Tetanus Toxoid Adsorbed
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Questions & Answers
Side Effects & Adverse Reactions
The stopper of the multi-dose vial contains dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.
Except under circumstances of wound management (see DOSAGE AND ADMINISTRATION section), booster doses of Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. should not be administered more frequently than as recommended for Td vaccines (ie, at 11-12 years of age if at least 5 years have elapsed since the last dose of tetanus and diphtheria toxoid-containing vaccine, and every 10 years thereafter).4 More frequent booster doses may be associated with increased incidence and severity of adverse reactions.1
Persons who experienced severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid usually have very high serum tetanus antitoxin levels and should not be given even emergency doses of Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. more frequently than every 10 years, even if they have a wound that is neither clean nor minor.5
Because intramuscular injection can cause injection site hematoma, Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. in such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection.
If Guillain-Barré Syndrome occurs within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.3
The Advisory Committee on Immunization Practices (ACIP) has published guidelines for vaccination of persons with recent or acute illness.3
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is indicated for active immunization of children 7 years of age or older, and adults, for prevention of tetanus.
For immunization of infants and children younger than 7 years of age against tetanus and diphtheria, refer to the manufacturers' package inserts for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and for Diphtheria and Tetanus Toxoids Adsorbed (For Pediatric Use) (DT).
Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is not to be used for the treatment of active tetanus disease. For use of this vaccine for tetanus prophylaxis in wound management, refer to DOSAGE AND ADMINISTRATION.
Persons who have had tetanus should still be immunized since this clinical infection does not always confer immunity.
As with any vaccine, vaccination with Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. may not protect 100% of individuals.
If passive protection against tetanus is required, Tetanus Immune Globulin (Human) (TIG) should be used (see DOSAGE AND ADMINISTRATION, TETANUS PROPHYLAXIS IN WOUND MANAGEMENT section).
History
There is currently no drug history available for this drug.
Other Information
Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc., for intramuscular injection, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.
Clostridium tetani culture is grown in a peptone-based medium containing an extract of bovine muscle tissue and detoxified with formaldehyde. The bovine muscle tissue used in this medium is US sourced. The detoxified material is then purified by serial ammonium sulfate fractionation and diafiltration, followed by sterile filtration. The toxoid is adsorbed to aluminum potassium sulfate (alum). The adsorbed toxoid is diluted with physiological saline solution (0.85%). Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is supplied in a unit dose 0.5 mL vial, which contains a trace amount of thimerosal [(mercury derivative), (≤0.3 μg mercury/dose)] from the manufacturing process. Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is also supplied in a 5 mL vial, which contains the preservative thimerosal [(mercury derivative), (25 μg mercury/dose)].
Each 0.5 mL dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and not more than 0.25 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. The tetanus toxoid induces at least 2 units of antitoxin per mL in the guinea pig potency test.
Sources
Tetanus Toxoid Adsorbed Manufacturers
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Sanofi Pasteur Inc.
![Tetanus Toxoid Adsorbed (Clostridium Tetani Toxoid Antigen (Formaldehyde Inactivated)) Injection, Suspension [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Tetanus Toxoid Adsorbed | Sanofi Pasteur Inc.
Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. (See DESCRIPTION section.) If these conditions exist, the vaccine should not be administered.
SHAKE VIAL WELL before withdrawing each dose. Discard vial if vaccine cannot be resuspended.
Before injection, the skin over the site to be injected should be cleansed with a suitable germicide.
Inject intramuscularly in the area of the vastus lateralis (mid-thigh laterally) or deltoid. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Primary ImmunizationFor persons 7 years of age and older who have not been immunized previously against tetanus, the primary immunization series of Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. consists of three 0.5 mL doses. The intervals between doses recommended by the ACIP are 4 to 8 weeks between the first and second dose, and 6 to 12 months between the second and third dose.1
Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. may be used to complete the primary immunization series for tetanus in children 7 years of age or older who have received one or two doses of whole-cell pertussis DTP, DTaP, and/or DT vaccine. However the safety and efficacy of Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. in such children have not been evaluated.
Interruption of the recommended schedule with a delay between doses should not interfere with the final immunity achieved with Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. There is no need to start the series over again, regardless of the time elapsed between doses.
Routine Booster ImmunizationTetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is approved for booster immunization in persons 7 years of age and older who have completed primary immunization against tetanus.
Booster immunization against tetanus is recommended by the ACIP in persons 11-12 years of age if at least 5 years have elapsed since the last dose of a tetanus and diphtheria toxoid-containing vaccine.4 Subsequent routine booster immunization against tetanus is recommended every 10 years.4,11 If a dose of a tetanus toxoid-containing vaccine is given sooner than 10 years, as part of wound management or on exposure to diphtheria, the next booster is not needed for 10 years thereafter.1 MORE FREQUENT BOOSTER IMMUNIZATION AGAINST TETANUS IS NOT RECOMMENDED AND MAY BE ASSOCIATED WITH INCREASED INCIDENCE AND SEVERITY OF ADVERSE REACTIONS.1,3 (See WARNINGS section).
TETANUS PROPHYLAXIS IN WOUND MANAGEMENTThe need for active immunization with a tetanus toxoid-containing preparation, with or without passive immunization with TIG (Human) depends on both the condition of the wound and the patient's vaccination history (TABLE 1).
A thorough attempt must be made to determine whether a patient has completed primary immunization. Persons who have completed primary immunization against tetanus, and who sustain wounds which are minor and uncontaminated, should receive a booster dose of a tetanus toxoid-containing preparation only if they have not received tetanus toxoid within the preceding 10 years. For tetanus prone wounds (eg, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite), a booster is appropriate if the patient has not received a tetanus toxoid-containing preparation within the preceding 5 years. If a booster dose is given sooner than 10 years as part of wound management, the next routine booster should not be given for 10 years thereafter.1
Persons who have not completed primary immunization against tetanus, or whose immunization history is unknown or uncertain, should be immunized with a tetanus toxoid-containing product. Completion of primary immunization thereafter should be ensured. In addition, if these persons have sustained a tetanus-prone wound, the use of TIG (Human) is recommended. TIG (Human) should be administered at a separate site, with a separate needle and syringe, according to the manufacturer's package insert. If a contraindication to using tetanus toxoid-containing preparations exists in a person who has not completed a primary immunizing course of tetanus toxoid and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.1
Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is approved for wound management in patients 7 years of age and older.
TABLE 11 SUMMARY GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT, FOR PERSONS 7 YEARS OF AGE AND OLDER* History of Adsorbed Tetanus Clean, Minor Wounds All Other Wounds† Toxoid (Doses) Td‡ TIG Td‡ TIG * Important details are in the text of the DOSAGE AND ADMINISTRATION section. † Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite. ‡ Td is preferred by the ACIP to tetanus toxoid alone to enhance diphtheria protection. Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. is approved for wound management in persons 7 years of age or older. § If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably an adsorbed toxoid should be given. ¶ Yes, if >10 years since last dose. # Yes, if >5 years since last dose. (More frequent boosters are not needed and can accentuate side effects.) Unknown or < three Yes No Yes Yes ≥ Three§ No¶ No No# No CONCOMITANT VACCINE ADMINISTRATIONNo safety and immunogenicity data are available on the concomitant administration of Tetanus Toxoid Adsorbed manufactured by Sanofi Pasteur Inc. with other US licensed vaccines.
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