MabThera 100 mg and 500 mg concentrate for solution for infusion
- Name:
MabThera 100 mg and 500 mg concentrate for solution for infusion
- Company:
Roche Registration GmbH
- 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: 08/08/19
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Roche Registration GmbH
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 August 2019 PIL
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Joint PIL superseded by individual PILs
Updated on 7 August 2019 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change from individual to joint SmPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 21 March 2019 PIL
Reasons for updating
- 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 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 21 March 2019 SmPC
Reasons for updating
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Non Safety, 29.0, Addition of a new therapeutic indication for MabThera (rituximab) for the treatment of patients with moderate to severe pemphigus vulgaris (PV) for MA numbers EU/1/98/067/001 – 002 (MabThera 100 mg concentrate for solution for infusion and MabThera 500 mg concentrate for solution for infusion, respectively).
Updated on 28 December 2018 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 December 2018 SmPC
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
EMEA/H/C/000165/II/0149 (Addition of a new therapeutic indication in GPA/MPA M(update of section 4.1, 4.2, 4.8 and 5.1)
Updated on 2 October 2018 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
IB/154 update to in-use stability to 30 days for MabThera IV
Updated on 16 August 2018 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 29 May 2018 SmPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- 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
Existing text in SmPC updated with 9 year follow-up data (final CSR) at request from Rapporteur.
Updated on 28 March 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 28 March 2018 SmPC
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
Underlined text has been added, text with strike-through deleted:
7. MARKETING AUTHORISATION HOLDER
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom
10. DATE OF REVISION OF THE TEXT
16 March 2018
Updated on 26 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 26 March 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 January 2018 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
Underlined text has been added, text with strike-through deleted:
6.3 Shelf life
Unopened vial
30 months
Diluted medicinal product
The prepared infusion solution of MabThera in 0.9% sodium chloride solution is physically and chemically stable for 24 7 days hours at 2 °C ‑ 8 °C and subsequently for a further 124 hours at ≤ 30 °Cat room temperature. The prepared infusion solution of MabThera in 5% D-glucose solution is physically and chemically stable for 24 hours at 2 °C - 8 °C and subsequently for a further 12 hours at room temperature.
From a microbiological point of view, the prepared infusion solution should be used immediately. If not used immediately, in‑use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C – 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
10. DATE OF REVISION OF THE TEXT
13 January 2018
Updated on 15 August 2017 SmPC
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Underlined text has been added, text with strike-through deleted:
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
[…]
Excipients with known effects:
This medicinal product contains less than 1mmol sodium per dose, i.e. essentially sodium free.
[…]
4.2 Posology and method of administration
[…]
Maintenance therapy
· Previously untreated follicular lymphoma
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with previously untreated follicular lymphoma who have responded to induction treatment is:
1400 mg once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (12 administrations in total).
· Relapsed/refractory follicular lymphoma
The recommended dose of MabThera subcutaneous formulation used as a maintenance treatment for patients with relapsed/refractory follicular lymphoma who have responded to induction treatment is:
1400 mg once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 administrations in total).
[…]
4.4 Special warnings and precautions for use
[…]
Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg ) sodium per 10 mL vial. To be taken into consideration by patients on a controlled sodium diet.
[…]
4.8 Undesirable effects
[…]
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
[…]
10. DATE OF REVISION OF THE TEXT
04 August 2017
Updated on 10 August 2017 PIL
Reasons for updating
- New individual PIL (was previously included in a combined PIL)