Havrix Monodose (Syringe)

  • Name:

    Havrix Monodose (Syringe)

  • Company:
    info
  • Active Ingredients:

    Hepatitis A 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: 22/11/19

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Summary of Product Characteristics last updated on medicines.ie: 22/11/2019

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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Amoxil Paediatric Suspension Active Ingredients Amoxicillin trihydrate
Medicine Name Amoxil Vial for Injection 500mg Active Ingredients Amoxicillin sodium
Medicine Name ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed Active Ingredients Umeclidinium bromide, Vilanterol trifenatate
Medicine Name Augmentin 250 mg/125 mg film-coated tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 500mg/125mg Film-coated Tablets Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin 875/125mg Film Coated tablets Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin Duo Mixed Fruit 400 mg/57 mg /5 ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Clavulanic Acid
Medicine Name Augmentin DUO Suspension 400/57mg Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name Augmentin Intravenous 1.2g Active Ingredients Amoxicillin sodium, Potassium clavulanate
Medicine Name Augmentin Paediatric 125mg/31.25mg per 5ml Powder for Oral Suspension Active Ingredients Amoxicillin trihydrate, Potassium clavulanate
Medicine Name AVAMYS 27.5 micrograms/spray nasal spray suspension Active Ingredients Fluticasone furoate
Medicine Name Avodart Soft Capsules 0.5mg Active Ingredients Dutasteride
Medicine Name Babyhaler Active Ingredients No Active Ingredients
Medicine Name Bactroban Nasal Ointment Active Ingredients Mupirocin calcium
Medicine Name Bactroban Ointment Active Ingredients Mupirocin
Medicine Name Becotide Evohaler 100 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 250 Active Ingredients Beclometasone Dipropionate
Medicine Name Becotide Evohaler 50 Active Ingredients Beclometasone Dipropionate
Medicine Name Benlysta 120 mg and 400 mg powder for concentrate for solution for infusion Active Ingredients Belimumab
Medicine Name Betnovate C 0.1% / 3% w/w Cream Active Ingredients Betamethasone Valerate, Clioquinol
Medicine Name Betnovate Cream 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Ointment 0.1% w/w Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Cream Active Ingredients Betamethasone Valerate
Medicine Name Betnovate RD Ointment Active Ingredients Betamethasone Valerate
Medicine Name Betnovate Scalp Application 0.1% w/v Cutaneous Solution Active Ingredients Betamethasone Valerate
1 - 0 of 136 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 22 November 2019 SmPC

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 PIL

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 2 July 2019 SmPC

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 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 21 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 21 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 April 2017 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 April 2017 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 31 March 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 17 July 2015 SmPC

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 PIL

Reasons for updating

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

Updated on 13 May 2014 SmPC

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 PIL

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 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

Change to Section:

Section 4.4 - Special warnings and precautions for use

Updated on 27 June 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 30 August 2012 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 7 October 2009 PIL

Reasons for updating

  • Change of inactive ingredient

Updated on 28 July 2009 SmPC

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 1 April 2009 SmPC

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 9 February 2006 SmPC

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 6 February 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 25 October 2005 SmPC

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 6 August 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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