Bexsero, suspension for injection in pre-filled syringe *

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 13 October 2021

File name

ieukni-spc-combined-bexsero-issue12draft1-clean_1634116357.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

SPC sections updated:
- Section 4.4 Sodium warning statement added
- Section 4.8 lymphadenopathy added as a new AE
-Section 10 - Date of revision updated to 07/10/2021

-Minor editorial changes throughout the SmPC

Updated on 13 October 2021

File name

ieukni-pl-combined-bexsero-issue10draft1-clean_1634116220.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

PIL sections updated:

-Section 4 - 'Enlarged lymph nodes' sentence added
-Section 6 - updated to the local country contact details and date of revision 

-Minor editorial changes throughout the PIL

Updated on 07 July 2020

File name

ie-pl-bexseroissue9draft1_1594144037.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL section 4 under the subheading 'Side effects that have been reported during marketed use include', added the adverse event 'Skin rash (adolescents from 11 years of age and adults)'.

PIL section 6 changed the date of revision to 07/2020.

Updated on 07 July 2020

File name

ie-spc-bexseroissue11draft1_1594143788.pdf

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

SPC section 4.8 under the subheading 'Adolescents (from 11 years of age) and adults', updated to add the adverse event 'rash' with a frequency of not known.

SPC section 10 updated with the new date of 02/07/2020

Updated on 12 May 2020

File name

ie-pl-bexseroissue8draft1_1589276460.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

PIL 3 How to use – vaccination schedule

 

PIL 4 Regulatory Authority adverse event reporting details updated to align with current guidance.

 

PIL 6 Date of revision changed to 04/2020

 

Updated on 12 May 2020

File name

ie-spc-bexseroissue10draft1_1589276355.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – 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

SPC 4.2

Removed reference to the age category ‘3 months to 5 months’

 

SPC 5.1

Under the subheading ‘Immunogenicity in infants and children’, revised the dose schedule statements to include the 2+1 schedule starting at 2 months.

Added the new subheading ‘Impact of vaccination on disease incidence’, with statements regarding the statistically significant reduction in Invasive Meningococcal Disease cases caused by Neisseria meningitidis group B following vaccination.

 

SPC 4.4

Added subheading ‘Traceability’, with the advisory statement regarding record keeping of the vaccine name and batch number.

 

SPC 4.8

Revision of statement regarding adverse event reporting to the Regulatory Authority to align with current guidance.

 

SPC 10

Changed the date of revision from 28/03/2019 to 28/04/2020.

Updated on 04 June 2019

File name

ie-pil-issue7draft2-medsie_1559633397.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 04 June 2019

File name

ie-spc-issue9draft2-medie_1559633326.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Sec 4.5 - Co-administration with Men A,C,W,Y

Updated on 08 April 2019

File name

ie-pil-issue7draft1-medie_1554729574.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents

Updated on 08 April 2019

File name

ie-spc-issue9draft1-medsie_1554729895.pdf

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

Section 4.2 - to add booster information on in individuals at continued risk of exposure to meningococcal disease

Section 5.1 -  to add information about antibody persistence and the extension study

Updated on 22 March 2019

File name

ie-pil-issue6draft1-MED.IE_1553254520.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 22 March 2019

File name

ie-spc-issue8draft1-MED.IE_1553254684.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 - formatiing
4.5 Interaction with other medicinal products and other forms of interaction - to include the co-administration with MenACWY

Updated on 30 January 2019

File name

ie-pil-issue5draft1 for Meds.ie_1548853122.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to warnings or special precautions for use

Updated on 30 January 2019

File name

ie-spc-issue7draft1 for Meds.ie_1548853050.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

4.4 Special warnings and precautions for use - ” update to section relative to individuals receiving treatment that inhibits terminal complement activation (for example eculizumab).
 

Updated on 07 December 2018

File name

ie-pil-issue4draft1-MED.IE_1544179600.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 07 December 2018

File name

ie-spc-issue6draft1-MED.IE_1544179519.pdf

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 - adding the meningeal irritation ADR in SmPC section 4.8 (in both subsection “Infants and children (up to 10 years of age)” and “Adolescents (from 11 years of age) and adults

 

Updated on 05 July 2018

File name

ie-spc-formedicinesie05-07-18.docx

Reasons for updating

  • 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 9 - Date of first authorisation/renewal of the 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

1. Update of section 4.2 of the SmPC to update the dosing schedule for infants aged 3 months to 5 months and aged 2 years to 10 years based on the results from studies V72_28 and V72_28E1.
2. Update of section 4.8 of the SmPC to include the number of subjects exposed to at least 1 dose based on the results from studies V72_28 and V72_28E1.
3. Update of section 5.1 of the SmPC to update the information about immunogenicity in infants and children based on the results from studies V72_28 and V72_28E1.
Update of section 9 of the SmPC to update latest renewal date
Furthermore, Bexsero is removed from the additional monitoring list and consequently the inverted black triangle is deleted from the SmPC

Updated on 03 July 2018

File name

uk-ie-pil-issue2draft1 for medicines compendia.pdf

Reasons for updating

  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Updated on 02 October 2017

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of first authorisation/renewal of the 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

4.8 Adverse event - MHRA AE reporting details updated in line with new guidance.

9. Renewal date of 18 Sept 2017 added.

Updated on 02 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 13 July 2017

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

Section 4.8: Addition of of ESL and injection site nodule

Updated on 13 July 2017

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 13 July 2017

File name

PIL_15904_338.pdf

Reasons for updating

  • New PIL for new product

Updated on 22 February 2017

Reasons for updating

  • 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 originally loaded had incorrect approval date on it (section 10) - amended from 15 Feb 2017 to 8 Feb 2017.

