FENDRIX 0.5 ML Injectable suspension

Зміст інструкції

1. Fendrix injectable suspension
   1. What is Fendrix and what is it used for
   2. What you need to know before you receive Fendrix
   3. How Fendrix is administered
   4. Possible side effects
   5. How to store Fendrix
   6. Contents of the pack and other information

F olio illustrativo: information for the user

Fendrix injectable suspension

Hepatitis B vaccine (recombinant DNA) (adjuvanted, adsorbed)

Read this leaflet carefully before you use this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Never give it to others.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Fendrix is and what it is used for
• 2. What you need to know before you are given Fendrix
• 3. How Fendrix is administered
• 4. Possible side effects
• 5. How to store Fendrix
• 6. Contents of the pack and other information

1. What is Fendrix and what is it used for

Fendrix is a vaccine that prevents hepatitis B.
It is used for patients with kidney problems:

• patients undergoing “hemodialysis” a condition in which a “dialysis” machine removes waste products from the blood
• patients who will undergo “hemodialysis” in the future.

Fendrix is indicated for adults and adolescents starting from 15 years of age.

What is hepatitis B?
Hepatitis B is caused by a virus that causes enlargement of the liver.

• Symptoms may not be noticed by the patient for 6 weeks and up to 6 months after contracting the infection.
• The main signs of the disease include mild flu-like symptoms such as headache or fever, a feeling of profound fatigue, dark urine, pale stools, yellowing of the skin or eyes (jaundice). These or other symptoms may require hospital treatment for the person. Most people recover from the disease.
• Some people with hepatitis B do not seem or feel ill, they do not have symptoms of the disease.
• The virus is found in body fluids such as vaginal fluids, blood, semen or saliva (sputum).

Hepatitis B carriers

• The hepatitis B virus remains in the body of some people for life.
• This means they can still infect others and are known as “carriers” of the virus.
• “Carriers” of the virus are predisposed to developing serious liver problems such as “cirrhosis” or liver cancer.

How Fendrix works

• Fendrix helps the body produce its own protection against the virus (antibodies). These antibodies will protect you against the disease.
• Fendrix contains two substances called “MPL” (a fatty substance, purified, non-toxic, derived from bacteria) and “aluminum phosphate”. These substances make the vaccine work better, faster and with a longer duration.
• As with all vaccines, a complete course of Fendrix may not fully protect all people who are vaccinated.
• Fendrix may not protect against the disease if you have already contracted the hepatitis B virus.
• Fendrix can only help protect against infection with the hepatitis B virus. It cannot protect against other infections that may affect the liver - even if these infections may have signs similar to those caused by the hepatitis B virus.

2. What you need to know before you receive Fendrix

Fendrix must not be administered:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction can include itchy rash, rapid breathing, swelling of the face or tongue;
• if you have had an allergic reaction to any other hepatitis B vaccine in the past;
• if you have a severe infection with high fever. The vaccine can be administered after recovery. A mild infection such as a cold does not pose a problem, but you should tell your doctor beforehand.

Fendrix must not be administered if you are in any of the conditions listed above. If you are not sure, talk to your doctor or pharmacist before receiving Fendrix.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Fendrix:

• if you have known allergies
• if you have had health problems after a vaccination in the past.

Fainting (especially in adolescents) may occur following, or even before, any injection with a needle. Therefore, inform your doctor or nurse if you have fainted with a previous injection
Talk to your doctor or pharmacist before receiving Fendrix if any of the conditions
above apply to you (or if you are not sure).

Other medicines and Fendrix
Talk to your doctor or pharmacist if you are taking, have recently taken or are about to
take any other vaccine.

• There must be an interval of 2 or 3 weeks between the administration of Fendrix and any other vaccine.
• It may be necessary to administer Fendrix at the same time as an injection of “immunoglobulin” for hepatitis B. The doctor will ensure that the vaccines are administered at different injection sites.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before using this medicine.

Driving and operating machinery
You may feel tired or have a headache after receiving Fendrix. If this happens,
be particularly careful while driving or using any tools or
machinery.

Fendrix contains sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
‘sodium-free’.

3. How Fendrix is administered

How the vaccine is administered
The doctor or nurse will administer Fendrix with an intramuscular injection. Usually
in the upper limbs.

How many injections need to be administered

• You will be given a series of 4 injections
• The injections must be administered within 6 months
• First injection: on a date agreed with the 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 inform you when you need to return for the subsequent injections.
• Once the first injection of Fendrix has been administered, Fendrix must be administered in the subsequent injections (not another type of hepatitis B vaccine).

The doctor will inform you about the possible need for further doses and future boosters. Fendrix
can be used as a booster dose after a cycle of a different hepatitis B vaccine.

If you do not attend one of the scheduled visits

• If you do not attend for an injection, talk to your doctor and schedule anothervisit.
• Make sure you have completed the cycle of four injections. Otherwise, you may not be fully protected against the disease.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects have been observed with this vaccine. Their frequency is defined
using the conventions listed below:

Very common(may affect more than 1 in 10 people): headache,
fatigue, pain or discomfort at the injection site.

Common(may affect up to 1 in 10 people): redness, swelling at the injection
site, fever, digestive and stomach disorders.

Uncommon(may affect up to 1 in 100 people): chills,
redness, raised skin rash, other reactions at the injection site.

