Prevenar 13 suspension for injectionPneumococcal polysaccharide conjugate vaccine (13-valent,adsorbed)

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.

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.

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.

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
• 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

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)
• 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.

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.

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 Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve Belgium Manufacturing Authorisation Holder responsible for batch release Wyeth Pharmaceuticals New Lane Havant Hampshire, PO9 2NG 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 GmbH Tel 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 {MM/YYYY}.

During storage, a white deposit and clear supernatant may be observed.

Inspect visually for any foreign particulate matter and/or abnormal physical appearance; do not use if either are found.

Shake well prior to use to obtain a homogeneous white suspension.

Administer the entire dose.

Prevenar 13 is for intramuscular use only. Do not administer intravascularly.

Prevenar 13 must not be mixed with any other vaccines in the same syringe.

Prevenar 13 can be given at the same time as other childhood vaccines; in this case, different injection sites should be used.

Any unused product or waste material should be disposed of in accordance with local requirements.