TWINRIX 1 ML Zawiesina do wstrzykiwań

Treść ulotki

1. Twinrix Adulti, injectable suspension in pre-filled syringe
   1. What is Twinrix Adulti and what is it used for
   2. What you need to know before you receive Twinrix Adulti
   3. How to use Twinrix Adulti
   4. Possible side effects
   5. How to store Twinrix Adulti
   6. Package contents and other information
2. Twinrix Pediatric, Prefilled syringe injectable suspension
   1. What Twinrix Pediatric is and what it is used for
   2. What you need to know before you take Twinrix Pediatric
   3. How Twinrix Pediatric is administered
   4. Possible side effects
   5. How to store Twinrix Pediatric
   6. Contents of the pack and other information

F olio illustrativo: information for the user

Twinrix Adulti, injectable suspension in pre-filled syringe

Vaccine (adsorbed) against hepatitis A (inactivated) and against hepatitis B (rDNA) (HAB)

Read this leaflet carefully
before the vaccine is administered to you as 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 vaccine 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 Twinrix Adulti is and what it is used for
• 2. What you need to know before you receive Twinrix Adulti
• 3. How to use Twinrix Adulti
• 4. Possible side effects
• 5. How to store Twinrix Adulti
• 6. Contents of the pack and other information

1. What is Twinrix Adulti and what is it used for

Twinrix Adulti is a vaccine used in adults and adolescents starting from 16 years of age for the
prevention of two infectious diseases: hepatitis A and hepatitis B. The vaccine works by stimulating the body to
produce a protection (antibodies) against these diseases.

• Hepatitis A:hepatitis A is an infectious disease that affects the liver and is caused by the hepatitis A virus. The hepatitis A virus can be transmitted from person to person through food and beverages containing the virus or by swimming in waters contaminated with sewage. The symptoms of hepatitis A begin 3-6 weeks after contact with the virus. These manifest with nausea (discomfort), fever, malaise and pain. After a few days, the whites of the eyes and the skin become yellow (jaundice). The severity and type of symptoms may vary. Young children may not develop jaundice. Most people fully recover but the pathology is usually severe enough to cause a state of discomfort for about a month.
• Hepatitis B:hepatitis B is caused by the hepatitis B virus. It causes enlargement of the liver (inflammation). The virus is found in body fluids such as blood, seminal fluid, vaginal secretions or saliva (sputum) of infected people.

Vaccination is the best solution for protection against these diseases. None of the
components contained in the vaccine can cause infection.

2. What you need to know before you receive Twinrix Adulti

Twinrix Adulti should not be administered if:

• if you are allergic
• to the active ingredient or to any of the other ingredients of this medicine (listed in section 6).
• to neomycin. Signs of an allergic reaction can include itchy, red skin, shortness of breath, swelling of the face or tongue.
• you have previously had an allergic reaction to any other hepatitis A or B vaccine.
• you have a severe infection with a high temperature (over 38°C). A mild infection such as a cold is not a problem, but you should inform your doctor first.

Warnings and precautions
Talk to your doctor or pharmacist before you receive Twinrix Adulti if:

• you have had any health problems following previous vaccinations.
• you have a weakened immune system due to illness or medical treatment.
• you have bleeding problems or a tendency to bruise easily.

Fainting (especially in adolescents) can occur after, or even before, any
injection with a needle. Therefore, inform your doctor or nurse if you have fainted with a previous injection.
A poor response to the vaccine has been observed in obese individuals, with the possibility that protection against hepatitis A may not be achieved.
A poor response to the vaccine has also been observed, with the possibility that protection against hepatitis B may not be achieved, in the elderly, in men
rather than women, in smokers, in obese individuals, in people who have been ill for a long time or who
are receiving certain types of medical treatment.
Your doctor may advise you to have a blood test after completing the vaccination course to check if you have achieved a satisfactory immune response. If not,
your doctor will be able to advise you about the possible need for further doses.

Other medicines and Twinrix Adulti
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before receiving this
vaccine. It is not known whether Twinrix Adulti passes into breast milk; however, problems for
breastfed babies are not expected.

