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Prevnar

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Prevnar

Prevnar®
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

FOR PEDIATRIC USE ONLY

For Intramuscular Injection Only

DRUG DESCRIPTION

Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), Prevnar (pneumococcal 7-valent conjugate) ®, is a sterile solution of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F individually conjugated to diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. The polysaccharides are chemically activated to make saccharides which are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. This is effected by reductive amination. CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium. CRM197 is purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography. The individual glycoconjugates are purified by ultrafiltration and column chromatography and are analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein.

The individual glycoconjugates are compounded to formulate the vaccine, Prevnar (pneumococcal 7-valent conjugate) ®. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens, and by the saccharide to protein ratios in the individual glycoconjugates.

Prevnar (pneumococcal 7-valent conjugate) ® is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 µg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 µg of serotype 6B per dose (16 µg total saccharide); approximately 20 µg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant.

After shaking, the vaccine is a homogeneous, white suspension.

What are the possible side effects of this vaccine (Prevnar)?

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if you or your child has a serious side effect such...

Read All Potential Side Effects and See Pictures of Prevnar »

What are the precautions when taking pneumococcal 7-valent conjugate (Prevnar)?

Before receiving this vaccine, tell your doctor or pharmacist if you are allergic to it; or to other vaccines (e.g., diphtheria, tetanus, Haemophilus influenzae); or if you have any other allergies. This product may contain inactive ingredients (such as latex or dry natural rubber that can be found in the product packaging), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: vaccination/immunization history, recent illness/fever, bleeding problems (e.g., low platelets).

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

It is unknown if this drug passes...

Read All Potential Precautions of Prevnar »

Last reviewed on RxList: 2/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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Prevnar - User Reviews

Prevnar User Reviews

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Report Problems to the Food and Drug Administration

 

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