Haemophilus B Polysaccharide Vaccine (Intramuscular Route, Injection Route)

The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

The following information applies only to the Haemophilus b polysaccharide vaccine .

Infection by Haemophilus influenzae 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 24 months up to 5 years of age (i.e., up to the 5th birthday). In addition, immunization is recommended for children 18 to 24 months of age, especially:

• Children attending day-care facilities.


• Children with chronic illnesses associated with increased risk of Hib disease. These illnesses include asplenia, sickle cell disease, antibody deficiency syndromes, immunosuppression, and Hodgkin`s disease.


• Children 18 to 24 months of age who have already had Hib disease. These children may get the disease again if they are not immunized. Children who developed Hib disease when 24 months of age or older do not need to be immunized, since most children in this age group will develop antibodies against the disease.


• Children with human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).


• Children of certain racial groups, such as American Indian and Alaskan Eskimo. Children in these groups seem to be at increased risk of Hib disease.


• Children living close together with groups of other persons. Close living conditions increase a child`s risk of being exposed to persons who have Hib infection or who carry the bacteria.

It is recommended that children immunized when they were 18 to 24 months of age receive a second dose of vaccine, since these children may not produce enough antibodies to fully protect them from Hib disease. Children who were first immunized when they were 24 months of age or older do not need to be reimmunized.

This vaccine is available only from your doctor or other authorized health care professional .

Before Using

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 18 months of age.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

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.

Other Interactions

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.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine . Make sure you tell your doctor if you have any other medical problems, especially:

• Fever or


• Serious illnessa€”The symptoms of the condition may be confused with the possible side effects of the vaccine

Proper Use

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 injection dosage form:
  
  
  
  • For prevention of Haemophilus influenzae type b infection:
    
    
    
    • Adults and children 5 years of age and oldera€”Use is not recommended .
    
    
    • Children up to 18 months of agea€”Use is not recommended .
    
    
    • Children 18 to 24 months of agea€”Use and dose must be determined by your doctor .
    
    
    • Children 24 months to 5 years of agea€”One dose injected under the skin or into a muscle.
    
    
    
    
  
  
  
  

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 .

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

Symptoms of allergic reaction

• 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

• Diarrhea


• Fever up to 102 A°F (39 A°C) (usually lasts less than 48 hours)


• Irritability


• Lack of appetite


• Lack of interest


• Redness at place of injection


• Reduced physical activity


• Tenderness at place of injection

Less common

• Fever over 102 A°F (39 A°C) (usually lasts less than 48 hours)


• Hard lump at place of injection


• Itching


• Joint aches or pains


• Skin rash


• Swelling at place of injection


• Trouble in sleeping


• Vomiting

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.