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.
Havrix Monodose Vaccine
⚠ 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 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
Havrix Monodose is a vaccine containing hepatitis A virus. It is used to boost the body's immune system to help protect against hepatitis A infection in adults and adolescents (16 years of age and above). How Havrix Monodose works
- The virus is not alive so this vaccine cannot cause hepatitis A infection.
- When you are given Havrix Monodose vaccine your body will make antibodies (the body's natural defence system) against the hepatitis A virus.
- After 2 to 4 weeks, these antibodies will have been produced and will protect you against hepatitis A infection.
- To ensure long term protection, you should receive a second (booster) vaccination 6 to 12 months after your first dose. As long as you receive the booster within 5 years, you should still be fully protected. Once you have had your booster vaccination, you are not expected to need an additional dose of Havrix.
- Having this vaccine will only protect against hepatitis A and not against any other type of hepatitis virus or any other illness that can cause hepatitis (inflammation of the liver). Some general information on hepatitis A infection is given at the end of this leaflet.
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What you need to know before you take it
e Havrix Monodose
Havrix Monodose should not be given if:
- you are allergic (hypersensitive) to any of the ingredients of Havrix (listed in section 6)
- you are allergic (hypersensitive) to any other hepatitis A injection or neomycin, an antibiotic that may be present in very small amounts
- you are between ages 1-15 years, as another product, Havrix Junior Monodose is recommended for this age group
- you have a high temperature (fever). The presence of a minor infection such as a cold should not be a problem. Talk to your doctor first.
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Do not have Havrix if any of the above apply to you. If you are not sure, talk to your doctor, nurse or pharmacist. Warnings and precautions Check with your doctor, nurse or pharmacist before Havrix Monodose is given if:
- you are on dialysis for a kidney problem
- you already have the hepatitis A virus or are living with someone who has caught the hepatitis A virus recently
- you have any problem with the way your body fights disease (immunosuppression). If any of the above apply to you Havrix Monodose can still be given, but you may not develop enough antibody after a single injection to protect you against infection. In these cases, the doctor or nurse may decide that extra doses of Havrix Monodose should be given and may take a blood test to measure the antibody levels in the blood before or after the vaccine is given. Sometimes, an injection of antibody will be needed to try to protect you until the vaccine starts to work. This can be given at the same time as the vaccine but will be injected into the opposite arm. 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. Check with the doctor, nurse or pharmacist before Havrix Monodose is given if you have a bleeding problem or bruise easily. Other medicines or vaccines and Havrix Monodose Tell your doctor or nurse if you are taking, about to take or have recently taken, any other medicine. Other vaccines can be given at the same time as Havrix Monodose. These vaccines will be given at different injection sites. Pregnancy and breast-feeding
- Women who are pregnant may sometimes be vaccinated.
- Talk to your doctor or nurse if you think you are, or might be pregnant.
- Talk to your doctor or nurse if you are breast-feeding. It is sometimes possible to have the vaccine when you are breast-feeding. Driving and using machines Havrix Monodose should not affect your ability to drive or operate machinery. However, some of the effects mentioned under Section 4 "Possible side effects" may temporarily affect the ability to drive or use machines. Havrix Monodose contains neomycin, potassium, sodium and phenylalanine. Please tell your doctor if you have had an allergic reaction to neomycin (antibiotic). This medicine contains potassium, less than 1 mmol (39 mg) per 1 ml dose, i.e. essentially 'potassium-free'. This medicine contains less than 1 mmol sodium (23 mg) per 1 ml dose, that is to say essentially 'sodium-free'. This vaccine contains 166 micrograms of phenylalanine in each dose. Phenylalanine may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
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How to take it
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Havrix Monodose is for use in adults and adolescents 16 years of age and above. Children (1 to 15 years of age) should be given Havrix Junior Monodose. Havrix Monodose (1 ml) is injected into the muscle in the upper arm. The vaccine should never be given into the buttock. The vaccine should never be given into a vein. The first dose of vaccine should protect you from infection with hepatitis A virus within 2 to 4 weeks after the injection. Protection should last for at least 1 year. The best way to ensure that protection continues for at least 40 years is to receive a second (booster) dose of the vaccine. This should be given 6 to 12 months after the first injection. If a second dose is not given within 5 years of the first dose, the doctor may decide that vaccination should start again, with 2 doses of vaccine within 1 year.
