Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion

  • Name:

    Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Trastuzumab

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/09/19

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Summary of Product Characteristics last updated on medicines.ie: 3/9/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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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 3 September 2019 SmPC

Reasons for updating

  • 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

  • Section 4.8 was updated to include tumour lysis syndrome as a potential adverse event.
  • Section 6.6 was updated to clarify reconstitution

Updated on 3 September 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of tumour lysis syndrome as a potential adverse effect.

Updated on 27 June 2019 PIL

Reasons for updating

  • Change to information for healthcare professionals

Updated on 27 June 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

150 mg shelf life updated from 4 to 5 years

Updated on 3 April 2019 SmPC

Reasons for updating

  • 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

Text correct to account for both product strengths:

1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised Herzuma, directing the stream into the lyophilised cake.

Updated on 6 March 2019 PIL

Reasons for updating

  • Individual PILs superseded by joint PIL

Updated on 6 March 2019 SmPC

Reasons for updating

  • Change from individual to joint SmPC

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

Free text change information supplied by the pharmaceutical company

Addition of information for the 420 mg strength 

Updated on 10 December 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 8 December 2018 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

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Updated following information from Pivotal study

 

Updated on 7 June 2018 SmPC

Reasons for updating

  • New SmPC 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

New SmPC due to product launch

Updated on 7 June 2018 PIL

Reasons for updating

  • New PIL for new product