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ENGERIX B 20 MICROGRAMS/1ML SUSPENSION FOR INJECTION

Active substance(s): HEPATITIS B SURFACE ANTIGEN / HEPATITIS B SURFACE ANTIGEN

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PACKAGE LEAFLET

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Package leaflet: Information for the user
ENGERIX B JUNIOR 10 micrograms/0.5 ml, suspension for injection
Hepatitis B (rDNA) vaccine (adsorbed) (HBV)
Read all of this leaflet carefully before you/your child start receiving this vaccine because it
contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This vaccine has been prescribed for you/your child only. Do not pass it on to others.
 If you/your child get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet, any reference to ‘you’ can also mean ‘your child’.
What is in this leaflet
1. What Engerix B Junior is and what it is used for
2. What you need to know before you receive Engerix B Junior
3. How Engerix B Junior is given
4. Possible side effects
5. How to store Engerix B Junior
6. Contents of the pack and other information
1.

What Engerix B Junior is and what it is used for

Engerix B Junior is a vaccine used to prevent hepatitis B infection. It can also help to prevent hepatitis
D infection.
This vaccine can be given to new born babies, children and adolescents up to and including 15 years
of age.
Hepatitis B is an infectious illness of the liver caused by a virus. Some people have the hepatitis B
virus in their body but cannot get rid of it. They can still infect other people and are known as carriers.
The disease is spread by the virus entering the body following contact with body fluids, most often
blood, from an infected person.
If the mother is a carrier of the virus she can pass the virus to her baby at birth. It is also possible to
catch the virus from a carrier through, for example, unprotected sex, shared injection needles or
treatment with medical equipment which has not been properly sterilised.
The main signs of the illness include headache, fever, sickness and jaundice (yellowing of the skin and
eyes) but in about three out of 10 patients there are no signs of illness.
In those infected with hepatitis B one out of 10 adults and up to nine out of 10 babies will become
carriers of the virus and are likely to go on to develop serious liver damage and in some cases cancer
of the liver.
How Engerix B Junior works
Engerix B Junior contains a small amount of the ‘outer coating’ of the hepatitis B virus. This ‘outer
coating’ is not infectious and cannot make you ill.
 When you are given the vaccine it will trigger the body’s immune system to prepare itself to
protect against these viruses in the future.
 Engerix B Junior will not protect you if you have already caught the hepatitis B virus.
 Engerix B Junior can only help to protect you against infection with hepatitis B virus.
2.

What you need to know before you receive Engerix B Junior

Engerix B Junior should not be given:
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If you are allergic (hypersensitive) to Engerix B Junior or any of the other ingredients of this
vaccine (listed in section 6)
 If you have a high temperature (fever).
Engerix B Junior should not be given if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist before receiving Engerix B Junior. Please tell your doctor or pharmacist if you
have any allergies or if you have ever had any health problems after being given a vaccine.
Warnings and precautions
Talk to your doctor or pharmacist before you receive Engerix B Junior if you:
 Are on dialysis for a kidney problem or have an illness which may affect your/her/his immune
system.
People who have dialysis, long term liver problems, carry hepatitis C or are HIV positive may still
be given Engerix B Junior by their doctor. This is because hepatitis B infections can be severe in
these patients. More information about kidney problems and dialysis is in section 3.
If you are not sure if any of the above apply to you, talk to your doctor before having Engerix B
Junior.
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.
Like other vaccines, Engerix B Junior may not be totally effective in protecting you against hepatitis
B. A number of factors, such as older age, gender, being overweight, smoking and some long term
problems reduce your immune response to the vaccine. If any of these apply to you, your doctor may
decide to give you a blood test or give you an additional dose of Engerix B Junior to make sure you
are protected.
Other medicines and Engerix B Junior
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Engerix B Junior can be given at the same time as most other routine vaccines. Your doctor will
ensure that the vaccines are injected separately and into different parts of the body.
Pregnancy and breast-feeding
 If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Engerix B Junior may affect your ability to drive or use machines. Do not drive or use machines if you
are feeling unwell.
Engerix B Junior contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree’.
3.

