Patient Medication Information: uses, side effects, how to take - Pneumovax 23 -(5-Dose)
What the vaccine is used for:
PNEUMOVAX® 23 is an injectable vaccine to help prevent infections, such as pneumonia and bacteremia (severe infection in the blood), caused by certain types of pneumococcal bacteria.
The vaccine can be administered routinely to persons 50 years of age or older. The vaccine can also be administered to persons 2 years of age and older if:
they have chronic illnesses (e.g., heart disease, lung
disease, liver disease or diabetes mellitus), alcoholism or cerebrospinal fluid leaks.
they do not have a spleen or have a spleen that does not
function properly.
they have HIV infection, Hodgkin’s disease, lymphoma,
multiple myeloma, leukemia, generalized malignancy, chronic renal failure or nephrotic syndrome, are receiving cancer chemotherapy or other immunosuppressive therapy (including corticosteroids) or have organ or bone marrow transplantation.
they are living in special environments or social settings
with an increased risk of pneumococcal infection.
A second dose of the vaccine may be recommended at a later date if you are at high risk for a pneumococcal infection.
What it does:
Your doctor has recommended or administered PNEUMOVAX® 23 to help protect you or your child against pneumococcal infections caused by the most common types of pneumococci.
Pneumococcal infection is a leading cause of death throughout the world and is a major cause of pneumonia, swelling of the coverings on the brain and spinal cord (meningitis), middle ear infections (otitis media), and a severe infection in the blood (bacteremia). These problems are more likely to occur in older people and those with certain diseases that make them more susceptible to a pneumococcal infection.
When it should not be used:
PNEUMOVAX® 23 should not be used by anyone who:
- is allergic to any of the ingredients in the vaccine. A list of ingredients can be found below.
- has had an allergic reaction from a previous dose of the vaccine.
What the medicinal ingredient is:
Each dose of vaccine contains 25 micrograms of each of 23 types of polysaccharide from bacteria known as pneumococci. These have been highly purified to make them suitable for you or your child to be given them as an injection. The 23 types of pneumococcal polysaccharide in the vaccine are types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F.
What the important nonmedicinal ingredients are: PNEUMOVAX® 23 also contains the following inactive ingredients: phenol, sodium chloride and water for injection.
What dosage forms it comes in:
PNEUMOVAX® 23 is supplied as a single-dose vial containing 0.5 mL of liquid vaccine.
WARNINGS AND PRECAUTIONS
Before you or your child receive PNEUMOVAX® 23, it is very important to tell your healthcare provider:
- if you or your child are allergic to any component of the vaccine; and
- about any medical problem you or your child have or have had, including any allergies.
Use in children
PNEUMOVAX® 23 can be used in children 2 years of age and older. It is not recommended for use in children below 2 years of age.
Use in pregnancy
It is not known whether the vaccine is harmful to an unborn baby when administered to a pregnant woman. Tell your doctor if you are pregnant. Your doctor will decide if you should receive PNEUMOVAX® 23.
Use in breast-feeding
Tell your doctor if you are breast-feeding or intend to breast-feed. Your doctor will decide if you should receive PNEUMOVAX®
23.
Use in elderly
Individuals 65 years and older may not tolerate medical interventions as well as younger individuals. Therefore, a higher number and/or a greater severity of reactions in some older individuals cannot be ruled out.
Can I drive or operate machinery following vaccination with PNEUMOVAX® 23?
There is no information to suggest that PNEUMOVAX® 23 affects your ability to drive or operate machinery.
What other important information about PNEUMOVAX®
23 should I know?
As with other vaccines, PNEUMOVAX® 23 may not fully protect all those who receive it.
| INTERACTIONS WITH THIS VACCINE |
PNEUMOVAX® 23 has been administered at the same time as influenza vaccines with satisfactory results. Your doctor will decide the vaccination schedule.
PNEUMOVAX® 23 should not be given at the same time as ZOSTAVAX™ (zoster vaccine live, attenuated [Oka/Merck]). For more information, talk to your doctor.
| PROPER USE OF THIS VACCINE |
Usual dose:
PNEUMOVAX® 23 is given by intramuscular or subcutaneous injection.
The dose of the vaccine is the same for everyone.
A second dose of PNEUMOVAX® 23 is not routinely recommended. However, for persons at the highest risk of serious pneumococcal infection, a second dose of the vaccine may be recommended. Your doctor will decide if and when you need a second dose of PNEUMOVAX® 23.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Any vaccine may have unintended or undesirable effects, so-called side effects. The most common side effects reported with PNEUMOVAX® 23 are soreness, redness, swelling, warmth and hardening at the injection site and fever.
Other side effects may also occur rarely (e.g., fatigue, chills, feeling unwell, nausea, vomiting, enlarged and/or inflamed lymph glands, arthritis, headache, allergic reaction, joint pain, muscle pain, altered skin sensation, hives or rash, pain, decreased ability to move limb, and seizures in children due to fever), and some of these may be serious.
Your doctor has a more complete list of side effects.
Tell your doctor promptly about any of these or any other unusual symptoms. If the condition persists or worsens, seek medical attention.
This is not a complete list of side effects. For any unexpected
effects while taking PNEUMOVAX® 23, contact your doctor or pharmacist.
HOW TO STORE IT
Store refrigerated at 2-8°C.
All vaccines must be discarded after the expiration date.
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects information on serious and unexpected adverse events following vaccination. If you suspect you have had a serious or unexpected event following receipt of a vaccine you should contact your physician or pharmacist. You may also notify the Public Health Agency of Canada:
By toll-free telephone: 1-866-844-0018
By toll-free fax: 1-866-844-5931
By email: caefi@phac-aspc.gc.ca
By regular mail:
Vaccine Safety Section
Centre for Immunization & Respiratory Infectious Diseases Public Health Agency of Canada
130 Colonnade Road, A/L 6502A
Ottawa, ON K1A 0K9
or Merck Frosst Canada Ltd.:
By toll-free telephone: 1-800-567-2594
By toll-free fax: 1-877-428-8675
By regular mail:
Merck Frosst Canada Ltd.
P.O. Box 1005
Pointe-Claire - Dorval, QC H9R 4P8
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada or Merck Frosst Canada Ltd. do not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.merckfrosst.com
or by contacting the sponsor, Merck Frosst Canada Ltd., at: 1-800-567-2594.
Last revised: April 24, 2009
PNEUMOVAX®23 is a Registered Trademark of Merck & Co., Inc. Used under license.