Section 4,2  - Posology and method of administration

-       Clarity on primary immunisation schedule

Section 4.3 – Contraindications

-       Administration of Fendrix should be postponed in subjects suffering from Action Severe febrile illness

Section 4.5 – Interactions

-       Interactions with immunosuppressive treatment

Section 4.6 – Pregnancy

-       Clarity on ‘no data’ available in pregnancy

Section 4.8 – addition of reporting adverse events info

Section 4.9 – overdose

-       Amendment to text that limited data is available on overdose

Section 10 - change to date of revision of text

Section 4.4 - Special warnings and precautions for use

4.1       Therapeutic indications

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).

4.2       Posology and method of administration

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.

4.6       Fertility, pregnancy and lactation

Added ‘Fertility’ to the heading and added the subheading ‘Fertility’ with the statement that:

No fertility data are available

4.7       Effects on the ability to drive and use machines

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.

4.8       Undesirable effects

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

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’.