Haemophilus B conjugate vaccine/hepatitis B vaccine recombinant (Injection)

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles. This vaccine is usually given in the thighs.
• A nurse or other trained health professional will give you this medicine.
• 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.

If a dose is missed:

• 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.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your child's doctor knows if your child is using any medicine that weaken the immune system (such as steroids, medicines to treat cancer, or radiation). These medicines may cause the vaccine to be less effective.

Warnings While Using This Medicine

• Make sure your child's doctor knows if your child has any illness, cancer, or any bleeding problems such as hemophilia or thrombocytopenia (low platelet count in the blood).
• Tell your doctor if your child has any type of illness or infection (such as a cold or the flu), especially if your child has a fever. Your doctor may want to delay giving the shot until your child is well.
• Patients who have problems with their immune systems, such as those who are receiving steroids, chemotherapy for cancer, or who have HIV infection or AIDS, may not be fully protected by this vaccine. Because there may be some benefit, your child's doctor may still want to give 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.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Black, tarry stools.
• Blistering, peeling, or red skin rash.
• Chills, cough, stuffy or runny nose, sore throat, and body aches.
• Fast heartbeat or fainting.
• Fever more than 103 degrees F.
• Unusual bleeding, bruising, or weakness.
• Unusual high-pitched crying.
• Weakness in your child's arms, legs, or face.

If you notice these less serious side effects, talk with your doctor:

• Diaper rash.
• Drowsiness, agitation, or seizures.
• Earache or swelling in the ear.
• Irritability.
• Mild diarrhea, vomiting, or loss of appetite.
• Mild skin rash.
• Pain, itching, burning, redness, swelling, or a lump under your child's skin where the shot was given.
• Red eyes.
• Sleepiness or unusual drowsiness.
• Sores or white patches in your child's mouth.

Introduction

Haemophilus B Conjugate Vaccine (hee-MOF-i-lus B KON-joo-gate VAX-een), Hepatitis B Vaccine Recombinant (hep-a-TYE-tis B VAX-een re-KOM-bin-ant)

Prevents infections caused by hepatitis B virus and Haemophilus influenzae type b virus. This vaccine is only given to infants and young children who are 6 weeks to 15 months of age.

Brand Name(s)

Comvax

If you notice other side effects that you think are caused by this medicine, tell your doctor

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