PENTACEL (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate- tetanus toxoid conjugate vaccine kit

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8C367IY4EY), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (UNII: 63GD90PP8X) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN - UNII:63GD90PP8X), BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (UNII: 1O0600285A) (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN - UNII:1O0600285A), POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 0LVY784C09) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:0LVY784C09), POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 23JE9KDF4R) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:23JE9KDF4R), POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 459ROM8M9M) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:459ROM8M9M)

Dostępny od:

Sanofi Pasteur Inc.

Wskazania:

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 progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine including Pentacel. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. The safety and effectiveness of Pentacel was established in the age group 6 weeks through 18 months on the basis of clinical studies [see Clinical Trials Experience (6.1) and Clinical Studies (14) ]. The safety and effectiveness of Pentacel in the age group 19 months through 4 years is supported by evidence in children 6 weeks through 18 months. The safety and effectiveness of Pentacel in infants less than 6 weeks of age and in children 5 to 16 years of age have not been established.

Podsumowanie produktu:

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. 49281-511-05) containing 5 vials of DTaP-IPV (Vial 1 of 2) component (NDC No. 49281-561-01) to be used to reconstitute 5 single-dose vials of lyophilized ActHIB (Vial 2 of 2) vaccine component (NDC No. 49281-544-58). 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.

Status autoryzacji:

Biologic Licensing Application

Charakterystyka produktu

PENTACEL- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED,
INACTIVATED POLIOVIRUS AND HAEMOPHILUS B CONJUGATE (TETANUS TOXOID
CONJUGATE) VACCINE
SANOFI PASTEUR INC.
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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
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 neurologic disorder until a treatment regimen has been
established and the condition has
stabilized.