AVAXIM

  • Name:

    AVAXIM

  • Company:
    info
  • Active Ingredients:

    Inactivated 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: 31/10/19

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Summary of Product Characteristics last updated on medicines.ie: 26/9/2019

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Sanofi Pasteur

Sanofi Pasteur

Company Products

Medicine NameActive Ingredients
Medicine Name AVAXIM Active Ingredients Inactivated Hepatitis A Vaccine
Medicine Name Quadrivalent Influenza vaccine (split virion, inactivated) Active Ingredients Influenza vaccine (split virion, inactivated)
Medicine Name Rabies Vaccine BP Active Ingredients Rabies Vaccine BP
Medicine Name REVAXIS Active Ingredients Diphtheria Vaccine, Poliomyelitis Vaccine, Tetanus Vaccine
Medicine Name STAMARIL Active Ingredients Yellow Fever Vaccine
Medicine Name TYPHIM Vi Active Ingredients Vi Capsular Polysaccharide vaccine
Medicine Name ViATIM Active Ingredients Hepatitis A Vaccine, Purified Inactivated, for Adults, Typhoid Vaccine
1 - 0 of 7 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 31 October 2019 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Marketing distributor change.

Updated on 26 September 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Sections 2, 5 and 6 of the PIL have been amended to reflect the changes made to the SPC.

Updated on 26 September 2019 SmPC

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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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

Sections 2, 4.4, 4.8. 6.1 and 6.4 & 10 of the SPC have been updated to correct the description of composition of the vaccine (making specific mention of ethanol & phenylalanine excipients) & to amend the storage recommendations (protect from light).

Updated on 19 June 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 to PDF

Updated on 6 December 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 15 May 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • 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

Following the evaluation and approval of RMP (Risk Management Plan) for Hepatitis A vaccines

(European procedure) in December 2017, the SPC and PIL are being updated regarding the breastfeeding.

Updated on 8 May 2018 PIL

Reasons for updating

  • 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 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 5 January 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 5 January 2018 SmPC

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)

Free text change information supplied by the pharmaceutical company

Change of MAH address from 2, avenue Pont Pasteur 69007 Lyon, France to 14 Espace Henry Vallée 69007 Lyon, France

Updated on 4 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 January 2018 PIL

Reasons for updating

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

Updated on 23 March 2017 PIL

Reasons for updating

  • Change in co-marketing arrangement

Updated on 17 January 2017 SmPC

Reasons for updating

  • Company name change or merger

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

Free text change information supplied by the pharmaceutical company

Sanofi Pasteur MSD company name changed to Sanofi Pasteur

Updated on 16 January 2017 PIL

Reasons for updating

  • Company name change or merger

Updated on 2 March 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 2 March 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 addition of syncope (fainting)

Section 4.8 addition of vasovagal syncope in response to injection and inclusion of reporting of suspected adverse reactions

 

Section 10 revision date revised to January 2015

Updated on 12 February 2015 SmPC

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

 

 

 

Section 6.5: The addition of alternative primary packaging components (ready-to-use primary packaging components) has an impact on sections 6.5. (chlorobromobutyl or chlorobutyl) amended to (bromochlorobutyl or chlorobutyl or bromobutyl)
Section 10: revision date changed to January 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 7 September 2011 SmPC

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

In section 6.5 (nature and contents of container), added 'or chlorobutyl' after chlorobromobutyl to extend the nature of the plunger stopper

Updated on 26 November 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - 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)

Free text change information supplied by the pharmaceutical company

Addition of information related to the long term protectin provided by Avaxim

4.1     Therapeutic indications

 

AVAXIM is indicated for active immunisation against infection caused by hepatitis A virus in susceptible adults and adolescents of 16 years of age and above.

The use of AVAXIM should be based on official recommendations.

 
In section 4.2: clarification of the section and move part of the information in section 5.1

4.2     Posology and method of administration

Posology

The recommended dosage for subjects of at least 16 years of age is 0.5 millilitre for each injection.  Individuals having grown up in areas of high endemicity and/or with a history of jaundice may be immune to hepatitis A, in which case the vaccine is unnecessary. Testing for antibodies to hepatitis A prior to a decision on immunisation should be considered in such situations. If not, seropositivity against hepatitis A is not a contraindication. AVAXIM is as well tolerated in seropositive as in seronegative subjects (see Section 4.8). AVAXIM is not recommended for use in children of less than or equal to 15 years of age due to insufficient data on safety and efficacy.

 

Initial protection is achieved with one single dose of vaccine. Protective levels of antibody may not be reached until 14 days after administration of the vaccine. There are serological data to show that there should be continuing protection against hepatitis A for up to 36 months after a first dose in subjects who responded to the initial vaccination.

 

 

In order to provide long-term protection, a second dose (booster) of an inactivated hepatitis A vaccine should be given. The second dose is preferably given between 6 and 12 months after the primary immunisation but may be administered up to 36 months after the primary immunisation first dose (see section 5.1). It is predicted that HAV antibodies persist for many years (beyond 10 years) after the booster vaccination second dose.

