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 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 of the text has been revised from December 2007 to 03/2011

Section 10 - changed date of revision to March 2007

·       Section 1 - update to name

·       Section 2 - words updated for clarification

·       Section 3 - updated to include description of pharmaceutical form

·       Section 4.2 Booster – recommendations on a booster dose have been amended.

·       Section 4.2 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 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