Fendrix
hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
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 only. Do not pass it on to others.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What Fendrix is and what it is used for
What you need to know before you receive Fendrix
How Fendrix is given
Possible side effects
How to store Fendrix
Contents of the pack and other information
Fendrix is a vaccine which prevents hepatitis B. It is used for patients with kidney problems:
patients having “haemo-dialysis”- where a “dialysis” machine removes waste products from the blood
patients who are going to have “haemo-dialysis” in the future.
Fendrix is for adults and young people aged 15 years and above.
Hepatitis B is caused by a virus which makes the liver swollen.
Signs may not be seen for 6 weeks to 6 months after infection.
The main signs of the illness include mild signs of flu such as headache or fever, feeling very tired, dark urine, pale stools (faeces), yellow skin or eyes (jaundice). These or other signs may mean the person might need treatment in hospital. Most people fully recover from the illness.
Some people with hepatitis B do not look or feel ill - they do not have any signs of illness.
The virus is found in body fluids such as in the vagina, blood, semen, or saliva (spit).
The hepatitis B virus stays in the body of some people all through their lives.
This means they can still infect other people and are known as virus “carriers”.
Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer.
Fendrix helps your body to produce its own protection against the virus (antibodies). These antibodies will protect you against the disease.
Fendrix contains two things called “MPL” (a non-toxic purified fat derivative from bacteria) and “aluminium phosphate”. These make the vaccine work quicker, better and last for longer.
As with all vaccines, a course of Fendrix cannot fully protect all people that are vaccinated.
Fendrix may not protect you from being ill if you have already caught the hepatitis B virus.
Fendrix can only help to protect you against infection with the hepatitis B virus. It cannot protect you against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis B virus.
if you are allergic to the active substance, or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue
if you have ever had an allergic reaction to any vaccine against hepatitis B
if you have a severe infection with a high temperature. The vaccine can be given after you have recovered. A minor infection such as a cold should not be a problem, but talk to your doctor first.
Fendrix should not be given if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Fendrix.
Talk to your doctor or pharmacist before you are given Fendrix:
if you have any known allergies
if you have had any health problems after having a vaccine in the past.
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.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having Fendrix.
Tell your doctor if you are taking, have recently taken, might take any other medicines or have recently received any other vaccine.
You should have a gap of at least 2 to 3 weeks between having Fendrix and any other vaccine.
Fendrix may need to be given at the same time as an injection of hepatitis B “immuno-globulins”.
Your doctor will make sure that the vaccines are injected into different parts of the body.
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this vaccine.
You may feel tired or get a headache after receiving Fendrix. If this happens, take special care while driving or using any tools or machines.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.
The doctor or nurse will give Fendrix as an injection into your muscle. This is usually in your upper arm.
You will have a series of four injections.
The injections will be given within 6 months:
First injection - on a date agreed with your doctor.
Second injection - 1 month after the first injection.
Third injection - 2 months after the first injection.
Fourth injection - 6 months after the first injection.
The doctor or nurse will tell you when you should come back for the next injections.
Once you have had the first injection of Fendrix, the next injections need also to be Fendrix (not another sort of hepatitis B vaccine).
Your doctor will tell you if you need any extra or “booster” injections in the future. Fendrix can also be used as a booster after a course of a different type of hepatitis B vaccine.
Make sure you finish the complete course of four injections. If not, you may not be fully protected against the disease.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects may happen with this vaccine. Their frequency is defined using the conventions listed below:
headache
feeling tired
pain or discomfort where the injection was given.
redness or swelling where the injection was given
fever
stomach and digestion problems.
chills
red, raised skin rash
other reactions where the injection was given.
allergy
hot flushes
feeling dizzy
feeling thirsty
feeling nervous
infection caused by a virus
back pain, swelling of your tendons.
Additionally, the following side effects have also been reported with other hepatitis B vaccines:
fits
fainting
problems with the nerves of your eye (optic neuritis)
multiple sclerosis
loss of feeling or problems moving some parts of your body
severe headache with a stiff neck
numbness or weakness of the arms and legs (neuropathy), inflammation of nerves (neuritis), weakness and paralysis in the extremities and often progressing to the chest and face (Guillain-Barré syndrome), swelling or infection of the brain (encephalitis, encephalopathy).
allergic reactions, including anaphylactoid reactions. These may be 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 and loss of consciousness. Such reactions may occur before leaving the doctor’s surgery. However, you should seek immediate treatment in any event.
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 thenationalreportingsystem listedinAppendixV. By reporting side effects you can help provide more information on the safety of
this medicine.
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine 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 to protect the environment.
The active substance in 1 dose (0.5 ml) of Fendrix is:
Hepatitis B surface antigen 1, 2, 3 20 micrograms
1adjuvanted by AS04C containing:
3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2 50 micrograms
2adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total)
3produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
The other ingredients in Fendrix are: sodium chloride, water for injections.
Suspension for injection in a prefilled syringe.
Fendrix is a white, milky suspension presented in a glass prefilled syringe (0.5 ml).
Fendrix is available in packs of 1 (with or without a separate needle) and in a pack size of 10 without needles.
Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals s.a. Rue de l’Institut 89
B-1330 Rixensart Belgium
For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
GlaxoSmithKline Biologicals SA Tel. +370 80000334
GlaxoSmithKline Biologicals SA
Тел. +359 80018205
GlaxoSmithKline Biologicals SA Tel.: +36 80088309
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
GlaxoSmithKline Biologicals SA
Tel: +356 80065004
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
GlaxoSmithKline Biologicals SA
Tel: +372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. Tηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089
Smith Kline & French Portuguesa - Produtos
Farmacêuticos, Lda. Tel: + 351 21 412 95 00
GlaxoSmithKline Biologicals SA
Tel: +40 800672524
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000
GlaxoSmithKline Biologicals SA
Tel: +386 80688869
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A.
Tel: + 39 (0) 45 7741111
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017
GlaxoSmithKline Biologicals SA
Tel: +371 80205045
Tel: +44(0)800 221441
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The following information is intended for healthcare professionals only:
Upon storage, a fine white deposit with a clear colourless supernatant can be observed. Before administration, the vaccine should be well shaken to obtain a slightly opaque, white
suspension.
The vaccine should be visually inspected both before and after re-suspension for any foreign particulate matter and/or change in physical appearance. The vaccine must not be used if any change in the appearance of the vaccine has taken place.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Fendrix should not be given to subjects with hypersensitivity to the active substance or to any of the excipients.
Fendrix should not be given to subjects with hypersensitivity after previous administration of other hepatitis B vaccines.
Fendrix should not be given to subjects suffering from acute severe febrile illness. The presence of a minor infection such as a cold, is not a contraindication for immunisation.
Fendrix should be injected intramuscularly in the deltoid region.
Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, this route should be avoided.
Fendrixshouldundernocircumstancesbeadministeredintradermallyorintravenously.
As pre-haemodialysis and haemodialysis patients are particularly exposed to HBV and have a higher risk to become chronically infected, a precautionary attitude should be considered i.e. giving a booster dose in order to ensure a protective antibody level as defined by national recommendations and guidelines.
Appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.