Infanrix Penta – Suspension for injectionDiphtheria (D), tetanus (T), pertussis (acellular, component)(Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV)vaccine (adsorbed)

Infanrix Penta is a vaccine used in children to prevent five diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B and poliomyelitis (Polio). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

• Diphtheria: Diphtheria mainly affects the airways and sometimes the skin. Generally the airways become inflamed (swollen) causing severe breathing difficulties and sometimes suffocation. The bacteria also release a toxin (poison), which can cause nerve damage, heart problems, and even death.
• Tetanus (Lockjaw): Tetanus bacteria enter the body through cuts, scratches or wounds in the skin. Wounds that are especially prone to infection are burns, fractures, deep wounds or wounds contaminated with soil, dust, horse manure/dung or wood splinters. The bacteria release a toxin (poison), which can cause muscle stiffness, painful muscle spasms, fits and even death. The muscle spasms can be strong enough to cause bone fractures of the spine.
• Pertussis (Whooping cough): Pertussis is a highly infectious illness. The disease affects the airways causing severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied by a ?whooping? sound, hence the common name ?whooping cough?. The cough may last for 1-2 months or longer. Pertussis can also cause ear infections, bronchitis which may last a long time, pneumonia, fits, brain damage and even death.
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen (inflamed). The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.
• Poliomyelitis (Polio): Poliomyelitis, sometimes called simply ?polio? is a viral infection that can have variable effects. Often it causes only a mild illness but in some people it causes permanent damage or even death. In its severest form, polio infection causes paralysis of the muscles (muscles cannot move), including those muscles needed for breathing and walking. The limbs affected by the disease may be painfully deformed.

Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.

Infanrix Penta should not be given:

• if your child has previously had any allergic reaction to Infanrix Penta, or any ingredient contained in this vaccine. The active substances and other ingredients in Infanrix Penta are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
• if your child has previously had an allergic reaction to any vaccine against diphtheria, tetanus, pertussis (whooping cough), hepatitis B or poliomyelitis diseases.
• if your child experienced problems of the nervous system within 7 days after previous vaccination with a vaccine against pertussis (whooping cough) disease.
• if your child has a severe infection with a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your doctor first.

Take special care with Infanrix Penta

• if after previously having Infanrix Penta or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ? A high temperature (over 40°C) within 48 hours of vaccination ? A collapse or shock-like state within 48 hours of vaccination ? Persistent crying lasting 3 hours or more within 48 hours of vaccination ? Seizures/fits with or without a high temperature within 3 days of vaccination
• if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy. After control of the disease the vaccine should be administered.
• if your child has a bleeding problem or bruises easily
• if your child has a tendency to seizures/fits due to a fever, or if there is a history in the family of this As with all vaccines, Infanrix Penta may not completely protect all people who are vaccinated.

Using other medicines or vaccines

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

Important information about some of the ingredients of Infanrix Penta

Please tell your doctor if your child has had an allergic reaction to neomycin and polymyxin (antibiotics).

Your child will receive a total of two or three injections with an interval of at least one month between each one. Each injection is given on a separate visit. You will be informed by the doctor or nurse when you should come back for subsequent injections.

If additional injections or ?booster? are necessary, the doctor will tell you.

If your child misses a scheduled injection, talk to your doctor and arrange another visit.

Make sure your child finishes the complete vaccination course of three injections. If not, your child may not be fully protected against the diseases.

The doctor will give Infanrix Penta as an injection into the muscle.

The vaccine should never be given into blood vessels or into the skin.

Like all medicines, Infanrix Penta can cause side effects, although not everybody gets them. As with all injectable vaccines, there is an extremely small risk of serious allergic reactions (anaphylactic and anaphylactoid reactions). Signs of serious allergic reactions may be:

• rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pressure and loss of consciousness. Such reactions will usually occur before leaving the doctor?s surgery. However, if your child gets any of these symptoms you should contact a doctor urgently. As with other vaccines against pertussis (whooping cough) disease, following side effects may occur very rarely within 2 to 3 days after vaccination:
• collapse or periods of unconsciousness or lack of awareness
• seizures or fits with or without fever If your child gets any of these side effects you should contact a doctor urgently.

Other side effects that have been reported are:

Very common (These may occur in 1 in 10 doses or more of the vaccine)

• loss of appetite
• fever greater than or equal to 38°C
• swelling, pain, redness at the injection site
• tiredness
• abnormal crying, irritability, restlessness.

Common (These may occur in up to 1 in 10 doses of the vaccine)

• diarrhoea, vomiting
• fever greater than 39.5°C
• swelling larger than 5 cm at the injection site, hard lump at the injection site.

Uncommon (These may occur in up to 1 in 100 doses of the vaccine)

• sleepiness
• cough
• dermatitis, rash
• large swelling at the injected limb
• nervousness.

Very rare (These may occur in up to 1 in 10,000 doses of the vaccine)

• 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
• hives
• swelling of the entire injected limb.

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.

Keep out of the reach and sight of children.

Do not use Infanrix Penta after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C ? 8°C).
Store in the original package in order to protect from light.
Do not freeze. Freezing destroys the vaccine.

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.

What Infanrix Penta contains

• The active substances are: Diphtheria toxoid 1not less than 30 IU Tetanus toxoid 1not less than 40 IU Bordetella pertussis antigens Pertussis toxoid 125 micrograms Filamentous Haemagglutinin 125 micrograms Pertactin 18 micrograms Hepatitis B surface antigen 2,310 micrograms Poliovirus (inactivated) type 1 (Mahoney strain) 440 D-antigen unit type 2 (MEF-1 strain) 48 D-antigen unit type 3 (Saukett strain) 432 D-antigen unit

1adsorbed on aluminium hydroxide, hydrated AlOH3 0.5 milligrams Al 2produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology 0.2 milligrams Al3adsorbed on aluminium phosphate AlPO44propagated in VERO cells

• The other ingredients in Infanrix Penta are: sodium chloride (NaCl), medium 199 containing principally amino acids, mineral salts, vitamins and water for injections.

What Infanrix Penta looks like and contents of the pack

Suspension for injection

Infanrix Penta is a white, slightly milky liquid presented in a pre-filled syringe (0.5 ml).

Infanrix Penta is available in packs of 1, 10, 20 and 50 with or without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Biologicals s.a.Rue de l?Institut 89
B-1330 Rixensart
Belgium

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

BelgiëBelgiqueBelgien LuxembourgLuxemburg

GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11 GlaxoSmithKline s.a.n.v. TélTel 32 2 656 21 11

Magyarország GlaxoSmithKline Kft. Tel. 36-1-2255300 . .10 1408 . 359 2 953 10 34

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 2 22 00 11 11 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 infoglaxosmithkline.dk Nederland GlaxoSmithKline BV Tel 31 030 69 38 100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel 49 089 360448701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 667 6900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH. Tel 43 1 970 75-0 at.infogsk.com

GlaxoSmithKline A.E.B.E T 30 210 68 82 100 Polska GSK Commercial Sp. z.o.o. Tel. 48 22 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal Smith Kline French Portuguesa, Produtos Farmacêuticos, Lda. Tel 351 21 412 95 00 FI.PTgsk.com

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Lietuva

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Tel. +370 5 264 90 00
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This leaflet was last approved in

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

Upon storage, a white deposit and clear supernatant can be observed. This does not constitute a sign of deterioration.

The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.

The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the container.