HBVAXPRO 10mcg *

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 08 July 2021

File name

HBVAXPRO-10mcg-PFS-H-C-0373-II-071-G-SPC-IE-en April 2021_1625756867.pdf

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

Update to plunger stopper (gray chlorobutyl or bromobutyl).

 

Updated on 08 July 2021

File name

QRD-IE-HBVAXPRO-10MCG-LFT-II071G-29042021_1625755737.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 19 March 2020

File name

QRD_IE_HBVAXPRO_10MCG_Leaflet_IB067 (002).pdf_1584623282.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 10 February 2020

File name

HBVAXPRO-10mcg-PFS-H-C-0373-IB-067-SPC-IE-en Jan 2020 (002)_1581330185.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4: Added “Traceability” heading

 

Updated on 10 February 2020

File name

QRD_IE_HBVAXPRO_10MCG_Leaflet_IB067 (002)_1581330038.pdf

Reasons for updating

  • Change to section 6 - what the product contains

Updated on 11 March 2019

File name

QRD_IE_HBVAXPRO10MCG_Leaflet_II064_1552295975.pdf

Reasons for updating

  • Change to section 5 - how to store or dispose

Updated on 08 March 2019

File name

BM HBVAXPRO-10mcg-PFS-H-C-0373-II-064-SPC-IE-en Jan 2019_1552059798.pdf

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 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

  • Section 2: Added text: “Excipient(s) with known effect: Sodium less than 1mmol (23mg) per dose.”
  • Section 4.4: Added text: “Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23mg) per dose, and is considered to be essentially sodium free.”
  • Section 6.4: Added text: “Store in the original package in order to protect from light. HBVAXPRO should be administered as soon as possible after being removed from refrigeration. HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours. Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours. These are not, however, recommendations for storage.”

Updated on 08 March 2019

File name

HBVAXPRO-10mcg-PFS-H-C-0373-II-064-SPC-IE-en Jan 2019_1552048312.

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 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

  • Section 2: Added text: “Excipient(s) with known effect: Sodium less than 1mmol (23mg) per dose.”
  • Section 4.4: Added text: “Excipient(s) with known effect: This medicinal product contains less than 1mmol sodium (23mg) per dose, and is considered to be essentially sodium free.”
  • Section 6.4: Added text: “Store in the original package in order to protect from light. HBVAXPRO should be administered as soon as possible after being removed from refrigeration. HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours. Cumulative multiple excursions between 0°C and 2°C are also permitted as long as the total time between 0°C and 2°C does not exceed 72 hours. These are not, however, recommendations for storage.”

Updated on 24 August 2018

File name

QRD_IE_HBVAXPRO10MCG_Leaflet_BRX_PRO (2)_1535105285.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 03 March 2017

Reasons for updating

  • New SPC for new product

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

Updated on 03 March 2017

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

Marketing Authorisation Holder name change to MSD VACCINES

Updated on 02 March 2017

File name

PIL_10955_978.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 March 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 17 January 2017

Reasons for updating

  • Change to MA holder contact details

Updated on 05 June 2014

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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



In section 4.8 (undesirable effects), how to report side effects has been added
In section 7 the marketing authorisation has been updated with the new Lyon address
In section 10, date of revision has been updated

Updated on 05 June 2014

Reasons for updating

  • Change to MA holder contact details
  • Addition of information on reporting a side effect.

Updated on 09 September 2013

Reasons for updating

  • Change to further information section

Updated on 31 May 2013

Reasons for updating

  • Change to MA holder contact details

Updated on 03 October 2011

Reasons for updating

  • Change to side-effects

Updated on 30 September 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • 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


  • In section 4.8, Uveitis has been added as an undesirable effect under a new category of Eye Disorder
  • In section 4.4, 'vial stopper' has been deleted and replaced with 'the syringe plunger stopper and tip cap' in the latex warning paragraph
  • In section 9, the date of the last renewal has been updated to 27/4/2011
  • In section 10, the date of revision text is now 08/2011

Updated on 20 July 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • 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

  • In section 4.4, latex warning has been added
  • In section 4.9, No case of overdose reported has been changed to there have been reports of administration of higher than recommended dose"
  • In section 6.6, inserted the following text “The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered. Before use, the syringe should be well shaken”
  • In section 10, the date of the text has been revised from December 2007 to 03/2011

Updated on 06 July 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to further information section
  • Change to date of revision

Updated on 04 February 2010

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 03 December 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • 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

Change to section 6.5 Addition of 20 pack sizes for prefilled syringe with 2 separate needles presentation.


Change to section 8 Addition of new license numbers for new 20 pack sizes for prefilled syringe with 2 separate needles presentation.

 

Change to section 10 Date of revision updated.

Updated on 01 December 2008

Reasons for updating

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

Updated on 07 February 2008

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

Change to section 4.4 - addition of warning on potential of apnoea in very premature infants.
Change to section 4.8 - addition of apnoea in very premature infants.

Updated on 25 April 2007

Reasons for updating

  • Change to side-effects
  • Change to further information section

Updated on 06 September 2006

Reasons for updating

  • Change to packaging

Updated on 22 August 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • 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 1 - update to name

·       Section 2 - words updated for clarification

·       Section 3 - updated to include description of pharmaceutical form

·       Section 4.2 Primary vaccination - the need of the 4th dose at 12 months has been

       reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used.

·       Section 4.2 Immunocompromised vaccinees, Revaccination of non-responders and Special dosage recommendation for known of presumed exposure to hepatitis B virus - the recommendations for serologic testing, and administration of additional doses if needed have been strengthened.

·       Section 4.2 Method of administration - updated to ensure vaccine not injected intravascularly and reference to see section 6.6 for instructions for preparation.

·       Section 4.5 – inclusion of a sentence regarding concomitant administration

·       Section 4.7 – wording change for clarification.

·       Section 5.1 – additional information provided on clinical trials and booster doses.

·       Section 6.2 – wording change for clarification

·       Section 6.6 – inclusion of additional sentence with regards to disposal of waste.

·       Section 10 – update to date of revision of the text

Updated on 09 June 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 June 2005

Reasons for updating

  • 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)

Updated on 27 April 2005

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 7 - Marketing authorisation holder

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

Updated on 23 June 2003

Reasons for updating

  • New SPC for medicines.ie

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