Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Twinrix Paediatric, suspension for injection in pre-filled syringe
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hepatitis a vaccine, Hepatitis b vaccine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
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. •
Hepatitis A: Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month.
•
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.
Vaccination is the best way to protect against these diseases. None of the components in the vaccine are infectious.
2.
What you need to know before you take it
e Twinrix Paediatric
Twinrix Paediatric should not be given if • 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. 1
• •
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.
Warnings and precautions 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. Other medicines and Twinrix Paediatric 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. Pregnancy and breast-feeding 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. Twinrix Paediatric contains neomycin and sodium 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 'sodiumfree'.
3.
How to take it
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: Second dose: Third dose:
at an elected date 1 month later 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. 2
4.
Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Side effects that may occur are the following:
Possible 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. Very common (these may occur with more than 1 in 10 doses of the vaccine): pain and redness at the injection site. Common (these may occur with up to 1 in 10 doses of the vaccine): 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. Uncommon (these may occur with up to 1 in 100 doses of the vaccine): diarrhoea, vomiting, stomach pain, rash, aching muscles, upper respiratory tract infection. Rare (these may occur with up to 1 in 1,000 doses of the vaccine): 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. Very rare (these may occur with up to 1 in 10,000 doses of the vaccine): 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), 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. Serious allergic reactions (anaphylaxis, anaphylactoid reactions and mimicking serum sickness) may also occur very rarely (with up to 1 in 10,000 doses of the vaccine). 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. Reporting of side effects 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Twinrix Paediatric
3
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.
6.
Contents of the pack and other information
What Twinrix Paediatric contains –
The active substances are: Hepatitis A virus (inactivated)1,2 Hepatitis B surface antigen3,4
360 ELISA Units 10 micrograms
1
Produced on human diploid (MRC-5) cells Adsorbed on aluminium hydroxide, hydrated 0.025 milligrams Al3+ 3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4 Adsorbed on aluminium phosphate 0.2 milligrams Al3+ 2
–
The other ingredients in Twinrix Paediatric are: sodium chloride, water for injections.
What Twinrix Paediatric looks like and contents of the pack Suspension for injection in pre-filled syringe. Twinrix Paediatric is a white, slightly milky liquid. Twinrix Paediatric is available in 1-dose pre-filled syringe with or without separate needles, pack sizes of 1, 10 and 50. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder GlaxoSmithKline UK Limited 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 B-1330 Rixensart Belgium
4
Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information: Product name
Twinrix Paediatric, Suspension for injection in pre-filled syringe
Reference numbers
19494/0266
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in March 2025 Trade marks are owned by or licensed to the GSK group of companies. © 2025 GSK group of companies or its licensor.
(GlaxoSmithKline logo) ——————————————————————————————————————–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. Re-suspension of the vaccine to obtain a uniform hazy white suspension The vaccine should be re-suspended following the steps below. 1. Hold the syringe upright in a closed hand. 2. Shake the syringe by tipping it upside down and back again. 3. Repeat this action vigorously for at least 15 seconds. 4. Inspect the vaccine again: a. If the vaccine appears as a uniform hazy white suspension, it is ready to use – the appearance should not be clear. b. 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. Instructions for the pre-filled syringe after re-suspension
5
Luer Lock Adaptor
Hold the syringe by the barrel, not by the plunger. Unscrew the syringe cap by twisting it anticlockwise.
Plunger Barrel Cap
Needle hub To attach the needle, connect the hub to the Luer Lock Adaptor and rotate a quarter turn clockwise until you feel it lock. Do not pull the syringe plunger out of the barrel. If it happens, do not administer the vaccine.
Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6
Frequently asked questions about Twinrix Paediatric, suspension for injection in pre-filled syringe
How do I take Twinrix Paediatric, suspension for injection in pre-filled syringe?
Twinrix Paediatric, suspension for injection in pre-filled syringe comes as oral solution. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Twinrix Paediatric, suspension for injection in pre-filled syringe?
