Twinrix

F Patient Information Leaflet: Information for the User
Twinrix Adults, injectable suspension in a pre-filled syringe
Vaccine (adsorbed) against hepatitis A (inactivated) and hepatitis B (rDNA) (HAB)
Please read this leaflet carefully
before you are given this 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 for you only. Never give it to others.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Twinrix Adults is and what it is used for
2. What you need to know before receiving Twinrix Adults
3. How to use Twinrix Adults
4. Possible side effects
5. How to store Twinrix Adults
6. Contents of the pack and other information

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

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

• Hepatitis A: Hepatitis A is an infectious disease affecting the liver, caused by the hepatitis A virus. The hepatitis A virus can be transmitted from person to person through food and drinks contaminated with the virus, or by swimming in water polluted with sewage. Symptoms of hepatitis A typically appear 3 to 6 weeks after exposure to the virus. These include nausea (feeling unwell), fever, malaise, and body aches. After a few days, the whites of the eyes and the skin may turn yellow (jaundice). The severity and type of symptoms may vary. Young children may not develop jaundice. Most people recover completely, but the illness is usually severe enough to cause discomfort lasting about one month.
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes swelling of the liver (inflammation). The virus is present in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected individuals.

Vaccination is the best way to protect against these diseases. None of the components contained in the vaccine can cause infection.

2. What you should know before receiving Twinrix Adulti

Twinrix Adulti 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).
  • to neomycin. Signs of an allergic reaction may include itchy red rash on the skin, shortness of breath, swelling of the face or tongue.
• you previously had an allergic reaction to any other hepatitis A or B vaccine.
• you have a severe infection with high fever (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 receiving Twinrix Adulti if:

• you have previously experienced any health problems after vaccination.
• you have a weakened immune system due to illness or medical treatment.
• you have bleeding disorders or a tendency to develop excessive bruising.

Fainting (especially in adolescents) may occur during or even before any injection with a needle. Therefore, inform your doctor or nurse if you have ever fainted after an injection.
In obese individuals, a poor response to the vaccine may occur, which could result in lack of protection against hepatitis A. A poor response to the vaccine, possibly leading to lack of protection against hepatitis B, has also been observed in the elderly, in men compared to women, in smokers, in obese individuals, in people with chronic illnesses, or in those receiving certain types of medical treatment.
Your doctor may advise you to have a blood test after completing the vaccination course to check whether you have developed an adequate immune response. If not, your doctor will be able to advise you on whether additional doses are needed.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this vaccine. It is not known whether Twinrix Adulti passes into breast milk; however, problems for breastfed infants are not expected.

Twinrix Adulti contains neomycin and sodium
Inform 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, i.e. essentially 'sodium-free'.

3. How to use Twinrix Adults

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

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

Twinrix Adults may also be administered as a three-dose schedule within one month. This schedule may be used exclusively in adults who require rapid protection (e.g., travelers). The first dose will be given on a scheduled date. The remaining two doses will be administered 7 and 21 days after the first dose. A fourth dose at 12 months is recommended.

