QUADRACEL- diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine injection, suspens

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H), CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13), BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (UNII: F4TN0IPY37) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) - UNII:F4TN0IPY37

Available from:

Sanofi Pasteur Inc.

INN (International Name):

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN - UNII:IRH51QN26H)

Composition:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL

Administration route:

INTRAMUSCULAR

Therapeutic indications:

Quadracel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis and poliomyelitis. A single dose of Quadracel is approved for use 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® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus and Haemophilus b conjugate (Tetanus Toxoid Conjugate) Vaccine], DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine). Severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel [see Description (11) ] or following any diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, or inactivated poliovi

Product summary:

The vial stopper for this product is not made with natural latex rubber. Quadracel is supplied in a single-dose vial (NDC No. 49281-562-58) in packages of 10 vials (NDC No. 49281-562-10). Quadracel 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.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

QUADRACEL- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED
AND INACTIVATED POLIOVIRUS VACCINE INJECTION, SUSPENSION
SANOFI PASTEUR INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
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
Suspension for injection, supplied in single dose (0.5 mL) vials. (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:
-
-
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
I