Vaccine Information: Priorix (Page 3 of 3)

14.2 Concomitant Administration

Concomitant Administration with HAVRIX, VARIVAX, and PREVNAR 13

The concomitant use of PRIORIX or M-M-R II with HAVRIX and VARIVAX was evaluated in Study 1 (NCT01702428) in children 12 through 15 months of age. All participants received PRIORIX or M-M-R II administered concomitantly with HAVRIX and VARIVAX. Children enrolled in the U.S. also received PREVNAR 13 concomitantly.

In subsets of participants in Study 1, immune responses to the antigens contained in HAVRIX, VARIVAX, and PREVNAR 13 were measured in sera obtained 42 days after concomitant administration of PRIORIX or M-M-R II. There was no evidence that PRIORIX interfered with the antibody responses to these vaccines relative to the antibody responses when M-M-R II was concomitantly administered.

Concomitant Administration with KINRIX and VARIVAX

The concomitant use of PRIORIX or M-M-R II with KINRIX and VARIVAX was evaluated in Study 3 (NCT01621802) in children 4 through 6 years of age. A subset of participants received PRIORIX or M-M-R II administered concomitantly with KINRIX and VARIVAX.

Immune responses to the antigens contained in KINRIX and VARIVAX were measured in sera obtained 42 days after concomitant administration of PRIORIX or M‑M‑R II. There was no evidence that PRIORIX interfered with the antibody responses to these vaccines relative to the antibody responses when M-M-R II was concomitantly administered.

15 REFERENCES

1.
Centers for Disease Control and Prevention. Measles, Mumps, and Rubella- Vaccine Use and Strategies for Elimination of Measles, Rubella, and Congenital Rubella Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2013; 62(4);1-34.
2.
Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801, November 1993.
3.
Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta Paediatr Scand. 66: 367-372, May 1977.
4.
Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II. Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666, 1982.
5.
Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I. Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
6.
Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 97: 465-467, 1980.
7.
Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)

16 HOW SUPPLIED/STORAGE AND HANDLING

PRIORIX is supplied in a box (NDC 58160-824-15) containing:

10 single-dose vials of lyophilized antigen component: NDC 58160-831-03
10 single-dose prefilled ungraduated syringes of sterile water diluent (packaged without needles): NDC 58160-833-02

After reconstitution, each vial contains one dose (approximately 0.5 mL) of PRIORIX.

16.1 Storage before Reconstitution

Vials of lyophilized antigen component: Store refrigerated between 36° and 46°F (2° and 8°C). Protect vials from light.

Prefilled ungraduated syringes of sterile water diluent: Store refrigerated between 36° and 46°F (2° and 8°C) or at controlled room temperature up to 77°F (25°C).

Do not freeze lyophilized antigen component or sterile water diluent.

16.2 Storage after Reconstitution

Administer PRIORIX immediately after reconstitution. If not used immediately, store refrigerated between 36° and 46°F (2° and 8°C) and administer within 8 hours. Discard reconstituted vaccine if not used within 8 hours.

Do not freeze. Discard if the reconstituted vaccine has been frozen.

17 PATIENT COUNSELING INFORMATION

Inform vaccine recipients, parents, or guardians of the potential benefits and risks of vaccination with PRIORIX.
Question individuals of reproductive potential regarding the possibility of pregnancy prior to administration of PRIORIX. Instruct these individuals to avoid pregnancy for 1 month following vaccination [see Contraindications (4.3), Use in Specific Populations (8.1)].
Inform vaccine recipients, parents, or guardians about the potential for adverse reactions that have been observed following administration of PRIORIX.
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).

PRIORIX, HAVRIX, and KINRIX are trademarks owned by or licensed to the GSK group of companies.

The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, U.S. License 1617

Distributed by GlaxoSmithKline , Research Triangle Park, NC 27709

©2022 GSK group of companies or its licensor.

PRX:1PI

NDC 58160-824-15

PRIORIX

Measles, Mumps, and Rubella Vaccine, Live

MMR

Rx only

NOTICE: Reconstitue Lyophilized Antigen Component, Live with Sterile Water Diluent Component before use

For 12 Months of Age and Older

Contents: 10 Doses of PRIORIX

10 single-dose vials of Lyophilized Antigen Component, Live
10 single-dose prefilled ungraduated syringes of Sterile Water Diluent Component
After reconstitution, a single dose of PRIORIX is approximately 0.5 mL

For subcutaneous injection only.

PRIORIX

©2022 the GSK group of companies or its licensor.

Rev. 05/22

507390

Priorix 10 dose carton
(click image for full-size original)
PRIORIX measels, mumps, and rubella vaccine, live kit
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-824
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-824-15 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 10 VIAL 5 mL
Part 2 10 SYRINGE 5 mL
Part 1 of 2
PRIORIX measels, mumps, and rubella vaccine, live injection, powder, lyophilized, for suspension
Product Information
Item Code (Source) NDC:58160-831
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED (MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED) MEASLES VIRUS STRAIN SCHWARTZ ATTENUATED 2512 [CCID_50] in 0.5 mL
MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK (MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK) MUMPS VIRUS STRAIN RIT-4385 ATTENUATED CHICK 15842 [CCID_50] in 0.5 mL
RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN (RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN) RUBELLA VIRUS STRAIN WISTAR RA 27/3 LIVE ANTIGEN 1995 [CCID_50] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SORBITOL
MANNITOL
AMINO ACIDS
Product Characteristics
Color WHITE (whitish to slightly pink) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-831-03 0.5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125748 06/03/2022
Part 2 of 2
DILUENT water injection, solution
Product Information
Item Code (Source) NDC:58160-833
Route of Administration SUBCUTANEOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-833-02 0.5 mL in 1 SYRINGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125748 06/03/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125748 06/03/2022
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 06/2022 GlaxoSmithKline Biologicals SA

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