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Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only. After shaking, the product is a homogenous white suspension.
The tetanus toxoid is derived from Clostridium tetani , which is grown in a growth medium containing beef heart infusion according to the method of Mueller and Miller. 1 The toxin is detoxified with formaldehyde. 2 The toxoid is refined by the Pillemer alcohol fractionation method 2 and then diluted with a solution containing sodium phosphate monobasic, sodium phosphate dibasic, glycine, aluminum phosphate as adjuvant, and thimerosal (mercury derivative) as a preservative to a final concentration of 1:10,000 (approximately 25 µg per 0.5 mL dose).
Each 0.5 mL dose is formulated to contain 5 Lf units of tetanus toxoid and 0.11 mg of aluminum from the aluminum phosphate adjuvant. The residual free formaldehyde content by assay is <0.02%. The tetanus toxoid induces at least 2 neutralizing units/mL of serum in the guinea pig potency test.
Tetanus manifests systemic toxicity primarily by neuromuscular dysfunction caused by a potent exotoxin elaborated by C. tetani. The incidence of tetanus in the US has dropped dramatically with the routine use of tetanus toxoid, with an average of 57 cases reported annually from 1985-1994. 3 During the period from 1995 through 1997, 124 cases of tetanus were reported from 33 states and the District of Columbia, resulting in an average annual incidence of 0.15 cases per 1,000,000 population. The case-fatality ratio varied from 2.3% for persons aged 20-39 years to 16% for persons aged 40-59 years and to 18% for persons aged >/=60 years. Previous immunization status was directly related to the severity of the disease, with the case-fatality ratio ranging from 6% for persons who had received 1 to 2 doses of tetanus toxoid to 15% for persons who were unvaccinated. Tetanus remains a severe disease, with adults >/=60 years at the highest risk of severe disease. 4
Spores of C. tetani are ubiquitous and there is essentially no natural immunity to tetanus toxin. Thus, universal primary immunization with tetanus toxoid with subsequent maintenance of adequate antitoxin levels by means of timed boosters, is recommended to protect all age groups. 5 Tetanus toxoid is a highly effective antigen and a completed primary series generally induces serum antibody levels of at least 0.01 antitoxin units/mL, a level that has been reported to be protective. 6,7 It is thought that protection persists for at least 10 years. 5
The tetanus toxoid induces neutralizing antibodies to the toxin produced by the infecting organism. Protective serum antibody levels of at least 0.01 antitoxin units/mL were achieved in 20/20 (100%) of subjects following a single dose of Lederle-produced Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED®. 8 In a study in adults 18 to 55 years of age, protective levels (0.01 antitoxin units/mL) were achieved in 34/34 (100%) subjects following a booster dose of Lederle-produced Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (Td) which is a combined tetanus and diphtheria toxoid product formulated with Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED®. 8
Tetanus Toxoid Adsorbed, Aluminum Phospohate Adsorbed, PUROGENATED® (TT), is indicated for active immunization against tetanus disease in adults and children 2 months of age or older including active immunization in wound management (see DOSAGE AND ADMINISTRATION for " Tetanus Prophylaxis in Wound Management " ).
The Advisory Committee on Immunization Practices (ACIP) recommends the use of combined toxoid vaccines rather than single component vaccines for both primary and booster injections, including active tetanus immunization in wound management. 5
Therefore, the ACIP recommends that Tetanus and Diphtheria Toxoids Adsorbed, For Adult Use (Td), be used for immunization against tetanus disease in persons 7 years of age or older. However, if diphtheria toxoid is contraindicated (e.g., if there is a suspicion of hypersensitivity to diphtheria toxoid), Tetanus Toxoid Adsorbed is recommended for both primary and booster injections, including active tetanus immunization in wound management (see DOSAGE AND ADMINISTRATION for " Tetanus Prophylaxis in Wound Management " ). 5
The ACIP recommends that infants and children 6 weeks of age up to the seventh birthday be immunized with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP). If a contraindication to the use of pertussis vaccine exists, the child may be immunized with Diphtheria and Tetanus Toxoids Adsorbed (DT). If a contraindication to both pertussis and diphtheria exists, Tetanus Toxoid (TT) Adsorbed may be used for active immunization against tetanus disease including active immunization in wound management (see DOSAGE AND ADMINISTRATION for " Tetanus Prophylaxis in Wound Management " ).
