Havrix Monodose (Syringe)
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 12 September 2024
File name
ie-pl-havrixadultissue8draft1-clean-no headers.pdf
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 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
Updated on 12 September 2024
File name
ie-spc-havrixadultmonodoseissue9draft1-clean-no headers.pdf
Reasons for updating
- 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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 December 2023
File name
ie-spc-havrixadultmonodoseissue 8draft1- emc.pdf
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)
Free text change information supplied by the pharmaceutical company
Updated section 6.5 Nature and Contents of Container inline with the license
Updated on 31 May 2023
File name
ie-spc-havrixadultmonodoseissue7draft1- clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 May 2023
File name
ie-pl-havrixadultissue7draft1-clean.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to information for healthcare professionals
Updated on 27 January 2022
File name
ie-pl-havrixadultissue6draft1-clean_for compendia.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 27 January 2022
File name
ie-spc-havrixadultmonodoseissue6draft2- compendia.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 6.1 - List of excipients
- 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 22 November 2019
File name
ie_spc_havrixadultmonodoseissue5draft2.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of first authorisation/renewal of the 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
1. SPC 4.1 Added Central America and the Middle East as areas of high risk of contracting hepatitis A. Revised the high-risk non-immune group ‘homosexual men’ to the more general ‘Homosexuals’ and ‘Persons with multiple sexual partners’.
2. Section 4.2, Method of Administration updated to change contraindicated route of administration from ‘intravenously’ to ‘intravascularly’ and to add the instruction regarding administration to patients with thrombocytopenia and bleeding disorders ‘Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.’
3. SPC 4.5 Replaced the acronym ‘ISG’ with ‘immunoglobulins’.
4. SPC 4.4 Updated the potassium and sodium excipient content statements to align with the current guidance
This medicine contains potassium, less than 1 mmol (39 mg) per 1 ml dose, i.e. essentially ‘potassium- free’. This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml dose, i.e. that is to say essentially ‘sodium- free’
5. SPC 6.6 Updated with a description of the vaccine following storage and the instruction that ‘The vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration’.
6. SPC 10 updated to 07 October 2019
7. SPC 4.2, 4.5, 4.6, 6.3 and 9 formatting and editorial changes to align with QRD.
8. SPC 1 Removed the registered trade mark symbols.
Updated on 22 November 2019
File name
ie_pl_havrixadultissue5draft2.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
1. PIL 2: Removed the reference 'any antibiotic' from the contraindication statement:
Do not take Havrix Monodose:
…
if you are allergic to any other hepatitis A injection, any antibiotic, or neomycin; an antibiotic used to treat skin infections
2. PIL 2: Updated the potassium and sodium excipient content statements to align with the current guidance:
This medicine contains potassium, less than 1 mmol (39 mg) per 1 ml dose, i.e. essentially ‘potassium- free’. This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml dose, i.e. that is to say essentially ‘sodium- free’.
3. PIL 3: Revised the statement regarding duration protection following the first dose from ‘at least 1 year’ to ‘up to 5 years’, i.e.:
The first dose of vaccine should protect you from infection with hepatitis A virus within 2 to 3 weeks after the injection. Protection should last for at least 1 year up to 5 years.
4. Updated the revision date to November 2018.
5. Removed the registered trade mark symbols and updated the trade mark and copyright statements.
Updated on 02 July 2019
File name
ie-spc-havrixadultmonodoseissue4draft3.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
File format updated from word to PDF. Approval date of SPC 20 March 2017.
Updated on 01 June 2018
File name
ie-spc-havrixadultmonodose.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 21 May 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 April 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 April 2017
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.4 - Special precautions for storage
- 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)
Free text change information supplied by the pharmaceutical company
Section 4.8: Simplification with no changes to the clinical information.
Section 5.1 Updated to add data on the Havrix UMV experience in Israel and Panama. Added subheadings 'Immune response', 'Persistence of immune response', 'Efficacy of Havrix for outbreak control' and 'Impact of mass vaccination on disease incidence'.
Section 6.4: Included wording regarding the thermostability of the vaccine when stored up to 25°C for 3 days.
Section 8: Formatting change.
Updated on 31 March 2017
File name
PIL_9852_216.pdf
Reasons for updating
- New PIL for new product
Updated on 31 March 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to information for healthcare professionals
Updated on 17 July 2015
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
Section 7 - change to address of the Irish MA Holder from Stonemasons Way, Rathfarnham, Dublin 16 to 12 Riverwalk, Citywest Business Campus, Dublin 24.
Section 10 - change to date of revision of the text.
Updated on 16 July 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 13 May 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Improved electronic presentation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Posology and method of administration - Revised the administration instruction wording for subcutaneous injection.
4.4 Special warnings and precautions for use - added statement regarding excipients sodium and potassium.
4.7 Effects on ability to drive and use machines - added the following:
Havrix has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects - added a statement regarding the reporting of side effects to the IMB.
5.1 Pharmacodynamic properties - updated the information regarding long term persistence from the previous statements based on 10 years to data of ≥ 17 years.
6.6 Special precautions for disposal - added instructions for disposal.
Updated on 12 May 2014
Reasons for updating
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to date of revision
- Change to dosage and administration
- Addition of information on reporting a side effect.
- Improved electronic presentation
Updated on 28 June 2013
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 - Special warnings and precautions for use
Updated on 27 June 2013
Reasons for updating
- Change to warnings or special precautions for use
Updated on 30 August 2012
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.3 - Contraindications,
Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose,
Section 5.1 - Pharmacodynamic properties
Updated on 30 August 2012
Reasons for updating
- Change to warnings or special precautions for use
Updated on 07 October 2009
Reasons for updating
- Change of inactive ingredient
Updated on 28 July 2009
Reasons for updating
- Change to section 6.1 - List of excipients
- 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
Summary of updates to the SPC changes made in Red
HAVRIX SPC M Havrix adult susp for Inj in PFS May 2009
6. Pharmaceutical Particulars
6.1 List of Excipients
Deletion of 2-Phenoxyethanol
10. Date of Revision of the Text
January 2009 replaced by May 2009
Updated on 01 April 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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 1. Trade name of Adult updated to include strength.
Section 3. Description of appearance added.
Section 6.1. Corrected names of excipients.
Section 6.4. Storage instructions updated.
Section 6.6. Title of section updated.
Updated on 09 February 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 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2006
Reasons for updating
- Improved electronic presentation
Updated on 25 October 2005
Reasons for updating
- 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 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 09 August 2004
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 August 2004
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)