Advanced Consumer Information

Pedvaxhib

Generic Name: haemophilus b conjugate vaccine (Intramuscular route)

hum-OFF-i-lus B KON-joo-gate vak-seen

Commonly used brand name(s):

In the U.S.

ActHIB
Hibtiter
Pedvaxhib

Available Dosage Forms:

Solution
Powder for Suspension
Powder for Solution

Therapeutic Class: Vaccine

Uses For Pedvaxhib

Haemophilus b conjugate vaccine is an active immunizing agent used to prevent infection by 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 an haemophilus b vaccine that has been prepared by adding a diphtheria-, meningococcal-, or tetanus-related substance. However, this vaccine does not take the place of the regular diphtheria or tetanus toxoid injections (for example, DTP, DT, or T) that children should receive, the regular tetanus toxoid or diphtheria and tetanus toxoid injections (for example T or Td) that adults should receive, or the meningococcal vaccine injection that some children and adults should receive.

Infection by Haemophilus influenza type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis, which affects the brain; epiglottitis, which can cause death by suffocation; pericarditis, which affects the heart; pneumonia, which affects the lungs; and septic arthritis, which affects the bones and joints. Hib meningitis causes death in 5 to 10% of children who are infected. Also, approximately 30% of children who survive Hib meningitis are left with some type of serious permanent damage, such as mental retardation, deafness, epilepsy, or partial blindness.

Immunization against Hib is recommended for all children 2 months up to 5 years of age (i.e., up to the 5th birthday).

Immunization against Hib may also be recommended for adults and children over 5 years of age with certain medical problems.

This vaccine is to be administered only by or under the supervision of your doctor or other authorized health care professional.

Before Using Pedvaxhib

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.

Pediatric

This vaccine is not recommended for children less than 2 months of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of this vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults.

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 haemophilus b conjugate vaccine

This section provides information on the proper use of a number of products that contain haemophilus b conjugate vaccine. It may not be specific to Pedvaxhib. Please read with care.

Haemophilus b conjugate vaccine is an haemophilus b vaccine that has been prepared by adding a diphtheria-, meningococcal-, or tetanus-related substance to it. If the vaccine was prepared using a diphtheria-related substance, it is called either HbOC or PRP-D. If the vaccine was prepared using a meningococcal-related substance, it is called PRP-OMP. If the vaccine was prepared using a tetanus-related substance, it is called PRP-T. All of these subtypes of haemophilus b conjugate vaccine work the same way, but may be given at different ages or times.

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.

For prevention of Haemophilus influenzae type b infection:
- For HbOC or PRP-T injection dosage forms:
  - Adults and children 5 years of age and older—Use and dose must be determined by your doctor.
  - Children 15 to 59 months of age at the first dose—One dose injected into a muscle.
  - Children 12 to 14 months of age at the first dose—One dose, then a booster dose at fifteen months of age. The doses are injected into a muscle.
  - Children 7 to 11 months of age at the first dose—Two doses, two months apart, then a booster dose at fifteen months of age. The doses are injected into a muscle.
  - Infants 2 to 6 months of age at the first dose—Three doses, two months apart, then a booster dose at fifteen months of age. The doses are injected into a muscle.
For PRP-D injection dosage form:
- Adults and children 5 years of age and older—Use and dose must be determined by your doctor.
- Children 15 to 59 months of age at the first dose—One dose injected into a muscle.
- Infants and children up to 15 months of age—Use is not recommended.
For PRP-OMP injection dosage form:
- Adults and children 5 years of age and older—Use and dose must be determined by your doctor.
- Children 15 to 59 months of age at the first dose—One dose injected into a muscle.
- Children 12 to 14 months of age at the first dose—One dose, then a booster dose at fifteen months of age. The doses are injected into a muscle.
- Children 7 to 11 months of age at the first dose—Two doses, two months apart, then a booster dose at fifteen months of age. The doses are injected into a muscle.
- Infants 2 to 6 months of age at the first dose—Two doses, two months apart, then a booster dose at twelve months of age. The doses are injected into a muscle.

Precautions While Using Pedvaxhib

This vaccine may interfere with laboratory tests that check for Hib disease. Make sure your doctor knows that you have received Hib vaccine if you are treated for a severe infection during the 2 weeks after you receive this vaccine.

Pedvaxhib Side Effects

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.

Get emergency help immediately if any of the following side effects occur:

Symptoms of allergic reactions

Difficulty in breathing or swallowing
hives
itching (especially of feet or hands)
reddening of skin (especially around ears)
swelling of eyes, face, or inside of nose
unusual tiredness or weakness (sudden and severe)

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

Rare

Convulsions (seizures)

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

Fever of up to 102 °F (39 °C) (usually lasts less than 48 hours)
irritability
loss of appetite
lack of interest
redness at place of injection
reduced physical activity
tenderness at place of injection
tiredness

Less common

Diarrhea
fever over 102 °F (39 °C) (usually lasts less than 48 hours)
hard lump, swelling, or warm feeling at place of injection
skin rash
vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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