ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Fendrix suspension for injection
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
2.
1 dose (0.5 ml) contains:
Hepatitis B surface antigen
1, 2, 3
20 micrograms
1
adjuvanted by AS04C containing:
- 3-
O
-desacyl-4’- monophosphoryl lipid A (MPL)
2
50 micrograms
2
adsorbed on aluminium phosphate (0.5 milligrams Al
3+
in total)
3
produced in yeast cells (
Saccharomyces cerevisiae
) by recombinant DNA technology.
For a full list of excipients, see section 6.1
3.
Suspension for injection.
Turbid white suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be
observed.
Fendrix is indicated in adolescents and adults from the age of 15 years onwards for active
immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with
renal insufficiency (including pre-haemodialysis and haemodialysis patients).
Posology
Primary immunisation schedule
:
A four dose schedule, with immunisations at the elected date, 1 month, 2 months and 6 months from
the date of the first dose is recommended.
Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with
Fendrix, and not with other commercially available HBV vaccine.
Booster dose
:
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.
2
Fendrix can be used as a booster dose after a primary vaccination course with either Fendrix or any
other commercial recombinant hepatitis B vaccine.
Special posology recommendation for known or presumed exposure to HBV
:
Data on concomitant administration of Fendrix with specific hepatitis B immunoglobulin (HBIg) have
not been generated. However, in circumstances where exposure to HBV has recently occurred (e.g.
stick with contaminated needle) and where simultaneous administration of Fendrix and a standard
dose of HBIg is necessary, these should be given at separate injection sites.
Paediatric population
The safety and efficacy of Fendrix in children aged less than 15 years have not been established.
Method of administration
Fendrix should be injected intramuscularly in the deltoid region.
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity after previous administration of other hepatitis B vaccines.
Subjects suffering from acute severe febrile illness. The presence of a minor infection such as a cold,
is not a contraindication for immunisation.
Appropriate medical treatment should always be readily available in case of rare anaphylactic
reactions following the administration of the vaccine.
Because of the long incubation period of hepatitis B, it is possible that patients could have been
infected before the time of immunisation. The vaccine may not prevent hepatitis B infection in such
cases.
The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and
hepatitis E or other pathogens known to infect the liver.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
A number of factors have been observed to reduce the immune response to hepatitis B vaccines. These
factors include older age, male gender, obesity, smoking, route of administration, and some chronic
underlying diseases. Consideration should be given to serological testing of those subjects who may be
at risk of not achieving seroprotection following a complete course of Fendrix. Additional doses may
need to be considered for persons who do not respond or have a sub-optimal response to a course of
vaccinations.
Since intramuscular administration into the gluteal muscle could lead to a suboptimal response to the
vaccine, this route should be avoided.
Fendrix should under no circumstances be administered intradermally or intravenously.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be
precluded from vaccination against hepatitis B
.
The vaccine could be advised since HBV infection can
3
be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case
basis by the physician.
No data on the concomitant administration of Fendrix and other vaccines or with specific hepatitis B
immunoglobulin have been generated. If concomitant administration of specific hepatitis B
immunoglobulin and Fendrix is required, these should be given at different injection sites. As no data
are available for the concomitant administration of this particular vaccine with other vaccines, an
interval of 2 to 3 weeks should be respected.
Pregnancy
No clinical data on use during pregnancies are available with Fendrix.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy,
embryonal/foetal development, parturition or postnatal development.
Vaccination during pregnancy should only be performed if the risk-benefit ratio at individual level
outweighs possible risks for the foetus.
Breastfeeding
Adequate human data on use during lactation are not available. In a reproductive toxicity study in
animals which included post-natal follow-up until weaning (see section 5.3), no effect on the
development of the pups was observed. Vaccination should only be performed if the risk-benefit ratio
at individual level outweighs possible risks for the infant.
Fertility
No fertility data are available.
Fendrix has moderate influence on the ability to drive and use machine.
Some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate
machinery.
•
Clinical trials
Clinical trials involving the administration of 2,476 doses of Fendrix to 82 pre-haemodialysis and
haemodialysis patients and to 713 healthy subjects ≥ 15 years of age allowed to document the
reactogenicity of the vaccine.
Pre-haemodialysis and haemodialysis patients
The reactogenicity profile of Fendrix in a total of 82 pre-haemodialysis and haemodialysis patients
was generally comparable to that seen in healthy subjects.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and
considered as being related or possibly related to vaccination have been categorised by frequency.
Frequencies are reported as:
Very common: (≥1/10)
4
Common: (≥1/100 to <1/10)
Uncommon: (≥1/1,000 to <1/100)
Rare:
(≥1/10,000 to <1/1,000)
Very rare:
(<1/10,000)
Nervous system disorders
:
Very common:
headache
Gastrointestinal disorders
:
Common:
gastrointestinal disorder
General disorders and administration site conditions
Very common
: fatigue, pain
Common:
fever, injection site swelling, redness
Unsolicited symptoms considered to be at least possibly related to vaccination were uncommonly
reported and consisted of rigors, other injection site reaction and maculo-papular rash.
