Haemophilus B Conjugate Vaccine (Intramuscular Route)

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

Haemophilus b conjugate vaccine is a haemophilus b vaccine that is 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 (e.g., DTP, DT, or T) that children should receive, the regular tetanus toxoid or diphtheria and tetanus toxoid injections (e.g., T or Td) that adults should receive, or the meningococcal vaccine that some children and adults should receive.

If the haemophilus b conjugate 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 they may be given at different ages or using a different schedule.

Infection with 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 to 5 years of age (i.e., up to the 5th birthday).

The HiberixA® vaccine is used as a booster dose for children who have already received the primary series with a haemophilus b conjugate vaccine .

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 .

This product is available in the following dosage forms:

• Solution


• Powder for Solution


• Powder for Suspension

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of the haemophilus b conjugate vaccine in children 2 months to 5 years of age. However, safety and efficacy have not been established in children 5 to 16 years of age and children below 2 months of age.

Geriatric

No information is available on the relationship of age to the effects of haemophilus b conjugate vaccine in geriatric patients.

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:

• Guillain-BarrA© syndrome (severe nerve and muscle problem), history ofa€”May cause the symptoms of this condition to return.

• Immune system problems (e.g., cancer, HIV)a€”This vaccine may not work as well if you have a weak immune system .

Proper Use

A nurse or other trained health professional will give your child this vaccine . This vaccine is given as a shot into your child`s muscle.

This vaccine needs to be given on a fixed schedule. If your child misses a scheduled shot, call your child`s doctor to make another appointment as soon as possible.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Precautions

It is very important that your child return to your doctora€™s office at the right time for the second dose (booster). Be sure to notify your doctor of any side effects that occur after your child receives this vaccine .

This vaccine may interfere with laboratory tests that check for Hib disease. Make sure your doctor knows that your child received Hib vaccine if he/she is treated for a severe infection during the 2 weeks after the vaccine is given.

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:

More common

• Diarrhea


• Loss of appetite


• Vomiting

Rare

• Chest pain


• Convulsions (seizures)


• Cough


• Chills


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


• Lack or loss of strength


• Shortness of breath


• Sneezing


• Sore throat


• Tightness in the chest


• Troubled breathing


• Wheezing

Incidence not known

• Bluish lips or skin


• Difficulty with breathing or swallowing


• Dizziness


• Fast heartbeat


• Hives


• Itching (especially of feet or hands)


• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Reddening of the skin (especially around the ears)


• Skin rash


• Swelling of the eyes, face, or inside of the nose


• Unusual tiredness or weakness (sudden and severe)

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 A°F (39 A°C) (usually lasts less than 48 hours)


• Irritability


• Lack of interest


• Redness, pain, swelling, tenderness, or warm feeling at the injection site


• Reduced physical activity


• Restlessness


• Sleepiness

Incidence not known

• Hives or welts


• Sleepiness or unusual drowsiness

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.