"Individuals who have received no prior injections of tetanus toxoid, or who have received only one injection of tetanus toxoid should be given an adequate dose of tetanus immune globulin (human) at time of injury."

Mosby's GenRx®, 10th ed.

Copyright © 2000 Mosby, Inc.

------------------------------------------------------------------------

Tetanus Toxoid (002324)

CATEGORIES:

Indications: Immunization, tetanus

Pregnancy Category C

WHO Formulary

FDA Pre 1938 Drugs

FDA DRUG CLASS: Vaccines/Antisera

BRAND NAMES: Anatetall (Malaysia, Philippines, Thailand); Anatoxal Tetanica Berna (Peru); TE Anatoxal (Austria); TE Anatoxal Berna (Switzerland); Tetatox (Italy); Tetanol (Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, Ivory-Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe; Bahrain, Cyprus, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates, Germany, Greece, Colombia, Ecuador, Honduras, Mexico); Tetanus Toxoid Adsorbed (US); Tetavax (England, Germany, Hong-Kong, Malaysia, Philippines, Thailand); (International brand names outside U.S. in italics)

DESCRIPTION:

Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, Wyeth, is prepared by growing a suitable strain of Cl. tetani on a protein-free, semisynthetic medium (Appl. Microbiol. 10: 146, 1962). Formaldehyde is used as the toxoiding (detoxifying) agent for tetanus toxin. The final product contains no more than 0.02% free formaldehyde and contains 0.01% thimerosal (mercury

derivative) as preservative.

Tetanus Toxoid Adsorbed, Wyeth, is refined by methods which eliminate at least 97% of the nontoxoid nitrogen. Adsorption of purified antigens on an optimal quantity of aluminum phosphate, a mineral adjuvant, prolongs and enhances the antigenic properties by retarding the rate of absorption. The aluminum content of the final product does not exceed 0.85 mg per 0.5 ml dose. During processing, hydrochloric acid and sodium hydroxide are used to adjust the pH. Sodium chloride is added to the finished product to control isotonicity.

INDICATIONS AND USAGE:

Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, Wyeth, is indicated for active immunization against tetanus.

CONTRAINDICATIONS:

An acute respiratory infection or other active infection is reason for deferring administration of routine primary immunizing or recall (booster) doses but not emergency recall (booster) doses. Prolonging the interval between primary immunizing doses, for six months or longer, does not interfere with the final immunity. Any dose of tetanus toxoid an individual has received, even a decade earlier, should be counted as one of his immunizing injections.2

PRECAUTIONS:

Only well individuals should be injected.

If the vial is used, rather than the Tubex Sterile Cartridge-Needle Unit, a separate syringe and needle which have been adequately cleaned and sterilized should be used for each patient to prevent transmission of hepatitis B virus and other infectious agents from one person to another.

Individuals receiving therapy with corticosteroids or other immunosuppressive agents (antimetabolites, irradiation, alkylating agents) may not respond optimally to active immunization procedures. Administration of immunizing agents should be deferred in such individuals or repeated thereafter.

Before the injection of any biological, the physician should take all precautions known for prevention of allergic or any other side reactions. This should include: A review of the patient's history regarding possible sensitivity; the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned.

ADVERSE REACTIONS:

A small area of erythema and induration surrounding the injection site, persisting for a few days, is not unusual. A nodule may be palpable at the site of injection for a few weeks.

The occurrence of significant local and systemic reactions, following administration of tetanus toxoid, either fluid or adsorbed, is not nearly as rare as once believed.1,6-12 Severe systemic reactions, on the other hand, are extremely rare. Over the past several years, published reports from this and foreign countries have appeared describing extensive local reactions which, in some instances, were accompanied by mild-to-moderate systemic responses. A typical reaction of this type, as described in the literature, is manifested by a delayed onset (usually 12 hours or more) of erythema, boggy edema, and induration surrounding the point of injection. Pain and tenderness, if present, are usually not the primary complaints. Frequently there is itching of the edematous area, and it may resemble a giant "hive". The edema is occasionally extensive: shoulder to elbow or shoulder to wrist. Axillary lymphadenopathy has also been reported. Systemic manifestations have included low-grade fever, malaise, generalized aches and pains, flushing, generalized urticaria or pruritus, tachycardia, and hypotension. The majority of the extensive delayed-type local responses reported in the literature or to the manufacturers have occurred following BOOSTER doses in adults and especially in veterans of the armed forces, members of national guard units, employees of industries, members of hospital staffs, or others who have received routine booster doses of tetanus toxoid on a regular basis. The incidence of severe, extensive local reactions in hospital immunization programs, for instance, has been as high as five percent. Reports have also appeared concerning the occurrence of such reactions in children who have received several doses of tetanus toxoid in the past.11,12 The increasing incidence of extensive local reactions is one of the reasons why a ten-year interval between ROUTINE booster doses is recommended by the U.S. Public Health Service, American Academy of Pediatrics, American College of Surgeons, and others. Local reactions typical of the type described above have been reported from this and other countries following use of both fluid and adsorbed tetanus toxoids prepared by many different manufacturers. Although their cause is unknown, hypersensitivity to the toxin or bacillary protein of the tetanus organism itself is assumed to be a possibility in some; in others, interreaction between the injected antigen and high levels of preexisting tetanus antibody (antitoxin) from prior booster doses seems to be the most likely cause of the Arthus-type response. Edsall1 suggests: "If doubt exists as to a patient's tolerance for toxoid and if an emergency booster dose is indicated, a small dose (e.g., 0.05 to 0.1 ml) may be given subcutaneously and the rest of the dose given 12 hours later if no reaction has occurred. If a marked reaction should ensue, further toxoid injections at that time may be safely omitted since it has been shown years ago that reducing the dose of tetanus toxoid does not proportionately reduce the magnitude of the response obtained."

