Ambirix

Package leaflet: Information for the user

Ambirix, injectable suspension in pre-filled syringe

Hepatitis A (inactivated, adsorbed) and hepatitis B (rDNA) vaccine (HAB)
Please read this leaflet carefully before you/your child is given the vaccine 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, nurse or pharmacist.
• This medicine has been prescribed for you/your child. Never give it to others.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

This patient information leaflet has been written assuming that the person receiving the vaccine will read it; however,
this vaccine may be administered to adolescents and children, so it should be read by you on behalf of your child.
Contents of this leaflet

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

1. What Ambirix is and what it is used for

Ambirix is a vaccine used in infants, children, and young individuals from 1 year of age up to and including 15 years of age. It is used to prevent two diseases: hepatitis A and hepatitis B.

• Hepatitis A: infection with the hepatitis A virus can cause swelling (inflammation) of the liver. The virus is usually transmitted through food or drinks contaminated with the virus. However, it can sometimes be spread in other ways, such as swimming in water contaminated by sewage or through contact with infected individuals. The virus is present in body fluids such as faeces, serum, or saliva. Symptoms begin 3–6 weeks after infection. Some people may feel unwell, have fever, aches, and pains. After a few days, they may feel very tired, have dark-coloured urine, pale stools, and yellowing of the skin or eyes (jaundice). The severity and type of symptoms may vary. Young children may not show all symptoms. Most children recover completely, but the illness is usually severe enough to last about 1 month.
• Hepatitis B: infection with the hepatitis B virus can cause swelling (inflammation) of the liver. The virus is usually transmitted from another infected person. It is present in body fluids such as blood, semen, vaginal secretions, or saliva (spit). Symptoms may not appear until 6 weeks to 6 months after infection. Infected individuals do not always look or feel sick. Some people may feel unwell, have fever, aches, and pains. However, in others, a more serious illness may develop. These individuals may feel very tired, have dark-coloured urine, pale stools, and yellowing of the skin or eyes (jaundice). Some people may require hospitalisation.

Most adults recover fully from the disease, but some individuals (particularly children) who may not show symptoms remain infected. These individuals are known as "carriers" of hepatitis B and can continue to infect others throughout their lives. Carriers are also at risk of developing serious liver problems, such as scarring (cirrhosis) or liver cancer.

How Ambirix works

• Ambirix helps the body produce antibodies against these diseases. The vaccine does not contain live viruses (see section 6 for the vaccine content) and therefore cannot cause hepatitis A or B infections.
• As with all vaccines, some people may respond less effectively than others.
• Ambirix cannot protect you from the disease if you have already been infected with the hepatitis A or B virus.
• Ambirix can only help protect you from infection caused by hepatitis A or B viruses. It cannot protect against other infections affecting the liver—even if these infections cause signs similar to those caused by hepatitis A or B viruses.

2. What you should know before receiving Ambirix

Ambirix must not be given if:

• you are allergic to Ambirix or to any of the other ingredients of this vaccine (listed in section 6). 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. The vaccine can be given after you have recovered. A mild infection such as a cold is not a problem, but you should inform your doctor beforehand.

Do not receive Ambirix if any of the conditions listed above apply to you.
If you are unsure, speak to your doctor, nurse, or pharmacist before receiving Ambirix.
Warnings and precautions:
Tell your doctor, nurse, or pharmacist before receiving Ambirix if:

• you need to be fully protected against hepatitis A and B infection within the next 6 months – your doctor may recommend a different vaccine
• you have bleeding problems or bruise easily – the injection may be given under the skin rather than into the muscle to reduce the risk of bleeding or bruising
• you have problems with your immune system (for example due to illness, treatment, or dialysis) – the vaccine may not work fully. This means you may not be completely protected against one or both of the hepatitis A and B viruses. Your doctor will perform blood tests to see if additional doses are needed to help ensure adequate protection
• you have fainted before or during a previous injection – this could happen again. Fainting (especially in adolescents) may occur following, or even before, any injection with a needle.

If any of the above conditions apply to you (or if you are unsure), inform your doctor,
nurse, or pharmacist before receiving Ambirix.
Other medicines and Ambirix
Tell your doctor if you are taking, have recently taken, or might take any other
medicines or vaccines. This includes medicines without a prescription or herbal medicines.
Ask your doctor, nurse, or pharmacist if you are unsure.
If you are taking medicines that affect the immune response, you may still receive
Ambirix if it is considered necessary. However, the vaccine may not work fully. This
means you may not be protected against one or both of the hepatitis A and B viruses. Your doctor
will perform blood tests to see if additional doses are needed to help ensure adequate protection.
Ambirix may need to be given at the same time as other vaccines against measles, mumps,
rubella, diphtheria, tetanus, pertussis (whooping cough), poliomyelitis, Haemophilus influenzae type b, or
certain treatments for hepatitis infections called "immunoglobulins". Your doctor will ensure
that the vaccines are injected at different sites on the body.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor, nurse, or pharmacist before receiving this vaccine.
Ambirix is not usually given to pregnant or breastfeeding women.
Driving and using machines
You may feel tired or dizzy after receiving Ambirix. If this happens, do not drive, ride a bicycle, or use any kind of tools or machinery.
Ambirix contains neomycin and sodium
This vaccine contains neomycin (an antibiotic). Ambirix must not be given if you are
allergic to neomycin.
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to receive Ambirix

How the injection is given

• Your doctor or nurse will administer Ambirix as an intramuscular injection, usually into the upper arm.
• They will take care to ensure that Ambirix is never injected into a vein.
• In very young children, the injection may be given into the muscle of the thigh.