Healthy subjects
The reactogenicity profile of Fendrix in healthy subjects was generally comparable to that seen in pre-
haemodialysis and haemodialysis patients.
In a large double-blind randomised comparative study, healthy subjects were enrolled to receive a
three dose primary course of Fendrix (N= 713) or a commercially available hepatitis B vaccine
(N= 238) at 0, 1, 2 months. The most common adverse reactions reported were local reactions at the
injection site.
Vaccination with Fendrix induced more transient local symptoms as compared to the comparator
vaccine, with pain at the injection site being the most frequently reported solicited local symptom.
However, solicited general symptoms were observed with similar frequencies in both groups.
Adverse reactions reported in a clinical trial following primary vaccination with Fendrix and
considered as being at least possibly related to vaccination have been categorised by frequency.
Nervous system disorders
:
Common:
headache
Ear and labyrinth disorders
:
Rare:
vertigo
Gastrointestinal disorders
:
Common:
gastrointestinal disorder
Muskuloskeletal and connective tissue disorders
:
Rare:
tendinitis, back pain
Infections and infestations
:
Rare:
viral infection
5
General disorders and administration site conditions
Very common
: injection site swelling, fatigue, pain, redness
Common:
fever
Uncommon:
other injection site reaction
Rare:
rigors,
hot flushes, thirst, asthenia
Immune system disorders
:
Rare
: allergy
Psychiatric disorders
:
Rare:
nervousness
No increase in the incidence or severity of these adverse reactions was seen with subsequent doses of
the primary vaccination schedule.
No increase in the reactogenicity was observed after the booster vaccination with respect to the
primary vaccination.
•
Experience with hepatitis B vaccine:
Following widespread use of hepatitis B vaccines, in very rare cases, syncope, paralysis, neuropathy,
neuritis (including Guillain-Barré syndrome, optic neuritis and multiple sclerosis), encephalitis,
encephalopathy, meningitis and convulsions have been reported. The causal relationship to the
vaccine has not been established.
Anaphylaxis, allergic reactions including anaphylactoid reactions and mimicking serum sickness have
also been reported very rarely with hepatitis B vaccines.
No case of overdose has been reported.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vaccines, hepatitis vaccines, ATC code J07BC01.
Fendrix induces specific humoral antibodies against HBsAg (anti-HBs antibodies). An anti-HBs
antibody titre ≥ 10 mIU/ml correlates with protection to HBV infection.
It can be expected that hepatitis D will also be prevented by immunisation with Fendrix as hepatitis D
(caused by the delta agent) does not occur in the absence of hepatitis B infection.
Immunological data
In pre-haemodialysis and haemodialysis patients
:
In a comparative clinical study in 165 pre-haemodialysis and haemodialysis patients (15 years and
above), protective levels of specific humoral antibodies (anti-HBs titres ≥ 10 mIU/ml) were observed
in 74.4% of Fendrix recipients (N = 82) one month after the third dose (i.e at month 3), as compared to
52.4% of patients in the control group who received a double dose of a
commercially available
hepatitis B vaccine (N = 83) for this population.
6
At month 3, Geometric Mean Titres (GMT) were 223.0 mIU/ml and 50.1 mIU/ml in the Fendrix and
control groups respectively, with 41.0% and 15.9% of subjects with anti-HBs antibody titres ≥100
mIU/ml respectively.
After completion of a four dose primary course (i.e at month 7), 90.9% of Fendrix recipients were
seroprotected (≥ 10 mIU/ml) against hepatitis B, in comparison with 84.4% in a control group who
received the commercially available hepatitis B vaccine.
At month 7, GMTs were 3559.2 mIU/ml and 933.0 mIU/ml in the Fendrix and control groups who
received the commercially available hepatitis B vaccine respectively, with 83.1% and 67.5% of
subjects with anti-HBs antibody titres ≥100 mIU/ml respectively.
Antibody persistence
In pre-haemodialysis and haemodialysis patients:
Anti-HBs antibodies have been shown to persist for at least 36 months following a 0, 1, 2, 6 month
primary course of Fendrix in pre-haemodialysis and haemodialysis patients. At month 36, 80.4% of
these patients retained protective antibody levels (anti-HBs titres ≥ 10mIU/ml), as compared to 51.3%
of patients who received a commercially available hepatitis B vaccine.
At month 36, GMTs were 154.1 mIU/ml and 111.9 mIU/ml in the Fendrix and control groups
respectively, with 58.7% and 38.5% of subjects with anti-HBs antibody titres ≥100 mIU/ml
respectively.
