TWINRIX® ADULT AND TWINRIX® JUNIOR
Inactivated hepatitis A and recombinant DNA hepatitis B vaccine
In this leaflet, TWINRIX refers to both TWINRIX ADULT and TWINRIX JUNIOR.
What Is In This Leaflet
This leaflet answers some of the common questions about TWINRIX vaccine. It
does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has weighed
the possible risks of you or your child having TWINRIX against the expected
benefits.
If you have any concerns about receiving TWINRIX talk to your doctor,
nurse or pharmacist.
What Twinrix Is Used For
TWINRIX is a combination vaccine used to prevent hepatitis A and hepatitis B
infection. The vaccine works by causing the body to produce its own protection
(antibodies) against these diseases.
Hepatitis A and hepatitis B are infectious diseases, which cause the liver to
be become inflamed (swollen). These diseases are caused by viruses - hepatitis A
and hepatitis B viruses.
Hepatitis A
Symptoms of hepatitis A usually begin 3 to 6 weeks after coming into contact
with the virus. These consist of nausea (feeling sick), fever, aches and pains.
After a few days the skin and/or the whites of the eyes may become yellowish
(jaundice). The severity and type of symptoms can vary. Hepatitis A is often
milder in young children. Most people recover completely but the illness is
usually severe enough to keep adults off work for about a month.
The hepatitis A virus can be passed from person to person in food and drink,
or by swimming in water contaminated by sewage. Hepatitis A is very common in
many parts of the world and the risk of infection is greatest in those areas
where hygiene and sanitation are poor. Areas include Asia, India, Africa,
Central and South America, the Pacific Islands, the Middle East, and the
Mediterranean Basin. Vaccination is recommended for travellers to these areas,
including people in the armed forces.
Some groups of people however are at a higher risk of exposure to the
disease. Vaccination is recommended for these people:
- nursing staff and healthcare workers in contact with patients in
children's wards, infectious diseases wards, emergency rooms and intensive
care units - day-care centre staff particularly where children have not been toilet
trained - staff and residents of homes or institutions
- sewerage workers
- food handlers
- homosexual men
- people in contact with an infected person
- people with chronic liver disease or liver transplants, or people who
receive certain blood products - some travellers to areas where the incidence of hepatitis A is high.
Hepatitis B
The hepatitis B virus is found in body fluids such as blood, semen vaginal
secretions, or saliva of infected people. You can catch the virus if it can
enter your bloodstream. Ways this can happen are through:
- injection (e.g. needlestick injury, or sharing needles for IV drug use)
- sexual intercourse
- sores, cuts or tiny wounds coming into contact with infected fluids (e.g.
from a human bite, sharing razors or toothbrushes, or working with human blood
or body fluids) - an infected mother passing the virus onto her baby during or shortly after
birth.
Some people infected with hepatitis B may not look or feel sick yet others
will get symptoms. Symptoms may not appear for 6 weeks to 6 months after
infection. Sometimes people will only have mild flu-like symptoms, but other
people can become very ill. They may be extremely tired, and have dark urine,
pale faeces, yellowish skin and/or eyes (jaundice), and other symptoms possibly
requiring hospitalisation. There is a risk of serious liver disease, such as
cirrhosis (liver scarring) and liver cancer for all chronic hepatitis B
carriers.
Some groups of people are at a higher risk of exposure to hepatitis B.
Vaccination is recommended for these people:
- some healthcare workers
- abusers of injectable drugs
- people with many sexual partners
- homosexual men
- haemodialysis patients or people who receive certain blood products
- people with chronic liver disease or hepatitis C
- people in contact with a hepatitis B carrier or an infected person
- staff and residents of institutions or homes
- inmates and prison staff at some correctional institutions
- some travellers to areas where the incidence of hepatitis B is high.
There is no specific treatment for hepatitis A or hepatitis B. Vaccination
is the best way to protect against infection.
TWINRIX will not protect against hepatitis caused by other agents or viruses
(such as hepatitis C or hepatitis E). If a person is already infected with
hepatitis A or hepatitis B virus at the time of vaccination, TWINRIX may not
prevent the disease in these people.