Tetanus Toxoid Adsorbed is intended only for active immunization against tetanus disease, and is not to be used for treatment of actual infection. While either Tetanus Toxoid Adsorbed or Tetanus Toxoid Fluid can be used for active immunization against tetanus disease, the adsorbed preparation is preferred. Comparative tests have shown that the adsorbed toxoids are superior to the fluid toxoids for primary immunization, routine booster doses, wound management, and simultaneous administration of tetanus toxoid and Tetanus Immune Globulin (TIG) for active-passive immunization. Although the rate of seroconversion is essentially equivalent with either type of tetanus toxoid, the adsorbed toxoid induces a more persistent antitoxin titer. 5 When human tetanus immune globulin (TIG) is to be administered at the same visit as tetanus toxoid, the adsorbed toxoid should be used (see PRECAUTIONS ). 5,9
If a contraindication to using a tetanus toxoid-containing preparation 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 should be given using human TIG (see DOSAGE AND ADMINISTRATION ). 5
Persons recovering from tetanus Persons recovering from tetanus infection may not develop protective immunity; therefore, initiation or completion of active immunization is indicated at the time of recovery from this infection. 5
Neonatal tetanus prevention The risk to the fetus from tetanus toxoid is unknown. 10 The ACIP recommends that a previously unimmunized pregnant woman, who may deliver her child under nonhygienic circumstances and/or surroundings, should receive two properly spaced doses of a tetanus toxoid-containing preparation before delivery, preferably during the last two trimesters. Incompletely immunized pregnant women should complete the three-dose immunization series. Those immunized more than 10 years previously should have a booster dose (see PRECAUTIONS -- Pregnancy ). 5
Protection against tetanus disease is based on a full course of immunization.
As with any vaccine, Tetanus Toxoid Adsorbed may not protect 100% of individuals receiving the vaccine.
HYPERSENSITIVITY TO ANY COMPONENT OF THE VACCINE, INCLUDING THIMEROSAL, A MERCURY DERIVATIVE, IS A CONTRAINDICATION (see WARNINGS and PRECAUTIONS ).
THE OCCURRENCE OF ANY TYPE OF NEUROLOGICAL SYMPTOMS OR SIGNS OR AN ALLERGIC OR ANAPHYLACTIC REACTION FOLLOWING ADMINISTRATION OF THIS PRODUCT IS A CONTRAINDICATION TO FURTHER USE. ALTERNATIVELY, BECAUSE OF THE IMPORTANCE OF TETANUS VACCINATIONS, INDIVIDUALS WITH AN ANAPHYLACTIC REACTION TEMPORALLY ASSOCIATED WITH TETANUS VACCINATION MAY BE REFERRED FOR EVALUATION BY AN ALLERGIST. 5,11,12
THE DECISION TO ADMINISTER OR DELAY VACCINATION BECAUSE OF A CURRENT OR RECENT FEBRILE ILLNESS DEPENDS LARGELY ON THE SEVERITY OF SYMPTOMS AND THEIR ETIOLOGY. ALTHOUGH A MODERATE OR SEVERE FEBRILE ILLNESS IS SUFFICIENT REASON TO POSTPONE VACCINATION, MINOR ILLNESSES SUCH AS A MILD UPPER RESPIRATORY INFECTION WITH OR WITHOUT LOW GRADE FEVER ARE NOT CONTRAINDICATIONS. 5,11,12
ROUTINE IMMUNIZATION SHOULD BE DEFERRED DURING AN OUTBREAK OF POLIOMYELITIS, PROVIDED THE PATIENT HAS NOT SUSTAINED AN INJURY THAT INCREASES THE RISK OF TETANUS DISEASE. 13
THE CLINICAL JUDGMENT OF THE ATTENDING PHYSICIAN SHOULD PREVAIL AT ALL TIMES.