Rare(may affect up to 1 in 1,000 people): allergy, hot flushes,
dizziness, thirst, nervousness, viral infection, back pain,
tendon inflammation.
In addition, the following side effects have been observed with other hepatitis B vaccines:

Very rare(may affect up to 1 in 10,000 people): convulsions,
fainting, problems with the nerves of the eye (optic neuritis), multiple sclerosis, loss
of sensation or problems moving some parts of the body, severe headache with
stiff neck, numbness or weakness of the arms and legs (neuropathy),
inflammation of the nerves (neuritis), weakness and paralysis of the limbs, which often
progresses to the chest and face (Guillain-Barré syndrome) swelling or infection of the
brain (encephalitis, encephalopathy).
Allergic reactions including anaphylactoid reactions (may occur very rarely up to 1 in 10,000
doses). These may be local or widespread skin rashes which 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 can occur before
leaving the doctor's office. However, in any case, immediate medical treatment
should be sought.

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
through the national reporting system listed in Annex V . By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Fendrix

• 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 packaging. The expiry date refers to the last day of the month.
• Store in a refrigerator (2°C - 8°C).
• Store in the original package to protect the medicine from light.
• Do not freeze. Freezing will damage the vaccine.
• Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fendrix contains

• The active ingredient in 1 dose (0.5 ml) of Fendrix is:

Hepatitis B surface antigen 20 micrograms
adjuvanted with AS04C containing

• 3- O-desacyl-4’- monophosphoryl lipid A (MPL)² 50 micrograms

adsorbed on aluminium phosphate (0.5 milligrams Al in total)
produced by yeast cells ( Saccharomyces cerevisiae) by recombinant DNA
technology.

• The other components contained in Fendrix are: sodium chloride, water for injections.

Description of the appearance of Fendrix and contents of the pack
Fendrix is a white, milky suspension.
Fendrix is available in a pre-filled 1 dose syringe with or without separate needles and in a
pack of 1 and 10.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart
Belgium
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder.

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals SA/NV
Tél/Tel: + 32 10 85 52 00

Lietuva
GlaxoSmithKline Biologicals SATel. +370
80000334

България
GlaxoSmithKline Biologicals SAТел. +359
80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals SA/NV
Tél/Tel: + 32 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
[email protected]

Magyarország
GlaxoSmithKline Biologicals SATel.: +36
80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GlaxoSmithKline Biologicals SATel: +356
80065004

Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
[email protected]

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Tηλ: + 30 210 68 82 100

Eesti
GlaxoSmithKline Biologicals SATel: +372
8002640

Österreich
GlaxoSmithKline Pharma GmbH.
Tel: + 43 1 970 75-0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000

Portugal
Smith Kline & French Portuguesa - Produtos
Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
[email protected]

România
GlaxoSmithKline Biologicals SATel: +40
800672524

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
[email protected]

Hrvatska
GlaxoSmithKline Biologicals SATel.: +385
800787089

Slovenija
GlaxoSmithKline Biologicals SATel: +386
80688869

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
GlaxoSmithKline Biologicals SA.
Tel: +421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: + 39 (0) 45 7741 111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 (0)10 30 30 30

Κύπρος
GlaxoSmithKline Biologicals SAΤηλ: +357
80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GlaxoSmithKline Biologicals SATel: +371
80205045

United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SATel: +44 (0)800
221441
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the
European Medicines Agency: http://www.ema.europa.eu/.

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The following information is intended exclusively for healthcare professionals:
During storage, a fine white precipitate may be observed with a clear supernatant.
Before administration, the vaccine must be shaken well to obtain a
milky white suspension.
The vaccine must be visually inspected before administration, both before and
after reconstitution, to check for the absence of particles and/or any change
in physical appearance. The vaccine should not be used if any
change in the physical appearance of the vaccine is observed.
Unused medicine or waste material shall be disposed of in accordance with
local regulations.
Fendrix must not be administered to subjects with hypersensitivity to the active substance or
to any of the excipients.
Fendrix must not be administered to subjects with hypersensitivity after a previous
administration of other hepatitis B vaccines.
Fendrix must not be administered to subjects suffering from severe acute febrile illnesses. The
presence of a minor infection such as a cold does not constitute a contraindication
to vaccination.
Fendrix must be injected intramuscularly into the deltoid region.
Since intramuscular administration into the gluteus may elicit a sub-optimal
response to the vaccine, this route of administration should be avoided.
Under no circumstances should Fendrix be administered intradermally or intravenously.
Since patients undergoing pre-dialysis and haemodialysis are particularly exposed to the hepatitis B
virus and have a higher risk of chronic infection, the administration of a booster dose should be
carefully considered as a precautionary measure to ensure antibody coverage as provided by
national recommendations and guidelines.
Appropriate medical treatment must always be readily available in the event of rare anaphylactic reactions
following vaccine administration.
Instructions for the pre-filled syringe

Luer Lock Adapter
Hold the syringe by the body, not by the
plunger.
Unscrew the syringe cap by rotating it
counterclockwise.
Plunger
Body
Cap

To attach the needle to the syringe, gently connect
the needle hub
to the Luer Lock Adapter and rotate a
quarter turn clockwise until
you feel it lock.
Needle hub
Do not pull the syringe plunger out of the
body. If this happens, do not administer the
vaccine.
Unused medicine or waste material from such medicine must be disposed of in
compliance with current local regulations.