Boostrix
INDICATIONS
BOOSTRIX® is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.
DOSAGE AND ADMINISTRATION
Preparation for Administration
Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.
Dose and Schedule
BOOSTRIX is administered as a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.
Do not administer this product intravenously, intradermally, or subcutaneously.
There are no data to support repeat administration of BOOSTRIX.
Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) vaccine and the administration of BOOSTRIX.
Additional Dosing Information
Primary Series: The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied.
Wound Management: If tetanus prophylaxis is needed for wound management, BOOSTRIX may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.
HOW SUPPLIED
Dosage Forms and Strengths
BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.
BOOSTRIX is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes (packaged without needles):
NDC 58160-842-01 Vial (contains no latex) in Package of 10: NDC 58160-842-11 NDC 58160-842-34 Syringe (tip cap may contain latex; plunger contains no latex) in Package of 1: NDC 58160-842-34
NDC 58160-842-43 Syringe (tip cap may contain latex; plunger contains no latex) in Package of 10: NDC 58160-842-52
NDC 58160-842-41 Syringe (tip cap and plunger contain latex) in Package of 1: NDC 58160-842-32
NDC 58160-842-41 Syringe (tip cap and plunger contain latex) in Package of 5: NDC 58160-842-46
NDC 58160-842-41 Syringe (tip cap and plunger contain latex) in Package of 10: NDC 58160-842-51
Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.
Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium. Revised: July 2011
Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Boostrix Information
Report Problems to the Food and Drug Administration
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