Truxima 100 mg and 500 mg concentrate for solution for infusion
- Name:
Truxima 100 mg and 500 mg 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: 08/10/20
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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 8 October 2020 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 1 - Addition of information on use in paediatric patients for Non-Hodgekin's Lymphoma and Granulomatosis with polyangiitis or microscopic polyangiitis
Section 2 - Addition of warnings on use in paediatric patients for Non-Hodgekin's Lymphoma and Granulomatosis with polyangiitis or microscopic polyangiitis. Update to sodium warnings in line with excipient guidelines.
Section 3 - Addition of dose frequency for paediatric patients.
Section 4 - Addition of statements on side effects in paediatric patients with Non-Hodgekin's Lymphoma and Granulomatosis with polyangiitis or microscopic polyangiitis. Addition of possible side effects for patients being treated for pemphigus vulgaris.
Updated on 8 October 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 - Amendment to sodium warning in line with excipient guidelines.
Section 3 - Addition of pH and osmolality.
Section 4.1 - Addition of indications for the treatment of paediatric patients with previously untreated advanced stage CD20 positive DLBCL, BL, BAL or BLL, and for the induction of remission in paediatric patients with severe active GPA and MPA.
Section 4.2 - Addition of premedication and prophylactic medicines, posology and method of administration for paediatric indications.
Section 4.4 - Amendment to sodium warning in line with excipient guidelines. Addition of cross reference to section 5.1 for paediatric data. Editorial changes.
Section 4.8 - Addition of section on experience in paediatric studies, and addition of paediatric safety data. Addition of safety data from PV Study 2.
Section 5.1 - Addition of data from paediatric studies. Addition of data from PV Study 2.
Section 5.2 - Addition of PK data from paediatric studies and PV Study 2.
Section 6.1 - Addition of excipient E numbers.
Updated on 21 December 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
6.3 - Update shelf life for Truxima 100 mg from 3 years to 4 years
Updated on 8 August 2019 PIL
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 4 - possible side effects
Updated on 7 August 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
The SmPC has been updated as follows:
- Addition of Pemphigus Vulgaris indication
- Extension of the GPA/MPA indications
- Update of the final results of the PRIMA study
- Update of the sodium content
Updated on 27 June 2019 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
In use stability shelf-life
Updated on 21 December 2018 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Correction to Qualitative and quantitative composition to say Each mL of concentrate contains 10 mg of rituximab. for the 500 mg concentrate as well asthe 100 ml.
Updated on 10 December 2018 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Individual PILs superseded by joint PIL
Updated on 8 December 2018 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- 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
Shelife increased
Updated on 21 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 21 February 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 19 February 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 19 February 2018 SPC
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
Updated on 10 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 9 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)