IT IS RECOMMENDED THAT BOOSTER DOSES BE ADMINISTERED EVERY 10 YEARS, EXCEPT UNDER CIRCUMSTANCES OF WOUND MANAGEMENT (see DOSAGE AND ADMINISTRATION ). MORE FREQUENT ADMINISTRATION MAY BE ASSOCIATED WITH INCREASED INCIDENCE AND SEVERITY OF REACTIONS. 5
Persons who experience Arthus-type hypersensitivity reactions or temperature greater than 39.4°C (103°F) after a previous dose of tetanus toxoid usually have very high serum tetanus antibody levels and should not be given even emergency doses of tetanus toxoid more frequently than every 10 years, even if they have a wound that is neither clean nor minor. 5,12
If a contraindication to using tetanus toxoid 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 should be given using human TIG (see INDICATIONS AND USAGE ). 5
Tetanus Toxoid Adsorbed should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration. If the decision is made to administer Tetanus Toxoid Adsorbed to individuals with coagulation disorders, it should be given with caution (see PRECAUTIONS , Drug Interactions ).
Deaths have been reported in temporal association with the administration of preparations containing tetanus antigens (see ADVERSE REACTIONS ).
Health care professionals should prescribe and/or administer this product with caution to patients with a possible history of latex sensitivity since this packaging contains dry natural rubber.
CARE IS TO BE TAKEN BY THE HEALTH CARE PROFESSIONAL FOR THE SAFE AND EFFECTIVE USE OF THIS PRODUCT.
PRIOR TO THE ADMINISTRATION OF THIS VACCINE, HEALTH CARE PROFESSIONALS SHOULD INFORM THE PARENT, GUARDIAN, OR ADULT PATIENT OF THE RECOMMENDED IMMUNIZATION SCHEDULE FOR PROTECTION AGAINST TETANUS DISEASE AND THE BENEFITS AND RISKS OF VACCINATION AGAINST TETANUS DISEASE. GUIDANCE SHOULD BE PROVIDED ON MEASURES TO BE TAKEN SHOULD ADVERSE EVENTS OCCUR, SUCH AS ANTIPYRETIC MEASURES FOR ELEVATED TEMPERATURES, AND THE NEED TO REPORT ANY SUSPECTED ADVERSE EVENTS OR SUSPECTED OCCURRENCES TO THE HEALTH CARE PROFESSIONAL. PARENTS, GUARDIANS, OR ADULT PATIENTS SHOULD BE PROVIDED WITH VACCINE INFORMATION MATERIALS PRIOR TO THE TIME OF VACCINATION, AS REQUIRED BY THE NATIONAL CHILDHOOD VACCINE INJURY ACT 17 (see Adverse Event Reporting ).
THE HEALTH CARE PROFESSIONAL SHOULD INFORM THE PARENT, GUARDIAN, OR ADULT PATIENT OF THE IMPORTANCE OF COMPLETING THE IMMUNIZATION SERIES UNLESS CONTRAINDICATED.
PATIENTS, PARENTS, OR GUARDIANS SHOULD BE INSTRUCTED TO REPORT ANY ADVERSE REACTIONS OR SUSPECTED ADVERSE EVENTS TO THEIR HEALTH CARE PROFESSIONAL (see Adverse Event Reporting ).
Patients receiving immunosuppressive therapy (including irradiation, systemic corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may have a reduced antibody response to active immunization procedures. 5,11,14,15 Although no specific studies are available, if immunosuppressive therapy will be discontinued shortly, it would be reasonable to defer immunization until the patient has been off therapy for one month; otherwise the patient should be vaccinated while still on therapy. 14 Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids is not thought to be immunosuppressive 14 (see PRECAUTIONS , General ).
As with other intramuscular injections, TT should be given with caution to individuals on anticoagulant therapy (see WARNINGS ).
Human TIG, if used, should be given in a separate site with a separate needle and syringe.
Tetanus Toxoid Adsorbed has not been evaluated for its carcinogenic or mutagenic potential or for impairment of fertility.
Pregnancy Category C.
