Sanofi Pasteur MSD Limited

Change to section 6.5 – Addition of 20 and 50 pack sizes for prefilled syringe with 2 separate needles presentation.

Change to section 8 – Addition of new license numbers for new 20 and 50 pack sizes for prefilled syringe with 2 separate needles presentation.

Change to section 10 – Date of revision updated.

·        Section 1 - update to name

·        Section 2 - words updated for clarification

·        Section 3 - updated to include description of pharmaceutical form

·        Section 4.2 Primary vaccination - the need of the 4^th dose at 12 months has been reinforced, when the compressed administration schedule 0, 1, 2 and 12 months is used.

·        Section 4.2 Immunocompromised vaccinees, Revaccination of non-responders and Special dosage recommendation for known of presumed exposure to hepatitis B virus - the recommendations for serologic testing, and administration of additional doses if needed have been strengthened.

·        Section 4.2 Method of administration - updated to ensure vaccine not injected intravascularly and reference to see section 6.6 for instructions for preparation.

·         Section 4.5 – inclusion of a sentence regarding concomitant administration

·         Section 4.7 – wording change for clarification.

·         Section 5.1 – additional information provided on clinical trials and booster doses.

·         Section 6.2 – wording change for clarification

·         Section 6.6 – inclusion of additional sentence   

        with regards to disposal of waste.

·         Section 10 – update to date of revision of the text