BOOSTRIX- tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed 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:

CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: K3W1N8YP13) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:K3W1N8YP13), CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (UNII: IRH51QN26H) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) - UNII:IRH51QN26H), BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (UNII: QSN5XO8ZSU) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE IN

から入手可能:

A-S Medication Solutions

投与経路:

INTRAMUSCULAR

適応症:

BOOSTRIX is indicated for:     •    active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,     •    immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. Do not administer BOOSTRIX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of BOOSTRIX or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine [see Description (11)] . Encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to BOOSTRIX during pregnancy. Healthcare providers are encouraged to register women by calling

製品概要:

Product: 50090-1831 NDC: 50090-1831-9 .5 mL in a VIAL / 10 in a POUCH

認証ステータス:

Biologic Licensing Application

製品の特徴

BOOSTRIX- TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR
PERTUSSIS
VACCINE, ADSORBED SUSPENSION
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BOOSTRIX SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BOOSTRIX.
BOOSTRIX (TETANUS TOXOID, REDUCED DIPHTHERIA TOXOID AND ACELLULAR
PERTUSSIS VACCINE,
ADSORBED) INJECTABLE SUSPENSION, FOR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2005
RECENT MAJOR CHANGES
Indications and Usage (1)
10/2022
Dosage and Administration (2.2)
10/2022
INDICATIONS AND USAGE
BOOSTRIX is a vaccine indicated for:
•
•
DOSAGE AND ADMINISTRATION
FOR INTRAMUSCULAR USE ONLY.
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Single-dose vials and single-dose prefilled syringes containing a
0.5-mL suspension for injection. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
active booster immunization against tetanus, diphtheria, and pertussis
in individuals aged 10 years
and older, (1)
immunization during the third trimester of pregnancy to prevent
pertussis in infants younger than 2
months of age. (1)
Each dose of BOOSTRIX is administered as a 0.5-mL injection. (2.2)
An initial dose of BOOSTRIX is administered 5 years or more after the
last dose of the Diphtheria and
Tetanus Toxoids and Acellular Pertussis (DTaP) series or 5 years or
more after a dose of Tetanus and
Diphtheria Toxoids Adsorbed (Td). BOOSTRIX may be administered as an
additional dose 9 years or
more after the initial dose of Tetanus Toxoid, Reduced Diphtheria
Toxoid and Acellular Pertussis
Vaccine Adsorbed (Tdap). (2.2)
BOOSTRIX may be administered for tetanus prophylaxis for wound
management. For management of
a tetanus-prone wound, a dose of BOOSTRIX may be administered if at
least 5 years have elapsed
since previous receipt of a tetanus toxoid-containing vaccine. (2.2)
To provide protection against pertussis in infants younger than 2
months of age, administer
BOOSTRIX during the third trimester of pregnancy.