5.2 Pharmacokinetic properties
Pharmacokinetic properties of Fendrix or MPL alone has not been studied in humans.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional animal studies consisting
of acute and repeated dose toxicity, cardiovascular and respiratory safety pharmacology and
reproductive toxicity including pregnancy and peri and postnatal development of the pups till weaning
(see section 4.6).
6.1 List of excipients
Sodium chloride
Water for injections
For adjuvants, see section 2.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
products.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
7
Do not freeze.
Store in the original package in order to protect from light.
6.5 Nature and contents of container
0.5 ml of suspension in pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or
without separate needle in a pack size of 1, or without needles in a pack size of 10.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
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 product or waste material should be disposed of in accordance with local requirements.
7.
GlaxoSmithKline Biologicals s.a.
Rue de l'Institut 89
B-1330 Rixensart, Belgium
EU/1/04/0299/001
EU/1/04/0299/002
EU/1/04/0299/003
Date of first authorisation: 02 February 2005
Date of latest renewal: 10 December 2009
Detailed information on this product is available on the website of the European Medicines Agency
8
ANNEX II
A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE
SUBSTANCE ANDMANUFACTURING AUTHORISATION
HOLDER RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
9
A
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer of the biological active substance
GlaxoSmithKline Biologicals S.A.
89, rue de l’Institut – 1330 Rixensart
Belgium
Name and address of the manufacturer responsible for batch release
GlaxoSmithKline Biologicals S.A.
89, rue de l’Institut – 1330 Rixensart
Belgium
B
CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to medical prescription
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
The Marketing Authorisation Holder will continue to submit yearly PSUR’s, unless otherwise
specified by the CHMP.
Official batch release: in accordance with Article 114 of Directive 2001/83/EC, the official batch
release will be undertaken by a state laboratory or a laboratory designated for that purpose.
10
ANNEX III
LABELLING AND PACKAGE LEAFLET
11
A. LABELLING
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
PRE-FILLED SYRINGE WITH SEPARATE NEEDLE: PACK OF 1
PRE-FILLED SYRINGE WITHOUT NEEDLE: PACK OF 1
PRE-FILLED SYRINGE WITHOUT NEEDLES: PACK OF 10
1.
Fendrix suspension for injection
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
1 dose (0.5 ml):
Hepatitis B surface antigen
1, 2, 3
20 micrograms
1
adjuvanted by AS04C containing:
- 3-
O
-desacyl-4’- monophosphoryl lipid A (MPL)
2
2
adsorbed on aluminium phosphate (0.5 milligrams Al
3+
in total)
50 micrograms
3
produced in yeast cells (
Saccharomyces cerevisiae
) by recombinant DNA technology.
3.
LIST OF EXCIPIENTS
Sodium chloride
Water for injections
4.
Suspension for injection
1 pre-filled syringe
1 separate needle
1 dose (0.5 ml)
1 pre-filled syringe
1 dose (0.5 ml)
10 pre-filled syringes
1 dose (0.5 ml)
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Intramuscular use
Shake before use
Read the package leaflet before use.
13
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
OF THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP
9.
SPECIAL STORAGE CONDITIONS
Store in a refrigerator
Do not freeze
Store in the original package in order to protect from light
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
APPROPRIATE
Dispose of in accordance with local regulations
GlaxoSmithKline Biologicals s.a.
Rue de l’Institut 89
B-1330 Rixensart, Belgium
EU/1/04/0299/001 – pack of 1 with separate needle
EU/1/04/0299/002 – pack of 1 without needle
EU/1/04/0299/003 – pack of 10 without needles
13. BATCH NUMBER
Lot
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription
15. INSTRUCTIONS ON USE
14
16. INFORMATION IN BRAILLE
Justification for not including Braille accepted
15
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
PACK SIZE OF 1 SYRINGE WITH A SEPARATE NEEDLE
PACK SIZE OF 1 SYRINGE WITHOUT NEEDLE
PACK SIZE OF 10 SYRINGES WITHOUT NEEDLES
1.
Fendrix suspension for injection
IM
2.
METHOD OF ADMINISTRATION
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
Lot
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
1 dose (0.5 ml)
6.
OTHER
16
B. PACKAGE LEAFLET
17
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fendrix suspension for injection
Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Read all of this leaflet carefully before you receive this vaccine.
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. Do not pass it on to others.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Fendrix is and what it is used for
2.
Before you receive Fendrix
3.
How Fendrix is given
4.
Possible side effects
5.
How to store Fendrix
6.
Further information
1.
WHAT FENDRIX IS AND WHAT IT IS USED FOR
What Fendrix is
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.
What is hepatitis B?
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).
•
•
Carriers of hepatitis B
•
•
•
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 know as virus “carriers”.
