TYPHIM Vi

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: 8/5/2019

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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
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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 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 9 May 2019 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 8 May 2019 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Sections 4.3 Contraindications has been modified to mention hypersensitivity to casein. Section 4.4 Special Warnings and Precautions has been updated following discussions with HPRA. Section 4.8 Undesirable Effects has been updated following an Integrated Safety Analysis, and section 5.1 Pharmacodynamic Properties has been updated to include paediatric data and introduce variability depending on endemicity. Section 10 Date of revision of text.

Updated on 27 November 2018 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to packaging

Updated on 27 February 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 27 February 2018 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: Addition of a new type of tip cap.

Updated on 19 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 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

 

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

Updated on 19 January 2018 PIL

Reasons for updating

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

Updated on 1 February 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 24 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

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 13 June 2011 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

In section 6.5 (nature and contents of container), bromobutyl & chlorobutyl have been added
In section 10 (date of revision of the text), the date 7th April 2011 has been added replacing the last revised date

Updated on 11 September 2009 PIL

Reasons for updating

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

Updated on 12 June 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects

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

Immune system disorders

·          Anaphylactoid reactions, serum sickness

Has been amended

Immune system disorders

·          Anaphylactic/anaphylactoid reactions, including shock; serum sickness

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

May 2009

Updated on 28 July 2008 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 May 2008 PIL

Reasons for updating

  • Change to side-effects

Updated on 13 May 2008 SmPC

Reasons for updating

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

Section 4.7 – removal of the MedDRA frequency ‘very rare’ which was previously assigned ‘tiredness’.

Section 4.8 – removed mention of the MedDRA frequency ‘very rare’ to which had been assigned to those side effects spontaneously reported during commercial use of the vaccine.

Section 10 – changed to April 2008.

Updated on 3 March 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 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 4.7 - Effects on ability to drive and use machines
  • 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 6.6 - Special precautions for disposal and other handling
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

Section 1 – updated name to Typhim Vi, Solution for Injection, Typhoid Polysaccharide Vaccine.

Section 3 – added ‘Typhim Vi is a clear, colourless solution’

Section 4.1 – reworded for clarification

Section 4.2 – Add instruction not to give the vaccine i.v..  Clarified information on administration to children.

Section 4.4 – added warning on : 1) reduced immunogenicity in immuno-compromised patients; 2) administration to patients with bleeding disorders; 3) traces of formaldehyde; 4_ vaccine will only protect against disease caused by Salmonella typhi and may not work in all recipients;

Section 4.5 – added information on concomitant administration with other vaccines

Section 4.7 – added warning that vaccine may cause tiredness

Section 4.8 – reorganised according to SPC guideline and Medra categories and frequencies.

Section 5.1 – added ATC code and pharmacodynamic information

Section 6.4 – add instruction to keep the vaccine in the carton

Section 6.6 – added instruction to visually inspect the vaccine

Other sections were re-worded in line with the QRD template

 

Updated on 3 March 2008 PIL

Reasons for updating

  • Change to side-effects
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Changes to therapeutic indications

Updated on 27 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 13 February 2007 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 13 February 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:               Changed the address of the Marketing Authorisation Holder to Sanofi Pasteur MSD Limited, Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24

 

Section 10:             Changed date of the revision of the text to January 2007

Updated on 4 September 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
  • 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 - 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 31 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 6 August 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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)