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|Menactra

MENINGOCOCCAL VACCINE, DIPHTHERIA CONJUGATE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Menactra

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineMCV4

† Not commercially available in Canada.

Category

• Immunizing agent (active)

Description

Meningococcal diphtheria conjugate (ma-nin-ja-KOK-kal dif-THEE-ree-a kanju-git) vaccine is an active immunizing agent used to prevent infection by certain groups of meningococcal bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

The following information applies only to the meningococcal vaccine used for meningococcal bacteria Groups A, C, Y, and W-135. These groups cause nearly all of the meningococcal meningitis cases in the U.S. The vaccine will not protect against infection caused by other meningococcal bacteria groups, such as Group B.

Meningococcal infection can cause life-threatening illnesses, such as meningococcal meningitis, which affects the brain, and meningococcemia, which affects the blood. Some persons with meningococcal meningitis and/or meningococcemia also may die. The rate of these diseases peak in adolescence and early adulthood and are more likely to occur in persons with certain diseases or conditions that make them more susceptible to a meningococcal infection or more likely to develop serious problems from a meningococcal infection.

Immunization against meningococcal disease is recommended for persons 11 to 55 years of age who are at risk of getting the disease because:

• They have certain diseases or conditions that make them more susceptible to a meningococcal infection or more likely to develop serious problems from a meningococcal infection.
• They are living in, working in, or visiting an area where there is a strong possibility of contracting meningococcal disease.

Usually a person needs to receive meningococcal vaccine only once.

Meningococcal polysaccharide vaccine is to be administered only by or under the supervision of your doctor or other health care professional. It is available in the following dosage form:

• Parenteral
• Injection (U.S.)

Before Receiving This Vaccine

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 meningococcal diphtheria conjugate vaccine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to meningococcal diphtheria conjugate vaccine. Also tell your doctor and pharmacist if you are allergic to any other vaccines or substances, such as foods, preservatives, or dyes.

Pregnancy—Meningococcal diphtheria conjugate vaccine has not been studied in pregnant women. Studies in animals have not shown this vaccine to cause birth defects or other problems. Before taking this vaccine, make sure your doctor knows if you are pregnant of if you may become pregnant.

Breast-feeding—It is not known whether meningococcal diphtheria conjugate vaccine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who need to take this vaccine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this vaccine have been done only in patients older than 11 years of age, and there is no specific information comparing use of meningococcal diphtheria conjugate vaccine in children with use in other age groups. This vaccine has been tested in children 11 and 12 years of age and teenagers and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Older adults—Studies on this vaccine have been done only in patients younger than 55 years of age, and there is no specific information comparing use of meningococcal diphtheria conjugate vaccine in the elderly with use in other age groups.

Other 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 meningococcal diphtheria conjugate vaccine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Anticoagulants (blood thinners) (Heparin [e.g., Calciparine], Warfarin [e.g., Coumadin])—Can increase chances of bleeding after vaccine injection

Other medical problems—The presence of other medical problems may affect the use of meningococcal diphtheria conjugate vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Guillain-Barre syndrome (GBS), history of—This vaccine should not be used if you have this condition.

• Hemophilia (blood disorder with tendency to bleed uncontrollably) or
• Other bleeding problems—May be worsened by meningococcal diphtheria conjugate vaccine

• Illness, recent or critical—May make your condition worse

• Lower immune system response (body"s ability to fight infection is suppressed)—This vaccine has not been studied in patients with this problem.

Proper Use of This Vaccine

Dosing—The dose of meningococcal diphtheria conjugated vaccine will be different for different patients. The following information includes only the average doses of meningococcal diphtheria conjugated vaccine.

• For injection dosage form:
  • For prevention of meningococcal meningitis:
    • Adults and teenagers—One dose injected into the shoulder muscle
    • Children 11 to 12 years of age—One dose injected into the shoulder muscle
    • Children younger than 11 years of age—Use and dose must be determined by your doctor

Precautions While Using This Medicine

It is very important to tell your doctor if you are allergic to rubber. The stopper of the vial contains dry natural rubber latex, which may cause an allergic reaction if you have a latex allergy.

Check with your doctor right away if you experience a cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue, shortness of breath, skin rash, tightness in chest, unusual tiredness or weakness, and/or wheezing. These could be symptoms of an allergic reaction to the vaccine.

Contact your doctor immediately if you have sudden weakness or are not able to move your arms or legs. This could be a sign of a serious condition called Guillain-Barre Syndrome.

Side Effects of This Medicine

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.

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

Developed: 03/11/2005
Revised: 11/10/2005

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