Twinrix Adulti contains neomycin and sodium
Tell your doctor if you have had allergic reactions to neomycin (an antibiotic).
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially ‘sodium-free’.

3. How to use Twinrix Adulti

You will receive a total of 3 injections over 6 months. Each injection will be administered during different
visits. The remaining 2 doses will be administered one month and six months after the first dose.

• First dose: on the scheduled date
• Second dose: 1 month after
• Third dose: 6 months after the first dose

Twinrix Adulti can also be administered as a three-dose cycle in one month. This schedule may
be used exclusively in those adults who require rapid protection (e.g.:
travellers). The first dose will be administered on a scheduled date. The remaining two doses will be
given 7 and 21 days after the first dose. The administration of a fourth dose at 12
months is recommended.

• First dose: on the scheduled date
• Second dose: 7 days after
• Third dose: 21 days after the first dose
• Fourth dose: 12 months after the first dose

The doctor will inform you if further injections or boosters are necessary.
As indicated in paragraph 2, a poor response to the vaccine, with the possibility of not achieving
protection against hepatitis B, is much more common in the elderly and in men rather than in
women, smokers, obese individuals, people who have been ill for a long time or who are receiving certain types of
pharmacological treatment.
The doctor may advise you to undergo a blood test after completing the vaccination cycle in order to check if you have achieved a satisfactory immune response. If not, the doctor will be able to advise you on the possible need for further doses.
If you do not follow the scheduled vaccination schedule, inform your doctor to arrange another visit.
Make sure that the entire vaccination cycle consisting of three injections has been completed. Otherwise,
you may not be fully protected against the diseases.
The doctor will administer Twinrix Adulti in the form of an intramuscular injection in the upper part of the
arm.
The vaccine must not be injected (deeply) into the skin or intramuscularly into the buttock
as protection may be lower.
The vaccine must never be administered intravenously.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Twinrix Adulti can cause side effects, although not everybody gets them.
The side effects that may occur are as follows:

Very common(may affect 1 in 10 or more doses of vaccine): headache, pain and swelling at the
injection site, fatigue.

Common(may affect up to 1 in 10 doses of vaccine): diarrhoea, nausea, swelling, bruising or
itching at the injection site, general feeling of being unwell.

Uncommon(may affect up to 1 in 100 doses of vaccine): dizziness, vomiting, stomach pain, muscle
aches, upper respiratory tract infection, fever greater than or equal to
37.5°C.

Rare(may affect up to 1 in 1,000 doses of vaccine): swelling of the lymph nodes in the neck, armpits or
groin (lymphadenopathy), loss of skin sensation to pain or touch
(hypoaesthesia)tingling (paresthesia), skin rash, itching, joint pain, loss of appetite,
low blood pressure, flu-like symptoms such as high temperature, sore throat, runny nose,
cough and chills.

Very rare(may affect up to 1 in 10,000 doses of vaccine):

• Side effects that have been reported very rarely during clinical studies or routine use of the vaccine or the individual hepatitis A and hepatitis B vaccines include: reduced platelets in the blood, which increases the risk of bleeding or bruising (thrombocytopenia), purplish or brownish-red spots visible through the skin (thrombocytopenic purpura), swelling or infection of the brain (encephalitis), degenerative brain disease (encephalopathy), inflammation of the nerves (neuritis), numbness or weakness of the arms and legs (neuropathy), paralysis, convulsions, swelling of the face, mouth or throat (angioedema

angioneurotic edema), purplish or reddish-violet skin swellings (lichen planus), severe
skin rashes (erythema multiforme), hives, joint swelling, muscle weakness,
infection around the brain that can cause severe headache with stiff neck and
sensitivity to light (meningitis), inflammation of some blood vessels (vasculitis), abnormal
laboratory test results for the liver, multiple sclerosis, swelling of the spinal cord (myelitis), drooping
eyelids and muscle weakness on one side of the face (facial paralysis), temporary inflammation of the
nerves, causing pain, weakness and paralysis of the extremities that often progresses to the chest and
face (Guillain-Barré syndrome), disease of the optic nerves (optic neuritis), immediate pain at the
injection site, sharp and burning sensation.
Severe allergic reactions (anaphylaxis, anaphylactoid reactions and serum sickness-like reactions can
also occur very rarely (up to 1 in 10,000 doses of vaccine).). Signs of severe allergic reactions may be
skin rashes that may be itchy or blistering, swelling of the
eyes and face, difficulty breathing or swallowing, sudden drop in blood
pressure and loss of consciousness. These reactions can occur before leaving
the clinic. However, if you experience any of these symptoms, you should contact your
doctor urgently.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Twinrix Adulti

