Arepanrix
pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
What Arepanrix is and what it is used for
Before you receive Arepanrix
How Arepanrix is given
Possible side effects
How to store Arepanrix
Further information
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Arepanrix is a vaccine against a pandemic influenza (flu).
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly around the world. The symptoms of pandemic flu are similar to those of ordinary flu but may be more severe.
When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
As with all vaccines, Arepanrix may not fully protect all persons who are vaccinated.
if you have previously had a sudden life-threatening allergic reaction to any ingredient of Arepanrix (these are listed at the end of the leaflet) or to any of the substances that may be present in trace amounts as follows: egg and chicken protein, ovalbumin, formaldehyde or sodium deoxycholate. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, it may be appropriate for you to have the vaccine provided that appropriate medical treatment is immediately available in case of an allergic reaction.
If you are not sure, talk to your doctor or nurse before having this vaccine.
if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any
ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate. (see section 6. Further information).
if you have a severe infection with a high temperature (over 38°C). If this applies to you then your vaccination will usually be postponed until you are feeling better. A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Arepanrix.
if you have a poor immune response (as for example because of immunosuppressive therapy,
e.g. corticosteroid treatments or chemotherapy for cancer),
if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Arepanrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently been given Arepanrix.
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed.
If your child receives the vaccine, you should be aware that the side effects may be more intense after the second dose, especially temperature over 38°C. Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended.
Please inform your doctor or nurse if you have a bleeding problem or bruise easily.
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently been given any other vaccine.
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Areapanrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.
Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive Arepanrix after an interval of at least three weeks.
There is no information on administration of Arepanrix with other vaccines and no information on administration of the AS03-containing vaccine containing HA from H1N1v manufactured using a different process with any other vaccines than non-adjuvanted seasonal influenza vaccine. However, if this cannot be avoided, the vaccines should be injected into separate limbs. In such cases, you should be aware that the side effects may be more intense.
Tell your doctor if you are pregnant, think you may be pregnant, plan to become pregnant. You should discuss with your doctor whether you should receive Arepanrix.
The vaccine may be used during breast-feeding.
Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use machines.
This vaccine contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. Tell your doctor if you have any known allergies.
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose, i.e. essentially sodium- and potassium-free.
Your doctor or nurse will administer the vaccine in accordance with official recommendations. The vaccine will be injected into a muscle (usually in the upper arm).
Adults including the elderly and children from the age of 10 years onwards: A dose (0.5 ml) of the vaccine will be given
Clinical data with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process suggest that a single dose may be sufficient.
If a second dose is administered there should be an interval of at least three weeks between the first and second dose.
Children from 6 months to 9 years of age
A dose (0.25 ml) of the vaccine will be given.
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.
Children aged less than 6 months of age
Vaccination is currently not recommended in this age group.
When Arepanrix is given for the first dose, it is recommended that Arepanrix (and not another vaccine against H1N1) be given for the complete vaccination course.
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Like all medicines, Arepanrix can cause side effects, although not everybody gets them.
Allergic reactions may occur following vaccination, in rare cases leading to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
The frequency of possible side effects listed below is defined using the following convention: Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
The side effects listed below have occurred with Arepanrix (H5N1) in clinical studies in adults, including the elderly. In these clinical studies most side effects were mild in nature and short term. The side-effects are generally similar to those related to seasonal flu vaccines.
These side effects have also been observed with similar frequencies in clinical studies in adults including the elderly and in children aged 10 to 17 years with a similar vaccine (H1N1), except for redness (uncommon in the adults and common in the elderly) and fever (uncommon in the adults and elderly). Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age. In children aged 3-9 years who received a first half adult dose of a similar vaccine (H1N1), the side effects were similar compared to the side effects reported in adults, with the exception of shivering, sweating and gastro-intestinal symptoms which were reported at a higher rate in children aged 3 to 9 years. Additionally, in children aged 3 to 5 years of age, drowsiness, irritability and loss of appetite were reported very commonly.
