Cancidas 70mg Powder for concentrate for solution for infusion

Product Information *

  • Company:

    MSD Ireland (Human Health) Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

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

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 02 March 2021

File name

QRD-IE-MT-CANCIDAS-LFT-IAIN0073-15022021 (002)_1614696046.pdf

Reasons for updating

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

Updated on 31 August 2020

File name

CANCIDAS-H-C-0379-IB-072 PIL QRD IE (002).pdf_1598890700.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 31 August 2020

File name

CANCIDAS-H-C-0379-IB-072-PI-en-IE-CRT (50mg 70mg) clean Aug 2020 (002).pdf_1598865867.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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • 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

Change to 2 Qualitative and Quantitative Composition, 4.4 Special Warnings and Precautions for use, 4.8 Undesirable effects, 6.1 List of excipients and section 10. Date of revision of the text following approval of  IB/0072 to implement the EU excipients guideline

 

Updated on 19 March 2019

File name

PIL CANCIDAS IB-070 QRD IE MT_1552991768.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Individual PILs superseded by joint PIL
  • Correction of spelling/typing errors

Updated on 04 March 2019

File name

CANCIDAS-H-C-0379-IB-070-PI-en-IE-CRT (50mg 70mg) clean Feb 2019_1551699839.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Change to section 5.1 Pharmacodynamic properties and Change to section 10 - Date of revision of the text following approval of IB/070 - implementation of Art 46 notification

 

Updated on 23 August 2018

File name

Cancidas 70mg PIL QRD MAT Brexit (2)_1535025315.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 22 August 2018

File name

SPC CANCIDAS-H-C-0379-T-0067-PI-en-IE-CRT (50mg70mg) clean Aug 2018 (2)_1534926222.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

Change to section 7 - Marketing authorisation holder and Change to section 10 - Date of revision of the text  following approval of the MA Transfer

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 26 July 2016

File name

PIL_9133_997.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 July 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 25 July 2016

Reasons for updating

  • New SPC for new product

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

Updated on 25 July 2016

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to joint SPC covering all presentations

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

Free text change information supplied by the pharmaceutical company

Updates following EMEA/H/C/0379/II/061 - SLU Post-marketing Adverse Events of Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome and Change to joint SPC covering all presentations

Updated on 06 July 2016

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 following approval of EMEA/H/C/0379/II/060 - Labelling breakpoints

Updated on 14 May 2015

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Sections 4.8, 10

Updated side effects (uncommon: gamma-glutamyltransferase increased)

Updated on 29 September 2014

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

4.4 Special warnings and precautions for use, 4.8 – Undesirable effects and section 10 date of revision.

Updated on 01 July 2014

Reasons for updating

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

Updated on 27 June 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

Change to Section 4.8, 6.6, 10

Updated on 03 July 2013

Reasons for updating

  • Change to further information section

Updated on 12 June 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Sections 4.4, 4.8, 10 - Updated warnings regarding allergic reactions

Updated on 17 October 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to improve clarity and readability

Updated on 29 August 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • 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

Changes to: Sections 2, 6.4, 10.

Updated on 22 June 2012

Reasons for updating

  • Change to further information section

Updated on 14 June 2012

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • 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 section 5.1 with information on standardised techniques for susceptibility testing.

Updated on 23 February 2012

Reasons for updating

  • Change to further information section

Updated on 26 October 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 21 September 2011

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • 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

Updated method of administration / side effects

Sections 3, 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3, 6.2, 6.5, 6.6

Updated on 04 January 2011

Reasons for updating

  • Change to side-effects

Updated on 14 December 2010

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

Updated side effects (angio-oedema).

Updated on 29 April 2010

Reasons for updating

  • Change to further information section

Updated on 21 July 2009

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 4.2 - Posology and method of administration
  • 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 6.4 - Special precautions for storage
  • 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

Update after variations II35 & II37 -

Section 4.2: Under the sub-heading "Dosage in adult patients", removal of the sentence "Doses higher than 70 mg daily have not been adequately studied"

Section 4.5: Included paragraph stating "All adult drug-drug interaction studies described above were conducted at a 50 or 70 mg daily caspofungin dose. The interaction of higher doses of caspofungin with other medications has not been formally studied"

Section 4.8: Extensive changes to side effects section. New side effects added. Information about a study which evaluated Cancidas at 150 mg daily has been added.

Section 4.9: 140 mg changed to 400 mg with regards to dosage of caspofungin inadvertently administered in one day (up to 400 mg).

Section 5.1: Paragraph added describing study involving patients with invasive candidiasis receiving daily doses of caspofungin at 50 mg/day (following a 70-mg loading dose on Day 1) or caspofungin at 150 mg/day (see section 4.8).

Section 6.4: Minor typographical correction

Section 10: Revision date updated

Updated on 06 May 2009

Reasons for updating

  • Change to dosage and administration

Updated on 04 December 2008

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
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic 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

As a result of a variation to include a paediatric indication the following sections have been changed:
4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2, 6.6

Updated on 27 August 2007

Reasons for updating

  • Change to MA holder contact details

Updated on 20 November 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

Changes to numerous sections as a result of renewal.

Updated on 16 November 2004

Reasons for updating

  • Change to drug interactions

Updated on 15 November 2004

Reasons for updating

  • 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

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

Updated on 15 November 2004

Reasons for updating

  • Change to drug interactions
  • Change to warnings or special precautions for use

Updated on 14 October 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 May 2004

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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

Updated on 18 November 2003

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 24 June 2003

Reasons for updating

  • New SPC for medicines.ie

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