Prevenar
pneumococcal saccharide conjugated vaccine, adsorbed
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
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.
What Prevenar is and what it is used for
Before your child receives Prevenar
How Prevenar is given
Possible side effects
How to store Prevenar
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Further information
Prevenar is a pneumococcal vaccine. Prevenar is given to children from 2 months to 5 years to help protect 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.
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 a cold, should not be a problem. However, talk to your doctor, pharmacist, or nurse first.
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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.
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.
This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially sodium-free
The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your child'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. Infantsaged6weeksto6monthsofage
Typically, your child should 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
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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.
Unvaccinatedinfantsandchildrenover7monthsofage
Infantsaged7to-11months 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.
Childrenaged12to23months should receive two injections. Each injection will be given at least 2 month apart.
Childrenaged2to5years 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.
Like all vaccines, Prevenar can cause side effects, although not everybody gets them. The following side effects may happen with this vaccine.
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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
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
Rash/hives (urticaria)
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
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.
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Keep out of the reach and sight of children Store in a refrigerator (2C – 8C).
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.
The active substances
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Each 0.5 ml dose contains:
Pneumococcal polysaccharide serotype 4* 2 micrograms Pneumococcal polysaccharide serotype 6B* 4 micrograms
Pneumococcal polysaccharide serotype 9V* 2 micrograms Pneumococcal polysaccharide serotype 14* 2 micrograms
Pneumococcal polysaccharide serotype 18C* 2 micrograms Pneumococcal polysaccharide serotype 19F* 2 micrograms
Pneumococcal polysaccharide serotype 23F* 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.
The vaccine is a suspension for injection and provided in a single-dose vial (0.5 ml). Pack sizes of 1 and 10 vials without syringe/needles.
Pack size of 1 vial with syringe and 2 needles (1 for withdrawal, 1 for injection).
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturing Authorisation Holder responsible for batch release: John Wyeth & Brother Ltd.
Huntercombe Lane South
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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:
Tél/Tel: +32 (0)2 554 62 11
Pfizer Luxembourg SARL filialas Lietuvoje
Tel. + 370 52 51 4000
Пфайзер Люксембург САРЛ, Клон
България
Teл: +359 2 970 4333
Pfizer Kft.
Tel: +36 1 488 3700
Pfizer s.r.o.
Tel: +420-283-004-111
Vivian Corporation Ltd.
Tel: + 35621 344610
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Pfizer ApS
Tlf: +45 44 201 100
Pfizer BV
Tel: +31 (0)10 406 43 01
Pfizer Pharma GmbH
Tel: +49 (0)30 550055-51000
Pfizer AS
Tlf: +47 67 526 100
Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500
Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800
Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
Pfizer, S.L. Télf:+34914909900
Pfizer Biofarmacêutica, Sociedade Unipessoal Lda Tel: +351 21 423 5500
Pfizer
Tél +33 1 58 07 34 40
Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00
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Pfizer Croatia d.o.o. Tel: + 385 1 3908 777
Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: + 386 (0) 1 52 11 400
Icepharma hf,
Simi: + 354 540 8000
Pfizer Oy
Puh/Tel: +358 (0)9 430 040
Pfizer S.r.l.
Tel: +39 06 33 18 21
Pfizer AB
Tel: +46 (0)8 550 520 00
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Pfizer Ελλάς A.E. (Cyprus Branch)
Tηλ: +357 22 817690
Pfizer Limited
Tel: +44 (0) 1304 616161
Pfizer Luxembourg SARL filiāle Latvijā
Tel.: + 371 670 35 775
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 age 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.
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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.
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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 because of 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
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genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunisation.
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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.