Animal reproductive studies have not been conducted with this product. The risk to the fetus from tetanus toxoid is unknown. 10 The ACIP recommends that an appropriate tetanus toxoid-containing preparation (usually Td) should be given to inadequately immunized women because it affords protection against neonatal tetanus. 19 Waiting until the second trimester is a reasonable precaution to minimize any theoretical concern. 12 Maintenance of adequate immunization by routine boosters in non-pregnant women of child-bearing age (see DOSAGE AND ADMINISTRATION ) can obviate the need to vaccinate women during pregnancy.
TT has not been isolated from breast milk. There is no evidence that breast milk from women receiving this product is harmful to infants. 19
The safety and effectiveness of Tetanus Toxoid Adsorbed in children below the age of 6 weeks have not been established (see DOSAGE AND ADMINISTRATION ).
For either primary or booster immunization against tetanus disease in children less than 7 years of age, the use of Diphtheria and Tetanus Toxoids Adsorbed and Acellular Pertussis Vaccine (DTaP) is recommended. 5
The response to immunization with tetanus toxoid has been demonstrated to be slower, of lower magnitude, and decreased duration in geriatric patients. A group of 17 geriatric subjects (mean age 70.6 ± 4.0 years) exhibited significantly lower antibody titers for up to 12 months after an injection of tetanus toxoid as compared to a group of 20 young subjects (mean age 31.3 ± 6.5 years). 20,21 In another study, subjects aged 65 to 84 years who received 5 Lf of adsorbed tetanus toxoid showed a decreased IgG antibody production as compared to adults aged 25 to 34 years. 22 In these clinical studies adequate protection was achieved in geriatric patients. 21,23,24
In a study of 161 nursing home residents, mean age 77 years, minor pain and/or tenderness at the injection site was reported by 9% of the patients and no systemic reactions were reported after a dose of tetanus and diphtheria toxoids (Td). Because patients were not examined for reactions and 23 vaccinated patients had decreased awareness and poor communication skills, the actual incidence of reactions may be higher. 25 The ACIP recommends that persons age 50 and over receive a Td booster every 10 years as part of routine health maintenance. 26
Local reactions, such as erythema, induration and tenderness, are common after the administration of TT. 27,28 With vaccines in general, it is not uncommon for patients to note within 48 to 72 hours at or around the injection site the following minor reactions: edema, pain or tenderness; redness, inflammation or skin discoloration; mass or induration; or local hypersensitivity. Such local reactions are usually self-limiting and require no therapy. As with other aluminum-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks following injection. 29 Sterile abscess formation or subcutaneous atrophy at the injection site may also occur.
Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection) may follow receipt of tetanus toxoid in persons who have very high serum antitoxin antibodies due to overly frequent injections of tetanus toxoid (see WARNINGS ). 12
Other adverse events which have been reported in temporal association with various tetanus toxoid-containing products include: warmth, swelling, headache, fever, chills, cellulitis, malaise, weakness or fatigue, dizziness, drowsiness, irritability, aches and pains, flushing, tachycardia, syncope, nausea, vomiting, lymphadenopathy, phlebitis, arthralgia, myalgia, pruritis/itching, hives, sweating, acute midbrain syndrome, EEG disturbances, accommodation pareses, paresthesia, radiculopathy, brachial plexus neuropathy, cranial nerve pareses, myelopathy, myelitis, persistent crying, fretfulness, and cochlear lesions.
NEUROLOGICAL COMPLICATIONS 30 SUCH AS CONVULSIONS, 31 ENCEPHALOPATHY, 31,32 AND VARIOUS MONO- AND POLYNEUROPATHIES, 32-38 INCLUDING GUILLAIN-BARRE SYNDROME, 39,40 HAVE BEEN REPORTED FOLLOWING ADMINISTRATION OF PREPARATIONS CONTAINING TETANUS ANTIGEN. A REVIEW BY THE INSTITUTE OF MEDICINE (I.O.M.) FOUND EVIDENCE OF A CAUSAL RELATIONSHIP BETWEEN TETANUS TOXOID AND BRACHIAL NEURITIS AND GBS. 41
ALLERGIC AND HYPERSENSITIVITY REACTIONS, URTICARIA, ERYTHEMA MULTIFORME OR OTHER RASH, ARTHRALGIAS 31 AND, MORE RARELY, A SEVERE ANAPHYLACTIC REACTION 41 (i.e., URTICARIA WITH SWELLING OF THE MOUTH, DIFFICULTY BREATHING, HYPOTENSION OR SHOCK, OR DEATH) HAVE BEEN REPORTED FOLLOWING ADMINISTRATION OF PREPARATIONS CONTAINING TETANUS ANTIGEN.
