SHINGRIX Australian Product Information which has been updated as of the 1st of November

SHINGRIX Australian Product Information has been updated as of the 1st of November. These changes will further support the quality use and safe administration of SHINGRIX.

The changes include:

• The addition of a recommended needle gauge for reconstitution (21G-25G)

• Specific instruction to administer 0.5mL of the reconstituted vaccine.

The inclusions in section 4.2 of the Australian PI are below:

Instructions for Use and Handling: The powder and suspension should be inspected visually for any particulate matter and/or variation to the expected appearance (i.e. white powder and opalescent, colourless to pale brownish liquid). If either is observed, do not reconstitute the vaccine¹.

How to prepare SHINGRIX:

SHINGRIX must be reconstituted prior to administration¹.

1. Withdraw the entire contents of the vial containing the suspension into a syringe with a suitable needle (21G to 25G)¹.

2. Add the entire contents of the syringe into the vial containing the powder¹.

3. Shake gently until the powder is completely dissolved¹.

The reconstituted vaccine is an opalescent, colourless to pale brownish liquid¹.

The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine¹.

After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2°C – 8°C). If not used within 6 hours it should be discarded¹.

Before administration:

1. Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe¹.

2. Change the needle so that you are using a new needle to administer the vaccine¹.

3. Administer 0.5mL intramuscularly¹.

AUSTRALIAN PRODUCT INFORMATION SHINGRIX (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN) POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION (ACCESSED ON 21 NOVEMBER 2024).