Details for: PREVNAR 13
Company: PFIZER CANADA ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02335204 | PREVNAR 13 | PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F; CORYNEBACTERIUM DIPHTHERIAE CRM-197 PROTEIN | 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 4.4 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 2.2 MCG / 0.5 ML; 34 MCG / 0.5 ML | SUSPENSION | INTRAMUSCULAR |
Summary Reports
Regulatory Decision Summary
Regulatory Decision Summary
Regulatory Decision Summary
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
Prevnar 13 is a pneumococcal vaccine given to:
- Children from 6 weeks to 5 years to help protect against diseases such as: bacteraemic pneumonia (lung infection with bacteria in the blood stream), sepsis or bacteraemia (bacteria in the blood stream), meningitis (inflammation around the brain) and ear infections.
- Children from 6 years to 17 years to help protect against diseases such as: bacteraemic pneumonia (lung infection with bacteria in the blood stream), sepsis or bacteraemia (bacteria in the blood stream), and meningitis (inflammation around the brain).
- Adults aged 18 years and older to help prevent diseases such as: pneumonia (lung infection), bacteraemic pneumonia (lung infection with bacteria in the blood stream), sepsis or bacteraemia (bacteria in the blood stream), and meningitis (inflammation around the brain).
What it does
The vaccine works by helping the body to make its own antibodies, which protects you or your child against diseases caused by thirteen types of the bacteria Streptococcus pneumoniae.
When it should not be used
If you or your child is allergic (hypersensitive) to the active substances, to any other ingredients, or to any other vaccine that contains diphtheria toxoid.
What the medicinal ingredient is
The active substances are:
- 2.2 µg of saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F
- 4.4 µg of saccharide for serotype 6B
What the non-medicinal ingredients are
Sodium chloride, succinic acid, Polysorbate 80 and water for injection.
What dosage form it comes in
The vaccine is a white suspension for injection and provided in a single-dose, pre-filled syringe (0.5 mL). Pack size of 1 or 10, without needle.
Warnings and precautions
Serious Warnings and Precautions
Take special care with Prevnar 13:
- If you or your child has any present or past medical problems after any dose of Prevnar (7-valent) or Prevnar 13
- If you or your child is sick with a high fever
- If you or your child has any bleeding problems
As with any vaccine, Prevnar 13 will not protect 100% of those who receive the vaccine.
BEFORE you use Prevnar 13 talk to your doctor or
pharmacist:
Please tell your doctor, nurse or pharmacist if you or your child is
taking, or has recently taken any other medicines, including
medicines obtained without prescription, or has recently received
any other vaccine.
Increased reporting rates of seizures (fits), with or without fever,
and collapse or shock-like state were observed when Prevnar 13
was given at the same time as Infanrix hexa.
Some of the effects mentioned under the section “Side Effects and
What To Do About Them” may temporarily affect the ability to
drive or use machines.
Interactions with this medication
The vaccine is not to be mixed with other vaccines/products in
the same syringe.
Different injectable vaccines should always be given at
different vaccination-sites.
Proper use of this medication
Usual Dose
The doctor or nurse will inject the recommended dose (0.5 mL) of
the vaccine into you or your child's arm or leg muscle.
Infants and children
Typically, your child should receive 3 or 4 doses of the vaccine.
According to official recommendations in your province, an
alternative schedule may be used by your health care provider.
Each dose will be given on a separate occasion. It is important to
follow the instructions from the doctor/nurse so that your child
completes the course of injections.
Premature infants (born < 37 weeks of gestation) should receive
the vaccine according to the same schedule as full-term infants.
Prevnar 13 can be given at the same time as other childhood
vaccines; in this case, different vaccination-sites should be used.
Prevnar 13 should not be mixed with any other vaccines in the
same syringe.
Children and adolescents 6 to 17 years of age (prior to 18th
birthday)
Prevnar 13 is to be administered as a single dose to children and
adolescents 6 to 17 years of age.
Adults aged 18 years and older
Prevnar 13 is to be administered as a single dose to adults 18 years
and older including those previously vaccinated with
pneumococcal polysaccharide vaccine.
The need for revaccination with a subsequent dose of Prevnar 13
has not been established.
Special populations
Individuals not previously vaccinated with Prevnar 13 and
considered to be at a higher risk of pneumococcal infection (such
as those with sickle cell disease or HIV infection) may receive 1
dose of Prevnar 13, including those previously vaccinated with
pneumococcal polysaccharide vaccine.
Individuals with a stem cell transplant (blood-forming) may
receive 3 injections, with the first given at 3 to 6 months after the
transplant and with an interval of at least 1 month between doses.
