Country: Сједињене Америчке Државе
Језик: Енглески
Извор: 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.
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN - UNII:IRH51QN26H)
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL
Pentacel® is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to fifth birthday). A severe allergic reaction (eg, anaphylaxis) after a previous dose of Pentacel or any other diphtheria toxoid, tetanus toxoid, or pertussis-containing vaccine, inactivated poliovirus vaccine or H. influenzae type b vaccine, or any ingredient of this vaccine is a contraindication to administration of Pentacel. [See Description (11). ] Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including Pentacel. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progres
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). 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.
Biologic Licensing Application
PENTACEL- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE SANOFI PASTEUR INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PENTACEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PENTACEL. PENTACEL (DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS ADSORBED, INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID CONJUGATE) VACCINE SUSPENSION FOR INTRAMUSCULAR INJECTION INITIAL U.S. APPROVAL: 2008 RECENT MAJOR CHANGES Dosage and Administration (2.1) 7/2022 Warnings and Precautions (5.8) 7/2022 INDICATIONS AND USAGE Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to _Haemophilus influenzae_ type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5 birthday). (1) DOSAGE AND ADMINISTRATION The four dose immunization series consists of a 0.5 mL intramuscular injection, after reconstitution, administered at 2, 4, 6 and 15-18 months of age. (2.1) Pentacel consists of a liquid vaccine component (DTaP-IPV component) and a lyophilized vaccine component (ActHIB vaccine). Reconstitute the ActHIB vaccine component with the DTaP-IPV component immediately before administration. (2.2) DOSAGE FORMS AND STRENGTHS Suspension for injection (0.5 mL dose) supplied as a liquid vaccine component that is combined through reconstitution with a lyophilized vaccine component, both in single-dose vials. (3) CONTRAINDICATIONS Severe allergic reaction (eg, anaphylaxis) after a previous dose of Pentacel, any ingredient of Pentacel, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or _H. influenzae_ type b vaccine. (4.1) Encephalopathy within 7 days of a previous pertussis-containing vaccine with no other identifiable cause. (4.2) Progressive neu Прочитајте комплетан документ