The active substance in Twinrix Paediatric, suspension for injection in pre-filled syringe is hepatitis a vaccine, hepatitis b vaccine.
Are there equivalent medicines to Twinrix Paediatric, suspension for injection in pre-filled syringe?
Medicines with the same active substance, strength and form include: Twinrix Adult Vaccine, suspension for injection. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Twinrix Paediatric, suspension for injection in pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Twinrix Paediatric, suspension for injection in pre-filled syringe without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: hepatitis a vaccine, hepatitis b vaccine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Twinrix Paediatric is indicated for use in non immune infants, children and adolescents from 1 year up to and including 15 years who are at risk of both hepatitis A and hepatitis B infection.
4.2. Posology and method of administration
Posology
- Dosage
The dose of 0.5 ml (360 ELISA Units HA/10 µg HBsAg) is recommended for infants, children and adolescents from 1 year up to and including 15 years of age.
- Primary vaccination schedule
The standard primary course of vaccination with Twinrix Paediatric consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose. The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
- Booster dose
In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given. The safety and immunogenicity of Twinrix Paediatric administered as a booster dose following a three-dose primary course have not been evaluated.
Long-term antibody persistence data following vaccination with Twinrix Paediatric are available up to 15 years after vaccination (see section 5.1).
The anti-HBs and anti-HAV antibody titres observed following a primary vaccination course with the combined vaccine are in the range of what is seen following vaccination with the monovalent vaccines. General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Hepatitis B
The need for a booster dose of hepatitis B vaccine in healthy individuals who have received a full primary vaccination course has not been established; however some official vaccination programmes currently include a recommendation for a booster dose of hepatitis B vaccine and these should be respected.
For some categories of subjects or patients exposed to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure a protective antibody level ≥ 10IU/l.
Hepatitis A
It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory. Guidelines for boosting are based on the assumption that antibodies are required for protection.
In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix Paediatric can be given. Alternatively, subjects primed with Twinrix Paediatric may be administered a booster dose of either of the monovalent vaccines.
Method of administration
Twinrix Paediatric is for intramuscular injection, preferably in the deltoid region in adolescents and children or in the anterolateral thigh in infants.
Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. However, this route of administration may result in suboptimal immune response to the vaccine (see section 4.4).
4.3. Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or neomycin.
Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
The administration of Twinrix Paediatric should be postponed in subjects suffering from acute severe febrile illness.
4.4. Special warnings and precautions for use
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
It is possible that subjects may be in the incubation period of a HA or HB infection at the time of vaccination. It is not known whether Twinrix Paediatric will prevent HA and HB in such cases.
The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Twinrix Paediatric is not recommended for postexposure prophylaxis (e.g. needle stick injury).
The vaccine has not been tested in patients with impaired immunity. In haemodialysis patients, patients receiving immunosuppressive treatment or patients with an impaired immune system, the anticipated immune response may not be achieved after the primary immunisation course. Such patients may require additional doses of vaccine; nevertheless immunocompromised patients may fail to demonstrate an adequate response.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided. However, exceptionally Twinrix Paediatric can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects (see section 4.2).
Twinrix Paediatric should under no circumstances be administered intravascularly.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
4.5. Interaction with other medicinal products and other forms of interaction
No data on concomitant administration of Twinrix Paediatric with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated. However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins, no influence on seroconversion was observed although it may result in lower antibody titres.
Twinrix Paediatric can be given concomitantly with Human Papillomavirus (HPV) vaccine.
Administration of Twinrix Paediatric at the same time as Cervarix (HPV vaccine) has shown no clinically relevant interference in the antibody response to the HPV and hepatitis A antigens. Anti-HBs geometric mean antibody concentrations were lower on co-administration, but the clinical significance of this observation is not known since the seroprotection rates remain unaffected. The proportion of subjects reaching anti-HBs ≥ 10 mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix alone.
Only the concomitant administration of Twinrix Paediatric with Cervarix has been specifically studied. It is advised that vaccines other than Cervarix should not be administered at the same time as Twinrix Paediatric.
