PEDIARIX (diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis b- recombinant and inactivated poliovirus vaccine combined injection, suspension

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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 (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) - UNII:QSN5XO8ZSU), BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: 8C367IY4EY) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:8C367IY4EY), BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: I05O535NV6) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:I05O535NV6), HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN (UNII: 9GCJ1L5D1P) (HEPATITIS B VIRUS SUBTYPE ADW2 HBSAG SURFACE PROTEIN ANTIGEN - UNII:9GCJ1L5D1P), 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)

から入手可能:

GlaxoSmithKline Biologicals SA

INN（国際名）:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN - UNII:IRH51QN26H)

構図:

CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 25 [iU] in 0.5 mL

投与経路:

INTRAMUSCULAR

適応症:

PEDIARIX is indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the seventh birthday). A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis antigen-, hepatitis B-, or poliovirus-containing vaccine or any component of this vaccine, including yeast, neomycin, and polymyxin B, is a contraindication to administration of PEDIARIX [see Description (11)] . Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration 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 PEDIARIX. Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy, is a contraindication to administration of any pertussis-containing vaccine, including PEDIARIX. PEDIARIX should not be administered to individuals with such conditions until the neurologic status is clarified and stabilized. Safety and effectiveness of PEDIARIX were established in the age group 6 weeks through 6 months on the basis of clinical studies [see Adverse Reactions (6.1), Clinical Studies (14.1, 14.2)] . Safety and effectiveness of PEDIARIX in the age group 7 months through 6 years are supported by evidence in infants aged 6 weeks through 6 months. Safety and effectiveness of PEDIARIX in infants younger than 6 weeks and children aged 7 to 16 years have not been evaluated.

製品概要:

PEDIARIX is available in 0.5-mL single-dose, disposable, prefilled TIP-LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. NDC 58160-811-43 Syringe in Package of 10: NDC 58160-811-52. Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

認証ステータス:

Biologic Licensing Application

製品の特徴

PEDIARIX- DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED,
HEPATITIS B (RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE
COMBINED INJECTION, SUSPENSION
GLAXOSMITHKLINE BIOLOGICALS SA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PEDIARIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PEDIARIX.
PEDIARIX [DIPHTHERIA AND TETANUS TOXOIDS AND ACELLULAR PERTUSSIS
ADSORBED, HEPATITIS B
(RECOMBINANT) AND INACTIVATED POLIOVIRUS VACCINE], SUSPENSION FOR
INTRAMUSCULAR INJECTION
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Warnings and Precautions, Latex (5.3) - Removed
4/2023
INDICATIONS AND USAGE
PEDIARIX is a vaccine indicated for active immunization against
diphtheria, tetanus, pertussis, infection
caused by all known subtypes of hepatitis B virus, and poliomyelitis.
PEDIARIX is approved for use as a 3-
dose series in infants born of hepatitis B surface antigen
(HBsAg)-negative mothers. PEDIARIX may be
given as early as 6 weeks of age through 6 years of age (prior to the
seventh birthday). (1)
DOSAGE AND ADMINISTRATION
Three doses (0.5-mL each) by intramuscular injection at 2, 4, and 6
months of age. (2.2)
DOSAGE FORMS AND STRENGTHS
Single-dose, prefilled syringes containing a 0.5-mL suspension for
injection. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Common solicited adverse reactions following any dose (≥25%)
included local injection site reactions
(pain, redness, and swelling), fever (≥100.4°F), drowsiness,
irritability/fussiness, and loss of appetite. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLAXOSMITHKLINE AT
1-888-825-5249 OR
VAERS AT 1-800-822-7967 OR WWW.VAERS.HHS.GOV.
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
any diphtheria toxoid-, tetanus
toxoid-, pertussis-, hepatitis B-, or poliovirus-containing vaccine,
or to any component of PEDIARIX.
(4.1)
Encephalopathy within 7 days of administration of a previous
pert