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

Your doctor will inform you if additional injections or booster doses are needed.
As stated in section 2, a poor response to the vaccine, with the possibility of failing to achieve protection against hepatitis B, is much more common in elderly individuals, men compared to women, smokers, obese individuals, those with long-term illnesses, or those receiving certain types of medical treatment.
Your doctor may recommend a blood test after completion of the vaccination course to check whether you have achieved a satisfactory immune response. If not, your doctor will be able to advise you on whether additional doses may be necessary.
If you miss a scheduled vaccination appointment, inform your doctor to arrange another visit.
Make sure that the full vaccination course consisting of three injections is completed. Otherwise, you may not be fully protected against the diseases.
Your doctor will administer Twinrix Adults as an intramuscular injection into the upper arm.
The vaccine must not be injected (deeply) into the skin or intramuscularly into the buttock, as protection may be reduced.
The vaccine must never be administered intravenously.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Twinrix Adulti can cause side effects, although not everybody will experience them.
The possible side effects are listed below:
Very common (may occur in 1 out of 10 or more doses of vaccine): headache, pain and swelling at the injection site, fatigue.
Common (may occur in up to 1 out of 10 doses of vaccine): diarrhoea, nausea, swelling, bruising or itching at the injection site, general feeling of being unwell.
Uncommon (may occur in up to 1 out of 100 doses of vaccine): dizziness, vomiting, stomach pain, muscle pain, upper respiratory tract infection, fever ≥ 37.5°C.
Rare (may occur in up to 1 out of 1,000 doses of vaccine): swelling of the glands in the neck, armpits or groin (lymphadenopathy), reduced skin sensitivity to pain or touch (hypoesthesia), tingling (paraesthesia), skin rash, itching, joint pain, loss of appetite, low blood pressure, flu-like symptoms such as elevated temperature, sore throat, runny nose, cough and chills.
Very rare (may occur in up to 1 out of 10,000 doses of vaccine):

• The following side effects have been reported very rarely during clinical studies or routine use of the vaccine or of the individual hepatitis A and hepatitis B vaccines: reduction in platelets in the blood, increasing the risk of bleeding or bruising (thrombocytopenia), purple or reddish-brown spots visible under the skin (thrombocytopenic purpura), swelling or infection of the brain (encephalitis), degenerative brain disease (encephalopathy), inflammation of nerves (neuritis), numbness or weakness of arms and legs (neuropathy), paralysis, seizures, swelling of the face, mouth or throat (angioneurotic oedema), purple or reddish-purple skin lesions (lichen planus), severe skin rashes (erythema multiforme), urticaria, joint swelling, muscle weakness, localized infection around the brain that may cause severe headache with neck stiffness and light sensitivity (meningitis), inflammation of certain blood vessels (vasculitis), abnormal liver function test results, multiple sclerosis, swelling of the spinal cord (myelitis), drooping eyelids and muscle weakness on one side of the face (facial paralysis), temporary inflammation of nerves causing pain, weakness and paralysis in the limbs, often progressing to the chest and face (Guillain-Barré syndrome), nerve disease of the eye (optic neuritis), immediate pain at the injection site, stabbing pain and burning sensation.
  Severe allergic reactions (anaphylaxis, anaphylactoid reactions and serum-sickness-like reactions) may also occur very rarely (up to 1 in 10,000 doses of vaccine). Signs of severe allergic reactions may include skin rashes, which 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 may occur before leaving the clinic. However, if you experience any of these symptoms, contact your doctor immediately.
  Reporting of side effects
  If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Adults

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Keep in the original packaging to protect the medicine from light.
Do not freeze. Freezing damages 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 Adult 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+

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

Description of the appearance of Twinrix Adult and contents of the pack
Injectable suspension in a pre-filled syringe.
Twinrix Adult is a slightly milky white liquid.
Twinrix Adult is available in 1-dose pre-filled syringes with 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 Adult, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA/NV GlaxoSmithKline Biologicals SA
Tél/Tel: + 32 10 85 52 00 Tel. +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA GlaxoSmithKline Pharmaceuticals SA/NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 970 75-0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline Smith Kline & French Portuguesa - Produtos
Tél: + 33 (0) 1 39 17 84 44 Farmacêuticos, Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA
Tel: + 353 (0)1 495 5000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA
Sími: +354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel: +371 80205045 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 website of the European Medicines Agency: http://www.ema.europa.eu/.

The following information is intended for healthcare professionals only:

During storage, a fine white deposit and a clear supernatant may be observed.
The vaccine must be resuspended before use. Once the suspension has been re-established, the vaccine will have a uniform white, cloudy appearance.

