Login

Havrix Monodose (Syringe)

*
Pharmacy Only: Prescription

  • Company:

    GlaxoSmithKline (Ireland) Ltd

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Hepatitis A Vaccine

    *Additional information is available within the SPC or upon request to the company

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 4.5: Updated to clarify the list of vaccines that can be co-administered with Havrix Monodose and Havrix Junior Monodose vaccines (i.e. monovalent and combination vaccines comprised of measles, mumps, rubella and varicella).

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 4.8 - updated IMB name change, IMB to HPRA and updated details for reporting of side effects.

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

Change to Section:

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

Changes to:

 

 

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)