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. 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.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Twinrix Adulti contains

• The active substances are: Hepatitis A virus (inactivated) 720 ELISA Units Hepatitis B surface antigen 20 micrograms

Produced on human diploid cells (MRC-5)
Adsorbed on aluminium hydroxide, hydrate 0.05 milligrams Al 3+
Produced on yeast cells ( Saccharomyces cerevisiae) using recombinant DNA
technology
Adsorbed on aluminium phosphate 0.4 milligrams Al 3+

• Other components of the vaccine are: sodium chloride, water for injections.

Description of the appearance of Twinrix Adulti and package contents
Injectable suspension in a pre-filled syringe.
Twinrix Adulti is a white, slightly cloudy liquid.
Twinrix Adulti is available in pre-filled 1-dose syringes with or without separate needles, in packs
of 1, 10 and 25.
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 Twinrix Adulti, 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 SA
Tel. +370 80000334

България
GlaxoSmithKline Biologicals SA
Тел. +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 SA
Tel.: +36 80088309

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

Malta
GlaxoSmithKline Biologicals SA
Tel: +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 (0)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

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

Hrvatska
GlaxoSmithKline Biologicals SA
Tel.: +385 800787089

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

România
GlaxoSmithKline Biologicals SA
Tel: +40 800672524

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

Slovenija
GlaxoSmithKline Biologicals SA
Tel: +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 7741111

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

Κύπρος
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017

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

Latvija
GlaxoSmithKline Biologicals SA
Tel: +371 80205045

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

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

---------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:
During storage, a fine white deposit and a clear supernatant may be observed.
The vaccine must be resuspended before use. Once the suspension is recreated, the vaccine will have a
uniform milky white appearance.

Preparation of the vaccine suspension to obtain a uniform milky white appearance
The vaccine must be resuspended following the steps below.

• 1. Hold the syringe upright with your hand closed.
• 2. Shake the syringe by inverting it up and down.
• 3. Repeat this action vigorously for at least 15 seconds.
• 4. Check the vaccine again:

• a. if the vaccine appears as a uniform milky white suspension, it is ready for use - the appearance should not be clear.
• b. if the vaccine does not yet appear as a uniform milky white suspension – shake the syringe again up and down and then again for at least another 15 seconds - then inspect again.

The vaccine must be visually inspected for any foreign particles and/or changes
in physical appearance before administration. If the above is observed, do not administer
the vaccine.
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

Needle hub
To attach the needle to the syringe, gently connect
the needle hub to the Luer Lock Adapter and rotate a quarter turn clockwise until a click is felt.
Do not pull the syringe plunger out of the body.
If this happens, do not administer the vaccine.
Unused medicine and waste materials derived from such medicine must be disposed of in accordance
with current local regulations.

Twinrix Pediatric, Prefilled syringe injectable suspension

Vaccine (adsorbed) against hepatitis A (inactivated) and against hepatitis B (rDNA) (HAB)

Read this leaflet carefully before the child receives the vaccine as 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 vaccine has been prescribed only for the child. Never give it to anyone else.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

This vaccine can be administered to adolescents and children, therefore you should read it for your
child.

Contents of this leaflet:

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

1. What Twinrix Pediatric is and what it is used for

Twinrix Pediatric is a vaccine used in children and adolescents from 1 year up to and including 15 years
of age for the prevention of two diseases: hepatitis A and hepatitis B. The vaccine works by stimulating
the body to produce a protection (antibodies) against these diseases.

