Clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 October 2020

File name

DEC202069779_Adv PIL ECW 18_0 UK & IE Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 05 June 2020

File name

DEC202034701_Adv SPC ECW 15_0 UK & IE Clean.pdf

Reasons for 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 June 2020

File name

DEC202034701_Adv PIL ECW 17_0 UK & IE Clean.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 03 March 2020

File name

DEC202010826_Adv SPC ECW 14_0 UK & IE CLEAN.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 March 2020

File name

DEC202010826_Adv PIL ECW 16_0 UK & IE CLEAN.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 06 December 2019

File name

DEC201968262_Adv PIL ECW 15_0 UK & IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 12 April 2019

File name

DEC201919164_Adv PIL ECW 14_0 UK & IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

DEC201919164_Adv SPC ECW 13_0 UK & IE clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 April 2019

File name

DEC201919234_Adv SPC ZI 5_0 UK & IE Clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 October 2018

File name

Adv PIL ECW 13_0 UK IE clean.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 29 October 2018

File name

Adv SPC ECW 12_0 UK IE clean.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 10.

DATE OF REVISION OF THE TEXT – 10/2018

Updated on 01 October 2018

File name

Adv PIL ECW 12_0 UK IE clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 01 October 2018

File name

Adv SPC ECW 11_0 UK IE clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:


SPC: Section 7 MA Holder changed to;

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Updated on 12 May 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 September 2017

File name

PIL_14635_363.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 September 2017

Reasons for 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 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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.

Updated on 04 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 June 2016

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 23 June 2016

Reasons for updating

  • Change to date of revision

Updated on 25 June 2015

Reasons for updating

  • Change to MA holder contact details

Updated on 06 October 2014

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 10 September 2014

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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.

Updated on 04 September 2014

Reasons for updating

  • Change to improve clarity and readability

Updated on 03 September 2014

Reasons for updating

  • Change to marketing authorisation holder
  • Change to improve clarity and readability
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to date of revision

Updated on 28 August 2014

Reasons for updating

  • Improved electronic presentation

Updated on 28 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability
  • Addition of marketing authorisation holder

Updated on 27 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details
  • Change to improve clarity and readability

Updated on 04 September 2013

Reasons for updating

  • Change to date of revision
  • Addition of marketing authorisation holder

Updated on 06 September 2012

Reasons for 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 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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

Updated on 04 September 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 30 July 2012

Reasons for 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 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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.

Updated on 18 July 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 August 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to section 4.4 and section 5.3

Updated on 18 March 2011

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

6.3 Shelf life
6.4 Special precautions for storage

Updated on 11 March 2011

Reasons for updating

  • Change to storage instructions

Updated on 05 November 2010

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 02 November 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects

Updated on 16 April 2010

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 08 April 2010

Reasons for updating

  • New PIL for new product