DOSAGE AND ADMINISTRATION:

The basic immunizing course for all age groups consists of two (primary) doses of 0.5 ml each, given at an interval of 4 to 8 weeks, followed by a third (reinforcing) dose of 0.5 ml 6 to 12 months later. The third

(reinforcing) dose is an integral part of the basic immunizing course; basic immunization cannot be considered completed until the third dose has been given.1 Prolonging the interval between primary immunizing doses, for six months or longer, does not interfere with the final immunity. Any dose of tetanus toxoid an individual has received, even a decade earlier, should be counted as one of his immunizing injections.2 Injections should be given intramuscularly, preferably into the deltoid or midlateral muscles of the thigh. The same muscle site should not be injected more than once during the course of basic immunization.

A routine recall (booster) dose of 0.5 ml should be given at 10-year intervals throughout life to maintain immunity.2-5

In event of injury for which tetanus prophylaxis is indicated, an emergency recall (booster) dose of 0.5 ml should be given:

a. For clean, minor wounds: if more than TEN (10) years have elapsed

since the time of administration of the last recall (booster) dose or

the last (reinforcing) dose of the basic immunizing series.

b. For all other wounds: if more than FIVE (5) years have elapsed

since the time of administration of the last recall (booster) dose or

the last (reinforcing) dose of the basic immunizing series.

If emergency tetanus prophylaxis is indicated during the period between the second primary dose and the reinforcing dose, a 0.5 ml dose of toxoid 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.

A 0.5 ml dose of tetanus toxoid adsorbed and an appropriate dose of tetanus immune globulin (human), given with separate syringes and at different sites, are indicated at time of injury if:

a. The past immunization history with tetanus toxoid or the date of

the last recall (booster) dose is unknown or of questionable validity.

b. The interval since the third (reinforcing) dose of the basic

immunizing series or the last recall (booster) dose is more than 10

years; and a delay of more than 24 hours has occurred between the time

of injury and initiation of specific tetanus prophylaxis; and the

injury is of the type that could readily lead to fulminating tetanus2

(for example--compound fracture; extensive burn; crushing,

penetrating, or massively contaminated wound; injury causing

interruption or impairment of the local blood supply).

Individuals who have received no prior injections of tetanus toxoid, or who have received only one injection of tetanus toxoid should be given an adequate dose of tetanus immune globulin (human) at time of injury.

Technic For Injection: Before injection, the skin over the site to be injected should be cleansed and prepared with a suitable germicide. After insertion of the needle, aspirate to help avoid inadvertent injection into a blood vessel. Expel the antigen slowly and terminate the dose with a small bubble of air (0.1 to 0.2 ml). Do not inject intracutaneously or into superficial subcutaneous tissues.

Keep between 2 and 8° C (35 and 46° F)

REFERENCES:

1. EDSALL, G.: Specific prophylaxis of tetanus. JAMA 171: 417, 1959. 2. EDSALL, G.: Current status of tetanus immunization. Arch. Environ. Hlth.

8: 731, 1964.

3. Report of the Committee on Infectious Diseases, American Academy of Pediatrics (Red Book), 1977. 4. Control of Communicable Diseases in Man, 12th Edition, 1975, Am. Pub. Hlth. Assn. 5. Recommendation of the Public Health Service Advisory Committee on Immunization Practices, Morbidity and Mortality Weekly Report 26 (No. 49):401, 1977, CDC, USPHS, DHEW, Atlanta, Georgia. 6. KITTLER, F., et al.: Reactions to tetanus toxoid. Southern Med. J.59: 149, 1966. 7. LEVINE, L., et al.: Adult immunization: Preparation and evaluation of combined fluid tetanus and diphtheria toxoids for adult use. Am. J. Hyg.73: 20, 1961. 8. MCCOMB, J. and LEVINE, L.: Adult immunization: II. Dosage reduction as a solution to increasing reactions to tetanus toxoid. New Eng. J. Med.265: 1152, 1961. 9. EDSALL, G., et al.: Excessive use of tetanus toxoid boosters. JAMA202: 17, 1967. 10. FARDON, D.: Unusual reactions to tetanus toxoid. JAMA199: 125, 1967. 11. PEEBLES, T., et al.: Tetanus toxoid emergency boosters. A reappraisal. New Eng. J. Med. 280: 575, 1969. 12. STEIGMAN, A.: Abuse of tetanus toxoid. J. Pediatrics 72: 753, 1968. 13. GREEN, S. T.: Avoiding needle sticks. Lancet 1(8489): 1096, 1986.

------------------------------------------------------------------------

Bookmark URL: /das/drug/view/1/2324/top

--------------------------------------------------------

Sheri Nakken, R.N., MA wwithin@nccn.net

Well Within's Earth Mysteries & Sacred Site Tours

International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers

Education, Homeopathic Education

KVMR Broadcaster/Programmer/Investigative Reporter, Nevada City CA CEU's for nurses, Books & Multi-Pure Water Filters

--------------------------------------------------------

Sheri Nakken, R.N., MA

Vaccination Information & Choice Network, Nevada City CA & Wales UK $$ Donations to help in the work - accepted by Paypal account

vaccineinfo@btinternet.com

PO Box 1563 Nevada City CA 95959 530-740-0561 Voicemail in US

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL ADVICE. THE

DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

Well Within's Earth Mysteries & Sacred Site Tours

International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine Dangers Education, Homeopathic Education CEU's for nurses, Books & Multi-Pure Water Filters

---------------------------------------------------------------------~->

To unsubscribe from this group, send an email to: immunizations-unsubscribe@egroups.com