4.6. Fertility, pregnancy and lactation
Pregnancy
The effect of Twinrix Paediatrict on embryo-fetal, peri-natal and post-natal survival and development has been assessed in rats. This study did not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/fetal development, parturition or post-natal development.
The effect of Twinrix Paediatric on embryo-fetal, peri-natal and post-natal survival and development has not been prospectively evaluated in clinical trials.
Data on outcomes of a limited number of pregnancies in vaccinated women do not indicate any adverse effects of Twinrix Paediatric on pregnancy or on the health of the fetus/newborn child. While it is not expected that recombinant hepatitis B virus surface antigen would have adverse effects on pregnancies or the fetus it is recommended that vaccination should be delayed until after delivery unless there is an urgent need to protect the mother against hepatitis B infection.
Breast-feeding
It is unknown whether Twinrix Paediatric is excreted in human breast milk. The excretion of Twinrix Paediatric in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Twinrix Paediatric should be made taking into account the benefit of breast-feeding to the child and the benefit of Twinrix Paediatric therapy to the woman.
4.7. Effects on ability to drive and use machines
Twinrix Paediatric has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The safety profile presented below is based on data from approximately 800 subjects. The most commonly reported adverse reactions following Twinrix Paediatric administration are pain and redness occurring in a per dose frequency of 28.5% and 11.5% respectively.
Tabulated list of adverse reactions
Frequencies are reported as:
Very common:
Common:
Uncommon:
Rare:
Very rare:
≥ 1/10
≥ 1/100 to < 1/10
≥ 1/1,000 to < 1/100
≥ 1/10,000 to < 1/1,000
< 1/10,000
System Organ Class
Frequency
Adverse reactions
Clinical trials
Infections and infestations
Uncommon
Upper respiratory tract infection*
Blood and lymphatic system disorders
Rare
Lymphadenopathy
Metabolism and nutrition disorders
Common
Appetite lost
Psychiatric disorders
Common
Irritability
Nervous system disorders
Common
Drowsiness, headache
Rare
Hypoaesthesia*, paraesthesia*, dizziness
Vascular disorders
Rare
Hypotension*
Gastrointestinal disorders
Common
Gastrointestinal symptoms, nausea
Uncommon
Diarrhoea, vomiting, abdominal pain
Skin and subcutaneous tissue disorders
Uncommon
Rash
Rare
Urticaria, pruritus*
Musculoskeletal and connective tissue disorders
Uncommon
Myalgia*
Rare
Arthralgia*
General disorders and administration site conditions
Very common
Pain and redness at the injection site
Common
Swelling at the injection site, injection site reaction (such as bruising), fatigue, malaise, fever (≥ 37.5°C)
Rare
Influenza like illness*, chills*
Post-marketing surveillance
The following adverse reactions have been reported with either Twinrix or with GlaxoSmithKline monovalent hepatitis A or B vaccines:
Infections and infestations
Meningitis
Blood and lymphatic system disorders
Thrombocytopenia, thrombocytopenic purpura
Immune system disorders
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness
Nervous system disorders
Encephalitis, encephalopathy, neuritis, neuropathy, paralysis, convulsions
Vascular disorders
Vasculitis
Skin and subcutaneous tissue disorders
Angioneurotic oedema, lichen planus, erythema multiforme
Musculoskeletal and connective tissue disorders
Arthritis, muscular weakness
General disorders and administration site conditions
Immediate injection site pain
Following widespread use of the monovalent hepatitis A and/or hepatitis B vaccines, the following undesirable events have additionally been reported in temporal association with vaccination:
Nervous system disorders
Multiple sclerosis, myelitis, facial palsy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), optic neuritis
General disorders and administration site conditions
Stinging and burning sensation
Investigations
Abnormal liver function tests
* refers to adverse reactions observed in clinical trials performed with the adult formulation
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.
💬 Ask about this leaflet
Ask anything about Twinrix Paediatric, suspension for injection in pre-filled syringe. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.