TWINRIX is not recommended for prevention of hepatitis after exposure for
example in the case of needlestick injuries.
Before Receiving Twinrix
Do Not Have Twinrix If:
- you have/your child has had an allergic reaction to TWINRIX, or any
ingredient contained in this vaccine. The ingredients are listed at the end of
this leaflet. Signs of an allergic reaction may include an itchy skin rash,
shortness of breath and swelling of the face or tongue. - If you have/your child has had TWINRIX before and became unwell, tell your
doctor, nurse or pharmacist before the vaccine is given. - you have/your child has had an allergic reaction to any other hepatitis A
(Havrix® or Vaqta®) or hepatitis B (Engerix B®
or H-B-Vax II®) vaccine. - you have/your child has a severe infection with a high temperature. A
minor infection such as a cold should not be a problem, but talk to your
doctor about this before being vaccinated. - the expiry date printed on the pack has passed.
- the packaging is torn or shows signs of tampering.
If you are not sure whether TWINRIX should be given, talk to your doctor
or nurse.
Before Receiving Twinrix Tell Your Doctor If:
- you have/your child has an allergy to baker's yeast.
- you are or think you may be pregnant or if you intend to become pregnant.
Your doctor will discuss with you the possible risks and benefits of receiving
TWINRIX during pregnancy. - you are breast feeding. It is not known if TWINRIX passes into breast
milk, however the vaccine is not expected to cause problems for breast-fed
babies. - you have/your child has any medical conditions, such as:
- a liver or kidney problem
- an immune deficiency condition (e.g. HIV positive)
- a nervous system illness
- or a bleeding disorder.
- you have/your child has allergies to any other medicines or substances,
such as dyes, foods or preservatives. - you have/your child has received another vaccine recently, or are taking
any prescription or OTC (over-the-counter) medicines. In particular mention if
you are taking medicines which suppress the immune system, such as steroids or
cyclosporin.
Some vaccines may be affected by other vaccines or medicines. Your doctor
or pharmacist will be able to tell you what to do if TWINRIX is to be given with
another vaccine or medicine.
How Twinrix Is Given
The doctor or nurse will give TWINRIX as an injection. If you have any
concerns about how this vaccine is to be given, talk to your doctor or
pharmacist.
How Much Is Given
For adults and those aged 16 and over the TWINRIX ADULT dose is 1mL
For children and adolescents aged 1 to 15 years the TWINRIX JUNIOR dose is
0.5 mL
How It Is Given
TWINRIX will be injected into your upper arm muscle in adults and older
children, and into the thigh muscle in infants. For some people with bleeding
problems, the dose may need to be given under the skin (subcutaneously).
The vaccine should never be given intravenously (into the vein).
When Is It Given
TWINRIX is generally given as a total of three doses over 6 months. Each dose
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
It is important to return at the recommended times for follow up doses.
Your doctor will advise on the possible need for extra doses, and future
booster dosing.
Rapid Schedule: If you are going to be travelling within 1 month or
more after initiating the vaccination course, but insufficient time is available
to complete the 0, 1, 6 month schedule, a rapid vaccination schedule of 0, 7, 21
days may be used. A fourth dose is recommended at 12 months after the first
dose.
Speak to you doctor if you have any questions.
If You Miss A Dose
If you miss a scheduled dose, talk to your doctor and arrange another visit
as soon as possible.
While You Are Using Twinrix
Things You Must Do
Keep your follow up visits with the doctor or clinic. It is important that
the 2 follow-up doses of TWINRIX are given at the correct times. This will
ensure the best effect of the vaccine in protecting you against hepatitis A and
hepatitis B.
Things To Be Careful Of
Be careful driving or operating machinery until you know how TWINRIX affects
you. TWINRIX should not normally interfere with your ability to drive a car or
operate machinery. But in some people vaccination can cause dizziness or
lightheadedness. Make sure you know how you react to TWINRIX before you drive a
car or operate machinery, or do anything that could be dangerous if you feel
dizzy or lightheaded.
Side Effects
Tell your doctor, nurse or pharmacist as soon as possible if you or your
child do not feel well during or after a dose of TWINRIX.
