Tritanrix HepB, suspension for injection, multidoseDiphtheria (D), tetanus (T), pertussis (whole cell) (Pw) andhepatitis B (rDNA) (HBV) vaccine (adsorbed)

Tritanrix HepB is a vaccine used in children to prevent four diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough) and hepatitis B. 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 inflamed and swollen. The virus is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected people.

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

Tritanrix HepB should not be given:

• if your child has previously had any allergic reaction to Tritanrix HepB, or any ingredient contained in this vaccine. The active substances and other ingredients in Tritanrix HepB 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) or hepatitis B 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 Tritanrix HepB:

• if your child has experienced any health problems after previous administration of a vaccine.
• if after previously having Tritanrix HepB 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

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 Tritanrix HepB

This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction. Tell your doctor if your child has any known allergies.

Your child will receive a total of 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 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 Tritanrix HepB as an injection into the thigh muscle. Your child will remain under medical supervision for 30 minutes after each injection.

The vaccine should never be given into a vein.

Like all medicines, Tritanrix HepB can cause side effects, although not everybody gets them.

Side effects that occurred during clinical trials with Tritanrix HepB were as follows:

Very common side effects which may occur in more than 1 per 10 doses of vaccine pain or discomfort at the injection site redness or swelling at the injection site fever more than 38C drowsiness, irritability, unusual crying feeding problems

Common side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine infection of the middle ear bronchitis sore throat and discomfort when swallowing gastrointestinal symptoms such as vomiting and diarrhoea

Uncommon side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine pneumonia serious lung infection respiratory disorder

Very rare side effects which may occur in less than 10,000 doses of vaccine allergic reactions, including anaphylactic and anaphylactoid reactions. These may be local or widespread 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 may occur before leaving the doctors surgery. However, you should seek immediate treatment in any event. serum sickness like disease a hypersensitivity reaction to the administration of a foreign serum with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes

After the marketing of Tritanrix HepB, the following additional side effects have been reported on a few occasions:

• collapse or periods of unconsciousness or lack of awareness have been reported within 2 to 3 days after vaccination
• 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

Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B virus. The following undesirable events have occurred very rarely following the administration of hepatitis B containing vaccines:
? seizures or fits
? bleeding or bruising more easily than normal

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 Tritanrix HepB 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 Tritanrix HepB contains

• The active substances contained in 1 dose (0.5 ml) are: Diphtheria toxoid 1? 30 IU Tetanus toxoid 1? 60 IU Bordetella pertussis (inactivated) 2? 4 IU Hepatitis B surface antigen 2,310 µg

123 adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3 adsorbed on aluminium phosphate 0.37 mg Al3 produced in yeast cells Saccharomyces cerevisiae by recombinant DNA technology

• The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.

What Tritanrix HepB looks like and contents of the pack

Suspension for injection, multidose.

Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 2 doses (1 ml) or in a glass vial for 10 doses (5 ml).

Tritanrix HepB is available in the following pack sizes:
For 2 doses: pack size of 1
For 10 doses: pack size of 1

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

România GlaxoSmithKline GSK SRL Tel 40 021 3028 208 France Laboratoire GlaxoSmithKline Tél 33 0 1 39 17 84 44 diamgsk.com

Ireland GlaxoSmithKline Ireland Ltd Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 0 1 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354-530 3700 Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia GlaxoSmithKline S.p.A. Tel 39 04 59 21 81 11 SuomiFinland GlaxoSmithKline Oy PuhTel 358 10 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA United Kingdom GlaxoSmithKline UK

Tel 371 67312687 lv-epastsgsk.com Tel 44 0808 100 9997 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: +370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

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

Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).

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

The vaccine should be well shaken in order to obtain a homogeneous turbid white suspension and be inspected visually for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, discard the container.

When using a multidose vial, each dose should be taken with a sterile needle and syringe. As with other vaccines, a dose of vaccine should be withdrawn under strict aseptic conditions and precautions taken to avoid contamination of the contents.