Twinrix Paediatric
hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed)
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) 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 you/ your child only. Do not pass it on to others.
If you get / your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be given to adolescents and children so you may be reading it for your child.
What Twinrix Paediatric is and what it is used for
What you need to know before you receive Twinrix Paediatric
How Twinrix Paediatric is given
Possible side effects
How to store Twinrix Paediatric
Contents of the pack and other information
Twinrix Paediatric is a vaccine used in infants, children and adolescents from 1 year up to and including 15 years to prevent two diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases.
Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.
you are allergic to:
the active substances, or any of the ingredients of this medicine (listed in section 6).
neomycin.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
you have previously had an allergic reaction to any vaccine against hepatitis A and hepatitis B diseases.
you have 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.
Talk to you doctor or pharmacist before you receive Twinrix Paediatric if:
you have experienced any health problems after previous administration of a vaccine.
you have a poor immune system due to illness or drug treatment.
you have a bleeding problem or bruise/ bruises easily.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.
Twinrix Paediatric can be given with a Human Papillomavirus (HPV) vaccine at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before you are given this vaccine.
It is not known if Twinrix Paediatric passes into breast milk, however the vaccine is not expected to cause problems in breast-fed babies.
Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic).
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
You will receive a total of three injections over 6 months. Each injection is given on a separate visit. The first dose will be given on an elected date. The remaining two doses will be given one month, and six months after the first dose.
| First dose: | at an elected date |
| Second dose: | 1 month later |
| Third dose: | 6 months after the first dose |
Your doctor will advise on the possible need for extra doses, and future booster dosing. If you miss a scheduled injection, talk to your doctor and arrange another visit.
Make sure you finish the complete vaccination course of three injections. If not, you may not be fully protected against the diseases.
The doctor will give Twinrix Paediatric as an injection into your upper arm muscle or into the thigh muscle of your child.
The vaccine should never be given into a vein.
If you have any further questions on the use of this vaccine, ask your doctor or pharmacist.
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Side effects that may occur are the following:
Side effects occured during clinical studies or routine use of the vaccine or with individual hepatitis A and hepatitis B vaccines or with the adult formulation of Twinrix.
Pain and redness at the injection site
Drowsiness, headache
Nausea
Loss of appetite
Swelling or bruising at the injection site
Generally feeling unwell, tiredness
Fever equal to or greater than 37.5°C
Irritability
Diarrhoea, vomiting, stomach pain
Rash
Aching muscles
Upper respiratory tract infection
Swollen glands in the neck armpit or groin (lymphadenopathy)
Dizziness
Loss of skin sensitivity to pain or touch (hypoaesthesia)
Feeling of pins and needles (paraesthesia)
Hives, itching
Joint pain
Low blood pressure
Flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills
Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
Purple or red brown spots visible through the skin (thrombocytopenic purpura)
Swelling or infection of the brain (encephalitis)
Degenerative disease of the brain (encephalopathy)
Inflammation of nerves (neuritis)
Numbness or weakness of the arms and legs (neuropathy), paralysis
Fits or seizures
Swelling of the face, mouth or throat (angioneurotic oedema)
Purple or reddish-purple bumps on the skin (lichen planus), serious skin rashes (erythema multiforme)
Joint swelling, muscular weakness
Infection around the brain which may give severe headache with stiff neck and sensitivity to light (meningitis)
Inflammation of some blood vessels (vasculitis)
Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness).
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 may occur before leaving the doctor’s surgery. However, if you get any of these symptoms you should contact a doctor urgently.
Abnormal laboratory liver test results
Multiple sclerosis, swelling of the spinal cord (myelitis)
Drooping eyelid and sagging muscles on one side of the face (facial palsy)
A temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome)
A disease of the nerves of the eye (optic neuritis)
Immediate injection site pain, stinging and burning feeling
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystem
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances are:
Hepatitis A virus (inactivated)1,2 360 ELISA Units Hepatitis B surface antigen3,4 10 micrograms
1Produced on human diploid (MRC-5) cells
2Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al3+ 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
4Adsorbed on aluminium phosphate 0.2 milligrams Al3+
The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
Suspension for injection in pre-filled syringe.
Twinrix Paediatric is a white, slightly milky liquid presented in a glass pre-filled syringe (0.5 ml). Twinrix Paediatric is available in packs of 1, 10 and 50 with or without needles.
Not all pack sizes may be marketed.
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:
GlaxoSmithKline Biologicals SA
Tel. +370 80000334
GlaxoSmithKline Biologicals SA
Тел.: +359 80018205
GlaxoSmithKline Biologicals SA Tel.: +36 80088309
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline Biologicals SA Tel: +356 80065004
GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701
GlaxoSmithKline Biologicals SA Tel: +372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Tηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 970750
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089
Smith Kline & French Portuguesa - Produtos
Farmacêuticos, Lda. Tel: + 351 21 412 95 00
GlaxoSmithKline Biologicals SA
Tel: +40 800672524
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000
GlaxoSmithKline Biologicals SA
Tel: +386 80688869
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 111
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017
GlaxoSmithKline Biologicals SA
Tel: +371 80205045
Tel: +44(0)800 221441
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The following information is intended for healthcare professionals only:
Upon storage, a fine white deposit with a clear colourless layer above may be observed.
The vaccine should be re-suspended before use. When re-suspended, the vaccine will have a uniform hazy white appearance.
The vaccine should be re-suspended following the steps below.
Hold the syringe upright in a closed hand.
Shake the syringe by tipping it upside down and back again.
Repeat this action vigorously for at least 15 seconds.
Inspect the vaccine again:
If the vaccine appears as a uniform hazy white suspension, it is ready to use – the appearance should not be clear.
If the vaccine still does not appear as a uniform hazy white suspension - tip upside down and back again for at least another 15 seconds - then inspect again.
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, do not administer the vaccine.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.