Clinical Information
Gen. Code and Des.
59080 diphth,pertuss(acell),tet vac INTRAMUSC SYRINGE 2.5-8-5/.5
GCN and Des.
24619 diphth,pertuss(acell),tet vac INTRAMUSC SYRINGE 2.5-8-5/.5
Strength
Dose Form
SYRINGE (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80080000 TOXOIDS
Active Ingredients
3626 diphtheria,pertussis (acellular),tetanus vaccine
Inactive Ingredients
2551 polysorbates 9005645
9283 beef derived (bovine)
BOOSTRIX- clostridium tetani toxoid antigen, corynebacterium diphtheriae toxoid antigen, bordetella pertussis toxoid antigen, bordetella pertussis filamentous hemagglutinin antigen and bordetella pertussis pertactin antigen suspension
GlaxoSmithKline Biologicals SA
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.
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.
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.
2.3 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.
3 DOSAGE FORMS AND STRENGTHS
BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK� syringes.
5.1 Latex
The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.
BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated filamentous hemagglutinin [FHA] and pertactin). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens.
Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.
The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.
Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of pertactin (69 kiloDalton outer membrane protein).
Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice.
Each 0.5-mL dose contains aluminum hydroxide as adjuvant (not more than 0.39 mg aluminum by assay), 4.4 mg of sodium chloride, ≤100 mcg of residual formaldehyde, and ≤100 mcg of polysorbate 80 (Tween 80).
BOOSTRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.
BOOSTRIX is formulated without preservatives.
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.
PATIENT COUNSELING INFORMATION
The patient, parent, or guardian should be:
�
informed of the potential benefits and risks of immunization with BOOSTRIX.
�
informed about the potential for adverse reactions that have been temporally associated with administration of BOOSTRIX or other vaccines containing similar components.
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instructed to report any adverse events to their healthcare provider.
BOOSTRIX, FLUARIX, INFANRIX, and TIP-LOK are registered trademarks of the GSK group of companies. The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
Manufactured by GlaxoSmithKline Biologicals