TWINRIX helps protect most people from hepatitis A and hepatitis B, but it
may have unwanted side effects in a few people. All medicines and vaccines can
have side effects. Most of the time they are not serious; however, sometimes
they can be. Some side effects may need medical treatment.
Ask your doctor or pharmacist to answer any questions you may have.
Most unwanted effects with TWINRIX are mild and usually clear up within a few
days. These effects, generally occur around the injection site (soreness,
redness, swelling). Fatigue, headache, fever and generally feeling unwell have
also been reported, as have feeling sick and vomiting.
MILD EVENTS that have been reported after hepatitis A or hepatitis B
vaccination.
Tell your doctor if you notice any of the following that are troublesome or
ongoing:
- soreness, redness, swelling, bruising, hard lump or itching around the
injection site - headache, fatigue, fever, dizziness, disturbed sleep, fainting
- feeling sick or vomiting, gut pain, diarrhoea, loss of appetite
- cough, sore throat, respiratory infections
- ringing in the ears, neck stiffness
- sweating, chills, flushing or generally feeling unwell
- muscle aches and pains, painful joints.
MORE SERIOUS EVENTS that have been reported rarely after hepatitis A or
hepatitis B vaccination.
Tell your doctor immediately if you notice any of the following:
- feelings of numbness, weakness and/or fatigue in limbs, tingling in
fingers or toes, - generalised stiffness, visual changes
- swollen glands, unusual bleeding, difficulty passing urine
- drooping eyelids or sagging facial muscles
- sudden headache, neck stiffness, dislike of bright lights.
As with all vaccines given by injection there is a very small risk of
serious allergic reaction. This may occur days to weeks after vaccination.
Contact your doctor immediately or go to the accident and emergency department
of your nearest hospital if any of the following happens:
- swelling of limbs, face, eyes, inside of nose, mouth or throat
- shortness of breath, breathing or swallowing difficulties
- hives, itching (especially of the hands or feet), reddening of skin
(especially around the ears), or severe skin reactions - unusual tiredness or weakness that is sudden and severe.
Other side effects not listed above, can also occur during or soon after a
dose of TWINRIX. Check with your doctor, nurse or pharmacist if you or your
child have any other effects.
Do not be alarmed by this list of possible side effects. You or your child
may not experience any.
Storage
TWINRIX is usually stored at the doctor's clinic or surgery, or at the
pharmacy. But if you need to store TWINRIX always:
- Keep TWINRIX in the refrigerator stored between +2°C and +8°C. THE PACK
SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE. - Keep the vaccine out of the reach of children.
- Keep TWINRIX in the original pack until it is time for it to be given.
Ask your pharmacist what to do with any left over TWINRIX that has expired or
has not been used.
Product Description
What It Looks Like
TWINRIX comes in prefilled syringes or glass vials. It is a white, slightly
milky liquid.
Ingredients
The active ingredients of TWINRIX are killed hepatitis A virus and the
surface protein of the hepatitis B virus (from genetically engineered yeast
cells). The vaccine is not infectious, and will not give you hepatitis A or
hepatitis B.
Two different vaccine strengths are available:
- TWINRIX ADULT: 720 ELISA units of killed hepatitis A virus and 20
micrograms of the hepatitis B surface protein. - TWINRIX JUNIOR: 360 ELISA units of killed hepatitis A virus and 10
micrograms of the hepatitis B surface protein.
Inactive ingredients in the vaccine are: aluminium hydroxide, aluminium
phosphate, sodium chloride, 2-phenoxyethanol, amino acids for injection,
residual formaldehyde, neomycin sulphate, polysorbate 20, phosphate buffer,
trometamol and water.
TWINRIX is made without any human blood or blood products, or any other
substances of human origin.
Further Information
TWINRIX is only available if prescribed by a doctor.
TWINRIX ADULT is available as:
Prefilled syringes in packs of 1
TWINRIX JUNIOR is available as:
Prefilled syringes in packs of 1
The full Product Information for TWINRIX ADULT and TWINRIX JUNIOR is
available from the sponsor listed below.