dule. Non-inferiority of the 0- and 6-month schedule compared with the 0- and 2-month schedule based on anti-gE ELISA GMCs 1 month after the second dose was demonstrated.
14.5 Concomitant Administration with Influenza Vaccine
In an open-label clinical study, subjects 50 years and older received 1 dose each of SHINGRIX and Fluarix Quadrivalent (QIV) at Month 0 and 1 dose of Shingrix at Month 2 (n = 413), or 1 dose of QIV at Month 0 and 1 dose of Shingrix at Months 2 and 4 (n = 415). There was no evidence for interference in the immune response to any of the antigens contained in SHINGRIX or the coadministered vaccine.
16 HOW SUPPLIED/STORAGE AND HANDLING
SHINGRIX is supplied as 2 components: A single-dose vial of lyophilized gE antigen component (brown cap) and a single-dose vial of adjuvant suspension component (blue-green cap) (packaged without syringes or needles).
An outer package of 1 dose (NDC 58160-819-12) contains:
•Adjuvant Suspension Component (Vial 1 of 2) NDC 58160-829-01
•Lyophilized gE Antigen Component (Vial 2 of 2) NDC 58160-828-01
An outer package of 10 doses (NDC 58160-823-11) contains:
•Adjuvant Suspension Component (10 vials) NDC 58160-829-03
•Lyophilized gE Antigen Component (10 vials) NDC 58160-828-03
16.1 Storage before Reconstitution
Adjuvant suspension component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the adjuvant suspension has been frozen.
Lyophilized gE antigen component vials: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light. Do not freeze. Discard if the antigen component has been frozen.
16.2 Storage after Reconstitution
After reconstitution, administer SHINGRIX immediately or store refrigerated between 2° and 8°C (36° and 46°F) and use within 6 hours. Discard reconstituted vaccine if not used within 6 hours. Do not freeze. Discard if the vaccine has been frozen.
17 PATIENT COUNSELING INFORMATION
•Inform patients of the potential benefits and risks of immunization with SHINGRIX and of the importance of completing the 2-dose immunization series according to the schedule.
•Inform patients about the potential for adverse reactions that have been temporally associated with administration of SHINGRIX.
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SPL UNCLASSIFIED SECTION
Trademarks are owned by or licensed to the GSK group of companies.
Manufactured by GlaxoSmithKline Biologicals
Rixensart, Belgium, U.S. License 1617, and
Distributed by GlaxoSmithKline
Research Triangle Park, NC 27709
©2017 GSK group of companies or its licensor.
SHX:1PI
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 58160-819-12
SHINGRIX
Zoster Vaccine Recombinant, Adjuvanted
Rx only
NOTICE: One vial of lyophilized powder and one vial of liquid suspension MUST BE COMBINED BEFORE USE
Contents (a single dose of SHINGRIX):
1 Vial containing Lyophilized gE Antigen Component
1 Vial containing Adjuvant Suspension Component
After reconstitution, a single dose of SHINGRIX is 0.5 mL
For 50 Years of Age and Older
Trademark is owned by or licensed to the GSK group of companies.
Antigen and Adjuvant Made in Belgium
©2017 GSK group of companies or its licensor.
490503 Rev. 10/17
Shingrix 1 count carton
PRINCIPAL DISPLAY PANEL
One Count Adjuvant Vial Label
NDC 58160-829 |
