Cuvitru 200 mg/ml solution for subcutaneous injection

  • Name:

    Cuvitru 200 mg/ml solution for subcutaneous injection

  • Company:
    info
  • Active Ingredients:

    Human Normal Immunoglobulin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 20/04/21

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Summary of Product Characteristics last updated on medicines.ie: 20/4/2021
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.

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Takeda Products Ireland Ltd

Takeda Products Ireland Ltd

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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 20 April 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 April 2021 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 20 April 2021 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 20 April 2021 SPC

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

The following changes have been made to the SmPC:

Description of change

Changes (in red)

4.4          Special warnings and precautions for use

 

 

 

4.8     Undesirable effects

 

Aseptic Meningitis Syndrome (AMS)

 

Aseptic meningitis syndrome (AMS) has been reported to occur in association with immune globulin treatments, including Cuvitru (see section 4.8 Undesirable Effects – Postmarketing). AMS may occur more frequently in female patientsTable 1: Frequency of Adverse Reactions (ADRs) in clinical studies with Cuvitru

Table 2: Post-Marketing Adverse Reactions (ARs)

Post-Marketing Adverse Reactions (ARs)

MedDRA

System Organ Class (SOC)

Adverse reaction

Frequency

Infections and infestations

Meningitis aseptic

Not known

10. Date of revision of the text

April 2021

Updated on 28 May 2020 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 28 May 2020 PIL

Reasons for updating

  • Introduction of new pack/pack size
  • Change to date of revision

Updated on 3 December 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

The pack size has changed and not all pack sizes may be marketed now 

Updated on 3 December 2019 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Change in pack size 

Updated on 29 May 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 29 May 2019 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 2 (QUALITATIVE AND QUANTITATIVE COMPOSITION): To inclue 50 ml/ 10g

Section 6.5 (Nature and contents of container): to include 50ml to the pack size list

Updated on 15 August 2017 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 15 August 2017 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

  1. In Section 4.2 (posology and method of administration) an update to the "method of administration" has been made that the infusion of Cuvitru must be started immediately upon transfer into the syringe to prevent particulate formation including what to do if an administration shorter than 2 hours is not possible.
  2. In section 4.4 (special warnings and precautions for use) a warning regarding particulate formation if Cuvitru remains in a siliconized syringe for more than 2 hours has been added.
  3. Accordingly, the date of revision (section 10) has been updated.

Updated on 8 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 28 April 2017 SPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

In section 5.2, typographical error with the units has been correct from ‘mg’ to ‘g’. The text should now read 0.3 to 1.0 g/kg body weight/4 weeks.

Updated on 8 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 February 2017 SPC

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