Pronunciation:

NOO-moe-KOK-al 7-VAY-lent VAX-een, dif-THEER-ee-a KON-joo-gate

Brand Names:

• Prevnar

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Pneumococcal 7-valent diphtheria conjugate vaccine is an active immunizing agent used to prevent infection by pneumococcal bacteria. It works by causing your body to produce its own protection (antibodies) against the disease.

Pneumococcal infection can cause serious problems, such as pneumonia, which affects the lungs; meningitis, which affects the brain; and bacteremia, which is a severe infection in the blood. Pneumococcal infection is also an important cause of ear infections in children.

Unless otherwise contraindicated, immunization against pneumococcal disease is recommended for infants and young children.

Immunization requires 1 to 4 doses of the vaccine, depending on the age at the first dose. This vaccine can be given at the same time as other routine vaccinations.

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

Before Using This Medicine:

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

Children—

This vaccine is generally well-tolerated and effective in infants. The safety and effectiveness in infants below 6 weeks of age and in children older than 10 years of age have not been established.

Older adults—

This vaccine is not recommended for adult populations.

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—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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.

Proper Use of This Medicine:

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.

The number of injections your child will receive for protection from pneumococcal infection will depend on your child's age at the first dose:

• Children 6 weeks to 6 months of age—4 doses
• Children 7 to 11 months of age—3 doses
• Children 12 to 23 months of age—2 doses
• Children 2 years through 9 years of age—1 dose
• Children older than 9 years of age—Use of this vaccine is not recommended in this age group.

Your doctor will tell you when your child should receive the next dose.

Precautions While Using This Medicine:

If your child has more than one doctor, be sure they all know that your child has received pneumococcal 7-valent diphtheria conjugate vaccine so they can put the information into your child's medical record.

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.

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

Symptoms of allergic reaction

Difficulty with breathing or swallowing

hives

itching, especially of the feet or hands

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

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

Less common

Fever over 39 °C (102.2 °F)

Rare

Collapse or shock-like state

convulsions

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

Decreased appetite

diarrhea

drowsiness

fever of less than 39 °C (102.2 °F)

irritability

redness, soreness, hard lump, swelling, or pain at the injection site

restless sleep

vomiting

Less common

Skin rash or hives

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.