Decavac (Tetanus and Diphtheria Toxoids Adsorbed)
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Decavac (Tetanus and Diphtheria Toxoids Adsorbed)

DECAVAC®
(tetanus and diphtheria toxoids adsorbed)

DRUG DESCRIPTION

DECAVAC®, Tetanus and Diphtheria Toxoids Adsorbed (Td), manufactured by Sanofi Pasteur Inc. for intramuscular injection, is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The bovine muscle tissue used in this medium is US sourced. Tetanus and diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum.

Each 0.5 mL dose of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is formulated to contain the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. The tetanus and diphtheria toxoids induce at least 2 units and 0.5 units of antitoxin per mL of serum, respectively, in the guinea pig potency test. Each 0.5 mL dose also contains a trace amount of thimerosal [mercury derivative, ( ≤ 0.3 μg mercury/dose) not as a preservative] from the manufacturing process, aluminum adjuvant (not more than 0.28 mg aluminum by assay), and not more than 100 μg (0.02%) of residual formaldehyde.

What are the possible side effects of this vaccine (Decavac (Td), Tetanus-Diphtheria Toxoids, Adult (Td))?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side...

Read All Potential Side Effects and See Pictures of Decavac »

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:1941;21-32.

What are the possible side effects of this vaccine (Decavac (Td), Tetanus-Diphtheria Toxoids, Adult (Td))?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side...

Read All Potential Side Effects and See Pictures of Decavac »

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DECAVAC vaccine is indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older.

DOSAGE AND ADMINISTRATION

Primary Immunization

DECAVAC vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria, as a primary immunization series of three 0.5 mL doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose.

DECAVAC vaccine may be used to complete the primary immunization series for tetanus and diphtheria in persons 7 years of age or older who have received one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT). However, the safety and efficacy of DECAVAC vaccine in such regimens have not been evaluated.

Routine Booster Immunization

DECAVAC vaccine may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.7 The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.7,10,11

Tetanus Prophylaxis in Wound Management

For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.12 DECAVAC vaccine is approved for wound management of patients 7 years of age and older.

The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).

When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.12

Table 1: Summary Guide to Tetanus Prophylaxis in Routine Wound Management for Persons 7 Years of Age and Older10,11,12

History of Adsorbed Tetanus Toxoid (doses) Clean, Minor Wounds All Other Wounds*
Td† TIG Td† TIG
Unknown or < three Yes No Yes Yes
≥ 3‡ No§ No No|| No
* 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.
† The ACIP has specific recommendations on use of Td or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) in adolescents and adults.10,11
‡ 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 the last tetanus toxoid-containing vaccine dose.
|| Yes, if ≥ 5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.)

Diphtheria Prophylaxis for Case Contacts

DECAVAC vaccine may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis.12

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, DECAVAC vaccine should not be administered.

DECAVAC vaccine, after shaking, is a turbid liquid, whitish-gray in color.

For DECAVAC vaccine supplied in vials, shake the vial well before withdrawing the dose. Discard vial if DECAVAC vaccine cannot be resuspended.

For DECAVAC vaccine supplied in syringes, shake the syringe well before administering the dose. Discard syringe if DECAVAC vaccine cannot be resuspended.

Inject 0.5 mL intramuscularly. The preferred site is the deltoid muscle. DECAVAC vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer DECAVAC vaccine intravenously or subcutaneously.

DECAVAC vaccine should not be combined through reconstitution or mixed with any other vaccine.

HOW SUPPLIED

Vial (latex-free), 1 Dose (10 per package) – NDC 49281-291-83

Syringe (latex-free), 1 Dose (10 per package, without needle) – NDC 49281-291-10

Storage

Store at 2°to 8°C (35°to 46°F). Do not freeze.

Do not use vaccine after expiration date.

REFERENCES

7. CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

10. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-3):1-43.

11. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria, and pertussis among adults: Use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR 2006;55(No. RR-17):1-37.

12. .CDC. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991:40(No. RR-10):1-28.

Manufactured by: Sanofi Pasteur Inc., Swiftwater, PA 18370 USA. Product Information as of December 2008.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates.

In a clinical study involving 58 individuals 6-58 years of age, 19% of the individuals noted local reactions consisting of erythema, tenderness and induration at the injection site and 2% systemic reactions consisting of headache, malaise and temperature elevations.5

Data from Post-Marketing Experience

The following adverse events have been spontaneously reported during the post-marketing use of Td manufactured by Sanofi Pasteur Inc. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse events were included based on severity, frequency of reporting or the strength of causal association to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine.

Blood and lymphatic system disorders

Lymphadenopathy.