A fourth injection (booster) is recommended 6 months after the
third injection.
Overdose
Overdose with Prevnar 13 is unlikely due to it being in a pre-filled syringe.
Missed Dose
If you forget to go back to the doctor or nurse at the scheduled
time, ask the doctor or nurse for advice.
If you have any further questions on the use of Prevnar 13, ask
your doctor.
Side effects and what to do about them
Like all vaccines, Prevnar 13 can cause side effects, although not
everybody gets them.
The following side effects include those reported for Prevnar 13 in
infants and children aged 6 weeks to 5 years.
The most common side effects reported in at least 1 in 10 children are:
- Decreased appetite
- Irritability
- Drowsiness/increased sleep, restless sleep/decreased sleep
- Fever; any pain, tenderness, redness, swelling or hardness at the vaccination-site
- Diarrhea, vomiting
- Rash
- Fever > 39°C, pain or tenderness at the vaccination-site interfering with movement
- Crying
- Seizures (including febrile seizures)
- Urticaria or urticaria-like rash
- Redness, swelling, or hardness at the vaccination-site > 7.0 cm
- Hypotonic-hyporesponsive episode (collapse or shock-like state)
- Hypersensitivity reaction including swelling of the face and/or lips, difficulty in breathing
The following side effects include those reported for Prevnar 13 in children and adolescents aged 5-17 years of age.
The most common side effects reported in at least 1 in 10 children and adolescents 5-17 years of age were:
- Decreased appetite
- Irritability
- Any pain, tenderness (including impaired movement), redness, swelling or hardness at the vaccination-site
- Drowsiness/increased sleep, restless sleep/decreased sleep
- Hives (urticaria)
- Fever
Other side effects observed in other age groups may also be applicable in this age group but due to the small sample size in this study were not seen.
The following side effects include those reported for Prevnar 13 in adults aged 18 years and older.
The most common side effects reported in at least 1 in 10 adults are:
- Decreased appetite
- Headache
- Diarrhea; vomiting (in adults aged 18-49 years)
- Rash
- New joint pain/aggravated joint pain; new muscle pain/aggravated muscle pain
- Chills; fatigue; any pain, tenderness, redness, swelling or hardness at the injection site; limitation of arm movement
- Vomiting (in adults aged 50 years and over)
- Fever
- Nausea
- Hypersensitivity reaction including swelling of the face and/or lips, difficulty breathing
- Enlarged lymph nodes (lymphadenopathy) in the region of the injection site.
Other side effects have been seen with Prevnar 13 since being introduced onto the market:
- Enlarged lymph nodes (lymphadenopathy) in the region of the vaccination-site
- Anaphylactic/anaphylactoid reaction including shock (cardiovascular collapse)
- Angioneurotic edema, erythema multiforme
- Vaccination-site dermatitis, vaccination-site urticaria, vaccination-site pruritus
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | |
|---|---|---|---|
| Common | |||
| Diarrhea; vomiting |
✔ | ||
| Rash | ✔ | ||
| Fever greater than 39C | ✔ | ||
| Vaccination-site swelling | ✔ | ||
| Uncommon | |||
| Seizures | ✔ | ||
| Rare | |||
| Hypotonichyporesponsive episode (collapse or shock-like state) | ✔ | ||
| Hypersensitivity reaction including facial swelling, difficulty breathing | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking Prevnar 13, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Do not use Prevnar 13 after the expiry date stated on the carton
and label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.
Reporting side effects
Reporting Side Effects
To monitor vaccine safety, the Public Health Agency of
Canada collects case reports on adverse events following
immunization.
For Health Care Professionals:
If a patient experiences an adverse event following
immunization, please complete the appropriate Adverse Events
Following Immunization (AEFI) Form and send it to your local
Health Unit in your province/territory.
For the General Public:
Should you experience an adverse event following
immunization, please ask your doctor, nurse, or pharmacist to
complete the Adverse Events Following Immunization (AEFI)
Form.
If you have any questions or have difficulties contacting your
local health unit, please contact Vaccine Safety Section at
Public Health Agency of Canada.
By toll-free telephone: 866-844-0018
By toll-free fax: 866-844-5931
Email: caefi@phac-aspc.gc.ca
Web: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php
Mail:
The Public Health Agency of Canada
Vaccine Safety Section
130 Colonnade Road, A/L 6502A
Ottawa, ON K1A 0K9
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 does not provide medical
advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found at www.pfizer.ca or can be
obtained by contacting the sponsor, Pfizer Canada ULC, at:
1-800-463-6001 (Medical Information).
This leaflet was prepared by Pfizer Canada ULC
Last revised: August 8, 2019