Pneumococcal Polyvalent-23 Vaccine (with isolate 12F) Solution for injection

What is this medicine?

PNEUMOCOCCAL VACCINE, POLYVALENT (NEU mo KOK al vak SEEN, pol ee VEY luhnt) is a vaccine to prevent pneumococcus bacteria infection. These bacteria are a major cause of ear infections, Strep throat infections, and serious pneumonia, meningitis, or blood infections worldwide. These vaccines help the body to produce antibodies (protective substances) that help your body defend against these bacteria. This vaccine is recommended for people 2 years of age and older with health problems. It is also recommended for all adults over 50 years old. This vaccine will not treat an infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• bleeding problems
• bone marrow or organ transplant
• cancer, Hodgkin's disease
• fever
• infection
• immune system problems
• low platelet count in the blood
• seizures
• an unusual or allergic reaction to pneumococcal vaccine, diphtheria toxoid, other vaccines, latex, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This vaccine is for injection into a muscle or under the skin. It is given by a health care professional.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• medicines for cancer chemotherapy
• medicines that suppress your immune function
• medicines that treat or prevent blood clots like warfarin, enoxaparin, and dalteparin
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Mild fever and pain should go away in 3 days or less. Report any unusual symptoms to your doctor or health care professional.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• confused
• fever over 102 degrees F
• pain, tingling, numbness in the hands or feet
• seizures
• unusual bleeding or bruising
• unusual muscle weakness

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches and pains
• diarrhea
• fever of 102 degrees F or less
• headache
• irritable
• loss of appetite
• pain, tender at site where injected
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This does not apply. This vaccine is given in a clinic, pharmacy, doctor's office, or other health care setting and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.