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Haemophilus b conjugate and hepatitis b vaccine (Intramuscular)

hee-MOF-i-lus B KON-joo-gate VAX-een, hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Commonly used brand name(s)

In the U.S.

  • Comvax

Available Dosage Forms:

  • Suspension

Therapeutic Class: Vaccine

Uses For This Medicine

Haemophilus b conjugate vaccine and hepatitis B vaccine is a combination immunizing agent that is used to prevent infection caused by the Haemophilus influenzae type b (Hib) bacteria and hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Infections with Haemophilus influenza type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis (a brain disease), epiglottitis (a throat disease that can cause suffocation), pericarditis (a heart disease), pneumonia (a lung disease), and septic arthritis (a bone and joint disease). Hib meningitis may cause death or leave the child with serious and permanent damage, such as mental retardation, deafness, epilepsy, or partial blindness.

HBV infection is a major cause of serious liver diseases, such as hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, and young children.

This vaccine is to be administered only by or under the direct supervision of your doctor.

Before Using This Medicine

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 haemophilus b conjugate and hepatitis b vaccine 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 have not been performed on the relationship of age to the effects of Comvax® vaccine in infants younger than 6 weeks and older than 15 months of age. Safety and efficacy have not been established.

Geriatric

Comvax® vaccine is not recommended for adult or geriatric patients.

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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.

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:

  • Allergy to yeast—Should not be used in patients with this condition.
  • Bleeding problems (e.g., hemophilia, thrombocytopenia)—Use with caution. May have an increased risk of bleeding at the injection site.
  • Severe illness with a fever—Your child's dose may need to be given at a later time.
  • Weak immune system from a disease or medicine (e.g., those who are receiving a steroid, chemotherapy for cancer, or who have HIV infection)—May not work as well in patients with this condition.

Proper Use of This Medicine

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into one of your child's muscles, usually in the thighs.

This vaccine is usually given as 3 doses. It is usually given at 2, 4, and 12 to 15 months of age, unless your child's doctor tells you otherwise.

It is important that your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.

Precautions While Using This Medicine

It is very important that your child return to your doctor’s office at the right time for the second and third dose. Be sure to notify your child's doctor of any unwanted effects that occur after he or she receives the vaccine.

If your child develops a skin rash, hives, or any allergic reaction after receiving this vaccine, tell your child's doctor right away.

Tell your child's doctor right away if your child is allergic to latex rubber. The vaccine vials may contain dry natural latex rubber. This may cause an allergic reaction in patients who are sensitive to latex.

Before your child have any medical tests, tell the medical doctor in charge that your child is receiving this vaccine. The results of some tests may be affected by this vaccine.

This vaccine may not protect your child against diseases caused by haemophilus influenzae type b or hepatitis B infection if your child is already infected with the virus at the time he or she receives the shot.

This Medicine 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 or nurse immediately if any of the following side effects occur:

More common
  • Fever more than 103 degrees F
Less common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • convulsions
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • shortness of breath
  • skin rash
  • sores, ulcers, or white spots in the mouth or on the lips
  • tightness in the chest
  • unusual bleeding or bruising
  • wheezing

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
  • Hard lumps, pain, redness, soreness, swelling, or warmth at the injection site
  • irritability
  • sleepiness or unusual drowsiness
  • unusual, high-pitched crying
Less common
  • Earache
  • loss of appetite
  • redness or swelling in the ear
  • vomiting
  • weight loss
Rare
  • Sore mouth or tongue
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
Incidence not known
  • Hives or welts
  • redness of the skin

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.

See also: Side effects (in more detail)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about haemophilus b conjugate (prp-omp) vaccine/hepatitis b pediatric vaccine

Consumer resources

Other brands: Comvax

Related treatment guides

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