Possible side effects
Like all medicines, this vaccine can have side effects, although not everybody gets them. Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine) See your doctor straight away, if you have an allergic reaction. The signs may include:
- 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
- a very fast heart beat
- loss of consciousness. These signs usually start very soon after the injection has been given to you. See a doctor straight away if they happen after leaving the clinic. Other side effects include: Very common (these may occur with more than 1 in 10 doses of the vaccine):
- Headache
- Pain and redness at the injection site
- Fatigue Common (these may occur with up to 1 in 10 doses of the vaccine):
- Loss of appetite
- Stomach upset e.g. diarrhoea and nausea
- Swelling or hard lump at the injection site
- Generally feeling unwell
- Fever Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
- Upper respiratory tract infection, runny or blocked nose
- Dizziness
- Vomiting
- Aching muscles, muscular stiffness not caused by exercise
- Flu-like symptoms, such as high temperature, sore throat, runny nose, cough and chills Rare (these may occur with up to 1 in 1000 doses of the vaccine):
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• • •
Abnormal sensation such as of burning, prickling, tickling or tingling, pins and needles, loss of feeling or numbness Itching Chills
Not known: frequency cannot be estimated from the available data
- Fits or seizures
- Inflammation of the blood vessels, often with skin rash
- Hives, red, often itchy spots which starts on the limbs and sometimes on the face and the rest of the body.
- Joint pain Occasionally tests for liver function can become abnormal for a short time. Extremely rarely there may be reactions involving the nerves. You should tell your doctor immediately if you have problems moving your arms or legs or difficulty with walking and moving about. If any of the side effects gets serious or if you notice any side effects not mentioned in this leaflet, please tell your doctor or nurse. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.
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How to store it
Havrix Monodose Keep out of the sight and reach of children. Store between 2°C and 8°C in a refrigerator. Do not freeze. Store in the original package with this leaflet in order to protect from light. Do not use after the expiry date which is stated on the label and carton. 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.
Contents of the pack and other information
What Havrix Monodose contains
- The active ingredient is inactivated hepatitis A virus. Each 1 mL dose of the vaccine contains 1440 ELISA units of hepatitis A viral protein, adsorbed on aluminium hydroxide, hydrated.
- The other ingredients are polysorbate 20, amino acids for injection (containing phenylalanine), disodium phosphate, monopotassium phosphate, sodium chloride, potassium chloride and water for injections. What Havrix Monodose looks like and contents of the pack Havrix Monodose is a cloudy white injectable liquid vaccine. Havrix Monodose is available in 1-dose pre-filled syringe that contains a single 1 mL dose. The vaccine is available in packs of 1 or 10 pre-filled syringes.
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Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder: SmithKline Beecham Ltd, 79 New Oxford Street London WC1A 1DG United Kingdom Manufacturer: GlaxoSmithKline Biologicals s.a., Rixensart, Belgium. 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 Havrix Monodose Vaccine Reference number 10592/0037 This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in November 2024 Trade marks are owned by or licensed to the GSK group of companies. © 2024 GSK group of companies or its licensor. Instructions for the pre-filled syringe
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
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Any unused product or waste material should be disposed of in accordance with local requirements. General information on hepatitis A Hepatitis A virus causes an infection of the liver. You can catch the virus by eating or drinking contaminated food or water. The virus is present in the bowel movement (motion) of infected people, even when they may have no signs of the infection. You can catch hepatitis A infection in any country but the risk is highest in places and countries where sanitation and food and water hygiene are poor. After catching the virus, it can be up to 6 weeks before signs of illness are seen. Some people have the virus and never get ill but they can still infect other people during this time. The main signs of the illness include sickness, yellowing of the skin and eyes (jaundice), fever and headache. These signs are all due to an inflammation of the liver while it is infected with the virus. Most patients get better, usually after a couple of weeks or months, but a few people may take up to a year to make a full recovery. While recovering, people affected with hepatitis A may be unable to work. They may not be able to drink alcohol and may need to avoid certain foods according to their doctors' advice. Severe complications are very rare but sometimes the liver stops working and hospital care is needed until the infection gets better. There are many other types of virus that can cause hepatitis. The signs may be the same as in hepatitis A infection but the viruses are not always caught through food and drink.
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Frequently asked questions about Havrix Monodose Vaccine
What is the active substance in Havrix Monodose Vaccine?
The active substance in Havrix Monodose Vaccine is hepatitis a vaccine.
Are there equivalent medicines to Havrix Monodose Vaccine?
Medicines with the same active substance, strength and form include: Havrix Junior Monodose Vaccine. 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 Havrix Monodose Vaccine, 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 Havrix Monodose Vaccine 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
- 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
Active immunisation against infections caused by hepatitis A virus. The vaccine is particularly indicated for those at increased risk of infection or transmission. For example immunisation should be considered for the following risk groups:
Travellers visiting areas of medium or high endemicity, i.e. anywhere outside northern or western Europe, Australia, North America and New Zealand.
Military and diplomatic personnel.
Persons for whom Hepatitis A is an occupational hazard or for whom there is an increased risk of transmission. These include employees in day care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and paediatric units, sewage workers and food packagers or handlers.
Haemophiliacs.
Intravenouse drug abusers.
Homosexual men.
Patients with chronic liver disease (including alcoholic cirrhosis, chronic hepatitis B, chronic hepatitis C, autoimmune hepatitis, primary biliary cirrhosis).
Since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts may be considered.
In addition there may be other groups at risk or specific circumstances such as an outbreak of hepatitis A infection when immunisation should be given.
4.2. Posology and method of administration
Posology
Adults (16 years and over)
Primary immunisation consists of a single dose given intramuscularly. This provides anti-HAV antibodies for at least one year.
This vaccine confers protection against hepatitis A within 2-4 weeks.
In order to obtain more persistent immunity, a booster dose is recommended between 6 and 12 months after primary immunisation.
Although a booster should be given within 6 – 12 months of the initial vaccination, it has been shown that immunocompetent subjects given a booster up to 3 years after the initial vaccination can develop similar antibody levels to subjects given a booster within the recommended time period. Subjects given a booster up to 5 years after initial vaccination can also show a satisfactory antibody response but approximately 30% of individuals receiving a delayed booster have no detectable anti-HAV antibodies prior to booster dosing.
It is unnecessary to restart the primary vaccination schedule if the booster is administered within 5 years of the primary vaccination.
Current recommendations do not support the need for further booster vaccination among immunocompetent subjects after a 2-dose vaccination course (see section 5.1).
The results described above should be considered to apply only to immunocompetent adults.
Havrix Monodose can be used as a booster in subjects previously immunised with any inactivated hepatitis A vaccine.
In the event of a subject being exposed to a high risk of contracting hepatitis A within 2 weeks of the primary immunisation dose human normal immunoglobulin may be given simultaneously with this vaccine at different injection sites.
Children/adolescents (1-15 years)
Havrix Monodose is not recommended (Havrix Junior Monodose should be used).
Method of administration
The vaccine should be injected intramuscularly in the deltoid region. The vaccine should not be administered in the gluteal region.
The vaccine should never be administered intravascularly.
The vaccine should not be administered subcutaneously/intradermally since administration by these routes may result in a less than optimal anti-HAV antibody response. In subjects with a bleeding disorder who are at risk of haemorrhage following intramuscular injection (e.g. haemophiliacs), this vaccine may be administered by deep subcutaneous injection as per local guidance. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to neomycin (present at traces).
4.4. Special warnings and precautions for use
Immunisation should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
As for all vaccinations, appropriate medication e.g. epinephrine (adrenaline) should be readily available for immediate use in case of anaphylaxis.
It is possible that subjects may be in the incubation period of a hepatitis A infection at the time of immunisation. It is not known whether Havrix Monodose will prevent hepatitis A in such cases.
In haemodialysis patients and in subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained after the primary immunisation and such patients may therefore require administration of additional doses of vaccine.
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.
Excipients
This vaccine contains 166 micrograms phenylalanine in each dose. Phenylalanine may be harmful to patients that have phenylketonuria (PKU).
This medicine contains potassium, less than 1 mmol (39 mg) per 1 mL dose, i.e. essentially 'potassium- free'.
This medicinal product contains less than 1 mmol sodium (23 mg) per 1 mL dose, that is to say essentially 'sodium- free'.
4.5. Interaction with other medicinal products and other forms of interaction
Simultaneous administration of Havrix at a dose of 720 ELISA units/mL with normal immunoglobulin does not influence the seroconversion rate to Havrix, however, it may result in a lower antibody titre. A similar effect could be observed with Havrix Monodose.
Preliminary data on the concomitant administration of Havrix at a dose of 720 ELISA units/mL, with recombinant hepatitis B virus vaccine suggest that there is no interference in the immune response to either antigen. Havrix Monodose can be given concomitantly with monovalent and combination vaccines comprised of measles, mumps, rubella and varicella. When concomitant administration is considered necessary the vaccines must be given at different injection sites.
Havrix Monodose must not be mixed with other vaccines in the same syringe.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of this vaccine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. However, as with all inactivated viral vaccines, the risks to the foetus are considered negligible. The use of this vaccine may be considered during pregnancy, if necessary.
Breast-feeding
It is unknown whether this vaccine is excreted in human milk.
A decision must be made whether to discontinue breast-feeding or to abstain from vaccination taking into account the benefit of breast feeding for the child and the benefit of vaccination for the woman.
Fertility
No fertility data are available.
4.7. Effects on ability to drive and use machines
No studies on the effects of Havrix Monodose on the ability to drive and use machines have been performed. However, some of the effects mentioned under section 4.8 “Undesirable effects” may temporarily affect the ability to drive or use machines.
4.8. Undesirable effects
The safety profile presented below is based on data from more than 5300 subjects that participated in clinical trials, plus reactions observed through post-marketing surveillance. It should be noted that it was not possible to calculate the frequency of reactions from the post-marketing data, therefore the frequency is noted as “Not known”.
The most frequently reported reactions are pain and redness at site of injection (Havrix Monodose reports in over 50% of doses, Havrix Junior Monodose reports in 18.2% of doses overall). Swelling at the site of injection was the next most frequently reported reactions.
Frequencies per dose are defined as follows:
Very common:
≥ 1/10
Common:
≥ 1/100 to < 1/10
Uncommon:
≥ 1/1,000 to < 1/100
Rare:
≥ 1/10,000 to < 1/1,000
Very rare:
< 1/10,000
Not Known:
Cannot be estimated from the data available
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
* refers to adverse reaction reported only for Havrix Monodose (1ml adult dose)
** refers to adverse reactions reported only for Havrix Junior Monodose (0.5ml children's dose)
# this adverse reaction was identified through post-marketing surveillance but was not observed in randomised controlled clinical trials. The frequency category of rare was estimated from a statistical calculation based on the total number of paediatric patients exposed to Havrix in randomised controlled clinical trials (n=4574).
System Organ Classes
Frequency
Adverse reaction
Infections and infestations
Uncommon
Upper respiratory tract infection*
Rhinitis*
Immune system disorders
Not known
Anaphylaxis
Allergic reactions including anaphylactoid reactions and mimicking serum sickness
Metabolism and nutrition disorders
Common
Appetite lost
Psychiatric disorders
Very common
Irritability**
Nervous system disorders
Very common
Headache (common with Havrix Junior Monodose formulation)
Common
Drowsiness**
Uncommon
Dizziness*
Rare
Hypoaesthesia
Paraesthesia
Not known
Convulsions
Guillain Barre Syndrome
Transverse myelitis
Neuralgic amyotrophy
Vascular disorders
Not known
Vasculitis
Gastrointestinal disorders
Common
Gastrointestinal symptoms* (rare with Havrix Junior Monodose formulation#)
Nausea
Diarrhoea (uncommon with Havrix Junior Monodose formulation)
Uncommon
Vomiting
Hepatobiliary disorders
Not known
Transient increase in liver function tests
Skin and subcutaneous tissue disorders
Uncommon
Rash**
Rare
Pruritus
Not known
Angioneurotic oedema
Erythema multiforme
Urticaria
Musculoskeletal and connective tissue disorders
Uncommon
Myalgia*
Musculoskeletal stiffness*
Not known
Arthralgia
General disorders and administration site conditions
Very common
Pain and redness at the injection site
Fatigue* (rare with Havrix Junior Monodose formulation#)
Common
Fever (≥ 37.5 °C)
Injection site reaction, such as swelling or induration (uncommon with Havrix Junior Monodose formulation)
Malaise
Uncommon
Influenza like illness*
Rare
Chills
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 the Yellow Card Scheme at: 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 Havrix Monodose Vaccine. 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.