Vaccine Information: Shingrix (Page 5 of 5)

16.2 Storage after Reconstitution

Administer immediately or store refrigerated between 2° and 8°C (36° and 46°F) for up to 6 hours prior to use.
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.
Provide the Vaccine Information Statements, which are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

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

©2021 GSK group of companies or its licensor.

SHX:6PI

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

For 50 Years of Age and Older and For 18 Years of Age and Older who are Immunocompromised and at Increased Risk of Herpes Zoster

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

SHINGRIX

Antigen and Adjuvant Made in Belgium

©2021 GSK group of companies or its licensor.

DFT-02815-5637442 Rev. 7/21
Shingrix 1 count carton
(click image for full-size original)

One Count Adjuvant Vial Label

NDC 58160-829-01

496837 Rev. 2/19
Adjuvant Vial Label
(click image for full-size original)

One Count Antigen Vial Label

NDC 58160-828-01

496835 Rev. 2/19
Antigen Vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 58160-823-11

SHINGRIX

Zoster Vaccine Recombinant, Adjuvanted

Rx only

For 50 Years of Age and Older and For 18 Years of Age and Older who are Immunocompromised and at Increased Risk of Herpes Zoster

Contents (10 doses of SHINGRIX):

10 Vials containing Lyophilized gE Antigen Component

10 Vials containing Adjuvant Suspension Component

After reconstitution, a single dose of SHINGRIX is 0.5 mL

SHINGRIX

Antigen and Adjuvant Made in Belgium

©2021 GSK group of companies or its licensor.

DFT-02815-5637444 Rev. 7/21
Shingrix 10 count carton
(click image for full-size original)

10 Count Adjuvant Vial Label

NDC 58160-829-03

490658 Rev. 10/17
Shingrix 10 count adjuvant vial label
(click image for full-size original)

10 Count Antigen Vial Label

NDC 58160-828-03

490735 Rev. 10/17
Shingrix 10 count antigen vial label
(click image for full-size original)
SHINGRIX zoster vaccine recombinant, adjuvanted kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-819
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-819-12 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 VIAL 1 mL
Part 2 2 VIAL 1 mL
Part 1 of 2
SHINGRIX ge recombinant varicella zoster virus (vzv) glycoprotein e injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:58160-828
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN) RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
DIBASIC POTASSIUM PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-828-01 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Part 2 of 2
AS01B as01b suspension
Product Information
Item Code (Source) NDC:58160-829
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MONOPHOSPHORYL LIPID A
QS-21
DIOLEOYLPHOSPHATIDYLCHOLINE, DL-
CHOLESTEROL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-829-01 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
SHINGRIX zoster vaccine recombinant, adjuvanted kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-823
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-823-11 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 20 VIAL 10 mL
Part 2 20 VIAL 10 mL
Part 1 of 2
SHINGRIX ge recombinant varicella zoster virus (vzv) glycoprotein e injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:58160-828
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN (RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN) RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E ANTIGEN 50 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
POLYSORBATE 80
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
DIBASIC POTASSIUM PHOSPHATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-828-03 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Part 2 of 2
AS01B as01b suspension
Product Information
Item Code (Source) NDC:58160-829
Route of Administration INTRAMUSCULAR DEA Schedule
Inactive Ingredients
Ingredient Name Strength
MONOPHOSPHORYL LIPID A
QS-21
DIOLEOYLPHOSPHATIDYLCHOLINE, DL-
CHOLESTEROL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
POTASSIUM PHOSPHATE, MONOBASIC
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-829-03 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125614 10/20/2017
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 07/2021 GlaxoSmithKline Biologicals SA

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