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:
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
- 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: 02/02/21
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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
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 2 February 2021 PIL
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 2 February 2021 SPC
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 7 April 2020 SPC
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 SPC
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 3 September 2019 SPC
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 SPC
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 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 4 - possible side effects
Updated on 8 December 2018 SPC
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 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
New SmPC due to product launch
Updated on 7 June 2018 PIL
Reasons for updating
- New PIL for new product