Prevenar - patient leaflet, side effects, dosage

4. 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:

iting, diarrhoea, decreased appetite

, tenderness, redness, swelling, or hardness at the injection site; fever of 38 °C or higher, bility, crying, drowsiness, restless sleep mmon 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)

5. HOW TO STORE PREVENAR

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* * 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

Eesti

Pfizer Luxembourg SARL Eesti filiaal

Tel: +372 666 7500

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15–0

EXXáóa Polska

Pfizer EXXàç A.E.

Tql.: +30 210 6785 800

España

Pfizer, S.L.

Télf:+34914909900

France

Pfizer

Tél +33 1 58 07 34 40

Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00

Pfizer Luxembourg SARL filiale Latvija

Tel.: + 371 670 35 775

This leaflet was last approved in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency website:

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 dis that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the ris administration.

Infants age 2 – 6 months: the primary infant series consists of three doses, each of 0.5 m usually given at 2 months of age and with an interval of at least 1 month between dose 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 inte 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 i doses.

Children aged 24 months – 5 years: one single dose.

The need for a booster dose after these immunisa

As with other vaccines, the administration evenar 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 local reactions has been observed in children older than 24 months of age compared with infants.

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 23valent 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 because of higher rate of febrile reactions

• – for children with seizure disorders or with a prior history of febrile seizures.