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.
Minor change to bring ‘in adolescents and adults from the age of 15 years onwards’ from then end of the paragraph to the beginning, to read:
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Minor changes to formatting of headings (i.e. use of underlining and italics)
Added subheading and statement regarding the use of Fendrix in the ‘Paediatric population’, i.e.:
Paediatric population
The safety and efficacy of Fendrix in children aged less than 15 years have not been established.
Added ‘Fertility’ to the heading and added the subheading ‘Fertility’ with the statement that:
No fertility data are available
Revised statement regarding ability to drive by removing reference to ‘minor’ influence, to read:
Fendrix has moderate influence on the ability to drive and use machine.
Added the bullet point subheading ‘Clinical trials’
Deleted the following:
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Moved the statement regarding allergic reactions from the listing of side effects due to Fendrix and placed it under the subheading ‘Experience with hepatitis B vaccine’, to read: Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines. 6.3 Shelf life Removed hyphenation from the heading to read ‘Shelf life’ 6.6 Special precautions for disposal and other handling Changed the description from ‘vaccine’ to ‘product’ in the statement regarding disposal
Moved the statement regarding allergic reactions from the listing of side effects due to Fendrix and placed it under the subheading ‘Experience with hepatitis B vaccine’, to read:
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have also been reported very rarely with hepatitis B vaccines.
6.3 Shelf life Removed hyphenation from the heading to read ‘Shelf life’ 6.6 Special precautions for disposal and other handling Changed the description from ‘vaccine’ to ‘product’ in the statement regarding disposal
Removed hyphenation from the heading to read ‘Shelf life’
Changed the description from ‘vaccine’ to ‘product’ in the statement regarding disposal
SPC UPDATES
Minor editorial changes are not described Section 4.2 Posology and method of administration Replaced word ‘dosage’ with ‘posology’ Section 4.4 Special warnings and precautions for use The following paragraph has been moved from the end to the beginning of the section: Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Section 4.8 Undesirable effects Deleted the statement ‘Fendrix was generally well tolerated’ and updated the terms ‘adverse events’ and ‘undesirable events’ to ‘adverse reactions’.
Minor editorial changes are not described
Section 4.2 Posology and method of administration
Replaced word ‘dosage’ with ‘posology’
Section 4.4 Special warnings and precautions for use
The following paragraph has been moved from the end to the beginning of the section:
Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Section 4.8 Undesirable effects
Deleted the statement ‘Fendrix was generally well tolerated’ and updated the terms ‘adverse events’ and ‘undesirable events’ to ‘adverse reactions’.
Section 4.4: Removed warning regarding the risk of sensitisation due to residual thiomersal preservative as approval was granted to no longer use thiomersal in the manufacturing process.
Section 4.8: Rearrangement of side effects in line with approved QRD version 7.2: No additional side effects or changes to frequency of side effects.