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Comvax Vaccine is used for:

Preventing infection caused by Haemophilus influenzae type B bacteria and hepatitis B virus.

Comvax Vaccine is a vaccine. It works by stimulating the body to produce antibodies against Haemophilus influenzae type B bacteria and hepatitis B virus.

Do NOT use Comvax Vaccine if:

• you are allergic to any ingredient in Comvax Vaccine
• you have a fever

Contact your doctor or health care provider right away if any of these apply to you.

Before using Comvax Vaccine:

Some medical conditions may interact with Comvax Vaccine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an infection, heart or lung problems, multiple sclerosis, a bleeding disorder (eg, hemophilia), low platelet counts, or cancer
• if you have a weakened immune system or are taking an immunosuppressive medicine (eg, cyclosporine)

Some MEDICINES MAY INTERACT with Comvax Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Immunosuppressive medicines (eg, cyclosporine) because they may decrease Comvax Vaccine's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Comvax Vaccine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Comvax Vaccine:

Use Comvax Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Comvax Vaccine is usually administered as an injection at your doctor'�s office, hospital, or clinic.
• If Comvax Vaccine contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• If you miss a dose of Comvax Vaccine, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Comvax Vaccine.

Important safety information:

• Comvax Vaccine may cause fever, irritability, and redness, tenderness, or a lump at the injection site. These symptoms should go away within 1 to 2 days.
• This medicine is not recommended for use in CHILDREN younger than 6 weeks of age or older than 15 years of age. Safety and effectiveness in these age groups have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Comvax Vaccine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Comvax Vaccine is excreted in breast milk. If you are or will be breast-feeding while you are using Comvax Vaccine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Comvax Vaccine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Crying; irritability; loss of appetite; low-grade fever; redness, tenderness, or a lump at the injection site; sleepiness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); high fever (above 103 degrees F).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Comvax Vaccine is usually handled and stored by a health care provider. If you are using Comvax Vaccine at home, store Comvax Vaccine as directed by your pharmacist or health care provider. Keep Comvax Vaccine out of the reach of children and away from pets.

General information:

• If you have any questions about Comvax Vaccine, please talk with your doctor, pharmacist, or other health care provider.
• Comvax Vaccine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Comvax Vaccine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.