"European Union (EU) regulators have recommended market approval of a combination bacterial and viral vaccine (Vaxelis, Sanofi Pasteur) that immunizes children against six different disorders.
The new injectable vaccine is indic"...
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.
For the prefilled syringes, attach a sterile needle and administer intramuscularly.
For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.
Do not administer this product intravenously, intradermally, or subcutaneously.
Dose And Schedule
BOOSTRIX is administered as a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.
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
The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied.
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.
Dosage Forms And Strengths
BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.
Storage And Handling
BOOSTRIX is available in 0.5-mL single-dose vials and disposable prefilled TIP-LOK syringes (packaged without needles):
NDC 58160-842-01 Vial in Package of 10: NDC 58160-842-11
NDC 58160-842-05 Syringe in Package of 1: NDC 58160-842-34
NDC 58160-842-43 Syringe in Package of 10: NDC 58160-842-52
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, US License 1617, and Novartis Vaccines and Diagnostics GmbH, Marburg, Germany, US License 1754. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/6/2014
Additional Boostrix Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.