Vaxelis (PF) 15 unit-5 unit-10 mcg/0.5 mL intramuscular syringe

Generic name:
Diphth/tetanus/pertuss/hep b/polio/haemoph b vaccine - injection

Pronunciation
(dif-THEER-ee-a/TET-a-nus/per-TUS-is/HEP-a-TYE-tis/POE-lee-oh/HEE-moe-FIL-us vak-SEEN)

Brand name(s)
Vaxelis

This medication is a combination of vaccines against diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, hepatitis B and Haemophilus influenzae B infection. Vaccination is the best way to protect against these life-threatening infections. Vaccines work by causing the body to produce its own protection (antibodies).

This combination of vaccines is usually used in infants and children.

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 injected into a muscle by a health care professional. It is usually given in the thigh or upper arm.

Vaccines are usually given in a series of doses to provide the best protection. Closely follow the vaccination schedule provided by the health care professional. Keep all scheduled medical appointments. It may be helpful to mark a calendar as a reminder. There are various combinations of vaccines available. Based on your child's age, vaccination history, and previous reaction to vaccines, the health care professional will decide which vaccines are best for your child. Discuss the risks and benefits of vaccination with the health care professional.

Pain/swelling/redness at the injection site may occur. Mild fever, irritability/crying, vomiting, loss of appetite, and diarrhea 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 temporary use of acetaminophen to treat pain and fever due to 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:

• crying that doesn't stop (beginning within 48 hours of the injection and lasting longer than 3 hours)
• high fever (105 degrees F/40 degrees C or higher)
• little or no response to sound/touch
• weak/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 vaccination, tell the health care professional if your child is allergic to any of the vaccines in this product; or to neomycin or polymyxin; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your health care professional for more details.

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

• current fever/illness/infection
• breathing problems
• immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment)
• personal/family history of seizure
• other brain/nervous system disorders (such as infantile spasms, encephalopathy)
• reaction to other vaccines
• Guillain-Barre syndrome

This vaccine is not usually used by adults. It is unlikely to be used during pregnancy or by a mother while breastfeeding. Consult the health care professional if you have any questions about using 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)

This vaccination may interfere with certain lab tests (such as antigen tests), possibly causing false test results. Make sure lab personnel and all the health care professionals know your child has been recently vaccinated.

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 make a note of when your child received their last vaccination for their medical record.

Store in the refrigerator away from light. 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.