Rx Item-Boostrix 10X0.5 ML diphth,pertuss(acell),tet SDV -KEEP REFRIG- by Glaxo

Rx Item-Boostrix 10X0.5 ML Single Dose Vial -KEEP REFRIG- by Glaxo Smith Kline Vaccines , Clinical Information:
Generic Code And Description: 59079 Diphtheria Pertuss(Acell) Tetanus Vaccine Intramuscular Vial 2.5-8-5/.5
Strength: 2.5 Lf Unit-(2.5 Mcg-8 Mcg-8 Mcg)-5 Lf Unit/0.5 Ml
Dose Form: Vial (Ml)
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 80080000 Toxoids
Active Ingredients: 3626 Diphtheria Pertussis (Acellular) Tetanus Vaccine
Inactive Ingredients: 9283 Beef Derived (Bovine)
9865 Polysorbate 80 9005656 Drug Class: Drug Class: 80080000 Toxoids, OMP Family: , Temparature Zone: 30 Refrige./DoNot Freez, Unit Dose Indicator: NO, Item Size: 10X0.5ML, Brand Label Flag: BRAND , Storage Temperature Zone: 30 Refrige./DoNot Freez, Item Size Code: 10X0.5ML, Item Strength Code: , Item Abbreviation: Boostrix , Generic Form: Vial

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:

•
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)

DOSAGE AND ADMINISTRATION

For intramuscular use only.

•
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. (2.2)

DOSAGE FORMS AND STRENGTHS

Single-dose vials and single-dose prefilled syringes containing a 0.5-mL suspension for injection. (3)
CONTRAINDICATIONS

•
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or to any component of BOOSTRIX. (4.1)
•
Encephalopathy within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)

WARNINGS AND PRECAUTIONS

•
The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions. (5.2)
•
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. (5.3)
•
Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. (5.4)
•
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive BOOSTRIX unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)

ADVERSE REACTIONS

•
Common solicited adverse reactions (≥15%) in adolescents (aged 10 to 18 years) were pain, redness, and swelling at the injection site; increase in arm circumference of the injected arm; headache; fatigue; and gastrointestinal symptoms. (6.1)
•
Common solicited adverse reactions (≥15%) in adults (aged 19 to 64 years) were pain, redness, and swelling at the injection site; headache; fatigue; and gastrointestinal symptoms. (6.1)
•
The most common solicited adverse reaction (≥15%) in the elderly (aged 65 years and older) was pain at the injection site. (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.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 6/2023

Rx Item-Boostrix 10X0.5 ML Single Dose V
Item No. RX041689, 041689, NDC No.: 58160-0842-11, 58160-842-11, 5816084211, 58160084211, 0842-11, 084211 UPC No. 3-58160-84211-5, 358160-842115, 358160842115

Rx Item-Boostrix 10X0.5 ML Single Dose V
Item No. RX041689, 041689, NDC No.: 58160-0842-11, 58160-842-11, 5816084211, 58160084211, 0842-11, 084211 UPC No. 3-58160-84211-5, 358160-842115, 358160842115

Rx Item-Boostrix 10X0.5 ML Single Dose V
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica