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Tetanus Toxoid Adsorbed

Tetanus Toxoid Adsorbed(tetanus toxoid) – Sanofi Pasteur

THERAPEUTIC CLASS

Toxoid

INDICATIONS

Active immunization against tetanus.

ADULT DOSAGE

Adults: Primary Immunization: 0.5mL IM. Repeat 4-8 weeks later. Give 3rd dose 6-12 months after 2nd dose. Booster: 0.5mL IM every 10 yrs.

PEDIATRIC DOSAGE

Pediatrics: <1 yr: 3 doses of 0.5mL IM 4 to 8 weeks apart, then 4th dose (0.5mL) 6 to 12 months after the 3rd dose. Last dose before 4 yrs. Give booster of 0.5mL at 4-6 yrs. No booster needed if last primary dose was given after 4 yrs. ≥1 yrs: Primary Immunization: 0.5mL IM. Repeat 4-8 weeks later. Give 3rd dose 6-12 months after 2nd dose. Booster: 0.5mL IM every 10 yrs.

HOW SUPPLIED

Inj: 5 LFU/0.5mL

CONTRAINDICATIONS

Neurological or systemic allergic reaction to previous dose. Defer during febrile illness, acute infection, or an outbreak of poliomyelitis. Thimerosal hypersensitivity.

WARNINGS/PRECAUTIONS

Suboptimal response may occur in immunocompromised patients. Avoid booster more frequently than every 10 yrs especially with Arthus-type hypersensitivity reactions or temperature >103°F after a previous dose of tetanus toxoid. Caution with IM injections in thrombocytopenia or any coagulation disorders. Have epinephrine injection available. Increased incidence of local/systemic reaction to booster doses.

ADVERSE REACTIONS

Local erythema, malaise, transient fever, pain, hypotension, nausea, arthralgia.

DRUG INTERACTIONS

Caution with anticoagulants. Immunosuppressive therapy (eg, radiation, corticosteroids, chemotherapy) may reduce antibody response to vaccine; defer routine vaccination. Separate syringes and sites should be used when Tetanus Immune Globulin (human) and vaccine are given concurrently.

PREGNANCY

Category C, safety in nursing not known.

MECHANISM OF ACTION

Development of neutralizing antibodies against tetanus toxin.

ASSESSMENT

Review current health status, previous sensitivity/immunization events (eg, Guillain-Barre syndrome, convulsions), pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor adverse events such as severe Arthus-type hypersensitivity reactions; anaphylactic reactions; injection site for hematoma, redness, warmth, edema, induration, and tenderness; urticaria; rash; malaise; fever; pain; hypotension; nausea; arthralgia; Guillain-Barre syndrome; brachial neuritis; EEG disturbances.

PATIENT COUNSELING

Inform patient and caregiver of potential benefits/risk ratio; report any adverse reactions to physician. Stress importance of completing vaccination series.

ADMINISTRATION/STORAGE

Administration: IM route (vastus lateralis or deltoid). Storage: 2-8°C (36-46°F). Do not freeze.


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    Tetanus Toxoid Adsorbed

    Tetanus Toxoid Adsorbed

    Generic Name: tetanus toxoid (Intramuscular route, Injection route)

    TET-a-nus TOX-oyd

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Commonly used brand name(s)

    In the U.S.

    • TE Anatoxal Berna

    In Canada

    • Tetanus Toxoid Adsorbed

    Available Dosage Forms:

    • Suspension
    • Solution

    Therapeutic Class: Toxoid

    Uses For Tetanus Toxoid Adsorbed

    Tetanus Toxoid is used to prevent tetanus (also known as lockjaw). Tetanus is a serious illness that causes convulsions (seizures) and severe muscle spasms that can be strong enough to cause bone fractures of the spine. Tetanus causes death in 30 to 40 percent of cases.

    Immunization against tetanus is recommended for all infants 6 to 8 weeks of age and older, all children, and all adults. Immunization against tetanus consists first of a series of either 3 or 4 injections, depending on which type of tetanus toxoid you receive. In addition, it is very important that you get a booster injection every 10 years for the rest of your life. Also, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster. In recent years, two-thirds of all tetanus cases have been in persons 50 years of age and older. A tetanus infection in the past does not make you immune to tetanus in the future.

    This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

    Before Using Tetanus Toxoid Adsorbed

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    In deciding to receive this vaccine, the risks of receiving the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For tetanus toxoid, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Use is not recommended for infants up to 6 weeks of age. For infants and children 6 weeks of age and older, tetanus toxoid is not expected to cause different side effects or problems than it does in adults.

    Geriatric

    This vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. However, the vaccine may be slightly less effective in older persons than in younger adults.

    Pregnancy

    Pregnancy Category Explanation
    All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

    Breast Feeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Interactions with Medicines

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Cyclosporine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Chloramphenicol

    Interactions with Food/Tobacco/Alcohol

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • A severe reaction or a fever greater than 103 °F (39.4 °C) following a previous dose of tetanus toxoid—May increase the chance of side effects with future doses of tetanus toxoid; be sure your doctor knows about this before you receive the next dose of tetanus toxoid
    • Bronchitis, pneumonia, or other illness involving lungs or bronchial tubes, or
    • Severe illness with fever—Possible side effects from tetanus toxoid may be confused with the symptoms of the condition

    Proper Use of tetanus toxoid

    This section provides information on the proper use of a number of products that contain tetanus toxoid. It may not be specific to Tetanus Toxoid Adsorbed. Please read with care.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For injection dosage forms:
      • For prevention of tetanus (lockjaw):
        • Adults, children, and infants 6 weeks of age and older—One dose is given at your first visit, then a second dose is given four to eight weeks later. Depending on the product given, you may receive a third dose four to eight weeks after the second dose, and a fourth dose six to twelve months after that; or you may receive a third dose six to twelve months after the second dose. Everyone should receive a booster dose every ten years. The doses are injected under the skin or into a muscle. In addition, if you get a wound that is unclean or hard to clean, you may need an emergency booster injection if it has been more than 5 years since your last booster dose.

