HBVAXPRO 5mcg
- Name:
HBVAXPRO 5mcg
- Company:
MSD Ireland (Human Health) Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/03/20
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MSD Ireland (Human Health) Limited
Company Products
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 19 March 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 10 February 2020 PIL
Reasons for updating
- Change to section 6 - what the product contains
Updated on 10 February 2020 SPC
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 PIL
Reasons for updating
- Change to section 6 - what the product contains
Updated on 11 March 2019 PIL
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 8 March 2019 SPC
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 8 March 2019 SPC
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 28 August 2018 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to other sources of information section
Updated on 3 March 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 3 March 2017 SPC
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
Updated on 2 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 2 March 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 17 January 2017 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 5 June 2014 SPC
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 5 June 2014 PIL
Reasons for updating
- Change to MA holder contact details
- Addition of information on reporting a side effect.
Updated on 9 September 2013 PIL
Reasons for updating
- Change to further information section
Updated on 10 April 2013 PIL
Reasons for updating
- Change to further information section
Updated on 3 October 2011 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 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 3 October 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 20 July 2011 SPC
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 6 July 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to further information section
- Change to date of revision
Updated on 4 February 2010 PIL
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 1 December 2008 PIL
Reasons for updating
- Introduction of new pack/pack size
- Change to date of revision
Updated on 28 November 2008 SPC
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
Updated on 7 February 2008 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 25 April 2007 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
Updated on 6 September 2006 PIL
Reasons for updating
- Change to packaging
Updated on 22 August 2006 SPC
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 19 June 2006 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 20 June 2005 SPC
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 SPC
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)
Updated on 23 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may not be renewed (A)