Pedvaxhib

PedvaxHIB is part of the drug class:

• Hemophilus influenzae B vaccines

Serious side effects have been reported with PedvaxHIB including the following:

• early onset Hib disease
• a condition in which the immune system attacks the nerves (Guillain-Barré syndrome)

Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.

Your child should not receive PedvaxHIB if your child has an allergy to PedvaxHIB or any component in the vaccine. 

• This vaccine will be administered by a healthcare provider.
• PedvaxHIB is a vaccine given as a shot into the upper arm or thigh. 
• If there is an interruption or delay between doses in the primary series, there is no need to repeat the series, but dosing should be continued at the next clinic visit. 

PedvaxHIB is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention. 

Haemophilus b conjugate vaccine is an active immunizing agent that is used to prevent infection caused by the Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Haemophilus b conjugate vaccine is prepared by adding a diphtheria, meningococcal, or tetanus-related substance to the process. However, this vaccine does not take the place of the regular vaccines for diphtheria, tetanus, or meningococcus that children and adults should receive. All of the haemophilus b conjugate vaccines work the same way, but they may be given at different ages or using a different schedule.

Infections with Haemophilus influenza type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis (a brain disease), epiglottitis (a throat disease that can cause suffocation), pericarditis (a heart disease), pneumonia (a lung disease), and septic arthritis (a bone and joint disease). Hib meningitis may cause death or leave the child with serious and permanent damage, such as mental retardation, deafness, epilepsy, or partial blindness.

Haemophilus b conjugate vaccine is recommended for all children 2 months to 5 years of age (i.e., up to the 6th birthday).

The Hiberix® vaccine is used as a booster dose for children who have already received the primary series with a haemophilus b conjugate vaccine. The vaccine will "boost" or increase the protection that the child had from an earlier dose.

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

• It is used to prevent Haemophilus influenzae type b disease.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Redness or swelling where the shot is given.
• Irritation where the shot is given.
• Feeling irritable.
• Feeling fussy.
• Feeling sleepy.
• Not hungry.
• Mild fever.
• Restlessness.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Liquid PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.

Liquid PedvaxHIB will not protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis. As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.

BECAUSE OF THE POTENTIAL FOR IMMUNE TOLERANCE, Liquid PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE. (See PRECAUTIONS.)

Revaccination

Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose (see DOSAGE AND ADMINISTRATION).

Hypersensitivity to any component of the vaccine or the diluent.

Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.