Tetanus Toxoid Adsorbed

DRUG DESCRIPTION

Tetanus Toxoid Adsorbed USP, for intramuscular use, is a sterile suspension of alum-precipitated (aluminum potassium sulfate) toxoid in an isotonic sodium chloride solution containing sodium phosphate buffer to control pH. The vaccine, after shaking, is a turbid liquid, whitish-gray in color.

Clostridium tetani culture is grown in a peptone-based medium and detoxified with formaldehyde. The detoxified material is then purified by serial ammonium sulfate fractionation, followed by sterile filtration, and the toxoid is adsorbed to aluminum potassium sulfate (alum). The adsorbed toxoid is diluted with physiological saline solution (0.85%) and thimerosal (a mercury derivative) is added to a final concentration of 1:10,000.

Each 0.5 mL dose is formulated to contain 5 Lf (flocculation units) of tetanus toxoid and not more than 0.25 mg of aluminum. The residual formaldehyde content, by assay, is less than 0.02%. The tetanus toxoid induces at least 2 units of antitoxin per mL in the guinea pig potency test.

What are the possible side effects of tetanus toxoid vaccine (Tetanus Toxoid, Tetanus Toxoid Adsorbed)?

Getting tetanus is much riskier than getting the tetanus toxoid vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of tetanus toxoid vaccine causing serious harm, or death, is extremely small.

Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from tetanus toxoid are experienced:

  • a serious allergic reaction including swelling of the...

Read All Potential Side Effects and See Pictures of Tetanus Toxoid Adsorbed

What are the precautions when taking tetanus toxoid adsorbed (Tetanus Toxoid Adsorbed)?

Before you or your child receives this vaccination, tell the doctor or pharmacist if you or your child is allergic to it; or to any other vaccines; or if you or your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you or your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if you or your child has: history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell the doctor or pharmacist your or your child's medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of...

Read All Potential Precautions of Tetanus Toxoid Adsorbed


Tetanus Toxoid Adsorbed Consumer (continued)

SIDE EFFECTS: Mild fever, joint pain, muscle aches, nausea, tiredness, or pain/itching/swelling/redness at the injection site may occur. Acetaminophen may be used to reduce these effects. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit is greater than the risk of side effects. Most people using this medication do not have serious side effects.

Tell the doctor immediately if any of these rare but very serious side effects occur: tingling of the hands/feet, hearing problems, trouble swallowing, muscle weakness, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before you or your child receives this vaccination, tell the doctor or pharmacist if you or your child is allergic to it; or to any other vaccines; or if you or your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you or your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if you or your child has: history of severe reaction to vaccine (e.g., paralysis, encephalopathy).

Before using this medication, tell the doctor or pharmacist your or your child's medical history, especially of: bleeding disorders (e.g., hemophilia, low platelets), history of Guillain-Barre syndrome, high fever (higher than 103 degrees F/39 degrees C) after previous vaccination, other reaction (e.g., swelling, itching at injection site) after previous vaccination, immune system disorders (e.g., autoimmune disorders, radiation treatment), illness/infection, seizures, other nervous system disorders (e.g., paralysis, numbness/tingling, extreme drowsiness, confusion).

This medication may contain mercury (in the preservative thimerosal) and should not be used in children younger than 7 years.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Tetanus Toxoid Adsorbed Patient Information Including Side Effects

Brand Names: Tetanus Toxoid, Tetanus Toxoid Adsorbed

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

  • What is tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?
  • What are the possible side effects of tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?
  • What is the most important information I should know about tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?
  • What should I discuss with my healthcare provider before receiving tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?
  • How are tetanus toxoid vaccine administered (Tetanus Toxoid Adsorbed)?
  • What happens if I miss a dose (Tetanus Toxoid Adsorbed)?
  • What happens if I overdose (Tetanus Toxoid Adsorbed)?
  • What should I avoid before or after getting tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?
  • What other drugs will affect tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?
  • Where can I get more information?

What is tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?

Tetanus is a serious disease caused by bacteria. Tetanus toxoid vaccine exposes the individual to a small amount of the bacteria (or to a protein from the bacteria) causing the body to develop immunity to the disease.

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.

Tetanus toxoid vaccine can help prevent tetanus. Tetanus toxoid vaccine is made for people 7 years of age and older. After a person completes the primary immunization schedule, a tetanus toxoid booster dose is needed every 10 years all through life. Talk to your doctor about the tetanus immunization and booster schedule.

What are the possible side effects of tetanus toxoid vaccine (Tetanus Toxoid Adsorbed)?

Getting tetanus is much riskier than getting the tetanus toxoid vaccine. However, a vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of tetanus toxoid vaccine causing serious harm, or death, is extremely small.

Seek emergency medical attention or contact your doctor immediately if any of the following rare but serious side effects from tetanus toxoid are experienced:

  • a serious allergic reaction including swelling of the lips, tongue, or face; difficulty breathing; closing of the throat; hives; paleness; weakness; dizziness; or a fast heart beat; or
  • deep, aching pain and muscle wasting in the upper arm(s) starting 2 days to 4 weeks after the shot, and lasting up to many months.

Other less serious side effects, such as soreness redness, or swelling where the shot was given, may be more likely to occur. These side effects usually start within hours to a day or two after vaccination. They may last 1-2 days. Your doctor may recommend reducing pain or soreness from the injection by taking an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24-48 hours. Your healthcare provider can tell you the appropriate dosages of these medications.

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 side effects to FDA at 1-800-FDA-1088.

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

Individuals with minor illnesses, such as a cold, may be vaccinated. Those who are moderately or severely ill should usually wait until they recover before getting tetanus toxoid vaccine.

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