How Engerix B Junior is given

How your vaccine is given
The doctor will give the recommended dose of Engerix B Junior to you.
Engerix B Junior will be given:
 as an injection into the muscle of the upper arm in children and adolescents.
 as an injection into the thigh muscle for babies and young children.
 as an injection under the skin if you bruise easily or have a bleeding problem.
How much is given
You will be given a series of injections of Engerix B Junior. Once you have completed the course of
injections you can expect long term protection against hepatitis B.
 New born babies, children and adolescents up to and including 15 years of age and under are
usually given the 10 microgram / 0.5 ml vaccine.
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There are several ways in which you can be given Engerix B Junior. Your doctor will choose the most
appropriate course for you:
Schedule 1 – for new born babies, children and adolescents up to and including 15 years of age
First injection
- now
Second injection
- 1 month after first injection
Third injection
- 6 months after first injection
Schedule 2 – for new born babies, children and adolescents up to and including 15 years of age
First injection
- now
Second injection
- 1 month after first injection
Third injection
- 2 months after first injection
Fourth injection
- 12 months after first injection
 In new born babies, schedule 2 will allow Engerix B Junior to be given at the same time as other
routine childhood vaccines.
 This schedule can also be used if you are being vaccinated due to recent exposure to hepatitis B, as
it will give protection more quickly.
It is very important for you to return for your injections at the recommended times. If you have any
questions about the amount of vaccine you are being given, please speak to your doctor.
Vaccination and child birth
If you have hepatitis B and just gave birth, schedule 1 or 2 can be used to vaccinate your baby.
 Your doctor may also decide to give your baby hepatitis B immunoglobulins (human antibodies) at
the time of first injection. This will help protect your baby from hepatitis B. It will be given at a
separate injection site.
Kidney problems and dialysis
If your child has a kidney problem or is on dialysis, your doctor may decide to do a blood test or give
extra doses of vaccine to make sure that your child is protected.
4.

Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them. The following
side effects may happen with this vaccine:
Allergic reactions
If you have an allergic reaction, see your doctor straight away. The signs may include:
 your face swelling
 low blood pressure
 difficulty breathing
 your skin going blue
 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
 feeling tired
 irritability
Common (these may occur with up to 1 in 10 doses of the vaccine)
 drowsiness
 nausea (feeling sick) or vomiting (being sick)
 diarrhoea or abdominal pain
 loss of appetite
 a high temperature (fever)
 feeling generally unwell
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swelling at the injection site
reactions at the injection site such as a hard lump

Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
 dizziness
 muscle pain
 flu like symptoms
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
 swollen glands
 hives, rash and itchiness
 joint pain
 pins and needles
 Side effects that have been reported during marketed use of Engerix B Junior include:bruising
easily and not being able to stop bleeding if you cut yourself
 low blood pressure
 inflammation of your blood vessels
 sudden swelling of your face around your mouth and throat area (angioneurotic oedema)
 being unable to move muscles (paralysis)
 inflammation of your nerves (neuritis) which may cause loss of feeling or numbness, including 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) and multiple sclerosis
 problems moving your arms or legs (neuropathy)
 inflammation of your brain (encephalitis)
 degenerative disease of the brain (encephalopathy)
 infection around the brain (meningitis)
 fit (convulsions)
 loss of skin sensitivity to pain or touch (hypoaesthesia)
 purple or reddish-purple bumps on the skin (lichen planus)
 red or purple spots on your skin
 painful and stiff joints (arthritis)
 weakness of the muscles
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between
breaths may occur for 2-3 days after vaccination.
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 the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
5.







6.

How to store Engerix B Junior
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 label and carton after EXP.
The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package.
Do not throw away any medicines of 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 Engerix B Junior contains
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The active substance is the ‘outer coating’ of the hepatitis B virus. Each dose contains 10
micrograms/0.5 ml of protein made up of this outer coat adsorbed on aluminium hydroxide
hydrated.
The other ingredients are sodium chloride, disodium phosphate dihydrate, sodium dihydrogen
phosphate and water for injections.

What Engerix B Junior looks like and contents of the pack
 Engerix B Junior is a cloudy white injectable liquid.
 For vial:
Suspension for injection (10 micrograms/0.5 ml). Pack size of 1, 10, 25 or 100.
 For pre-filled syringe:
Suspension for injection (10 micrograms/0.5 ml). Pack size of 1 or 10 with or without needles.
 Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
GlaxoSmithKline Biologicals s.a., Rue de l' Institut 89, B-1330 Rixensart, Belgium
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria, Denmark, Finland, Iceland, Norway, Sweden: Engerix-B
Belgium, Luxembourg: Engerix B Junior
France, Ireland, Italy: Engerix B-10
Germany: Engerix-B Children
Greece: Engerix
Netherlands, Spain: Engerix-B Junior
Portugal, United Kingdom: Engerix B
This leaflet was last revised in
[To be completed nationally]
Other sources of information
Detailed information on this medicine is available on the website of: {name of MS/Agency}
--------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only:
Upon storage, the content may present a fine white deposit with a clear colourless supernatant. Once
shaken the vaccine is slightly opaque.
The vaccine should be inspected visually for any foreign particulate matter and/or coloration prior to
administration. Discard if the content appears otherwise.
The entire contents of a mono-dose container must be withdrawn and should be used immediately.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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