Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion * Pharmacy Only: Prescription
Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 26 November 2021
File name
spc_1637923016.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Additional example of trastuzumab-containing products in statement regarding medication errors.
Updated on 26 November 2021
File name
pil_1637922948.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 3 - Additional example of trastuzumab-containing products in statement regarding medication errors.
Section 4 - Clarification that the possible side numbness or tingling of the fingers and toes may occasionally extend to the rest of the limb.
Updated on 04 August 2021
File name
spc Aug 2021_1628087289.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
Updates in line with the reference medicinal product Herceptin®.
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