 

Current recommendations do not support the need for further booster vaccinations for immunocompetent individuals after the initial two-dose vaccination course.

 

In the event that the second dose (booster) has been delayed after 36 months, there may be a decreased anti-hepatitis A antibody response. If long-term protection is required, the serum anti-hepatitis A antibody titre should be determined after AVAXIM administration of the second dose.

 

The vaccine may be used as a to provide the second dose (booster) in subjects from 16 years of age who received another inactivated hepatitis A vaccine (monovalent or with purified Vi polysaccharide typhoid) 6 months to up to 36 months previously.

 

AVAXIM is not recommended for use in children of less than or equal to 15 years of age due to insufficient data on safety and efficacy.

 
Addition of a precaution in section 4.4

4.4     Special warnings and precautions for use

 

Individuals having grown up in areas of high endemicity and/or with a history of jaundice may be immune to hepatitis A, in which case the vaccine is unnecessary. Testing for antibodies to hepatitis A prior to a decision on immunisation should be considered in such situations. If not, seropositivity against hepatitis A is not a contraindication. AVAXIM is as well tolerated in seropositive as in seronegative subjects (see Section 4.8).

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: Viral vaccine, ATC Code: J07BC02

 

AVAXIM confers immunity against hepatitis A virus by inducing antibody titres greater than those obtained after passive immunisation with immunoglobulin. Antibody appears shortly after the first injection and 14 days after vaccination more than 90% of immunocompetent subjects are seroprotected (titre above 20 mIU/millilitre).

 

One month after the first injection, almost 100% of subjects have antibody titres above 20mIU/millilitre. Serological data show continuing protection against hepatitis A for up to 36 months in subjects who responded to the first dose. In a study of 103 healthy adults who were followed serologically for three years after the first injection of AVAXIM, 99% still had at least 20 mIU/ml anti-HAV antibody at month 36.

 

The long-term persistence of protective antibody levels to hepatitis A virus after a second dose (booster) dose of AVAXIM is not currently available has not been fully evaluated. Nevertheless, available data (antibody titres obtained two years after the second dose) suggests that anti-HAV antibodies persist beyond 10 years after the booster vaccination second dose in healthy individuals.

 

Updated on 26 November 2010 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 8 July 2009 PIL

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 11 December 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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

Change to section 2 - qualitative and quantitative composition

Changed mL to millilitre in line with current guidelines.  Added Excipient(s) as per QRD template.

Change to section 4.1 - therapeutic indications

Wording at end of 1st paragraph changed to improve clarity.

Change to section 4.2 - Posology and method of administration

Added heading Posology to aid navigation, information moved into more appropriate sections, cross-reference to other sections to meet QRD template.

Change to section 4.3 - Contra-indications

Re-worded contraindication on hypersensitivity as per QRD template.

Change to section 4.4 - Special warnings & precautions for use

Information moved into more appropriate sections and re-ordered as per SPC guideline.

Change to section 4.5 - Interactions with other medicaments

Re-worded to improve clarity.

Change to section 4.6 - Pregnancy and lactation

Headings added to aid navigation and text on pregnancy re-worded in line with QRD template.

Change to section 4.7 - Effects on ability to drive and use machines

Re-worded in line with QRD template.

Change to section 4.8 - Undesirable effects

Section re-organised in line with QRD template.

Change to section 4.9 - Overdose

Amended to state whether any cases of overdose have been reported.

Change to section 5.1 - Pharmacodynamic properties

Pharmacotherapeutic group has been added, as per SPC guidelines.

Change to section 5.2 - Pharmacokinetic properties

Re-worded to improve clarity.

Change to section 5.3 - Preclinical safety data

Re-worded as per QRD template.

Change to section 6.1 - List of excipients

Re-formatted to improve clarity.  Mention of phenylalanine, as per guideline on excipients.

Change to section 6.4 Special precautions for storage

Re-worded according to QRD template.

Change to section 6.6. Instructions for use/handling

Added sentences as per the guideline Pharmaceutical aspects of the product information for human vaccines and as per QRD template.

Change to section 10 Date of partial revision of the text.

October 2008

Updated on 24 May 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 21 March 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 21 March 2007 SmPC

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

Section 7 - updated the address of the Marketing Authorisation Holder

Section 10 - changed date of revision to January 2007.

Updated on 13 September 2006 PIL

Reasons for updating

  • Change to date of revision

Updated on 4 September 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • 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

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION - Addition of the word “section” before “6.1”.

6.1    List of Excipients  - The wording “the formulation contains:” has been deleted

6.2    Incompatibilities - Rewording of sentence to bring it in line with the Guideline on Pharmaceutical aspects of the product information for human vaccines.

 

Section 6.5 - updated to include the addition of a prefilled syringe presentation with 1 or 2 separate needles.

Section 6.6 - sentence added to describe needle attachment.

Section 10 - update to date of revision of the text.

Updated on 9 June 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 May 2006 SmPC

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 17 August 2005 SmPC

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 10 March 2005 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 SmPC

Reasons for updating

  • New SPC for medicines.ie

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