Immune system disorders

Allergic reactions (such as rash, urticaria, pruritus, and face edema), including anaphylactoid reactions.

Nervous system disorders

Headache, paresthesia, dizziness, syncope, and convulsions.

Gastrointestinal disorders

Nausea, vomiting.

Musculoskeletal, connective tissue and bone disorders

Myalgia, arthralgia, pain in extremities, musculoskeletal stiffness.

General disorders and administration site conditions

Injection site reactions (including swelling, redness, warmth, induration, cellulitis, and nodules).

Pyrexia, chills, pain, malaise, asthenia, fatigue, edema peripheral.

Reporting of Adverse Events

The National Childhood Vaccine Injury Act of 1986 requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records of the manufacturer and lot number of the vaccine administered in the vaccine recipient's permanent medical record, along with the date of administration of the vaccine, and the name, address, and title of the person administering the vaccine.8 The Act further requires the health-care professional to report to the US Department of Health and Human Services the occurrence of certain adverse events following vaccination.8 For Td, events required to be reported are anaphylaxis or anaphylactic shock within 7 days; brachial neuritis within 28 days; any acute complication or sequelae (including death) of the above events; or any events that would contraindicate further doses of vaccine according to the manufacturer's package insert.9 These events and other suspected adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov. Health-care providers should also report adverse events following DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine to Sanofi Pasteur Inc. at 1-800-822-2463.

Read the Decavac (tetanus and diphtheria toxoids adsorbed) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine.

No safety and immunogenicity data are available regarding concomitant administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine with other US licensed vaccines.

REFERENCES

5. Myers MG, et al. Primary immunization with tetanus and diphtheria toxoids. JAMA 248:1982;2478-2480.

8. CDC. Current trends - national vaccine injury act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 1988;37(13):197-200.

9. CDC. Vaccine Adverse Event Reporting System (VAERS) Table of Reportable Events Following Vaccination. 2005;1-2. http://vaers.hhs.gov/pdf/ReportableEventsTable.pdf

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

More frequent administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine than described in DOSAGE AND ADMINISTRATION may be associated with increased incidence and severity of adverse reactions.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine usually have high serum tetanus antitoxin levels and should not receive DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management (see DOSAGE AND ADMINISTRATION).

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.6 If Guillain-Barré syndrome occurred within 6 weeks after receipt of a prior vaccine containing tetanus toxoid, the decision to give DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.7

Vaccination with DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine may not protect all individuals.

PRECAUTIONS

General

Prior to administration of any dose of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine, the vaccine recipient's current health status and personal health history should be reviewed. This should include a review of the patient's immunization history, any adverse events after previous immunizations and history concerning possible sensitivity to the vaccine, in order to determine the existence of any contraindications to administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine, and to allow an assessment of the benefits and risks of vaccination.

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.

Immune responses to inactivated vaccines and toxoids when given to immunocompromised persons may be suboptimal.7 The immune response to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine administered to immunocompromised individuals (whether from disease or treatment) has not been studied.

REFERENCES

7. CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed with DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine. It is also not known whether DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is administered to a nursing woman.

Pediatric Use

DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is not approved for use in infants and children younger than 7 years of age. Safety and effectiveness of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine in this age group have not been established.

Geriatric Use

The clinical study that evaluated the immunogenicity and safety of the tetanus and diphtheria toxoids contained in DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects.

REFERENCES

6. Institute of Medicine (US). Stratton KR, et al, eds. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington (DC): National Academy Press. 1994:67-117.

7. CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

It is a contraindication to use DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine after anaphylaxis or other serious allergic reaction following a previous dose of this vaccine, any other tetanus or diphtheria toxoid containing vaccine, or any component of this vaccine (see DESCRIPTION). Because of uncertainty as to which component of the vaccine may be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Tetanus

Tetanus is an acute and often fatal disease caused by an extremely potent neurotoxin produced by C tetani.

Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of 0.01 IU/mL, measured by neutralization assays, is considered the minimum protective level.2,3

Diphtheria

Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae.

Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection.3,4

Efficacy of DECAVAC (tetanus and diphtheria toxoids adsorbed) Vaccine

The efficacy of tetanus toxoid and diphtheria toxoid used in DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine was determined on the basis of an immunogenicity study, with a comparison to a serological correlate of protection (0.01 antitoxin units/mL) established by the Panel on Review of Bacterial Vaccines & Toxoids.3

A clinical study to evaluate the serological responses and adverse reactions was performed in 58 individuals 6-58 years of age. The results indicated protective levels of antibody were achieved in greater than 90% of the study population after primary immunization with both components. Booster effects were achieved in 100% of the individuals with pre-existing antibody responses.5

REFERENCES

2. Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company;2008:805-839.

