Pedvax HIB

DRUG DESCRIPTION

PedvaxHIB* [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] is a highly purified capsular polysaccharide (polyribosylribitol phosphate or PRP) of Haemophilus influenzae type b (Haemophilus b, Ross strain) that is covalently bound to an outer membrane protein complex (OMPC) of the B11 strain of Neisseria meningitidis serogroup B. The covalent bonding of the PRP to the OMPC which is necessary for enhanced immunogenicity of the PRP is confirmed by quantitative analysis of the conjugate's components following chemical treatment which yields a unique amino acid. The potency of PedvaxHIB is determined by assay of PRP.

Haemophilus influenzae type b and Neisseria meningitidis serogroup B are grown in complex fermentation media. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. The OMPC from Neisseria meningitidis is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration.

Liquid PedvaxHIB is ready to use and does not require a diluent. Each 0.5 mL dose of Liquid PedvaxHIB is a sterile product formulated to contain: 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225 mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate (previously referred to as aluminum hydroxide), in 0.9% sodium chloride, but does not contain lactose or thimerosal. Liquid PedvaxHIB is a slightly opaque white suspension.

This vaccine is for intramuscular administration and not for intravenous injection. (See DOSAGE AND ADMINISTRATION.)

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

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another haemophilus B vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with haemophilus B 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...

Read All Potential Side Effects and See Pictures of Pedvax HIB

What are the precautions when taking haemophilus b conjugate vaccine (Pedvax HIB)?

Before receiving this vaccination, tell your doctor or pharmacist if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if your child has: high fever, moderate/severe acute illness.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment),...

Read All Potential Precautions of Pedvax HIB


Pedvax HIB Consumer (continued)

SIDE EFFECTS: Pain, swelling, and redness at the injection site may occur. Drowsiness, irritability/crying, loss of appetite, diarrhea, fever, or vomiting may also occur. If any of these effects persist or worsen, notify the doctor or pharmacist promptly.

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

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, unresponsiveness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 vaccination, tell your doctor or pharmacist if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if your child has: high fever, moderate/severe acute illness.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment), vaccination history including previous reactions to any vaccines.

Patients with Hodgkin's disease should receive the vaccine at least 10-14 days before beginning treatment or wait at least 3 months after chemotherapy is stopped.

This vaccine is not recommended for use during pregnancy and is not usually used in adults.

It is not known whether this drug passes into breast milk. This vaccine is not usually used in adults. Consult your doctor before breast-feeding.


Pedvax HIB Patient Information Including Side Effects

Brand Names: Liquid PedvaxHIB

Generic Name: haemophilus b conjugate (PRP-OMP) vaccine (Pronunciation: hem OFF il us B KON ju gate)

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

What is haemophilus B conjugate (PRP-OMP) vaccine (Pedvax HIB)?

Haemophilus B is a type of influenza (flu) caused by bacteria.

Haemophilus B bacteria can infect the lungs or throat, and can also spread to the blood, bones, joints, brain, or spinal cord. It can cause breathing problems or meningitis, and these infections can be fatal.

Haemophilus B disease can spread from one person to another through small droplets of saliva that are expelled into the air when an infected person coughs or sneezes. The bacteria can also be passed through contact with objects the infected person has touched, such as a door handle, or other surface. The bacteria can also be passed through kissing, or sharing a drinking glass or eating utensil with an infected person.

Haemophilus B conjugate vaccine is used to prevent infection caused by haemophilus B bacteria. The vaccine will not protect against other types of influenza.

Haemophilus B conjugate vaccine 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. This vaccine will not treat an active infection that has already developed in the body.

Haemophilus B conjugate vaccine is for use in children between the ages of 2 months and 6 years old.

Like any vaccine, haemophilus B conjugate vaccine may not provide protection from disease in every person.

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

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives another haemophilus B vaccine in the future, you will need to tell the child's doctor if the first shot caused any side effects.

Becoming infected with haemophilus B 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 your face, lips, tongue, or throat.

Call your doctor at once if your child has any of these serious side effects:

  • pale skin, severe weakness, dizziness, fast heartbeat;
  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • low fever;
  • mild fussiness or crying;
  • joint pain, body aches;
  • drowsiness; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Pedvax HIB)?

The haemophilus B conjugate vaccine is given in a series of shots. The first shot may be given when the child is at least 2 months old. Booster shots may be given at 12 to 15 months of age.

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.

Be sure your child receives all recommended doses of this vaccine. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

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.

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 haemophilus B 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.

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