Ecalta 100 mg powder for concentrate for solution for infusion
- Name:
Ecalta 100 mg powder for concentrate for solution for infusion
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/20
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, 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 18 November 2020 SPC
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 PIL
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 SPC
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 PIL
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 5 June 2020 SPC
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 5 June 2020 PIL
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 3 March 2020 SPC
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 3 March 2020 PIL
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 6 December 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 12 April 2019 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 12 April 2019 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - date of revision
Updated on 29 October 2018 SPC
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 1 October 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 1 October 2018 SPC
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:
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium |
Updated on 12 May 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 September 2017 SPC
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 4 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 4 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 4 September 2017 PIL
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 PIL
Reasons for updating
- Change to date of revision
Updated on 23 June 2016 SPC
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
Updated on 25 June 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 6 October 2014 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 10 September 2014 SPC
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 4 September 2014 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 3 September 2014 PIL
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 PIL
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 28 August 2014 PIL
Reasons for updating
- Improved electronic presentation
Updated on 27 August 2014 PIL
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 4 September 2013 PIL
Reasons for updating
- Change to date of revision
- Addition of marketing authorisation holder
Updated on 6 September 2012 SPC
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
Updated on 4 September 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 30 July 2012 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 19 August 2011 SPC
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
Updated on 18 March 2011 SPC
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
6.4 Special precautions for storage
Updated on 11 March 2011 PIL
Reasons for updating
- Change to storage instructions
Updated on 5 November 2010 SPC
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
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 2 November 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
Updated on 16 April 2010 SPC
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
Updated on 8 April 2010 PIL
Reasons for updating
- New PIL for new product