Prepandrix
prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Prepandemic influenza vaccine (H5N1) (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.
This vaccine has been prescribed for you only. Do not pass it on to others.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.
What Prepandrix is and what it is used for
What you need to know before you receive Prepandrix
How Prepandrix is given
Possible side effects
How to store Prepandrix
Contents of the pack and other information
Prepandrix is a vaccine for use in adults from 18 years old. It is intended to be given before or during
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the next influenza (flu) pandemic to prevent flu caused by the H5N1 type of the virus.
Pandemic flu is a type of influenza that happens at intervals that vary from less than 10 years to many decades. It spreads rapidly around the world. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.
When a person is given the vaccine, the body’s natural defence system (immune system) produces its
own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. As with all vaccines, Prepandrix may not fully protect all persons who are vaccinated.
if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts such as: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or sodium deoxycholate. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
if you have a serious infection with a high temperature (over 38°C). If this applies to you then your vaccination will 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 Prepandrix.
Do not have Prepandrix if any of the above apply to you.
If you are not sure, talk to your doctor or nurse before having this vaccine.
Talk to your doctor or nurse before you are given Prepandrix:
if you have had any allergic reaction other than a sudden life threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate.
if you have problems with your immune system, since your response to the vaccine may then be poor.
if you are having a blood test to look for evidence of infection with certain viruses. In the first few weeks after vaccination with Prepandrix the results of these tests may not be correct. Tell the doctor requesting these tests that you have recently received Prepandrix.
if you have a bleeding problem or you bruise easily.
Fainting can occur following, or even before, any needle injection. Therefore tell the doctor or nurse if you fainted with a previous injection.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before having Prepandrix. This is because the 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.
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Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have recently received any other vaccine.
In particular, tell your doctor or nurse if you are having any treatments (such as corticosteroid treatments or chemotherapy for cancer) that affect the immune system. Prepandrix can still be given but your response to the vaccine may be poor.
Prepandrix is not intended to be given at the same time as some other vaccines. However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be more serious.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this vaccine
Some side effects listed in Section 4. “Possible side effects” may affect your ability to drive or use
tools or machines. It is best to see how Prepandrix affects you before you try these activities.
Prepandrix 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.
Prepandrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per
dose. It is essentially sodium- and potassium-free.
From 18 years onwards: you will receive two doses of Prepandrix. The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose.
From 80 years onwards: you may receive two double injections of Prepandrix. The first two injections should be given at the elected date and the two other injections should preferably be given 3 weeks after.
In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult
(0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004. Your doctor will decide the appropriate dose for your child.
Your doctor or nurse will give you Prepandrix.
They will give Prepandrix as an injection into a muscle.
This will usually be in the upper arm.
The double injections will be given in opposite arms.
If you have any further questions on the use of this vaccine, ask your doctor or nurse.
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
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Allergic reactions which may cause you to have dangerously low blood pressure. If this is not treated
it may lead to shock. Your doctors know that this might happen and will have emergency treatment ready to use.
Feeling tired
Headache
Pain, redness, swelling or a hard lump where the injection was given
Fever
Aching muscles, joint pain
Warmth, itching or bruising where the injection was given
Increased sweating, shivering, flu-like symptoms
Swollen glands in your neck, armpit or groin
Tingling or numbness of the hands or feet
Feeling dizzy
Sleepiness
Sleeplessness
Diarrhoea, vomiting, stomach pain, feeling sick
Itching, rash
Generally feeling unwell
In a clinical study, children 3 to 9 years of age have received either two adult (0.5 ml) or two half adult
(0.25 ml) doses of a similar vaccine containing A/Vietnam/1194/2004. The frequency of side effects was lower in the group of children who received half of the adult dose. There was no increase after
the second dose whether the children received half of the adult or the adult dose, except for some side
effects which were higher after the second dose, particularly for rates of fever in < 6 years old children.
In other clinical studies where children 6 months to 17 years received Prepandrix, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years.
The side effects listed below have happened with H1N1 AS03-containing vaccines. They may also happen with Prepandrix. If any of the side effects below occur, please tell your doctor or nurse immediately:
Allergic reactions leading to a dangerously low blood pressure. If this is not treated, it may lead to shock. Your doctors will know that this might happen and will have emergency treatment ready to use
Fits
Generalised skin reactions including urticaria (hives)
The side effects listed below have happened in the days or weeks after vaccination with other vaccines given routinely every year to prevent flu. These side effects may also happen with Prepandrix. If any of the side effects below occur, please tell your doctor or nurse immediately:
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Problems with your brain and nerves such as inflammation of the central nervous system (encephalomyelitis), inflammation of nerves (neuritis) or a type of paralysis known as ‘Guillain- Barré Syndrome’.
Inflammation of your blood vessels (vasculitis). This can cause skin rashes, joint pain and kidney problems
Serious stabbing or throbbing pain along one or more nerves
Low blood platelet count. This can cause bleeding or bruising
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this vaccine out of the sight and reach 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 - 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Split influenza virus, inactivated, containing antigen* equivalent to:
A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 3.75 micrograms** per 0.5 ml
*propagated in eggs
**expressed in microgram haemagglutinin
The vaccine contains an ‘adjuvant’ AS03. This adjuvant contains squalene (10.69 milligrams),
DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). Adjuvants are used to improve the body’s response to the vaccine.
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The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium
hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections
The suspension is a colourless light opalescent liquid.
The emulsion is a whitish to yellowish homogeneous milky liquid.
Before the vaccine is given, the two parts will be mixed together. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion.
One pack of Prepandrix 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 vaccine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
GlaxoSmithKline Lietuva UAB Tel: +370 5 264 90 00
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
GlaxoSmithKline (Malta) Ltd
Tel: + 356 21 238131
GlaxoSmithKline GmbH & Co. KG
Tel: + 49 (0)89 360448701
GlaxoSmithKline Eesti OÜ
Tel: +372 667 6900
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GlaxoSmithKline A.E.B.E
Tηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
GlaxoSmithKline (GSK) SRL
Tel: +40 (0)21 3028 208
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
GlaxoSmithKline (Cyprus) Ltd
Τηλ: + 357 22 39 70 00
GlaxoSmithKline Latvia SIA
Tel: + 371 67312687
The following information is intended for healthcare professionals only: Prepandrix consists of two containers:
Suspension: multidose vial containing the antigen,
Emulsion: multidose vial containing the adjuvant.
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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 (for a minimum of 15 minutes); each vial should be shaken 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.
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to equip the syringe with a 23-G needle. However, in the case this needle size would not be available, a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content.
After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion. In the event of other variation being observed, discard the vaccine.
The volume of the Prepandrix vial after mixing is at least 5 ml. The vaccine should be administered in accordance with the recommended posology (see section 3 “How Prepandrix 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.
Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly. It is recommended to equip the syringe with a needle gauge not larger than 23-
G.
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 (for a minimum of 15 minutes) before each withdrawal.
The vaccine should not be administered intravascularly.
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Any unused medicinal product or waste material should be disposed of in accordance with local requirements.