Vaccine Information: PENTACEL (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

The vial stoppers for the DTaP-IPV and ActHIB vaccine components of Pentacel are not made with natural rubber latex.

5 Dose Package (NDC No. 49281-510-05) containing 5 vials of DTaP-IPV component (NDC No. 49281-560-05) to be used to reconstitute 5 single-dose vials of lyophilized ActHIB vaccine component (NDC No. 49281-548-58).

16.2 Storage and Handling

Pentacel should be stored at 2° to 8°C (35° to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Pentacel should be used immediately after reconstitution.

17 PATIENT COUNSELING INFORMATION

Before administration of Pentacel, health-care personnel should inform the parent or guardian of the benefits and risks of the vaccine and the importance of completing the immunization series unless a contraindication to further immunization exists.

The health-care provider should inform the parent or guardian about the potential for adverse reactions that have been temporally associated with Pentacel or other vaccines containing similar ingredients. The health-care provider should provide the Vaccine Information Statements (VIS) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. The parent or guardian should be instructed to report adverse reactions to their health-care provider.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada

and Sanofi Pasteur SA
Marcy L’Etoile France

Distributed by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

Pentacel® is a registered trademark of Sanofi Pasteur, its affiliates and subsidiaries.

R9-0221 USA

PRINCIPAL DISPLAY PANEL — Kit Carton

DTaP-IPV/Hib

NDC 49281-510-05

Diphtheria and Tetanus Toxoids
and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and
Haemophilus b Conjugate
(Tetanus Toxoid Conjugate) Vaccine

5 single-dose vials
0.5 mL

5 single-dose vials

Rx only

Pentacel®

For children 6 weeks through4 years of age (prior to 5th birthday)

SANOFI PASTEUR

Principal Display Panel -- Kit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label — 560

NDC 49281-560-05
0.5 mL

DTaP-IPV Component
of Pentacel®

Not to be used alone.
For use only to reconstitute
ActHIB®.Rx only

Sanofi Pasteur Limited

Principal Display Panel -- 0.5 mL Vial Label -- 560
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label — 548

NDC 49281-548-58
Hib

Single dose
6 wks-4 yrs

Haemophilus b Conjugate Vaccine
(Tetanus Toxoid Conjugate)
ActHIB® Component of Pentacel®
Sanofi Pasteur SA
Rx only

Pentacel® NDC 49281-510-05

L

7588

Principal Display Panel -- 0.5 mL Vial Label -- 548
(click image for full-size original)
PENTACEL diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine kit
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-510
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-510-05 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 5 VIAL, SINGLE-DOSE 2.5 mL
Part 2 5 VIAL, SINGLE-DOSE 2.5 mL
Part 1 of 2
DTAP-IPV diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus injection, suspension
Product Information
Item Code (Source) NDC:49281-560
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) 40 [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) 8 [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) 32 [D’ag’U] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM PHOSPHATE 1.5 mg in 0.5 mL
PHENOXYETHANOL 3.3 mg in 0.5 mL
POLYSORBATE 80 10 in 0.5 mL
GLUTARAL 50 ng in 0.5 mL
FORMALDEHYDE 2 ug in 0.5 mL
ALBUMIN BOVINE 50 ng in 0.5 mL
NEOMYCIN 0.000004 ug in 0.5 mL
POLYMYXIN B SULFATE 0.000004 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE (YELLOW TINGE)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-560-05 0.5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125145 06/20/2008
Part 2 of 2
ACTHIB haemophilus b conjugate vaccine (tetanus toxoid conjugate) injection
Product Information
Item Code (Source) NDC:49281-548
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B STRAIN 1482 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE (YELLOW TINGE)) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-548-58 0.5 mL in 1 VIAL, SINGLE-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125145 06/20/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125145 06/20/2008
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE

Revised: 02/2021 Sanofi Pasteur Inc.

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