3. Department of Health and Human Services, Food and Drug Administration. Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Proposed Rule. Federal Register Vol 50 No 240:1985; 51002-51117.

4. Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company;2008:139-156.

5. Myers MG, et al. Primary immunization with tetanus and diphtheria toxoids. JAMA 248:1982;2478-2480.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Prior to administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine, health-care providers should inform the patient, parent, or guardian of the benefits and risks of immunization and of the importance of completing the primary immunization series or receiving recommended booster doses, as appropriate.

The health-care provider should inform the patient, parent, or guardian about the potential for adverse reactions that have been temporally associated with the administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine or other vaccines containing similar ingredients. Patients, parents or guardians should be instructed to report any suspected adverse reactions to their health-care professional.

The health-care provider should provide the Vaccine Information Statements (VISs), which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Prior to administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine, health-care providers should inform the patient, parent, or guardian of the benefits and risks of immunization and of the importance of completing the primary immunization series or receiving recommended booster doses, as appropriate.

The health-care provider should inform the patient, parent, or guardian about the potential for adverse reactions that have been temporally associated with the administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine or other vaccines containing similar ingredients. Patients, parents or guardians should be instructed to report any suspected adverse reactions to their health-care professional.

The health-care provider should provide the Vaccine Information Statements (VISs), which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

DECAVAC®
(tetanus and diphtheria toxoids adsorbed)

DRUG DESCRIPTION

DECAVAC®, Tetanus and Diphtheria Toxoids Adsorbed (Td), manufactured by Sanofi Pasteur Inc. for intramuscular injection, is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The bovine muscle tissue used in this medium is US sourced. Tetanus and diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum.

Each 0.5 mL dose of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is formulated to contain the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. The tetanus and diphtheria toxoids induce at least 2 units and 0.5 units of antitoxin per mL of serum, respectively, in the guinea pig potency test. Each 0.5 mL dose also contains a trace amount of thimerosal [mercury derivative, ( ≤ 0.3 μg mercury/dose) not as a preservative] from the manufacturing process, aluminum adjuvant (not more than 0.28 mg aluminum by assay), and not more than 100 μg (0.02%) of residual formaldehyde.

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:1941;21-32.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

DECAVAC®
(tetanus and diphtheria toxoids adsorbed)

DRUG DESCRIPTION

DECAVAC®, Tetanus and Diphtheria Toxoids Adsorbed (Td), manufactured by Sanofi Pasteur Inc. for intramuscular injection, is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The bovine muscle tissue used in this medium is US sourced. Tetanus and diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum.

Each 0.5 mL dose of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is formulated to contain the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. The tetanus and diphtheria toxoids induce at least 2 units and 0.5 units of antitoxin per mL of serum, respectively, in the guinea pig potency test. Each 0.5 mL dose also contains a trace amount of thimerosal [mercury derivative, ( ≤ 0.3 μg mercury/dose) not as a preservative] from the manufacturing process, aluminum adjuvant (not more than 0.28 mg aluminum by assay), and not more than 100 μg (0.02%) of residual formaldehyde.

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:1941;21-32.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

DECAVAC®
(tetanus and diphtheria toxoids adsorbed)

DRUG DESCRIPTION

DECAVAC®, Tetanus and Diphtheria Toxoids Adsorbed (Td), manufactured by Sanofi Pasteur Inc. for intramuscular injection, is a sterile suspension of alum (aluminum potassium sulfate)-precipitated toxoids in an isotonic sodium chloride solution. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Corynebacterium diphtheriae cultures are grown in a modified Mueller and Miller medium.1 Clostridium tetani cultures are grown in a peptone-based medium containing an extract of bovine muscle tissue. The bovine muscle tissue used in this medium is US sourced. Tetanus and diphtheria toxins produced during the growth of the cultures are detoxified with formaldehyde. The detoxified materials are then separately purified by serial ammonium sulfate fractionation and diafiltration, and adsorbed onto alum.

Each 0.5 mL dose of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is formulated to contain the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. The tetanus and diphtheria toxoids induce at least 2 units and 0.5 units of antitoxin per mL of serum, respectively, in the guinea pig potency test. Each 0.5 mL dose also contains a trace amount of thimerosal [mercury derivative, ( ≤ 0.3 μg mercury/dose) not as a preservative] from the manufacturing process, aluminum adjuvant (not more than 0.28 mg aluminum by assay), and not more than 100 μg (0.02%) of residual formaldehyde.

1. Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 40:1941;21-32.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

Decavac Patient Information Including Side Effects

Brand Names: Decavac (Td), Tetanus-Diphtheria Toxoids, Adult (Td)

Generic Name: tetanus and diphtheria toxoids vaccine (Td, adult) (Pronunciation: TET a nus and dif THEER ee a TOX oids)

What is tetanus and diphtheria toxoids vaccine (Decavac)?

Tetanus and diphtheria are serious diseases caused by bacteria.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria causes a thick coating in the nose, throat, and airways. It can lead to breathing problems, paralysis, heart failure, or death.

Diphtheria is spread from person to person. Tetanus enters the body through a cut or wound.

The tetanus and diphtheria toxoids vaccine (also called Td) is used to help prevent these diseases in adults and children who are at least 7 years old.

This vaccine works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Like any vaccine, the tetanus and diphtheria toxoids vaccine may not provide protection from disease in every person.

What are the possible side effects of this vaccine (Decavac)?

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, fainting;
  • severe headache or vomiting;
  • confusion, seizure (black-out or convulsions); or
  • high fever.

Less serious side effects include:

  • redness, pain, tenderness, swelling, or a hard lump where the shot was given;
  • mild fever;
  • joint pain, body aches;
  • mild drowsiness; or
  • mild vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Decavac (tetanus and diphtheria toxoids adsorbed) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about this vaccine (Decavac)?

The tetanus and diphtheria toxoids vaccine is given in a series of shots. The first shot is usually given to a person who is at least 7 years old. The booster shots are then given 4 to 8 weeks after the first shot, and 6 to 12 months after the second shot. After the initial series, a booster dose is given every 10 years.

A booster shot is also recommended in children who are 11 or 12 years old if more than 5 years have passed since the child's last tetanus and diphtheria vaccine.

If it has been longer than 5 years since your last booster, you may need an emergency booster shot if you have been exposed to tetanus through a skin wound.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

The adult version of this vaccine (Td) should not be given to anyone under the age of 7 years old. Another vaccine is available for use in younger children and infants.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you have had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with tetanus or diphtheria is much more dangerous to your health than receiving the vaccine to protect against these diseases. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers

Decavac Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving this vaccine (Decavac)?

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing diphtheria or tetanus, or if you have:

  • severe or uncontrolled epilepsy or other seizure disorder; or
  • if you have received cancer chemotherapy or radiation treatment in the past 3 months.

You may not be able to receive this vaccine if you have ever received a similar vaccine that caused any of the following:

  • a very high fever (over 104 degrees);
  • a neurologic disorder or disease affecting the brain;
  • fainting or going into shock;
  • Guillain-Barré syndrome (within 6 weeks after receiving a diphtheria, tetanus, or pertussis vaccine);
  • seizure (convulsions); or
  • a severe skin reaction.

Before receiving this vaccine, tell the doctor if you have:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;
  • a history of seizures;
  • a neurologic disorder or disease affecting the brain (or if this was a reaction to a previous vaccine);
  • an allergy to latex rubber;
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if you are taking a blood thinner such as warfarin (Coumadin).

You can still receive a vaccine if you have a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with diphtheria or tetanus.

It is not known whether this vaccine passes into breast milk or if it could harm a nursing baby. Do not use receive the vaccine without telling your doctor if you are breast-feeding a baby.

The adult version of this vaccine (Td) should not be given to anyone under the age of 7 years old. Another vaccine is available for use in younger children and infants.

How is this vaccine given (Decavac)?

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

The tetanus and diphtheria toxoids vaccine is given in a series of shots. The first shot is usually given to a person who is at least 7 years old. The booster shots are then given 4 to 8 weeks after the first shot, and 6 to 12 months after the second shot. After the initial series, a booster dose is given every 10 years.

A booster shot is also recommended in children who are 11 or 12 years old if more than 5 years have passed since the child's last tetanus and diphtheria vaccine.

If it has been longer than 5 years since your last booster, you may need an emergency booster shot if you have been exposed to tetanus through a skin wound.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

Side Effects Centers

Decavac Patient Information including If I Miss a Dose

What happens if I miss a dose (Decavac)?

Contact your doctor if you will miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (Decavac)?

An overdose of this vaccine is unlikely to occur.

What should I avoid before or after receiving this vaccine (Decavac)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect tetanus and diphtheria toxoids vaccine (Decavac)?

Before receiving this vaccine, tell your doctor about all other vaccines you have recently received.

Also tell the doctor if you have received drugs or treatments in the past 2 weeks that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

This list is not complete and there may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you are using. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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