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TYPHIM Vi

*
Pharmacy Only: Prescription

  • Company:

    Sanofi Pasteur

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Vi Capsular Polysaccharide Vaccine

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2024

File name

915593 PIL.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 16 February 2024

File name

093_ie_smpc_SEHxxxxWS487 type II variations- CMC variation with labeling impact.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 16 February 2024

File name

093_ie_smpc_SEHxxxxWS487 type II variations- CMC variation with labeling impact.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 21 December 2020

File name

093_ie_smpc_2020-12-17_SEHxxxxWS419_VarIB Update excipient guidelines (1).pdf

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)

Updated on 21 December 2020

File name

093_uk-ie_pil_2020-12-15_SEHxxxxWS419_VarIB Update excipient guidelines (1).pdf

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 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 March 2020

File name

093_ie_smpc_Var IB Update SPC with traceability statement_2020-03-19.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 4.4  and 10 of the SPC have been updated.

Updated on 05 September 2019

File name

uk-ie-typhim-pil-distributor address change-clean.pdf

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 09 May 2019

File name

uk-ie-typhim-pil-safetyupdate_pooledanalysis-AtoQ.pdf

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 08 May 2019

File name

ie-spc-typhim-safetyprofileupdate-clean.pdf

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

File name

uk-ie-typhim-pil-acf-compactbox.pdf

Reasons for updating

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

Updated on 27 February 2018

Reasons for updating

  • New SPC for new product

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

Updated on 27 February 2018

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

File name

PIL_10962_59.pdf

Reasons for updating

  • New PIL for new product

Updated on 19 January 2018

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

Reasons for updating

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

Updated on 01 February 2017

Reasons for updating

  • Change of distributor details

Updated on 17 January 2017

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

Reasons for updating

  • Company name change or merger

Updated on 24 July 2015

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 02 March 2015

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 02 March 2015

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

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

Reasons for updating

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

Updated on 12 June 2009

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

Reasons for updating

  • Change due to user-testing of patient information

Updated on 14 May 2008

Reasons for updating

  • Change to side-effects

Updated on 13 May 2008

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 03 March 2008

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 03 March 2008

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

Reasons for updating

  • Improved electronic presentation

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

Updated on 13 February 2007

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 13 February 2007

Reasons for updating

  • Change to MA holder contact details

Updated on 04 September 2006

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 10 August 2005

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 06 August 2004

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

Reasons for updating

  • New SPC for medicines.ie

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