Pediarix (PF) 10 mcg-25 Lf-25 mcg-10 Lf/0.5 mL intramuscular syringe

Generic name:
Diphtheria/tetanus/pertussis/hepatitis b/polio vaccine - injection

Pronunciation
(dip-THEER-ee-uh/TET-un-us/per-TUSS-iss/hep-uh-TIE-tuss B/POE-lee-oh)

Brand name(s)
Pediarix

This medication is a combination of vaccines. It is given to children between the ages of 6 weeks and 7 years old to prevent certain serious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and polio.

Vaccination is the best way to protect (provide immunity) against these life-threatening diseases. Vaccines work by getting the body to make its own protection (antibodies).

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is given by injection into a muscle by a health care professional. It is usually given in the thigh in infants and in the upper arm in older children.

This vaccine is usually given in a series of 3 doses at 2, 4, and 6 months of age or as directed by the health care professional. Closely follow the vaccination schedule provided by the health care professional.

Pain/swelling/redness at the injection site may occur. Mild fever, sleepiness, fussiness, and loss of appetite may also occur. If any of these effects last or get worse, tell the health care professional promptly. Consult the health care professional about the short-term use of acetaminophen to treat pain and fever caused by this vaccine.

Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell the health care professional right away if your child has any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.

Remember that this medication has been prescribed because the health care professional has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the health care professional right away if your child has any serious side effects, including:

• high fever (105 degrees F/40 degrees C or higher)
• crying that doesn't stop (beginning within 48 hours of the injection and lasting longer than 3 hours)
• little or no response to sound/touch
• unusual pain (such as shoulder pain)
• muscle weakness/floppy muscles
• seizures

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the health care professional.

Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Before your child receives this vaccine, tell the health care professional if your child is allergic to it; or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as dry natural rubber/latex found in the packaging of some products, yeast, neomycin, polymyxin B), which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before your child receives this vaccine, tell the health care professional your child's medical history, especially of:

• a previous reaction to any vaccines (such as high fever, seizures)
• current fever/illness
• immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment)
• brain/nervous system disorders (such as seizures)
• history of Guillain-Barre syndrome

This vaccine is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult your health care professional if you have any questions about this vaccine.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the health care professional. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

Some products that may interact with this vaccine include:

• drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone)

Not applicable.

Even if your child has already had any of the diseases that this vaccine prevents, your child may not be protected from getting those diseases again. Your child should still receive this vaccine if the health care professional orders it.

It is important that your child receives each vaccination as scheduled. Be sure to ask when your child should receive the next dose. It may help to make a note on your calendar to remind you. If you miss a dose, call the health care professional right away to reschedule.

Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.