Prevnar

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 (?197) 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 g of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 g of serotype 6B per dose (16 g total saccharide); approximately 20 g 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 pneumococcal conjugate vaccine (PCV) (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.

Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any...

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 your child is allergic to it; or to other vaccines (e.g., diphtheria, tetanus, Haemophilus influenzae); or if your child has 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 the child's medical history, especially of: vaccination/immunization history, recent illness/fever, bleeding problems (e.g., low platelets).

This product is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you...

Read All Potential Precautions of Prevnar


Prevnar Consumer (continued)

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, swelling, hard lump), muscle/joint aches, or fever may occur. Ask your doctor if the child should take a fever/pain reducer (e.g., acetaminophen) to help treat these symptoms. Drowsiness, irritability, loss of appetite, nausea, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

Tell your doctor immediately if any of these rare but very serious side effects occur: 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 receiving this vaccine, tell your doctor or pharmacist if your child is allergic to it; or to other vaccines (e.g., diphtheria, tetanus, Haemophilus influenzae); or if your child has 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 the child's medical history, especially of: vaccination/immunization history, recent illness/fever, bleeding problems (e.g., low platelets).

This product is not usually used in adults. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this product.


Prevnar Patient Information Including Side Effects

Brand Names: Prevnar

Generic Name: pneumococcal conjugate vaccine (PCV-pediatric only), 7-valent (Pronunciation: NOO moe KOK al KON joo gate)

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

What is pneumococcal conjugate vaccine (PCV) (Prevnar)?

Pneumococcal disease is a serious infection caused by a bacteria. Pneumococcal bacteria can infect the sinuses and inner ear. It can also infect the lungs, blood, and brain, and these conditions can be fatal.

Pneumococcal conjugate vaccine (PCV) is used to prevent infection caused by pneumococcal bacteria. PCV contains 7 different types of pneumococcal bacteria.

PCV works by exposing your child to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. PCV will not treat an active infection that has already developed in the body.

PCV is for use only in children between the ages of 6 weeks and 10 years. For adults and children who are 2 years of age and older, another vaccine called Pneumovax (pneumococcal polysaccharides vaccine [PPV] 23-valent) is used.

Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Like any vaccine, PCV may not provide protection from disease in every person.

What are the possible side effects of pneumococcal conjugate vaccine (PCV) (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.

Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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 your child has any of these serious side effects:

  • high fever (103 degrees or higher);
  • seizure (convulsions);
  • easy bruising or bleeding; or
  • severe pain, itching, irritation, or skin changes where the shot was given.

Less serious side effects include

  • mild soreness, redness, swelling, or a hard lump where the shot was given;
  • weakness, tired feeling;
  • crying, fussiness;
  • drowsiness, restless sleep;
  • low fever (102 degrees or less);
  • vomiting, diarrhea, loss of appetite; or
  • mild skin rash.

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 pneumococcal conjugate vaccine (PCV) (Prevnar)?

The pneumococcal conjugate vaccine is given in a series of shots. The first shot is usually given when the child is 2 months old. The booster shots are then given at 4 months, 6 months, and 12 to 15 months of age.

In a child older than 6 months who has not yet received a PCV, the first dose can be given any time from the age of 7 months through 9 years.

If the child is less than 1 year old at the time of the first shot, he or she will need 2 booster doses. If the child is 12 to 23 months old at the time of the first shot, he or she will need 1 booster dose. A child who is 2 years or older at the time of the first shot may need only the one shot and no booster doses.

The timing of this vaccination is very important for it to be effective. Your child's 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.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever has to receive another PCV in the future, you will need to tell the doctor if the first shot caused any side effects.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Becoming infected with pneumococcal disease (such as pneumonia or meningitis) is much more dangerous to your child's health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Be sure to keep your child on a regular schedule for other immunizations against diseases such as diphtheria, tetanus, pertussis (whooping cough), measles, mumps, hepatitis, or varicella (chicken pox). Your doctor or state health department can provide you with a recommended immunization schedule.

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