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USP DI Vol. II - HAEMOPHILUSB CONJUGATE VACCINE (Systemic)

HAEMOPHILUSB CONJUGATE VACCINE (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Act-Hib 4
  • Hibtiter 1
  • Pedvaxhib 3
  • Prohibit 2

In Canada?

  • Act-Hib 4
  • Hibtiter 1
  • Pedvaxhib 3
  • Prohibit 2

Other commonly used names are: HbOC, PRP-D, PRP-OMP, and PRP-T.

This information applies to the following medicines:
1.Haemophilus b Conjugate Vaccine (HbOC?DiphtheriaCRM 197 Protein Conjugate)??
2.Haemophilus b Conjugate Vaccine (PRP-D?DiphtheriaToxoid Conjugate)??
3.Haemophilusb Conjugate Vaccine (PRP-OMP?Meningococcal Protein Conjugate)?
4.Haemophilus b Conjugate Vaccine (PRP-T?TetanusProtein Conjugate)??
? Generic name product may be available in the U.S.
? Generic name product may be available in Canada

Category

  • Immunizing agent, active

Description

Haemophilus b conjugate (hem-OFF-fil-us BEE KON-ja-gat)vaccine is an active immunizing agent used to prevent infection by Haemophilus influenza type b (Hib) bacteria. The vaccine worksby causing your body to produce its own protection (antibodies) against thedisease.

Haemophilus b conjugate vaccine is an haemophilus b vaccine that has beenprepared by adding a diphtheria-, meningococcal-, or tetanus-related substance.However, this vaccine does not take the placeof the regular diphtheria or tetanus toxoid injections (for example, DTP,DT, or T) that children should receive, the regular tetanus toxoid or diphtheriaand tetanus toxoid injections (for example T or Td) that adults should receive,or the meningococcal vaccine injection that some children and adults shouldreceive.

Infection by Haemophilus influenza typeb (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 causesdeath in 5 to 10% of children who are infected. Also, approximately 30% ofchildren who survive Hib meningitis are left with some type of serious permanentdamage, such as mental retardation, deafness, epilepsy, or partial blindness.

Immunization against Hib is recommended for all children 2 months up to5 years of age (i.e., up to the 5th birthday).

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

This vaccine is to be administered only by or under the supervision ofyour doctor or other authorized health care professional. It is availablein the following dosage form:

    Parenteral
  • Injection (U.S. and Canada)


Before Receiving This Vaccine

In deciding to use a medicine, the risks of taking the medicine must beweighed against the good it will do. This is a decision you and your doctorwill make. For haemophilus b conjugate vaccine, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to haemophilus b conjugate vaccine, haemophilus b polysaccharidevaccine, diphtheria or tetanus toxoid, or meningococcal vaccine. Also tellyour health care professional if you are allergic to any other substances,such as preservatives.

Pregnancy?Studies on effects in pregnancy have not been donein either humans or animals.

Breast-feeding?This vaccine has not been reported to cause problemsin nursing babies.

Children?This vaccine is not recommended for children lessthan 2 months of age.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing 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 inolder people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of haemophilus b conjugate vaccine. Make sureyou tell your doctor if you have any other medical problems, especially:

  • Fever or
  • Serious illness?The symptoms of the condition may be confusedwith some of the possible side effects of the vaccine

Proper Use of This Vaccine

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

The dose of haemophilus b conjugate vaccine will be different for differentpatients. The following information includes only the average doses of haemophilusb conjugate vaccine.

  • For prevention of Haemophilus influenzaetype b infection:
    • For HbOC or PRP-T injection dosage form:
      • Adults and children 5 years of age and older?Use and dose mustbe 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 dosesare 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 dosesare 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 intoa muscle.
      • Children 15 to 59 months of age at the first dose?One doseinjected into a muscle.
    • For PRP-D injection dosage form:
      • Adults and children 5 years of age and older?Use and dose mustbe 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 doseinjected into a muscle.
    • For PRP-OMP injection dosage form:
      • Adults and children 5 years of age and older?Use and dose mustbe determined by your doctor.
      • Infants 2 to 6 months of age at the first dose?Two doses, twomonths apart, then a booster dose at twelve months of age. The doses are injectedinto 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 dosesare 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 intoa muscle.
      • Children 15 to 59 months of age at the first dose?One doseinjected 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 aretreated 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 maycause 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; unusualtiredness or weakness (sudden and severe)

    Checkwith your doctor immediately if the following side effect occurs:

      Rare

        Convulsions (seizures)

Other side effects may occurthat usually do not need medical attention. However, check with your doctorif any of the following side effects continue or are bothersome:

    More common

      Fever of up to 102 ?F (39 ?C) (usually lasts less than48 hours); irritability; loss of appetite; lack of interest; redness at place of injection; reducedphysical activity; tenderness at place of injection; tiredness

    Less common

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

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


Revised: 08/16/2000