Carriers of the virus are likely to get serious liver problems, such as “cirrhosis” or liver cancer.
How Fendrix works
•
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.
•
18
•
•
•
•
•
•
•
•
•
•
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.
2. BEFORE YOU RECEIVE FENDRIX
Fendrix should not be given if:
•
you are allergic (hypersensitive) to Fendrix or any of the ingredients in Fendrix (listed in
Section 6).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and
swelling of the face or tongue
you have ever had an allergic reaction to any vaccine against hepatitis B
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.
Take special care with Fendrix
Check with your doctor or pharmacist before having Fendrix if:
•
•
you have any known allergies
you have had any health problems after having a vaccine in the past.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having
Fendrix.
Using other medicines and vaccines
Please tell your doctor or pharmacist if you are taking, have recently taken, or are about to take any
other medicines or vaccines.
•
•
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.
Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are pregnant, might become pregnant or are
breast-feeding.
Driving and using machines
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.
3.
HOW FENDRIX IS GIVEN
How your injection is given
The doctor or nurse will give Fendrix as an injection into your muscle. This is usually in your
upper arm.
They will make sure that Fendrix is not given into a blood vessel or into the skin.
•
19
•
How much is given
•
•
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.
If you miss a dose
•
•
If you miss an injection, talk to your doctor and arrange another visit.
Make sure you finish the complete course of four injections. If not, you may not be fully protected
against the disease.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Fendrix 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:
Very common: these may occur with more than 1 in 10 doses of the vaccine
Common: these may occur with up to 1 in 10 doses of the vaccine
Uncommon: these may occur with up to 1 in 100 doses of the vaccine
Rare: these may occur with up to 1 in 1,000 doses of the vaccine
Very rare: these may occur with up to 1 in 10,000 doses of the vaccine
Very common
•
headache
•
feeling tired
•
pain or discomfort where the injection was given.
Common
•
redness or swelling where the injection was given
•
fever
•
stomach and digestion problems.
Uncommon
•
chills
•
red, raised skin rash
•
other reactions where the injection was given.
Rare
•
•
•
allergy
hot flushes
feeling dizzy
20
•
•
•
•
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:
Very rare
•
•
•
•
•
•
•
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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
5. HOW TO STORE FENDRIX
•
Keep out of the reach and sight of children.
•
Do not use Fendrix 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.
•
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
6.
FURTHER INFORMATION
What Fendrix contains
•
The active substance in 1 dose (0.5 ml) of Fendrix is:
Hepatitis B surface antigen
1, 2, 3
20 micrograms
1
adjuvanted by AS04C containing:
- 3-
O
-desacyl-4’- monophosphoryl lipid A (MPL)
2
50 micrograms
2
adsorbed on aluminium phosphate (0.5 milligrams Al
3+
in total)
21
3
produced in yeast cells (
Saccharomyces cerevisiae
) by recombinant DNA technology.
•
The other ingredients in Fendrix are: sodium chloride, water for injections.
What Fendrix looks like and contents of the pack
•
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.
Marketing Authorisation Holder and Manufacturer:
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.
België/Belgique/Belgien
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11
Luxembourg/Luxemburg
GlaxoSmithKline s.a./n.v.
Tél/Tel: + 32 2 656 21 11
България
ГлаксоСмитКлайн ЕООД
ул. Димитър Манов бл.10
София 1408
Тел. + 359 2 953 10 34
Magyarország
GlaxoSmithKline Kft.
Tel.: + 36-1-2255300
Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
gsk.czmail@gsk.com
Malta
GlaxoSmithKline Malta
Tel: + 356 21 238131
Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
dk-info@gsk.com
Nederland
GlaxoSmithKline BV
Tel: + 31 (0)30 69 38 100
nlinfo@gsk.com
Deutschland
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
produkt.info@gsk.com
Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00
firmapost@gsk.no
Eesti
GlaxoSmithKline Eesti OÜ
Tel: +372 667 6900
estonia@gsk.com
Österreich
GlaxoSmithKline Pharma GmbH.
Tel: + 43 1 970 75-0
at.info@gsk.com
Ελλάδα
Polska
22
GlaxoSmithKline A.E.B.E.
Tηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o.
Tel.: + 48 (22) 576 9000
España
GlaxoSmithKline, S.A.
Tel: + 34 902 202 700
es-ci@gsk.com
Portugal
Smith Kline & French Portuguesa, Produtos
Farmacêuticos, Lda.
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Lietuva
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This leaflet was last approved in
Detailed information on this medicine is available on the European Medicines Agency web site:
----------------------------------------------------------------------------------------------------------------------
The following information is intended for medical or healthcare professionals only
Upon storage, a fine white deposit with a clear colourless supernatant can be observed.
23
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 vaccine 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.
Fendrix should under no circumstances be administered intradermally or intravenously.
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.
24
Source: European Medicines Agency
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