Updated on 21 February 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

6.3 -  Increase in shelf life from 2 years to 3 years

Updated on 11 October 2016

Reasons for updating

  • 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 4.8 - 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

·         Section 4.4 – update to information regarding individuals with impaired immune response.

·         Section 4.5 – inclusion of meningococcal group C-CRM conjugate.

·         Section 4.8 – inclusion of the UEs (of unknown frequency): hypotonic-hyporesponsive episode, fever

·         Section 5.1 – inclusion of section regarding immunogenicity in special populations

 

Updated on 10 October 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 09 March 2016

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 09 December 2015

Reasons for updating

  • 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

Section 4.8
- correction to number of children in clinical study data

Section 5.1
– deletion of text on booster doses within the foot note to Table 2 regarding
– additional text after Table 3 regarding the clinical data in 4 year olds who had received priming and booster doses as infants
- The adult data in Table 5 has been extracted and presented in a new Table 7 with associated changes to text referencing these tables

Updated on 08 October 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details

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

Free text change information supplied by the pharmaceutical company

Section 7 -  Change to name of MAH (Novartis to GSK)

Updated on 07 October 2015

Reasons for updating

  • Change of manufacturer
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 23 September 2015

Reasons for updating

  • Change to side-effects

Updated on 17 August 2015

Reasons for updating

  • 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

Section 4.8, Updated numbes in clinical trial, 209 .  Headache and arthralgia added to under two years old section.

Updated on 06 February 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 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

4.4 added:

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see section 4.8). It is important that procedures are in place to avoid injury from fainting.This vaccine should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.

 

As with any vaccine, vaccination with Bexsero may not protect all vaccine recipients.  

 

The safe use of Bexsero in kanamycin-sensitive individuals has not been established.

 

4.8

Tabulated list of adverse reactions

 

Adverse reactions (following primary immunisation or booster dose) considered as being at least possibly related to vaccination have been categorised by frequency.

 

Frequencies are defined as follows:

Very common:        (≥1/10)

Common:                  (≥1/100 to <1/10)

Uncommon:            (≥1/1,000 to <1/100)

Rare:                           (≥1/10,000 to <1/1,000)

Very rare:                 (<1/10,000)

Not known:              (cannot be estimated from the available data)

 

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

In addition to reports in clinical trials, worldwide voluntary reports of adverse reactions received for Bexsero since market introduction are included in the list. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.

 

Infants and children (up to 10 years of age)

 

Metabolism and nutrition disorders

Very common: eating disorders

 

Immune system disorders

Not known: allergic reactions (including anaphylactic reactions)

 

 

General disorders and administration site conditions

Very common: fever (≥38°C), injection site tenderness (including severe injection site tenderness defined as crying when injected limb is moved), injection site erythema, injection site swelling, injection site induration, irritability

Uncommon: fever (≥40°C)

Not known: blisters at or around the injection site

 

Adolescents (from 11 years of age) and adults

 

Immune system disorders

Not known: allergic reactions (including anaphylactic reactions)

 

Nervous system disorders

Very common: headache

Not known: syncope or vasovagal responses to injection

 

Gastrointestinal disorders

Very common: nausea

 

General disorders and administration site conditions

Very common: injection site pain (including severe injection site pain defined as unable to perform normal daily activity), injection site swelling, injection site induration, injection site erythema, malaise

Not known: blisters at or around the injection site

 

Section 6.6. The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine. If two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular administration.

 

 

Updated on 30 January 2015

Reasons for updating

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

Updated on 01 October 2014

Reasons for updating

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

Section 4.2 - change to booster dose timing in infants

Section 5.1 - update to table 5 persistence of antibodies

Updated on 26 September 2014

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 09 June 2014

Reasons for updating

  • 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

Changes to number of clinical trials and numbers of subjects in clinical trials.

Summary of the safety profile

 

The safety of Bexsero was evaluated in 14 studies including 10 randomised controlled clinical trials with 8776 subjects (from 2 months of age) who received at least one dose of Bexsero. Among Bexsero recipients, 5849 were infants and children (less than 2 years of age), 250 were children (2 to 10 years of age) and 2677 were adolescents and adults. Of the subjects who received primary infant series of Bexsero, 3285 received a booster dose in the second year of life.

Updated on 02 December 2013

Reasons for updating

  • New PIL for new product

Updated on 02 December 2013

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