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

Product Information *

  • Company:

    Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
  • Status:

    No Recent Update
  • Active Ingredients :

    This medicinal product is subject to additional monitoring.

    *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 February 2021

File name

pil_1612280321.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Addition of sleepiness and dizziness to section 2 - Driving and using machines.

Addition of excipient warnings regarding sodium.

Updates to possible side effects in section 4 in line with the brand leader.

Updated on 02 February 2021

File name

spc_1612280185.pdf

Reasons for updating

  • 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

Addition of somnolence and dizziness to section 4.7.

Updates to possible side effects in section 4.8 in line with the brand leader.

Updated on 07 April 2020

File name

spc_1586251745.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Increase shelf life for 150 mg strength from 5 years to 6 years.

Updated on 27 January 2020

File name

spc_1580118454.pdf

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

  • Section 6.3 - Extension of shelf life for 420 mg presentation from 5 years to 6 years
  • Section 6.4 - Addition of instruction 'Do not freeze the reconstituted solution'
  • Section 6.6 - Addition of instructions on aseptic preparation, handling and storage

Updated on 03 September 2019

File name

spc_1567525060.pdf

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 03 September 2019

File name

pil_1567524916.pdf

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

File name

IE Hermuza PIL 150 mg and 420 mg June 2019_1561646326.pdf

Reasons for updating

  • Change to information for healthcare professionals

Updated on 27 June 2019

File name

IE Herzuma SmPC 150 and 420 mg June 2019_1561646100.pdf

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 03 April 2019

File name

IE SmPC Herzuma 150 and 420 mg April 2019_1554294399.pdf

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 06 March 2019

File name

IE Hermuza PIL clean- 21 Nov 2018_1544305517.pdf

Reasons for updating

  • Individual PILs superseded by joint PIL

Updated on 06 March 2019

File name

IE SmPC Herzuma 150 and 420 mg March 2019_1551880871.pdf

Reasons for updating

  • Change from individual to joint SPC

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

File name

IE Hermuza PIL clean- 21 Nov 2018_1544305517.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 08 December 2018

File name

IE Herzuma SPC 21 Nov 18_1544305388.pdf

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 07 June 2018

File name

Herzuma SPC IE.docx

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

New SmPC due to product launch

Updated on 07 June 2018

File name

Package leaflet IE.pdf

Reasons for updating

  • New PIL for new product