solution for injection, suspension in pre-filled syringe
Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine ( adsorbed )
What Twinrix Adult is and what it is used for
Twinrix Vuxen is a vaccine that is used for adults and young people aged 16 and over and that protects against two different diseases: hepatitis A and hepatitis B. The vaccine works by causing the body to produce its protection ( antibodies ) against these diseases.
- Hepatitis A: Hepatitis A is an infectious disease that can affect the liver. The disease is caused by the hepatitis A virus. Hepatitis A virus can be transmitted from one person to another through food and drink, or when swimming in water contaminated with sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. Symptoms consist of nausea (general malaise), fever, and aches and pains. After a few days, the whites of the eyes and the skin may turn yellowish (jaundice). The severity and type of symptoms can vary. Young children do not always develop jaundice. Most people make a full recovery, but the illness is often severe enough to make you feel sick for about a month.
- Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes swelling of the liver ( inflammation ). Virus et is found in body fluids such as blood, semen, vaginal secretions, or saliva (spit) from infected people.
Vaccination is the best way to protect yourself against these diseases. The vaccine does not contain any components that can cause infection.
What you need to know before you receive Twinrix Adult
Do not take Twinrix Adult
- you are allergic to:
- the active substances or any other ingredient in this medicine (listed in section 6)
- neomycin.
Signs of an allergic reaction may include an itchy rash, shortness of breath, and swelling of the face or tongue.
- you have previously had an allergic reaction to any hepatitis A or hepatitis B vaccine.
- you have a severe infection with a high fever (over 38 °C). A minor infection such as a common cold is probably not a problem, but talk to the doctor first.
Warnings and precautions
Talk to your doctor or pharmacist before receiving Twinrix Adult if:
- If you have had any health problems after previous vaccinations
- you have a poor immune system due to illness or drug treatment.
- you have a bleeding disorder or bruise easily.
Fainting may occur (mainly in young people) after, or even before, any needle injection. Therefore, tell the doctor or nurse if you have fainted during a previous injection.
In obese patients, a poor response to the vaccine has been seen, possibly without achieving protection against hepatitis A. A poor response to the vaccine, possibly without achieving protection against hepatitis B, has also been seen in older people, men rather than women, smokers, obese, long-term sick, or people with a certain type of drug treatment. Your doctor may advise you to have a blood test after you have completed the vaccination program to check whether you have achieved a sufficient response. If not, your doctor will let you know if you need an additional dose.
Other medicines and Twinrix Adult
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.
It is not known whether Twinrix Adult passes into breast milk. However, the vaccine is not expected to cause any problems for children who are breastfed.
Twinrix Adult contains neomycin and sodium
Tell your doctor if you have previously had an allergic reaction to neomycin ( an antibiotic ).
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is almost “sodium-free”.
How Twinrix Adult should be used
You will receive a total of three injections over 6 months. Each injection is given at a separate visit. The first dose will be given as agreed. The other two doses will be given one month and six months after the first dose.
| First dose one | as agreed |
| Second dose: | 1 month later |
| Third dose: | 6 months after the first dose one |
Twinrix Adult can also be given as a total of 3 doses within 1 month. This schedule should only be given to adults who need quick protection (eg international travelers). The first dose is given as agreed. The remaining 2 doses are given 7 days and 21 days after the first dose. A fourth dose is recommended at 12 months.
| First dose: | as agreed |
| Second dose: | 7 days later |
| Third dose: | 21 days after the first dose a |
| Fourth dose: | 12 months after the first dose a |
If an additional dose or a top-up dose is needed, the doctor will let you know.
As described in Section 2, a poor response to the vaccine, possibly without achieving protection against hepatitis B, is more common in older people, men rather than women, smokers, the obese, the chronically ill, or people on certain types of drug therapy. Your doctor may advise you to have a blood test after you have completed the vaccination program to check whether you have achieved a sufficient response. If not, your doctor will let you know if you need an additional dose.
If you miss an appointment for vaccination, you must talk to the doctor and get a new appointment.
Make sure you complete the vaccination program of three injections. Otherwise, you will not have complete protection against the diseases.
The doctor will give you Twinrix Adult as an injection into the upper arm muscle.