How many times it is given

• You will receive a total of 2 injections. These will be given during two separate visits.
• The injections will be administered within 12 months:
  • The first injection on the date agreed with your doctor.
  • The second injection – between 6 and 12 months after the first injection.

Your doctor will advise you on the possible need for additional doses and future booster doses.
If you miss a dose

• If you miss the second injection, speak to your doctor to arrange another visit as soon as possible.
• Make sure you complete the full two-dose course. If you do not, you may not be protected against the diseases.

4. Possible side effects

Like all medicines, this vaccine may cause side effects, although not everybody will experience them.
Serious side effects
Tell your doctor immediately if you notice any of the following serious side effects – you may
need urgent medical treatment:

• Allergic and anaphylactic reactions – signs may include a rash, which may be itchy or blistering, swelling of the eyes or face, difficulty breathing or swallowing, a sudden drop in blood pressure, and loss of consciousness. Inform your doctor immediately if you notice any of the adverse effects described above.

Side effects observed during clinical studies with Ambirix include the following:
Very common: (May occur in more than 1 in 10 doses of vaccine): headache, loss of appetite, feeling tired or irritable, pain and redness at the injection site.
Common: (May occur in up to 1 in 10 doses of vaccine): fever, drowsiness, digestive or stomach problems, swelling at the injection site.
Additional side effects reported during clinical studies with other combination hepatitis A and hepatitis B vaccines that are very similar include:
Common: (May occur in up to 1 in 10 doses of vaccine): general feeling of being unwell, diarrhoea, nausea, reaction at the injection site.
Uncommon: (May occur in up to 1 in 100 doses of vaccine): dizziness, stomach pain, vomiting, upper respiratory tract infections, muscle pain (myalgia).
Rare: (May occur in up to 1 in 1,000 doses of vaccine): low blood pressure, joint pain (arthralgia), itching, rash, tingling sensations (paraesthesia), swelling of the glands in the neck, armpits or groin (lymphadenopathy), influenza-like symptoms such as high temperature, sore throat, runny nose, cough and chills.
Very rare: (May occur in up to 1 in 10,000 doses of vaccine): urticaria.
Contact your doctor if you experience side effects like these.
Side effects reported during routine use of Ambirix include: fainting, reduced skin sensitivity to pain or touch (hypoesthesia).
Additional side effects reported during routine use of combination or non-combination hepatitis A and hepatitis B vaccines that are very similar include: multiple sclerosis, swelling of the spinal cord (myelitis), abnormal liver function tests, swelling or infection of the brain (encephalitis), inflammation of certain blood vessels (vasculitis), a degenerative brain disease (encephalopathy), swelling of the face, mouth and throat (angioneurotic oedema), severe headache with neck stiffness and sensitivity to light (meningitis), temporary inflammation of nerves causing pain, weakness and paralysis of arms and legs, which often progresses to the chest and face (Guillain-Barré syndrome), seizures or epileptic fits, nerve inflammation (neuritis), eye nerve disease (optic neuritis), numbness or weakness of arms and legs (neuropathy), immediate pain at injection site, sensation of pricking and burning, paralysis, drooping eyelids and muscle weakness on one side of the face (facial paralysis), a disease mainly affecting the joints with pain and swelling (arthritis), muscle weakness, purple or reddish-purple skin lesions (lichen planus), severe skin rash (erythema multiforme), reduction in blood platelets, increasing the risk of bleeding or bruising (thrombocytopenia), purple or brownish-red spots visible under the skin (thrombocytopenic purpura).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, 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 Ambirix

Keep this medicine out of the sight and reach of children.
Do not use this vaccine 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). Do not freeze. Freezing will destroy the vaccine.
Keep in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Other information

What Ambirix 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 hydrated aluminium hydroxide 0.05 milligrams Al 3+
Produced on yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Adsorbed on aluminium phosphate 0.4 milligrams Al 3+

• The other excipients in Ambirix are: sodium chloride and water for injections.

Description of the appearance of Ambirix and the contents of the pack
Ambirix is a slightly opalescent white liquid.
Ambirix is available in pre-filled syringes of 1 dose, with or without separate needles, in pack sizes 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 Ambirix, 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 GlaxoSmithKline AS
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 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 04 57741 111 Puh/Tel: + 358 (0)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)800 221 441
[email protected]

This leaflet was last approved 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 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 achieve a uniform, white, cloudy appearance
Resuspend the vaccine by following the steps below:

1. Hold the syringe in a vertical position with your hand closed around it.
2. Shake the syringe by inverting it upside down and back repeatedly.
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 change in physical appearance prior to 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 rotating 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 one-quarter turn clockwise until a secure lock is felt.
Do not remove the syringe plunger from the barrel.
If this occurs, do not administer the vaccine.

Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.