• Hepatitis A:hepatitis A is an infectious disease that can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be transmitted from person to person through food and beverages or by swimming in water contaminated by sewage. The symptoms of hepatitis A begin 3-6 weeks after contact with the virus. These manifest with nausea (feeling unwell), fever, malaise and pain. After a few days, the whites of the eyes and skin may turn yellow (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people fully recover but the disease is usually severe enough to require approximately one month off work.
• Hepatitis B:hepatitis B is caused by the hepatitis B virus. It causes enlargement of the liver (inflammation). The virus is found in body fluids such as blood, semen, vaginal secretions or saliva (sputum) of infected people.

Vaccination is the best solution for protection against these diseases. None of the
components of the vaccine can cause infection.

2. What you need to know before you take Twinrix Pediatric

Twinrix Pediatric must not be given if:

• you are allergic to:
• the active substance or any of the other ingredients of this medicine (listed in section 6).
• neomycin The signs of an allergic reaction can include itchy skin rash, shortness of breath, swelling of the face or tongue.
• you have previously had an allergic reaction to any other hepatitis A or B vaccine.
• you have a severe infection with a high temperature (over 38°C). A mild infection such as a cold does not pose a problem, but you should tell your doctor beforehand.

Warnings and precautions
Talk to your doctor or pharmacist before taking Twinrix Pediatric if:

• you have had any health problems following previous vaccinations
• your immune system is weakened due to illness or drug treatment
• you have bleeding problems or a tendency to bruise easily

Fainting (especially in adolescents) can occur after, or even before, any
injection with a needle. Therefore, tell your doctor or nurse if you have fainted with a previous
injection.

Other medicines and Twinrix Pediatric
Twinrix Pediatric can be given at the same time as a vaccine against Human
Papillomavirus (HPV) at a separate site (another part of the body, for example the other arm) during the same
visit.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Pregnancy and breastfeeding
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 or pharmacist for advice before receiving this vaccine.
It is not known whether Twinrix Pediatric passes into breast milk; however, no problems are expected for
breastfed infants.

Twinrix Pediatric contains neomycin and sodium
Tell your doctor if you have had allergic reactions to neomycin (an antibiotic).
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, which is essentially ‘sodium-free’.

3. How Twinrix Pediatric is administered

You will receive a total of 3 injections in 6 months. Each injection will be administered during
different visits. The first dose will be administered on the scheduled date. The remaining 2 doses will be
administered one month and six months after the first dose.

• First dose: on the scheduled date
• Second dose: one month after
• Third dose: six months after the first dose

The doctor will inform you if further injections or boosters are necessary.
If you do not follow the established vaccination schedule, inform the doctor to arrange another
visit.
Make sure you have completed the entire vaccination cycle consisting of three injections. Otherwise,
you may not be fully protected against the diseases.
The doctor will administer Twinrix Pediatric in the form of an intramuscular injection into the upper
arm or the upper thigh in children.
The vaccine must never be administered into a vein.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
The side effects that may occur are as follows:
The side effects that have been observed during clinical studies or during routine use of the
vaccine, or with the individual hepatitis A and hepatitis B vaccines, or with the adult formulation of Twinrix.

Very common(may affect 1 in 10 or more doses of vaccine): pain and redness at the injection
site.

Common(may affect up to 1 in 10 doses of vaccine): drowsiness, headache, nausea,
loss of appetite, swelling or bruising at the injection site, general feeling of being unwell,
fatigue, fever greater than or equal to 37.5°C, irritability.

Uncommon(may affect up to 1 in 100 doses of vaccine): diarrhoea, vomiting, stomach pain,
skin rash, muscle pain, upper respiratory tract infection.

Rare(may affect up to 1 in 1,000 doses of vaccine): swelling of the lymph nodes in the neck,
armpits or groin (lymphadenopathy), dizziness, loss of skin sensation to pain or touch
(hypoaesthesia), tingling (paraesthesia), hives, itching, joint pain, low blood pressure,
flu-like symptoms such as high temperature, sore throat, runny nose, cough and chills.