The vaccine should not be given on the skin or intramuscularly in the buttock, as the protection may be reduced.
The vaccine must never be given into a vein.
If you have any further questions about this vaccine, ask your doctor or pharmacist.
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:
| Very common (1 in 10 vaccine doses or more often): | |
| HeadachePain and redness at the injection site fatigue | |
| Common (up to 1 in 10 vaccine doses): | |
| Diarrhea, nausea welling, bruising or itching at the injection site feeling of illness. | |
| Uncommon (up to 1 in 100 vaccine doses): | |
| DizzinessVomiting, stomach ache muscle pain upper respiratory tract infectionFever 37.5°C or higher. | |
| Rare (up to 1 in 1000 vaccine doses): | |
| Swollen glands in the neck, armpits, or groin ( lymphadenopathy )Decreased sensitivity to pain or touch ( hypesthesia )Tingling and crawling ( paresthesia )Rash, itchingJoint painless of appetite low blood pressureFlu-like symptoms such as high fever, sore throat, runny nose, cough, and chills. | |
| Very rare (up to 1 in 10,000 vaccine doses): Adverse reactions that have occurred very rarely during clinical trials, with routine use of the vaccine, or with individual hepatitis A and hepatitis B vaccines include: | |
| Reduction in the number of blood platelets, which increases the tendency to bleed and the risk of bruising ( thrombocytopenia )Dark violet or brown-red spots visible through the skin (thrombocytopenic purpura)Swelling or inflammation of the brain ( encephalitis )Degenerative brain disease ( encephalopathy )Nerve inflammation ( neuritis )Numbness or weakness in arms and legs ( neuropathy ), paralysisCrampsSwelling of the face, mouth or throat ( angioneurotic edema)Dark violet or red-violet skin nodules ( lichen planus), severe skin rash (erythema multiforme), gives joint swelling, muscle weaknessInflammation of the membranes around the brain, which can cause severe headaches with neck stiffness and sensitivity to light ( meningitis )Inflammation in certain blood vessels ( vasculitis )Severe allergic reactions ( anaphylaxis, anaphylactoid reactions and symptoms similar to serum sickness). Signs of severe allergic reactions may include a skin rash that may itch or blister, swelling around the eyes and face, difficulty breathing or swallowing sudden drop in blood pressure and loss of consciousness. Such reactions can occur before you have time to leave the reception. If you experience any of these symptoms, contact your doctor immediately. Abnormal liver values multiple sclerosis, swelling of the spinal cord ( myelitis )Drooping eyelids, and paralysis of the muscles in one half of the face (facial paralysis)Transient nerve inflammation causes pain, weakness, and paralysis of the arms and legs, often progressing to the chest and face ( Guillain-Barré syndrome ). The disease of optic nerve one ( optic neuritis )Immediate pain at the injection site, stinging and burning sensation. |
How Twinrix Adult should be stored
Keep this medicine out of sight and reach of children.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ºC-8 ºC).
Store in the original packaging. Light sensitive.
Do not freeze. Freezing destroys the vaccine.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
What Twinrix Adult contains
| – | The active substances are: | |
| Hepatitis A virus (inactivated) 1,2 | 720 ELISA units | |
| Hepatitis B surface antigen 3,4 | 20 micrograms | |
| 1 Produced in human diploid cells (MRC-5) | ||
| 2 Adsorbed on hydrated aluminum hydroxide | 0.05 milligrams of Al 3+ | |
| 3 Produced in yeast cells ( Saccharomyces cerevisiae ) using recombinant DNA technology | ||
| 4 Adsorbed on aluminum phosphate | 0.4 milligrams of Al 3+ | |
| – | The other ingredients in Twinrix Adults are sodium chloride and water for injections. |
Appearance and package sizes of the medicine
Solution for injection, suspension in a prefilled syringe
Twinrix Adult is a white, slightly milky liquid packaged in a pre-filled glass syringe (1 ml).
Twinrix Adult is supplied in packs of 1, 10, and 25 with or without needles.
Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals said
Rue de l’Institut 89
B-1330 Rixen species
Belgium
For information regarding this medicinal product, please contact the local representative of the marketing authorization holder.
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