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GlaxoSmithKline (Ireland) Ltd

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 495 5000
Fax: +353 1 4955225
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5225
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC Bexsero Meningococcal Group B vaccine suspension for injection in pre-filled syringe

When a pharmaceutical company changes an SPC or PIL, 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 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06-Jul-2017
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 22/02/2017 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08-Feb-2017
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 21/02/2017 and displayed until 22/02/2017
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   08-Feb-2017
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 11/10/2016 and displayed until 21/02/2017
Reasons for adding or 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
Date of revision of text on the SPC:   16-Sep-2016
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 09/12/2015 and displayed until 11/10/2016
Reasons for adding or 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
Date of revision of text on the SPC:   19-Nov-2015
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 08/10/2015 and displayed until 09/12/2015
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
  • Change to MA holder contact details
Date of revision of text on the SPC:   24-Sep-2015
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 17/08/2015 and displayed until 08/10/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   26-Jun-2015
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 06/02/2015 and displayed until 17/08/2015
Reasons for adding or 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
Date of revision of text on the SPC:   22-Jan-2015
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 01/10/2014 and displayed until 06/02/2015
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   26-Jun-2014
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 09/06/2014 and displayed until 01/10/2014
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-May-2014
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 02/12/2013 and displayed until 09/06/2014
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

None provided

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