What is it and how is it used?

Prevenar is a pneumococcal vaccine. Prevenar is given to children from 2 months to 5 years to helpprotect against diseases such as: meningitis, sepsis or bacteraemia (bacteria in blood stream), pneumonia and ear infection caused by seven 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.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use Prevenar:

  • if your child is allergic (hypersensitive) to the active substances, to any other ingredients or to diphtheria toxoid.
  • 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 acold, should not be a problem. However, talk to your doctor, pharmacist, or nurse first.
Take special care with Prevenar:

  • if your child has any present or past medical problems after any dose of Prevenar.
  • if your child has any bleeding problems.

Prevenar 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:

Please tell your doctor, nurse or pharmacist if your child is taking or has recently taken any other medicines including medicines obtained without prescription or has recently received any other vaccine

Important information about some of the ingredients of Prevenar:

This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially sodium-free.

How is it used?

The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into yourchild's arm or leg muscle.
Prevenar can be given at the same time as other childhood vaccines; in this case different injection sites should be used.
Infants aged 6 weeks to 6 months of age

Typically, your child should receive receive an initial course of three injections followed by a booster dose

  • The first injection may be given from 2 months of age.
  • Each injection will be given at least 1 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 health-care provider. Please speak to your doctor, pharmacist, or nurse for more information Unvaccinated infants and children over 7 months of age

Infants aged7 to 11 months should receive two injections. Each injection will be given at least 1 month apart. A third injection will be given in the second year of life.
Children aged12 to 23 months should receive two injections. Each injection will be given at least 2 month apart.
Children aged2 to 5 years should receive one injection.

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 to the doctor or nurse at the scheduled time, ask the doctor or nurse for advice.

What are possible side effects?

Like all vaccines, Prevenar can cause side effects, although not everybody gets them. The following side effects may happen with this vaccine.

The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are: :

  • Vomiting, diarrhoea, decreased appetite.
  • Pain, tenderness, redness, swelling, or hardness at the injection site; fever of 38 °C or higher, irritability, crying, drowsiness, restless sleep

Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:

  • Redness, swelling, or hardness at the injection site greater than 2.4 cm; tenderness at the injection site interfering with movement
  • Fever of 39°C or higher

Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:

  • Rash/hives (urticaria)

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
  • Hypotonic-hyporesponsive episode (collapse or shock-like state)
  • Hypersensitivity reaction, including swelling of the face and/or lips, difficulty in breathing, rash, urticaria or urticaria-like rash (hives)
  • Flushing

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 or pharmacist.

How should it be stored?

Keep out of the reach and sight of children

Store in a refrigerator (2°C ? 8°C). Do not freeze.

Do not use Prevenar 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.

Further information

What Prevenar contains

The active substances Each 0.5 ml dose contains Pneumococcal polysaccharide serotype 4 Pneumococcal polysaccharide serotype 6B Pneumococcal polysaccharide serotype 9V Pneumococcal polysaccharide serotype 14 Pneumococcal polysaccharide serotype 18C Pneumococcal polysaccharide serotype 19F Pneumococcal polysaccharide serotype 23F 2 micrograms 4 micrograms 2 micrograms 2 micrograms 2 micrograms 2 micrograms 2 micrograms

Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate 0.5 mg

The other ingredients are sodium chloride and water for injections.

What Prevenar looks like and contents of the pack

The vaccine is a suspension for injection and provided in a single-dose pre-filled syringe (0.5 ml). Pack sizes of 1 and 10 with or without needle.

Multipack presentation of 5 packs of 10 pre-filled syringes without needles.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Wyeth Lederle Vaccines S.A.
Pleinlaan 17 Boulevard de la Plaine
1050 Brussel - Bruxelles
Belgium

Manufacturing Authorisation Holder responsible for batch release:
John Wyeth & Brother Ltd.
Huntercombe Lane South
Taplow, Maidenhead
Berkshire, SL6 0PH-UK
United Kingdom

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Pfizer S.A. N.V. TélTel 32 02 554 62 11 Latvija Wyeth Whitehall Export GmbH Tãlr. 43 1 89 1140

Wyeth Whitehall Export GmbH Te 43 1 89 1140 Lietuva Wyeth Whitehall Export GmbHTel 43 1 89 1140

eská Republika Pfizer s.r.o. Tel 420-283-004-111 Malta Vivian Corporation Ltd. Tel 35621 344610

Danmark Pfizer ApS Tlf 45 44 201 100 Nederland Wyeth Pharmaceuticals B.V. Tel 31 23 5672567

Deutschland Pfizer Pharma GmbH Tel 49 030 550055-51000 Norge Pfizer AS Tlf 47 67 526 100

Eesti Wyeth Whitehall Export GmbH Tel 43 1 89 1140 Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0

Pfizer Hellas A.E. . 30 210 6785 800 Polska Pfizer Polska Sp. z o.o. Tel. 48 22 335 61 00

España Pfizer, S.A. Télf34914909900 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 55 00

France Pfizer Tél 33 1 58 07 30 00 România Pfizer Romania S.R.L Tel 40 0 21 207 28 00

Ireland Wyeth Vaccines Tel 353 1 449 3500 Slovenská Republika Pfizer Luxembourg SARL, organizaná zloka Tel 421 2 3355 5500

Ísland Icepharma hf, Tel 354 540 8000 Slovenija Wyeth Whitehall Export GmbH Tel 43 1 89 1140

Italia Wyeth Lederle S.p.A. Tel 39 06 927151 SuomiFinland Pfizer Oy PuhTel 358 09 430 040

K Wyeth Hellas Cyprus Branch AEBE T 357 22 817690 Sverige Pfizer AB Tel 46 08 550 520 00

LuxembourgLuxemburg Pfizer S.A. N.V. TélTel 32 02 554 62 11 United Kingdom Wyeth Vaccines Tel 44 845 367 0098

Magyarország

Pfizer Kft.
Tel: +36 1 488 3700

This leaflet was last approved in

The following information is intended for medical or healthcare professionals only:

The vaccine should be well shaken to obtain a homogeneous white suspension and be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. Do not use if the content appears otherwise.

Prevenar is for intramuscular use only. Do not administer intravenously.This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.

Infants aged 2 - 6 months: the primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A fourth dose is recommended in the second year of life.

Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered. The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.

Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.
Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Children aged 24 months - 5 years: one single dose.

The need for a booster dose after these immunisation schedules has not been established.

As with other vaccines, the administration of Prevenar should be postponed in subjects suffering from acute moderate or severe febrile illness.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine or other micro-organisms that cause invasive disease or otitis media.

Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.

For children from 2 years through 5 years of age, a single dose immunisation schedule was used. A higher rate of local reactions has been observed in children older than 24 months of age compared with infants.

Different injectable vaccines should always be given at different injection sites.

Limited data have demonstrated that Prevenar induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups. Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e.g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome). Vaccination in high-risk groups should be considered on an individual basis.

Children below 2 years old (including those at high-risk) should receive the appropriate-for-age Prevenar vaccination series. The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ? 24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae. Whenever recommended, children at risk who are ? 24 months of age and already primed with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine. The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks. There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.

Prophylactic antipyretic medication is recommended:

  • for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis becauseof higher rate of febrile reactions
  • for children with seizure disorders or with a prior history of febrile seizures.Antipyretic treatment should be initiated whenever warranted or when the temperature rises above 39°C.

Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.

As with any vaccine, Prevenar may not protect all individuals receiving the vaccine from pneumococcal disease. Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low.

Cookies help us deliver our services. By using our services, you agree to our use of cookies. OK