Decavac

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 ?g 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 ?g (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...

Read All Potential Side Effects and See Pictures of Decavac »

What are the precautions when taking tetanus and diphtheria toxoids adsorbed (Decavac)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, a certain nerve disease (Guillain-Barre syndrome), bleeding disorders (such as hemophilia, thrombocytopenia).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more information.

During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits...

Read All Potential Precautions of Decavac »

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...

Read All Potential Side Effects and See Pictures of Decavac »

What are the precautions when taking tetanus and diphtheria toxoids adsorbed (Decavac)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, a certain nerve disease (Guillain-Barre syndrome), bleeding disorders (such as hemophilia, thrombocytopenia).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more information.

During pregnancy, this vaccine should be used only when clearly needed. Discuss the risks and benefits...

Read All Potential Precautions of Decavac »


Decavac Consumer (continued)

SIDE EFFECTS: Pain/redness/warmth/bruising/swelling at the injection site, tiredness, fever, or headache may occur. 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 to you or your child is greater than the risk of side effects. Many people using this medication do not have serious side effects. However, report all side effects to the doctor.

Tell the doctor immediately if any of these rare but serious side effects occur: shoulder pain, muscle weakness/tingling.

A severe reaction at the injection site may rarely occur. Tell the doctor if you or your child develop any of the following injection site reactions: severe pain, large area of swelling/redness/bruising, persistent lump.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 the 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 receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell your doctor or pharmacist your medical history, especially of: current fever/illness, a certain nerve disease (Guillain-Barre syndrome), bleeding disorders (such as hemophilia, thrombocytopenia).

Some brands of this product may contain a small amount of mercury from a preservative (thimerosal). Consult your doctor for more information.

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

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.


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)?
  • What are the possible side effects of this vaccine (Decavac)?
  • What is the most important information I should know about this vaccine (Decavac)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Decavac)?
  • How is this vaccine given (Decavac)?
  • What happens if I miss a dose (Decavac)?
  • What happens if I overdose (Decavac)?
  • What should I avoid before or after receiving this vaccine (Decavac)?
  • What other drugs will affect tetanus and diphtheria toxoids vaccine (Decavac)?
  • Where can I get more information?

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.

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.

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