Prevenar 13 suspension for injection
Pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed)
Read all of this leaflet carefully before your child receives this vaccine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This vaccine has been prescribed for your child. Do not pass it on to others.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.
In this leaflet:
- 1. What Prevenar 13 is and what it is used for
- 2. Before your child receives Prevenar 13
- 3. How Prevenar 13 is given
- 4. Possible side effects
- 5. How to store Prevenar 13
- 6. Further information
What Prevenar 13 Is And What It Is Used For
Prevenar 13 is a pneumococcal vaccine. Prevenar 13 is given to children from 6 weeks to 5 years to help protect against diseases such as: meningitis (inflammation around the brain), sepsis or bacteraemia (bacteria in the blood stream), pneumonia (lung infection) and ear infections caused by 13 types of the bacteria Streptococcus pneumoniae.
The vaccine works by helping the body to make its own antibodies, which protect your child against these diseases.
Before Your Child Receives Prevenar 13
Prevenar 13 should not be given:
- if your child is allergic (hypersensitive) to the active substances, to any other ingredients or to any other vaccine that contains diphtheria toxoid. The active substances and other ingredients are listed under “What Prevenar 13 contains” in section 6.
- if your child has a severe infection with a high temperature (over 38°C). If this applies to your child, then the vaccination will be postponed until your child is feeling better. A minor infection, such as a cold, should not be a problem. However, talk to your doctor, pharmacist, or nurse first.
Take special care with Prevenar 13
Tell the doctor, pharmacist, or nurse before the vaccination:
- if your child has any present or past medical problems after any dose of Prevenar or Prevenar 13 such as an allergic reaction or problems with breathing.
- if your child has any bleeding problems or bruises easily.
- if your child has a weakened immune system (such as due to HIV infection), she/he may not get the full benefit from Prevenar 13.
As with any vaccine, Prevenar 13 will not protect 100 % of those who receive the vaccine.
Prevenar 13 will only protect against ear infections caused by the types of Streptococcus pneumoniae for which the vaccine has been developed. It will not protect against other infectious agents that can cause ear infections.
Using other medicines/vaccines:
Your doctor may ask you to give your child paracetamol or other medicines that lower fever before Prevenar 13 is given. This will help to lower some of the side effects of Prevenar 13.
Please tell your doctor, pharmacist or nurse if your child is taking, has recently taken any other medicines, including medicines obtained without prescription, or has recently received any other vaccine.
How Prevenar 13 Is Given
The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your child's arm or leg muscle.
Infants aged 6 weeks to 6 months of age
Typically, your child should receive an initial course of three injections of the vaccine followed by a booster dose.
- The first injection may be given from the age of six weeks.
- Each injection will be given at least one month apart.
- A fourth injection (booster) will be given between 11 and 15 months of age.
- You will be told when your child should come back for the next injection.
According to official recommendations in your country, an alternative schedule may be used by your healthcare provider. Please speak to your doctor, pharmacist, or nurse for more information.
Unvaccinated infants and children over 7 months of age
Infants aged 7 to 11 months should receive two injections. Each injection will be given at least one month apart. A third injection will be given in the second year of life.
Children aged 12 to 23 months should receive two injections. Each injection will be given at least two months apart.
Children aged 2 to 5 years should receive one injection.
Infants and children previously vaccinated with Prevenar
Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the course of injections.
For children 1 to 5 years of age previously vaccinated with Prevenar, your doctor or nurse will recommend how many injections of Prevenar 13 are required.
It is important to follow the instructions from the doctor, pharmacist, or nurse so that your child completes the course of injections.
If you forget to go back at the scheduled time, ask the doctor, pharmacist, or nurse for advice.
If you have any further questions on the use of Prevenar 13, ask your doctor, pharmacist, or nurse.
Possible Side Effects
Like all vaccines, Prevenar 13 can cause side effects; although not everybody gets them.
The following side effects include those reported for Prevenar 13:
The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:
- Decreased appetite
- Fever; irritability; any pain, tenderness, redness, swelling or hardness at the injection-site;
drowsiness; restless sleep
Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:
- Fever of more than 39°C
Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:
- Vomiting; diarrhoea
- Redness, swelling, or hardness at the injection-site of more than 7 cm; crying
Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:
- Seizures (or fits), including those caused by a high temperature
- Hypersensitivity reaction, including swelling of the face and/or lips, difficulty in breathing
- Rash; urticaria or urticaria-like rash (hives)
- Flushing
Prevenar 13, which provides protection against 13 types of Streptococcus pneumoniae bacteria, replaces Prevenar, which provided protection against 7 types.
The following additional side effects have been seen with Prevenar because it has been available for a longer period of time. These side effects may be reported in the future with Prevenar 13:
Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:
- Anaphylactic/anaphylactoid reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)
- Hypotonic-hyporesponsive episode (collapse or shock-like state); urticaria (hives), dermatitis (redness and irritation) and pruritus (itching) at the injection-site
Very rare side effects (these may occur with up to 1 in 10,000 doses of the vaccine) are:
- Enlarged lymph nodes or glands (lymphadenopathy) near the injection site, such as under the arm or in the groin
- Erythema multiforme (a rash causing itchy red blotches)
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.
Please speak with your doctor, pharmacist, or nurse 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, pharmacist, or nurse.
How To Store Prevenar 13
Keep out of the reach and sight of children.
Do not use Prevenar 13 after the expiry date stated on the carton and label. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Prevenar 13 contains
The active substances are:
- 2.2 µg of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F
- 4.4 µg of polysaccharide for serotype 6B
Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium).
The other ingredients are sodium chloride, succinic acid, polysorbate 80 and water for injections.
What Prevenar 13 looks like and contents of the pack
The vaccine is a white suspension for injection, provided in a single-dose, pre-filled syringe (0.5 ml). Pack sizes of 1 and 10, with or without needle, and a multipack each containing 5 packs of 10 pre-filled syringes, with or without needle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Manufacturing Authorisation Holder responsible for batch release:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom
This leaflet was last approved in 03/2010.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website http://www.emea.europa.eu/home
Doc ID: 59628
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