MabThera 100 mg and 500 mg concentrate for solution for infusion

  • Name:

    MabThera 100 mg and 500 mg concentrate for solution for infusion

  • Company:
    info
  • Active Ingredients:

    Rituximab

  • 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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 7/8/2019

Click on this link to Download PDF directly

Roche Registration GmbH

Company Products

Medicine NameActive Ingredients
Medicine Name Alecensa 150 mg Hard Capsules Active Ingredients Alectinib hydrochloride
Medicine Name Avastin 25mg/ml concentrate for solution for infusion Active Ingredients Bevacizumab
Medicine Name CellCept 1g/5ml Powder for Oral Suspension Active Ingredients Mycophenolate Mofetil
Medicine Name CellCept 250mg Capsules Active Ingredients Mycophenolate Mofetil
Medicine Name CellCept 500mg Film-coated Tablets Active Ingredients Mycophenolate Mofetil
Medicine Name CellCept 500mg powder for concentrate for solution for infusion Active Ingredients Mycophenolate mofetil hydrochloride
Medicine Name Cotellic 20 mg film-coated tablets Active Ingredients Cobimetinib hemifumarate
Medicine Name Erivedge 150 mg Hard Capsules Active Ingredients Vismodegib
Medicine Name Esbriet 267 mg Hard Capsules Active Ingredients Pirfenidone
Medicine Name Esbriet 267 mg, 534 mg and 801 mg Film-coated Tablets Active Ingredients Pirfenidone
Medicine Name Gazyvaro 1,000 mg concentrate for solution for infusion Active Ingredients Obinutuzumab
Medicine Name Hemlibra 150 mg/mL Solution for Injection Active Ingredients Emicizumab
Medicine Name Hemlibra 30 mg/mL Solution for Injection Active Ingredients Emicizumab
Medicine Name Herceptin 150mg Powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Herceptin 600 mg Solution for Injection in Vial Active Ingredients Trastuzumab
Medicine Name Kadcyla 100mg & 160mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab emtansine
Medicine Name MabThera 100 mg and 500 mg concentrate for solution for infusion Active Ingredients Rituximab
Medicine Name MabThera 1400 mg Solution for Subcutaneous Injection Active Ingredients Rituximab
Medicine Name NeoRecormon solution for injection Pre-Filled Syringe Active Ingredients Epoetin beta
Medicine Name OCREVUS 300 mg concentrate for solution for infusion Active Ingredients Ocrelizumab
Medicine Name Pegasys 135 and 180 micrograms solution for injection in pre-filled pen Active Ingredients Peginterferon alfa-2a
Medicine Name Pegasys 90, 135 and 180 micrograms solution for injection in pre-filled syringe Active Ingredients Peginterferon alfa-2a
Medicine Name Perjeta 420 mg Concentrate for Solution for Infusion Active Ingredients Pertuzumab
Medicine Name RoActemra 162 mg solution for injection in pre-filled pen Active Ingredients tocilizumab
Medicine Name RoActemra 162 mg solution for injection in pre-filled syringe Active Ingredients tocilizumab
1 - 0 of 34 items.Total: Infinity pages

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)