Cancidas 50mg Powder for concentrate for solution for infusion

  • Name:

    Cancidas 50mg Powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    caspofungin acetate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/03/19

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Summary of Product Characteristics last updated on medicines.ie: 4/3/2019

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MSD Ireland (Human Health) Limited

MSD Ireland (Human Health) Limited

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1 - 0 of 84 items.Total: Infinity pages

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 19 March 2019 PIL

Reasons for updating

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  • Individual PILs superseded by joint PIL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

Updated on 4 March 2019 SmPC

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 PIL

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 26 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 July 2016 PIL

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 25 July 2016 SmPC

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 6 July 2016 SmPC

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 SmPC

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 SmPC

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 1 July 2014 PIL

Reasons for updating

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

Updated on 27 June 2014 SmPC

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 3 July 2013 PIL

Reasons for updating

  • Change to further information section

Updated on 12 June 2013 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to further information section

Updated on 14 June 2012 SmPC

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 PIL

Reasons for updating

  • Change to further information section

Updated on 26 October 2011 PIL

Reasons for updating

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

Updated on 21 September 2011 SmPC

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 4 January 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 14 December 2010 SmPC

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 PIL

Reasons for updating

  • Change to further information section

Updated on 21 July 2009 SmPC

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 6 May 2009 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 4 December 2008 SmPC

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 24 August 2007 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 20 November 2006 SmPC

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 PIL

Reasons for updating

  • Change to drug interactions

Updated on 15 November 2004 PIL

Reasons for updating

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

Updated on 15 November 2004 SmPC

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 14 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 May 2004 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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