Pain at the injection site
Headache
Tiredness
Aching muscles, joint pain
Redness and swelling at the injection site
Fever
Sweating
Shivering
Diarrhoea, feeling sick
Reactions at the injection site such as bruising, hard lump, itching, warmth
Swollen glands in the axilla
Dizziness
Generally feeling unwell
Unusual weakness
Being sick, stomach pain, acid indigestion
Inability to sleep
Tingling or numbness of the hands or feet
Shortness of breath
Pain in the chest
Itching, rash
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Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand
In children aged 6-35 months who received a half of the adult dose (0.25 ml) of a similar vaccine (H1N1), fever and irritability occurred more often compared to the children 3-9 years who received a half of the adult dose (0.25 ml) of a similar vaccine (H5N1).
In children aged 6-35 months who received two doses of 0.25 ml (half of the adult dose) the side effects after the second dose were more intense, especially fever (≥38°C), which occurred very commonly.
These side effects usually disappear within 1 to 2 days without treatment. If they persist, CONSULT YOUR DOCTOR.
The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1). These side effects may occur with Arepanrix.
Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock. Doctors are aware of this possibility and have emergency treatment available for use in such cases.
Generalised skin reactions including facial swelling and urticaria (hives)
Fits due to fever
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu. These side effects may occur with Arepanrix.
Severe stabbing or throbbing pain along one or more nerves
Low blood platelet count which can result in bleeding or bruising
Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems)
Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome
If any of these side effects occur, please tell your doctor or nurse immediately.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Keep out of the reach and sight of children.
Before the vaccine is mixed:
Do not use the suspension and the emulsion 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 to 8°C).
Store in the original package in order to protect from light. Do not freeze.
After the vaccine is mixed:
After mixing, use the vaccine within 24 hours and do not store above 25°C.
Medicinal product no longer authorised
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.
Split influenza virus, inactivated, containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms** per 0.5 ml dose
*propagated in eggs
**expressed in microgram haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response. This adjuvant contains
squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Suspension and emulsion for emulsion for injection.
The suspension is a translucent to off white opalescent suspension, which may sediment slightly. The emulsion is a whitish homogeneous liquid.
Prior to administration, the two components should be mixed. The mixed vaccine is a whitish emulsion.
One pack of Arepanrix consists of:
one pack containing 50 vials of 2.5 ml suspension (antigen)
two packs containing 25 vials of 2.5 ml emulsion (adjuvant)
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:
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Тел. + 359 2 953 10 34
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701
GlaxoSmithKline Eesti OÜ Tel: +372 667 6900
GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0
GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o. Tel.: + 48 (22) 576 9000
GlaxoSmithKline - Produtos Farmacêuticos, Lda. Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél: + 33 (0) 800 00 12 12
GlaxoSmithKline (GSK) SRL Tel: +40 (0)21 3028 208
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
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GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA Tel: + 371 67312687
GlaxoSmithKline Lietuva UAB Tel: +370 5 264 90 00
Arepanrix has been authorised under “Conditional Approval”.
This means that there is more evidence to come about this medicine.
The European Medicines Agency (EMEA) will regularly review any new information on the medicine and this package leaflet will be updated as necessary.
The following information is intended for medical or healthcare professionals only: Arepanrix consists of two containers:
Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant.
Prior to administration, the two components should be mixed. Instructions for mixing and administration of the vaccine:
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be allowed to reach room temperature. Whitish sediments may be observed in the suspension vial; these sediments are part of the normal physical appearance of the suspension. The emulsion presents as a whitish appearance
Each vial should be shaken and inspected visually for any foreign particulate matter (other than the white sediments described above) and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a syringe and by adding it to the vial containing the antigen.
After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.
The volume of the Arepanrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3 “How Arepanrix is given”).
The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed (including rubber particles from the stopper), discard the vaccine.
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Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a syringe for injection and administered intramuscularly.
After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature before each withdrawal.
The vaccine should not be administered intravascularly.
Any unused product or waste material should be disposed of in accordance with local requirements.