Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
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
Sanofi Pasteur Inc.
INTRAMUSCULAR
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
The vial stopper, syringe plunger stopper, and syringe tip cap are not made with natural rubber latex. Single-dose vial (NDC No. 49281-564-58) in packages of 10 vials (NDC No. 49281-564-10). Single-dose, prefilled syringe, without needle, (NDC No. 49281-564-88). Supplied as package of 10 (NDC No. 49281-564-15). 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.
Biologic Licensing Application
QUADRACEL- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED AND INACTIVATED POLIOVIRUS VACCINE INJECTION, SUSPENSION SANOFI PASTEUR INC. ---------- 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 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: - - 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 possi Przeczytaj cały dokument