Very rare(may affect up to 1 in 10,000 doses of vaccine): reduced platelets in the
blood, which increases the risk of bleeding or bruising (thrombocytopenia), spots
that are purple or reddish-brown in colour, visible through the skin (thrombocytopenic purpura), swelling or
infection of the brain (encephalitis), degenerative brain disease (encephalopathy), inflammation
of the nerves (neuritis), numbness or weakness of the arms and legs (neuropathy), paralysis,
convulsions, swelling of the face, mouth or throat (angioedema), swellings on the skin
that are purple or reddish-purple in colour (lichen planus), severe skin rashes (erythema multiforme),
swelling of the joints, muscle weakness, infection around the brain that can cause
severe headache with stiff neck and sensitivity to light (meningitis), inflammation of some blood
vessels (vasculitis), abnormal laboratory test results for the liver, multiple sclerosis, swelling
of the spinal cord (myelitis), drooping eyelids and muscle weakness on one side of the face (facial
paralysis), temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities
that often progresses to the chest and face (Guillain-Barré syndrome), disease of the optic
nerves (optic neuritis), immediate pain at the injection site, sharp and burning pain
Serious allergic reactions (anaphylaxis, anaphylactoid reactions and serum sickness-like conditions)
can also occur very rarely (up to 1 in 10,000 doses of vaccine). The signs of serious
allergic reactions can be skin rashes that may be itchy or blistering,
swelling of the eyes and face, difficulty breathing or swallowing, sudden drop in
blood pressure and loss of consciousness. These reactions can occur before leaving
the clinic. However, if you experience any of these symptoms, you should urgently contact
your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Twinrix Pediatric

Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. 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 from light.
Do not freeze. Freezing will damage the vaccine.
Medicines should not be disposed of via wastewater 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 Twinrix Paediatric contains

• The active substances are: Hepatitis A virus (inactivated) 360 ELISA Units Hepatitis B surface antigen 10 micrograms

Produced on human diploid cells (MRC-5)
Adsorbed on aluminium hydroxide, hydrate 0.025 milligrams Al 3+
Produced on yeast cells ( Saccharomyces cerevisiae) using recombinant DNA
technology
Adsorbed on aluminium phosphate 0.2 milligrams Al 3+

• The other ingredients of the vaccine are: sodium chloride, water for injections.

Description of the appearance of Twinrix Paediatric and contents of the pack
Injectable suspension in a pre-filled syringe.
Twinrix Paediatric is a whitish, slightly cloudy liquid.
Twinrix Paediatric is available in pre-filled 1-dose syringes with or without separate needles, packs
of 1, 10 and 50.
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 Twinrix Paediatric, 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 SA
Tel. +370 80000334

България
GlaxoSmithKline Biologicals SA
Тел. +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 SA
Tel.: +36 80088309

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

Malta
GlaxoSmithKline Biologicals SA
Tel: +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 SA
Tel: +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 SA
Tel.: +385 800787089

Slovenija
GlaxoSmithKline Biologicals SA.
Tel: +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 10 30 30 30

Κύπρος
GlaxoSmithKline Biologicals SA
Τηλ: +357 80070017

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

Latvija
GlaxoSmithKline Biologicals SA
Tel: +371 80205045

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

This leaflet was last updated on
Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
---------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals.
During storage, a fine white deposit and a clear supernatant may be observed.
The vaccine must be re-suspended before use. Once the suspension is recreated, the vaccine will have a
uniform milky white appearance.

Preparation of the vaccine suspension to obtain a uniform milky white appearance
The vaccine must be re-suspended following the steps below.

• 1. Hold the syringe vertically with your hand closed.
• 2. Shake the syringe by inverting it up and down.
• 3. Repeat this action vigorously for at least 15 seconds.
• 4. Check the vaccine again:
• a. if the vaccine appears as a uniform milky white suspension, it is ready for use
• the appearance should not be clear.
• b. if the vaccine does not yet appear as a uniform milky white suspension – shake the syringe again up and down and then again for at least another 15 seconds - then inspect again.

The vaccine must be visually inspected for any foreign particles and/or changes
in physical appearance before administration. If any of the above is observed, do not administer
the vaccine.
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

Needle hub
To attach the needle to the syringe, gently connect
the needle hub to the Luer Lock Adapter and rotate a quarter turn clockwise until a click is felt.
Do not pull the syringe plunger out of the body.
If this happens, do not administer the vaccine.
Unused medicine and waste materials derived from such medicine must be disposed of in accordance
with local legal requirements.