DEATHS HAVE BEEN REPORTED IN TEMPORAL ASSOCIATION TO RECEIPT OF PREPARATIONS CONTAINING TETANUS TOXOID. THE I.O.M. FOUND INADEQUATE EVIDENCE TO ACCEPT OR REJECT A CAUSAL RELATIONSHIP BETWEEN TETANUS TOXOID-CONTAINING PRODUCTS AND DEATH FROM CAUSES OTHER THAN ANAPHYLAXIS OR GBS. 41
A review of two large, active surveillance studies of adults and children who received approximately 0.7 to 1.2 million and 8.1 million doses of tetanus toxoid-containing vaccines, respectively, found that the number of cases of GBS after the administration of such vaccines was less than that expected by chance alone. 42
Any suspected adverse events following immunization should be reported by the health care professional to the US Department of Health and Human Services (DHHS). The National Childhood Vaccine Injury Act requires that the manufacturer and lot number of the vaccine administered be recorded by the health care professional in the vaccine recipient' permanent medical record (or in a permanent office log or file), along with the date of the administration of the vaccine and the name, address, and title of the person administering the vaccine.
The statute further requires the health care professional to report to the Secretary of the US DHHS the occurrence following immunization of any events set forth in the statute's Vaccine Injury Table, including anaphylaxis or anaphylactic shock within 7 days, brachial neuritis within 28 days, or any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above or any events that would contraindicate further doses of vaccine, according to this Tetanus Toxoid Adsorbed vaccine package insert. 17,43
The US DHHS has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine including, but not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. 17 The VAERS toll-free number for VAERS forms and information is 800-822-7967.
The dose is 0.5 mL to be given intramuscularly.
Since this product is a suspension containing an adjuvant, immediately prior to use shake vigorously to obtain a uniform suspension in the vaccine container. The vaccine should not be used if it cannot be resuspended.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (see DESCRIPTION ). The vaccine should not be used if particulate matter or discoloration is found.
The vaccine should be administered intramuscularly. The preferred injection sites are the anterolateral aspect of the thigh or the deltoid muscle of the upper arm. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. Before injection, the skin at the injection site should be cleansed and prepared with a suitable germicide. After insertion of the needle, aspirate and wait to see if any blood appears in the syringe, which will help avoid inadvertent injection into a blood vessel. If blood appears, withdraw the needle and prepare for a new injection at another site. The needle length for adult vaccine administration should be of sufficient length to deliver the vaccine intramuscularly; in particular for intramuscular injection into obese patients, a 1 inch or 1-1/2 inch needle may be necessary.
Safety and immunogenicity data are not available to support concurrent administration of Tetanus Toxoid Adsorbed with other vaccines. In general, ACIP recommends that inactivated vaccines can be administered simultaneously at separate sites, without impaired antibody responses or increased rates of adverse reactions. 18
When immunization with Tetanus Toxoid Adsorbed is begun in the first year of life, the primary series consists of three doses of 0.5 mL each, 4 to 8 weeks apart, followed by a fourth (reinforcing) dose of 0.5 mL, 6 to 12 months after the third dose. 5 The reinforcing dose is an integral part of the primary immunizing course.
If, after beginning combined immunization against diphtheria, tetanus, and pertussis, further doses of vaccine containing pertussis and diphtheria antigens become contraindicated, Tetanus Toxoid Adsorbed may be substituted for each of the remaining doses. 5
The primary immunizing course for unimmunized individuals one year of age or older consists of two doses of 0.5 mL each, 4 to 8 weeks apart, followed by a third (reinforcing) dose of 0.5 mL, 6 to 12 months after the second dose. The reinforcing dose is an integral part of the primary immunizing course. 5 In contrast, giving doses at less than recommended intervals may lessen the antibody response and therefore should be avoided.
