« Back to Medicines list

Truxima 100 mg and 500 mg concentrate for solution for infusion

  • Name:

    Truxima 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: 21/12/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

Click on this link to Download PDF directly

Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

mundi_logo

Company Products

Medicine NameActive Ingredients
Medicine Name Adizem-SR Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name BuTrans 15 microgram/hour transdermal patches Active Ingredients Buprenorphine
Medicine Name BuTrans transdermal patches Active Ingredients Buprenorphine
Medicine Name Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 micorgram/10 microgram per metered dose pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Flutiform K-haler 50 microgram /5 microgram, 125 microgram /5 microgram per actuation pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Invokana 100 mg and 300 mg film-coated tablets Active Ingredients Canagliflozin hemihydrate
Medicine Name Levact 25mg and 100 mg powder for concentrate for solution for infusion Active Ingredients Bendamustine Hydrochloride
Medicine Name MST Continus Suspension Active Ingredients Morphine sulfate
Medicine Name MST Continus Tablets Active Ingredients Morphine sulfate
Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
Medicine Name PALLADONE Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Pelmeg 6 mg solution for injection in pre-filled syringe Active Ingredients Pegfilgrastim
Medicine Name PHYLLOCONTIN CONTINUS Tablets Active Ingredients Aminophylline Hydrate
Medicine Name SEVREDOL Tablets Active Ingredients Morphine sulfate
Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 31 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 21 December 2019 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

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 February 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

Section 7$0Change of address for the marketing authorisation holder$0$0$0$0$0Section 10$0$0Updated in date of revision to '26 January 2018'$0

Updated on 10 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 January 2018 SmPC

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

None provided