Haemophilus b Conjugate Vaccine (Systemic)
  
Haemophilus b Conjugate Vaccine (Systemic)
US Brand Names
• Act-Hib
• Hibtiter
• Pedvaxhib
• Prohibit
Canadian Brand Names
• Act-Hib
• Hibtiter
• Pedvaxhib
• Prohibit
Other commonly used names are: HbOC, PRP-D, PRP-OMP, and PRP-T.
Description
Haemophilus b conjugate (hem-OFF-fil-us BEE KON-ja-gat) vaccine is an active immunizing agent used to prevent infection byHaemophilus influenzatype 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 byHaemophilus influenzatype 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. It is available in the following dosage form:
Before Receiving This Vaccine
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For haemophilus b conjugate vaccine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to haemophilus b conjugate vaccine, haemophilus b polysaccharide vaccine, diphtheria or tetanus toxoid, or meningococcal vaccine. Also tell your health care professional if you are allergic to any other substances, such as preservatives.
Pregnancy
Studies on effects in pregnancy have not been done in either humans or animals.
Breast-feeding
This vaccine has not been reported to cause problems in nursing babies.
Children
This vaccine is not recommended for children less than 2 months of age.
Older adults
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.
Other 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 health care professional if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other medical problems
The presence of other medical problems may affect the use of haemophilus b conjugate vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
• Fever or
• Serious illness-The symptoms of the condition may be confused with some of the possible side effects of the vaccine
Proper Use of This Vaccine
Dosing
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.
The dose of haemophilus b conjugate vaccine will be different for different patients. The following information includes only the average doses of haemophilus b conjugate vaccine.
• For prevention of Haemophilus influenzae type b infection:
o For HbOC or PRP-T injection dosage form:
§ Adults and children 5 years of age and older-Use and dose must be determined by your doctor.
§ 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.
§ 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.
§ 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 15 to 59 months of age at the first dose-One dose injected into a muscle.
o For PRP-D injection dosage form:
§ Adults and children 5 years of age and older-Use and dose must be determined by your doctor.
§ Infants and children up to 15 months of age-Use is not recommended.
§ Children 15 to 59 months of age at the first dose-One dose injected into a muscle.
o For PRP-OMP injection dosage form:
§ Adults and children 5 years of age and older-Use and dose must be determined by your doctor.
§ 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.
§ 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.
§ 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 15 to 59 months of age at the first dose-One dose injected into a muscle.
After Receiving This Vaccine
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.
Side Effects of This Vaccine
Along with its needed effects, a vaccine 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 the following side effect occurs:
Rare
Convulsions (seizures).
Other side effects may occur that usually do not need medical attention. However, check with your doctor if any of the following side effects continue or are bothersome:
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 above may also occur in some patients. If you notice any other effects, check with your doctor.
Notes
This information applies to the following medicines:
1. Haemophilus b Conjugate Vaccine (HbOC-Diphtheria CRM197Protein Conjugate)
2. Haemophilus b Conjugate Vaccine (PRP-D-Diphtheria Toxoid Conjugate)
3. Haemophilus b Conjugate Vaccine (PRP-OMP-Meningococcal Protein Conjugate)
4. Haemophilus b Conjugate Vaccine (PRP-T-Tetanus Protein Conjugate)
August 16, 2000 
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