Interruption of the recommended schedule with a delay between doses does not interfere with the final immunity achieved with Tetanus Toxoid Adsorbed. There is no need to start the series over again, regardless of the length of time elapsed between doses. 5
Any variation from the recommended volume or number of doses is discouraged. The serological response, clinical efficacy, and/or frequency and severity of adverse reactions of schedules other than those described above have not been adequately studied. 19
A booster dose of 0.5 mL of a tetanus toxoid-containing product is indicated at age 4 to 6 years (prior to the 7 th birthday) preferably prior to entrance into kindergarten or elementary school. However, if the last dose of the primary immunizing series was administered after the fourth birthday, a booster prior to school entry is not considered necessary. 5
A single injection of 0.5 mL of Tetanus Toxoid Adsorbed is given 10 years after completion of primary immunization and every 10 years thereafter. If a dose is given sooner as part of wound management, the next booster is not needed for 10 years thereafter. MORE FREQUENT BOOSTER DOSES ARE NOT INDICATED AND MAY BE ASSOCIATED WITH INCREASED INCIDENCE AND SEVERITY OF REACTIONS (see WARNINGS ). 5
The need for active immunization with a tetanus toxoid-containing preparation, with or without passive immunization with human TIG, depends on both the condition of the wound and the patient' immunization history. Tetanus has rarely occurred among persons with a documented primary series of toxoid injections. 5 A thorough attempt must be made to determine whether a patient has completed primary immunization. 5
In order to enhance diphtheria protection in the population, the ACIP recommends Tetanus and Diphtheria Toxoids, for adult use, as the preferred preparation for active tetanus immunization in wound management of patients 7 years of age or older who are not completely immunized. 5 When administration of preparations containing diphtheria toxoid is contraindicated, single antigen tetanus toxoid should be substituted. Completion of primary immunization thereafter should be ensured.
Individuals who have completed primary immunization against tetanus, and who sustain wounds which are minor and uncontaminated, should receive a booster dose of the appropriate tetanus toxoid-containing preparation (see INDICATIONS AND USAGE ) only if they have not received tetanus toxoid within the preceding 10 years. For other wounds, a booster is appropriate if the patient has not received tetanus toxoid within the preceding 5 years. Antitoxin antibodies develop rapidly in persons who have previously received at least two doses of tetanus toxoid. 5 If a booster dose is given sooner than 10 years as part of wound management, the next booster should not be given for 10 years thereafter.
For routine wound management of children under 7 years of age who are not completely immunized, DT should be used instead of single-antigen tetanus toxoid (if pertussis antigen is contraindicated or individual circumstances are such that potential febrile reactions following DTP or DTaP might confound the management of the patient). 5 Completion of primary vaccination thereafter should be ensured.
If emergency tetanus prophylaxis is indicated during the period between the last primary dose and the reinforcing dose, a 0.5 mL dose of DT should be given. If given before six months have elapsed, it should be counted as a primary dose; if given after six months, it should be regarded as the reinforcing dose.
For tetanus-prone wounds in individuals who have had fewer than three, or an unknown number of immunizations with a tetanus toxoid-containing product, passive immunization with human TIG is also recommended. 5 A separate syringe and site of injection should be used. When human TIG is to be administered at the same visit as tetanus toxoid, an adsorbed tetanus toxoid-containing preparation should be used. 5
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 should be given using human TIG. 5
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0005-1938-31 5.0 mL vial
0005-1938-47 10 × 0.5 mL LEDERJECT® disposable syringe.
DO NOT FREEZE. STORE REFRIGERATED AWAY FROM FREEZER COMPARTMENT AT 2°C to 8°C (36°F to 46°F).
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Manufactured by:
LEDERLE LABORATORIES
Division American Cyanamid Company
Pearl River, NY 10965 USA
US Govt. License No. 17
Marketed by:
WYETH LEDERLE
VACCINES
Wyeth-Ayerst Laboratories
Philadelphia, PA 19101 USA
CI 7467-1 Issued May 31, 2001