Preparation of the vaccine suspension to obtain a uniform white, cloudy appearance
The vaccine must be resuspended by following the steps outlined below:

1. Hold the syringe vertically in the hand, closed.
2. Shake the syringe by tilting it upside down and back again.
3. Repeat this action vigorously for at least 15 seconds.
4. Check the vaccine again:

a. If the vaccine appears as a uniform white, cloudy suspension, it is ready for use – the appearance should not be clear.
b. If the vaccine does not yet appear as a uniform white, cloudy suspension – shake the syringe again upside down and back, then continue shaking vigorously for at least another 15 seconds – then inspect again.

The vaccine should be inspected visually for foreign particles and/or any changes in physical appearance before administration. If any such abnormalities are 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 turning 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 one-quarter turn clockwise until a click is felt, indicating secure locking.
Do not remove the syringe plunger from the body.
If this occurs, do not administer the vaccine.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

Package leaflet: Information for the user

Twinrix Pediatric, Injectable Suspension in Pre-filled Syringe

Vaccine (adsorbed) against hepatitis A (inactivated) and hepatitis B (rDNA) (HAB)
Please read this leaflet carefully before your 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 for your child only. Never give it to others.
• If any adverse reactions occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

This patient information leaflet has been written assuming the person receiving the vaccine will read it; however, this vaccine may be administered to adolescents and children, so you should read it on behalf of 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 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 drinks or by swimming in water contaminated with sewage. Symptoms of hepatitis A begin 3–6 weeks after exposure to the virus. These include nausea (feeling unwell), fever, malaise, and body aches. After a few days, the whites of the eyes and the skin may turn yellow (jaundice). The severity and type of symptoms may vary. Young children may not develop jaundice. Most people recover completely, but the illness is usually severe enough to cause absence from school or normal activities for about one month.
• Hepatitis B: Hepatitis B is caused by the hepatitis B virus. It causes enlargement of the liver (inflammation). The virus is present in body fluids such as blood, semen, vaginal secretions, or saliva (spit) of infected individuals.

Vaccination is the best way to protect against these diseases. None of the components of the vaccine can cause infection.

2. What you should know before taking Twinrix Pediatric

Twinrix Pediatric 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).
  • neomycin. Signs of an allergic reaction may include itchy red rash, shortness of breath, swelling of the face or tongue.
• you previously had an allergic reaction to any other hepatitis A or B vaccine.
• you have a severe infection with high fever (over 38°C). A mild infection such as a cold is not a problem, but you should inform your doctor beforehand.

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

• you have experienced any health problems after previous vaccine doses
• your immune system is weakened due to illness or medical treatment
• you have bleeding disorders or bruise easily

Fainting (especially in adolescents) may occur during or even before any injection with a needle. Therefore, inform your doctor or nurse if you have ever fainted after an injection.

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

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this vaccine.
It is not known whether Twinrix Pediatric passes into breast milk; however, problems in breastfed infants are not expected.

Twinrix Pediatric contains neomycin and sodium
Inform 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, i.e. essentially "sodium-free".

3. How Twinrix Pediatric is administered

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

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

Your doctor will inform you if additional injections or booster doses are needed.
If you are unable to follow the scheduled vaccination plan, inform your doctor to arrange another appointment.
Make sure you complete the full vaccination course consisting of three injections. Otherwise, you may not be fully protected against the diseases.
Your doctor will administer Twinrix Pediatric as an intramuscular injection into the upper arm or the upper thigh in children.
This vaccine must never be given intravenously.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.
The side effects that may occur are listed below:
Side effects observed during clinical studies or during routine use of the vaccine, or with individual hepatitis A and hepatitis B vaccines, or with the adult formulation of Twinrix.

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

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

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

Rare (may occur in up to 1 out of every 1,000 doses of vaccine): swelling of the glands in the neck, armpits or groin (lymphadenopathy), dizziness, loss of skin sensitivity to pain or touch (hypoesthesia), tingling (paraesthesia), urticaria, itching, joint pain, low blood pressure, influenza-like symptoms such as high temperature, sore throat, runny nose, cough and chills.

