Sanofi Pasteur MSD Limited

• In section 4.8, Uveitis has been added as an undesirable effect under a new category of Eye Disorder
• In section 4.4, 'vial stopper' has been deleted and replaced with 'the syringe plunger stopper and tip cap' in the latex warning paragraph
• In section 9, the date of the last renewal has been updated to 27/4/2011
• In section 10, the date of revision text is now 08/2011

• In section 4.4, latex warning has been added
• In section 4.9, No case of overdose reported has been changed to there have been reports of administration of higher than recommended dose"
• In section 6.6, inserted the following text “The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered. Before use, the syringe should be well shaken”
• In section 10, the date has changed from December 2007 to 03/2011

   

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