Vaccine Information: VAXELIS (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 Syringe Package

NDC 63361-243-15

DTaP-IPV-Hib-HepB
10 single-dose prefilled syringes

Diphtheria and Tetanus Toxoids
and Acellular Pertussis,
Inactivated Poliovirus,
Haemophilus b Conjugate and Hepatitis B Vaccine

Vaxelis™

Rx only

For children 6 weeks through 4 years of age

MERCK

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 10 Syringe Package
(click image for full-size original)
VAXELIS diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:63361-243
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN) BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug in 0.5 mL
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 29 [D'ag'U] in 0.5 mL
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 7 [D'ag'U] in 0.5 mL
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 26 [D'ag'U] in 0.5 mL
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug in 0.5 mL
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 3 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80 28 ug in 0.5 mL
FORMALDEHYDE 14 ug in 0.5 mL
GLUTARAL 50 ng in 0.5 mL
ALBUMIN BOVINE 50 ng in 0.5 mL
NEOMYCIN 5 ng in 0.5 mL
POLYMYXIN B SULFATE 25 ng in 0.5 mL
STREPTOMYCIN 200 ng in 0.5 mL
AMMONIUM THIOCYANATE 0.125 ug in 0.5 mL
GI-6207 0.1 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63361-243-10 10 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (63361-243-58)
1 NDC:63361-243-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (63361-243-10)
2 NDC:63361-243-15 10 SYRINGE in 1 PACKAGE contains a SYRINGE (63361-243-88)
2 NDC:63361-243-88 0.5 mL in 1 SYRINGE This package is contained within the PACKAGE (63361-243-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125563 12/21/2018
Labeler — MSP Vaccine Company (079352454)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE (63361-243)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur SA 578763542 MANUFACTURE (63361-243)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 002387926 MANUFACTURE (63361-243)

Revised: 10/2020 MSP Vaccine Company

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