Menitorix powder and solvent for solution for injection

  • Name:

    Menitorix powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Hib/Meningococcal group C combined vaccine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/12/19

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Summary of Product Characteristics last updated on medicines.ie: 24/12/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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1 - 0 of 134 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 24 December 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

Information for healthcare professionals: Added information on the use and handling of Plastic Rigid Tip Cap (PRTC) syringes containing the solvent used for the reconstitution of the vaccine.

Section 5: Replaced the statement that the vaccine should be discarded if not used within 24 hours of reconstitution with a statement that the vaccine should not be administered.

Section 4: Updated the HPRA details for adverse event reporting.

Section 6: Deleted Poland from the list of countries where the vaccine is authorised.

Section 6: Changed the date of revision to 10/2019.

Updated on 24 December 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 6.6: Added information on the use and handling of Plastic Rigid Tip Cap (PRTC) syringes containing the solvent used for the reconstitution of the vaccine.

Sectrion 6.3: Replaced the statement that the vaccine should be discarded if not used within 24 hours of reconstitution with a statement that the vaccine should not be administered.

Section 4.8: Updated the HPRA details for adverse event reporting.

Section 10: Changed the date of revision to 19 December 2019.

Updated on 27 September 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Free text change information supplied by the pharmaceutical company

Deletion of Poland under the following section: This medicinal product is authorised in the Member States of the EEA under the following names

Updated on 27 September 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

section 6.3 - shelf life has changed from 3 years to 5 years

Updated on 17 April 2019 SmPC

Reasons for updating

  • 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

Section 4.4 has been updated from:

Individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group C even following vaccination with Menitorix.’

 

to:

‘Individuals with familial complement deficiencies (for example, C3 or C5 deficiencies) and individuals receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis group C, even if they develop antibodies following vaccination with Menitorix.’

Updated on 26 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 February 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - Marketing authorisation number(s)
  • 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 17 August 2018 SmPC

Reasons for updating

  • File format updated to PDF

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

Updated on 1 June 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 May 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 18 May 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 13 May 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 3 May 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 13 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 13 March 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors
  • Improved presentation of PIL

Updated on 6 May 2016 PIL

Reasons for updating

  • New PIL for medicines.ie