Tritanrix HepB
diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This vaccine has been prescribed for your child. Do not pass it on to others.
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.
In this leaflet:
What Tritanrix HepB is and what it is used for
Before your child receives Tritanrix HepB
How Tritanrix HepB is given
Possible side effects
How to store Tritanrix HepB
Further information
Medicinal product no longer authorised
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.
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.
Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.
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.
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
Medicinal product no longer authorised
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.
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 38°C)
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):
Medicinal product no longer authorised
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 doctor’s 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.
The active substances contained in 1 dose (0.5 ml) are:
Diphtheria toxoid1 ≥ 30 IU
Tetanus toxoid1 ≥ 60 IU
Bordetella pertussis (inactivated)2 ≥ 4 IU
Hepatitis B surface antigen2,3 10 µg
adsorbed on aluminium hydroxide, hydrated 0.26 mg Al3+
adsorbed on aluminium phosphate 0.37 mg Al3+ 3 produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
The other ingredients in Tritanrix HepB are: thiomersal, sodium chloride and water for injections.
Medicinal product no longer authorised
Suspension for injection.
Tritanrix HepB is a white, slightly milky liquid presented in a glass vial for 1 dose (0.5 ml). Tritanrix HepB is available in pack of 1.
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:
Тел. + 359 2 953 10 34
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701
GlaxoSmithKline Eesti OÜ Tel: +372 667 6900
GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0
GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o. Tel.: + 48 (22) 576 9000
Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
Medicinal product no longer authorised
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline Lietuva UAB
Tel: +370 5 264 90 00
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.
Medicinal product no longer authorised
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.