ViATIM

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/09/19

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Summary of Product Characteristics last updated on medicines.ie: 8/1/2018
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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 5 September 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

Section 6: Distributor address change

Section 6: Date of revision

Updated on 8 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 8 January 2018 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

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

Updated on 5 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 January 2018 PIL

Reasons for updating

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

Updated on 27 July 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 14 March 2017 PIL

Reasons for updating

  • Change of distributor details

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 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 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 November 2012 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company



Section 1: Name change from Suspension and solution for injection in a prefilled dual chamber syringe to Suspension and solution for suspension for injection in pre-filled syringe.

 

Section 2: Deletion of purified Vi polysaccharide and replaced with inactivated hepatitis A vaccine and 0.5 millilitre of typhoid polysaccharide.

Section 4.2: Inclusion of Paediatric population The safety and efficacy of ViATIM in children and adolescents below 16 years have not yet been established. No data are available.

Section 4.5: specific concomitant administration stated

Section 4.6: Headings included plus; Fertility No fertility data are available.

 

Section 4.7: Included ViATIM has a minor influence on the ability to drive and use machines.

 

Section 4.8: Frequencies re-arranged

 

Section 4.9: Included the following statement; Cases of overdose have been reported with ViATIM where it was administered concomitantly with typhoid polysaccharide and/or hepatitis A vaccines. When adverse reactions were reported, they did not differ in nature from those described in section 4.8.

 

Section 5.1: ATC code updated to J07CA10 typhoid-hepatitis A. Inclusion of tables containing the Seroconversion/seroprotection rates observed 28 days after vaccination.

 

Section 6.1: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.4: deleted if frozen the vaccine should be discarded

 

Section 6.5: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.6: Harmonised

 

Section 9: Date of authorisation corrected

 

Section 10: date of revision changed to October 2012

 

 

 

 

Updated on 1 November 2012 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 1 November 2012 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - 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 6.1 - List of excipients
  • 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
  • Change due to harmonisation of SPC

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

Free text change information supplied by the pharmaceutical company

Section 1: Name change from Suspension and solution for injection in a prefilled dual chamber syringe to Suspension and solution for suspension for injection in pre-filled syringe.

 

Section 2: Deletion of purified Vi polysaccharide and replaced with inactivated hepatitis A vaccine and 0.5 millilitre of typhoid polysaccharide.

Section 4.2: Inclusion of Paediatric population The safety and efficacy of ViATIM in children and adolescents below 16 years have not yet been established. No data are available.

Section 4.5: specific concomitant administration stated

Section 4.6: Headings included plus; Fertility No fertility data are available.

 

Section 4.7: Included ViATIM has a minor influence on the ability to drive and use machines.

 

Section 4.8: Frequencies re-arranged

 

Section 4.9: Included the following statement; Cases of overdose have been reported with ViATIM where it was administered concomitantly with typhoid polysaccharide and/or hepatitis A vaccines. When adverse reactions were reported, they did not differ in nature from those described in section 4.8.

 

Section 5.1: ATC code updated to J07CA10 typhoid-hepatitis A. Inclusion of tables containing the Seroconversion/seroprotection rates observed 28 days after vaccination.

 

Section 6.1: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.5: re-arranged section to be consistent with the rest of the changes in section 2

 

Section 6.6: Harmonised

 

Section 10: date of revision changed to 08/2012

Updated on 7 December 2011 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 4.2 there has been an inclusion of long term immunity
In section 5.1 there has been an insertion of serological data

Updated on 11 December 2009 SmPC

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)

Free text change information supplied by the pharmaceutical company



Change to section 4.8 - Undesirable effects

Update to mention both anaphylactic and anaphylactoid reactions (including shock) as immune system disorders

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

09/2009

Updated on 9 December 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 8 August 2008 PIL

Reasons for updating

  • Change to packaging
  • Change to date of revision

Updated on 21 July 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 March 2007 PIL

Reasons for updating

  • Change to marketing authorisation holder address
  • Change to date of revision

Updated on 19 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 22 January 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 22 January 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Sections 1-10:  Removal of ® symbol in line with QRD template.

 

Sections 4.3, 4.6, 4.7, 4.8, 5.3, 6.4, and 6.5: Updated in line with QRD template


Section 9: Changed to 3rd September 2001/3rd September 2006

 

Section 10: Changed to December 2006

Updated on 26 May 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 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 19 November 2004 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 26 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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)