Last Updated on eMC 29-09-2017 View medicine  | GlaxoSmithKline UK Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:18-09-2017

Legal Category:POM

Black Triangle (CHM): YES

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.

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:06-07-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8 - Addition of of ESL and injection site nodule

Reasons for adding or updating:

  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:08-02-2017

Legal Category:POM

Black Triangle (CHM): YES

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.

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:08-02-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

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

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:16-09-2016

Legal Category:POM

Black Triangle (CHM): YES

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

 

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:19-11-2015

Legal Category:POM

Black Triangle (CHM): YES

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

Reasons for adding or updating:

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

Date of revision of text on the SPC:24-09-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

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

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:12-06-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Section 4.8,  Data evaluated from a further study in 209  subjects.  Headache and arthralgia added in under 2 year olds section.

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:22-01-2015

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Additions are highlighted in yellow:

 

4.4     Special warnings and precautions for use

 

As with other vaccines, administration of Bexsero should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.

 

Do not inject intravascularly.

 

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

 

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.  

Bexsero is not expected to provide protection against all circulating meningococcal group B strains (see section 5.1).

 

 

Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture. If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.

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.

 

 

 

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:26-06-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In Section 4.2, further information about timing of the booster dose.

In Section 5.1, Table 5 updated with persistence of antibodies

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:01-05-2014

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Update 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.

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES