Details for: PNEUMOVAX 23
Company: MERCK CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02436442 | PNEUMOVAX 23 | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F | 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML | SOLUTION | INTRAMUSCULAR |
| 02436442 | PNEUMOVAX 23 | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F | 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML; 25 MCG / 0.5 ML | SOLUTION | SUBCUTANEOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication 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.
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 non-medicinal ingredients are
PNEUMOVAX® 23 also contains the following inactive ingredients: phenol, sodium chloride and water for injection.
What dosage form it comes in
PNEUMOVAX®
23 is supplied as a single-dose vial containing
0.5 mL of liquid vaccine. A multi-dose vial containing five 0.5 mL
doses can be made available for mass immunization programs.
PNEUMOVAX®
23 is also supplied as prefilled syringes 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.
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. Severe side effects after vaccination have been reported in some frail elderly people who have other serious medical problems.
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 medication
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 about these vaccines, talk to your doctor or health care provider, because it may be better to get these vaccines at least 4 weeks apart.
Proper use of this medication
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.
Overdose
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.
Tell your health care provider or get emergency help right away if
you get any of the following problems after vaccination because
these may be signs of an allergic reaction or other serious conditions:
- difficulty breathing
- wheezing
- rash
- hives
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
Store refrigerated at 2–8°C.
All vaccines must be discarded after the expiration date.
Reporting side effects
Reporting Suspected Vaccine Adverse Events
For the general public:
If you suspect you have had a serious or unexpected event following receipt of a vaccine, please ask your healthcare professional to complete the Adverse Events Following Immunization (AEFI) Form and send it to your local health unit in your province/territory.
For healthcare professionals:
If a patient experiences an adverse event following immunization, please complete the Adverse Events Following Immunization (AEFI) Form and send it to your local health unit in your province/territory.
If you have any questions or have difficulty contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada:
Toll-free telephone: 1-866-844-0018
Toll-free fax: 1-866-844-5931
By email: caefi@phac-aspc.gc.ca
NOTE: Should you require information related to the management of the adverse events,
please contact your health professional before notifying the Public Health Agency of
Canada. The Public Health Agency of Canada does not provide medical
advice.
More information
If you want more information about PNEUMOVAX® 23:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website or Merck Canada website www.merck.ca or by calling Merck Canada at 1-800-567-2594
To report an adverse event related to PNEUMOVAX® 23, please contact 1-800-567-2594.
This leaflet was prepared by Merck Canada Inc.
Last revised: April 15, 2016
® Merck Sharp & Dohme Corp. Used under license.
© 2011, 2016 Merck Canada Inc. All rights reserved.