Very rare (may occur in up to 1 out of every 10,000 doses of vaccine): reduction in platelets in the blood, increasing the risk of bleeding or bruising (thrombocytopenia), purple or reddish-brown spots visible under the skin (thrombocytopenic purpura), swelling or infection of the brain (encephalitis), degenerative brain disease (encephalopathy), nerve inflammation (neuritis), numbness or weakness in arms and legs (neuropathy), paralysis, seizures, swelling of the face, mouth or throat (angioneurotic oedema), purplish or reddish-purple skin lesions (lichen planus), severe skin eruptions (erythema multiforme), joint swelling, muscle weakness, localized infection around the brain that may cause severe headache with neck stiffness and light sensitivity (meningitis), inflammation of certain blood vessels (vasculitis), abnormal liver function laboratory tests, multiple sclerosis, swelling of the spinal cord (myelitis), drooping eyelids and muscle weakness on one side of the face (facial paralysis), temporary nerve inflammation causing pain, weakness and paralysis in the limbs, often progressing to the chest and face (Guillain-Barré syndrome), eye nerve disease (optic neuritis), immediate pain at the injection site, stabbing pain and burning sensation.

Severe allergic reactions (anaphylaxis, anaphylactoid reactions and serum-sickness-like reactions) may also occur, although very rarely (up to 1 in 10,000 doses of vaccine). Signs of severe allergic reactions may include skin rashes, which 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 may occur even before leaving the clinic. However, if you experience any of these symptoms, you must contact your doctor urgently.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system detailed 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Keep in the original packaging to protect from light.
Do not freeze. Freezing damages the vaccine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer require. This will help protect the environment.

6. Package contents and other information

What Twinrix Pediatric 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) by recombinant DNA technology
Adsorbed on aluminium phosphate 0.2 milligrams Al 3+

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

Description of the appearance of Twinrix Pediatric and contents of the pack
Injectable suspension in a pre-filled syringe.
Twinrix Pediatric is a slightly opaque white liquid.
Twinrix Pediatric is available in 1-dose pre-filled syringes, with or without separate needles, in 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 Pediatric, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA/NV GlaxoSmithKline Biologicals SA
Tél/Tel: + 32 10 85 52 00 Tel. +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Biologicals SA GlaxoSmithKline Pharmaceuticals SA/NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GlaxoSmithKline Biologicals SA
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Biologicals SA
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: + 49 (0)89 360448701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Biologicals SA Tel: +372 8002640 GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Tηλ: + 30 210 68 82 100 Tel: + 43 1 970 75-0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline Smith Kline & French Portuguesa - Produtos
Tél: + 33 (0) 1 39 17 84 44 Farmacêuticos, Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

Hrvatska România
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GlaxoSmithKline Biologicals SA
Tel: + 353 (0)1 495 5000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Biologicals SA
Sími: +354 535 7000 Tel.: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Biologicals SA GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA
Tel: +371 80205045 Tel: +44 (0)800 221441
[email protected]

This leaflet was last updated on

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

---

The following information is intended for healthcare professionals only.
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 re-established, the vaccine will have a uniformly cloudy white appearance.

Preparation of the vaccine suspension to obtain a uniformly cloudy white appearance
The vaccine must be re-suspended by following the steps below:

1. Hold the syringe in an upright vertical position with your hand closed around it.
2. Shake the syringe vigorously by tilting it upside down and back again.
3. Repeat this action vigorously for at least 15 seconds.
4. Check the vaccine again:
   a. if the vaccine appears as a uniformly cloudy white suspension, it is ready for use.
   • The appearance should not be clear.
     b. if the vaccine does not yet appear as a uniformly cloudy white suspension – shake the syringe again upside down and back, then continue shaking for at least another 15 seconds – then inspect again.

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

Instructions for the pre-filled syringe

Luer Lock adapter
Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning it counterclockwise.
Plunger
Barrel
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 securely locked.
Do not remove the plunger from the syringe barrel.
If this occurs, do not administer the vaccine.

Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local legal requirements.