Quadrivalent Influenza vaccine (split virion, inactivated)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 7/8/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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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
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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 8 August 2019 PIL

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 7 August 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

The SPC have been updated to reflect the strain composition for the 2019-2020 season flu vaccine.
Section 2 of the SPC has been updated to show the new strain composition for the 2019/2020 flu season.
Section 10  has been updated with the HPRA approval date for the strain change variation.

Wrong SPC uploaded initially heance reuploaded.

Updated on 7 August 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

The SPC have been updated to reflect the strain composition for the 2019-2020 season flu vaccine.
Section 2 of the SPC has been updated to show the new strain composition for the 2019/2020 flu season.
Section 10  has been updated with the HPRA approval date for the strain change variation.

 

Updated on 28 May 2019 PIL

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 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 28 May 2019 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 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 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

Maternal immunisation impacting sections 4.1, 4.2, 4.4, 4.6, 4.8, 5.1 and 10 of the SPC

Updated on 13 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 13 August 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

Annual flu strain change NH 2018-19

Updated on 18 January 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • 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

Therapeutic indication for active immunisation of adults and children has changed from 3 years and older to 6 months and older.

As a result of this major change, the following sections have been amended: section 4.1.Therapeutic indications; section 4.2. Posology and method of administration; section 4.8. Undesirable effects; section 5.1. Pharmacodynamic properties; section 7. Marketing Authorisation Holder and section 10. Date of Revision of the Text

Updated on 18 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 18 January 2018 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 18 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 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 4 January 2018 PIL

Reasons for updating

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

Updated on 17 July 2017 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided

Updated on 14 July 2017 PIL

Reasons for updating

  • New PIL for new product