    Tetanus Toxoid Adsorbed Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Symptoms of allergic reaction

    • Difficulty in breathing or swallowing
    • hives
    • itching, especially of feet or hands
    • reddening of skin, especially around ears
    • swelling of eyes, face, or inside of nose
    • unusual tiredness or weakness (sudden and severe)

    Check with your doctor as soon as possible if any of the following side effects occur:

    Rare

    • Confusion
    • convulsions (seizures)
    • fever over 103 °F (39.4 °C)
    • headache (severe or continuing)
    • sleepiness (excessive)
    • swelling, blistering, or pain at place of injection (severe or continuing)
    • swelling of glands in armpit
    • unusual irritability
    • vomiting (severe or continuing)

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Redness or hard lump at place of injection

    Less common

    • Chills, fever, irritability, or unusual tiredness
    • pain, tenderness, itching, or swelling at place of injection
    • skin rash

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

    See also: Tetanus Toxoid Adsorbed side effects (in more detail)

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    Tetanus Toxoid Adsorbed

    Tetanus Toxoid Adsorbed

    Generic Name: tetanus toxoid vaccine (TET a nus TOX oid)

    Brand Name: Tetanus Toxoid Adsorbed

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    What is Tetanus Toxoid Adsorbed (tetanus toxoid vaccine)?

    Tetanus is a serious disease 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 his mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

    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.

    The tetanus toxoid vaccine is used to help prevent this disease in adults and children who are at least 7 years old.

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

    What is the most important information I should know about Tetanus Toxoid Adsorbed (tetanus toxoid vaccine)?

    You can still receive a vaccine if you have a minor cold. 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 may not be able to receive tetanus toxoid vaccine if you have ever received a similar vaccine that caused a life-threatening allergic reaction or a neurologic disorder or disease affecting the brain.

    Before you receive this vaccine, tell your healthcare provider if you have a bleeding or blood-clotting disorder, easy bruising or bleeding, a history of Guillain Barré syndrome, an allergy to latex rubber, a weak immune system, or if you are receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

    You should not receive a booster vaccine if you 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 shot caused any side effects.

    Call your doctor at once if you have deep, aching pain and muscle wasting in the upper arm(s). This rare but serious reaction to a tetanus vaccine may begin 2 days to 4 weeks after you receive the vaccine, and could last up to many months.

    Becoming infected with tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

    What should I discuss with my healthcare provider before receiving Tetanus Toxoid Adsorbed (tetanus toxoid vaccine)?

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

    • a life-threatening allergic reaction; or

    • a neurologic disorder or disease affecting the brain.

    If you have any of these other conditions, your vaccine may need to be postponed or not given at all:

    • a bleeding or blood-clotting disorder, such as hemophilia;

    • thrombocytopenia purpura (easy bruising or bleeding);
    • Guillain Barré syndrome (within 6 weeks after receiving a vaccine that contains tetanus);
    • an allergy to latex rubber;
    • a weak immune system caused by disease (such as cancer, HIV, or AIDS); or
    • if you are receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

    You can still receive a vaccine if you have a minor cold. 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 the bacteria that causes tetanus.

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

    How is tetanus toxoid vaccine given?

    This vaccine is injected into a muscle. You will receive this injection in a doctor’s office or clinic setting.

    Tetanus toxoid vaccine is given every 10 years as a booster dose to the tetanus vaccines given during childhood as part of a routine immunization schedule. Follow your doctor’s instructions or the schedule recommended by the health department of the state you live in.

    Tetanus toxoid vaccine is often given immediately after an injury that causes a wound that may be infected with bacteria that causes tetanus. The next booster dose would then be given 10 years later.

    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 use.

    What happens if I miss a dose?

    If you miss a 10-year booster dose or if you get behind schedule, the next dose should be given as soon as possible.

    Be sure to receive all recommended doses of this vaccine. You may not be fully protected if you do not receive the full series.

    What happens if I overdose?

    An overdose of this vaccine is unlikely to occur.

    What should I avoid before or after receiving Tetanus Toxoid Adsorbed (tetanus toxoid vaccine)?

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

    Tetanus Toxoid Adsorbed (tetanus toxoid vaccine) side effects

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

    You should not receive a booster vaccine if you 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 shot caused any side effects.

    Call your doctor at once if you have deep, aching pain and muscle wasting in the upper arm(s). This rare but serious reaction to a tetanus vaccine may begin 2 days to 4 weeks after you receive the vaccine, and could last up to many months.

    Becoming infected with tetanus is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

    Less serious side effects may include:

    • fever, general ill feeling;

    • nausea;
    • feeling light-headed;
    • joint pain; or
    • redness, pain, tenderness, swelling, or a lump where the shot was given.

    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.

    See also: Tetanus Toxoid Adsorbed side effects (in more detail)

    What other drugs will affect Tetanus Toxoid Adsorbed (tetanus toxoid vaccine)?

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

    Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

    • an oral, nasal, inhaled, or injectable steroid;

    • chemotherapy or radiation cancer treatments;
    • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), 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).

    If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

    This list is not complete and other drugs may interact with tetanus toxoid vaccine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

    Next Page → Side Effects

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    • Drug Interactions
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    • Tetanus Prophylaxis

    Where can I get more information?

    • Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.

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