Quadracel diph,pertus(acel),tet,polio/PF IM Vial 10X0.5 By Sanofi

Rx Item-Quadracel diph,pertus(acel),tet,polio/PF IM Vial 10X0.5 By Sanofi

Part Number: RX743390

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Feature: Drug Class: Drug Class: 80120000 Vaccines

Feature: OMP Family:

Feature: Temparature Zone: 30 Refrige./DoNot Freez

Feature: Unit Dose Indicator: NO

Feature 5 Item Size: 5X0.5ML

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Description
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Feature 8

Item No. RX743390 743390 Details

NDC #: 49281-0564-10 49281056410 49281-564-10 4928156410

UPC #: 3-49281-56410-9 349281564109 349281-564109

ABC #: WHL 10265822

0050001857 SANOFI PASTEUR

Supplier Material #: 056410

Corporate Status: AC Active Only Physician,Pharmacy Or Licensed Facility Can Order This RX

Clinical Information

Gen. Code and Des.

83062 diph,pertus(acel),tet,polio/PF INTRAMUSC VIAL 15-48-5-62

GCN and Des.

51903 diph,pertus(acel),tet,polio/PF INTRAMUSC VIAL 15-48-5-62

Strength

Dose Form

VIAL (ML)

Product Category

RX Pharmaceuticals

Fine Line Class

850085008510 All Rx Products

DEA Class

OMP Family

AHFS Class

80120000 VACCINES

Active Ingredients

7715 diphtheria,pertussis (acell),tetanus,polio vaccine

9870 preservative free

Inactive Ingredients

2551 polysorbates 9005645

9283 beef derived (bovine)

These highlights do not include all the information needed to use Quadracel safely and effectively. See full prescribing information for Quadracel.

Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Suspension for Intramuscular Injection

Initial U.S. Approval: 2015

RECENT MAJOR CHANGES

Indications and Usage (1) 7/2022

Dosage and Administration (2) 1/2022

Warnings and Precautions (5.6) 7/2022

INDICATIONS AND USAGE

Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel, DAPTACEL and/or VAXELIS. (1)

DOSAGE AND ADMINISTRATION

A single intramuscular injection of 0.5 mL. (2)

DOSAGE FORMS AND STRENGTHS

Quadracel is a suspension for injection available in 0.5 mL single-dose vials and prefilled syringes. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel, or following any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine or inactivated poliovirus vaccine. (4.1) (11)

Encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause. (4.2)

Progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized. (4.3)

WARNINGS AND PRECAUTIONS

Carefully consider benefits and risks before administering Quadracel to persons with a history of:

fever =40.5°C (=105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting =3 hours within 48 hours after a previous pertussis-containing vaccine. (5.2)

seizures within 3 days after a previous pertussis-containing vaccine. (5.2)

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including Quadracel, should be based on careful consideration of the potential benefits and possible risks. (5.3)

ADVERSE REACTIONS

In a clinical study, the most common solicited injection site reactions were pain (>75%), increase in arm circumference (>65%), erythema (>55%), and swelling (>40%). Common solicited systemic reactions were myalgia (>50%), malaise (>35%), and headache (>15%). (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 7/2022

Rx Item-Quadracel diph,pertus(acel),tet,polio/PF IM Vial 10X0.5 By Sanofi

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