Prevnar 13 - Consumer Medicine Information
|Condition:||Pneumococcal Disease Prophylaxis|
|Form:||Liquid solution, Intramuscular (IM)|
|Ingredients:||saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F, 6B, sodium chloride, succinic acid, Polysorbate 80, water for injection|
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
About This Vaccine
What the Vaccine is Used For
Prevnar 13 is a pneumococcal vaccine given to:
- Children from 6 weeks 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
Conjugated to CRM197 carrier protein and adsorbed on aluminum phosphate (0.125 mg aluminum).
What the Important nonmedicinal ingredients Are
Sodium chloride, succinic acid, Polysorbate 80 and water for injection.
What Dosage Forms 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
Prevnar 13 will only protect against disease caused by the types of Streptococcus pneumoniae in the vaccine.
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 Vaccine
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 Vaccine
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.
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 with Prevnar 13 is unlikely due to it being in a pre-filled syringe.
In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
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
- Drowsiness/increased sleep, restless sleep/decreased sleep
- Fever; any pain, tenderness, redness, swelling or hardness at the vaccination-site
Common side effects reported in at least 1 in 100 children, but less than 1 in 10 children are:
- Diarrhea, vomiting
- Fever > 39°C, pain or tenderness at the vaccination-site interfering with movement
Uncommon side effects reported in at least 1 in 1,000 children, but less than 1 in 100 children are:
- Seizures (including febrile seizures)
- Urticaria or urticaria-like rash
- Redness, swelling, or hardness at the vaccination-site > 7.0 cm
Rare side effects reported in at least 1 in 10,000 children, but less than 1 in 1,000 children are:
- Hypotonic-hyporesponsive episode (collapse or shock-like state)
- Hypersensitivity reaction including swelling of the face and/or lips, difficulty in breathing
In babies born very prematurely (at or before 28 weeks of gestation), longer gaps than normal between breaths may occur for 2-3 days after vaccination.
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
- Any pain, tenderness (including impaired movement), redness, swelling or hardness at the vaccination-site
- Drowsiness/increased sleep, restless sleep/decreased sleep
Common side effects reported in at least 1 in 100 but less than 1 in 10 children and adolescents 5-17 years of age were:
- Hives (urticaria)
Children and adolescents aged 6-17 years with sickle cell disease or with HIV infection, and children and adolescents aged 2-17 years with a blood-forming stem cell transplant, generally had similar frequencies of side effects as healthy children and adolescents aged 5-17 years; however, the frequencies of muscle pain, fatigue, headache, joint pain, vomiting, fever and diarrhea were very common (>1/10). 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
- Diarrhea; vomiting (in adults aged 18-49 years)
- 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
Common side effects reported in at least 1 in 100 adults, but less than 1 in 10 adults are:
- Vomiting (in adults aged 50 years and over)
Uncommon side effects reported in at least 1 in 1,000 adults, but less than 1 in 100 adults are:
- Hypersensitivity reaction including swelling of the face and/or lips, difficulty breathing
- Enlarged lymph nodes (lymphadenopathy) in the region of the injection site.
Adults 18 years and older with HIV infection, or with a blood-forming stem cell transplant, had similar frequencies of side effects as healthy adults 18 years and older, however the frequencies of fever were very common (>1/10).
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
Please speak with your doctor or pharmacist should you have any questions or concerns. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Serious Side Effects how Often They Happen and What to Do About Them
|Symptom / effect||Talk with your doctor|
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 It
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 Suspected 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
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.
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 Inc., at: 1-800-463-6001 (Medical Information).