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FLUARIX SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE

Active substance(s): INFLUENZA A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE VIRUS / INFLUENZA A/CALIFORNIA/7/2009 (H1N1)PDM09-LIKE VIRUS

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Package leaflet: Information for the user
Fluarix® suspension for injection in a pre-filled syringe
Influenza vaccine (split virion, inactivated)

For use during the 2016-17 NH season
Read all of this leaflet carefully before you or your child start receiving this vaccine because it
contains important formation for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This vaccine has been prescribed for you or your child only. Do not pass it on to others.

If you or your child gets any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Fluarix is and what it is used for
What you need to know before you or your child receives Fluarix
How Fluarix is given
Possible side effects
How to store Fluarix
Contents of the pack and other information

1. What Fluarix is and what it used for
Fluarix is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in
subjects who run a high risk of associated complications. The use of Fluarix should be based on official
recommendations.
When a person is given the vaccine Fluarix, 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.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change
every year. Therefore, this is why you or your child might need to be vaccinated every year. The
greatest risk of catching flu is during the cold months between October and March. If you or your child
was not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or
your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to
be vaccinated.
Fluarix will protect you or your child against the three strains of virus contained in the vaccine from
about 2 to 3 weeks after the injection.
The incubation period for flu is a few days, so if you or your child are exposed to flu immediately before
or after your vaccination, you or your child could still develop the illness.
The vaccine will not protect you against the common cold, even though some of the symptoms are
similar to flu.

2. What you need to know before you or your child receives

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To make sure that Fluarix is suitable for you or your child, it is important to tell your doctor or pharmacist
if any of the points below apply to you or your child. If there is anything you do not understand, ask your
doctor or pharmacist to explain.
Do not use Fluarix
- if you or your child is allergic to the active substance or any of the other ingredients of this medicine
(listed in section 6) or any component that may be present in very small amounts such as eggs
(ovalbumin and chicken proteins), formaldehyde, gentamicin sulphate or sdoum deoxycholate:
-

if you or your child has an illness with a high temperature or acute infection, the vaccination should
be postponed until after you or your child has recovered.

Warnings and precautions
Talk to your doctor or pharmacist before you or your child receives Fluarix
if you or your child has a poor immune response (immunodeficiency or taking medicines
affecting the immune system).
-

if, for any reason, you or your child has a blood test within a few days following a flu
vaccination. This is because false positive blood test results have been observed in a few
patients who had recently been vaccinated.

Fainting can occur (mostly in adolescents) following, or even before, any needle injection, therefore tell
the doctor or nurse if you or your child fainted with a previous injection.
As with all vaccines, Fluarix may not fully protect all persons who are vaccinated.
Other medicines and Fluarix
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other
medicines.
Fluarix can be given at the same time as other vaccines by using separate limbs. It should be noted that
the side effects may be stronger.
The immunological response may decrease in case of immunosuppressant treatment, such as
corticosteroids, cytotoxic drugs or radiotherapy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Flu vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the
second and third trimester, compared with the first trimester; however, data from worldwide use of flu
vaccines do not indicate that the vaccine would have harmful effects on the pregnancy or the baby.
Fluarix may be used during breast-feeding.
Your doctor/pharmacist will be able to decide if you or your child should receive Fluarix. Ask your doctor
or pharmacist for advice before taking any medicine.

Driving and using machines
Fluarix has no or negligible influence on the ability to drive or use machines.

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Fluarix contains sodium
This medicinal product contains less than 1mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree’.

Fluarix contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

Fluarix contains ethanol
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How Fluarix is given
Dosage
Adults receive one 0.5 ml dose.
Use in children:
Children from 36 months and older receive one 0.5 ml dose.
Children from 6 months to 35 months may receive either one 0.25 ml dose or one 0.5 ml dose in
accordance with existing national recommendations.
If your child is younger than 9 years of age and has not been previously vaccinated against flu, a
second dose should be given after at least 4 weeks.
Method and/or route of administration
Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or
deep under the skin.
If you have any further questions on 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.
During clinical trials, the following side effects have been observed. Their frequencies have been
estimated as common (affects 1 to 10 users in 100):






headache
sweating
muscular pain (myalgia), joint pain (arthralgia)
fever, generally feeling unwell (malaise), shivering, fatigue
local reactions: redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the
area where the vaccine is injected.

These reactions usually disappear within 1-2 days without treatment.
The following side effects have been reported during clinical trials in children and adolescents from 6
months to 17 years of age:

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Very common (these may occur with more than 1 in 10 doses of the vaccine):










2

irritability
2
loss of appetite
2
drowsiness
3
headache
3
joint pain
3
muscle aches
2
fever
3
fatigue
1
1
1
local reactions: redness , swelling , pain

Common (these may occur with up to 1 in 10 doses of the vaccine):




gastrointestinal symptoms
3
shivering
3
fever

3

1

reported in children 6 months to 17 years of age
reported in children 6 months to <6 years of age
3
reported in children 6 years to 17 years of age
2

Next to the above common side effects, the following side effects occurred after the vaccine came on
the market:








allergic reactions:
- discharge with itching of the eyes and crusty eyelids (conjunctivitis)
- leading to medical emergency with a failure of the circulatory system to maintain adequate
blood flow to the different organs (shock) in rare cases,
- swelling most apparent in the head and neck, including the face, lips, tongue, throat or any
other part of the body (angioedema) in very rare cases.
skin reactions that may spread throughout the body including itchiness of the skin (pruritus,
urticaria), rash
blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in
temporary kidney problems.
pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and
cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result
in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of
reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barré syndrome)
temporary reduction in the number of certain types of particles in the blood called platelets; a low
number of these can result in excessive bruising or bleeding (transient thrombocytopenia);
temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy)

Reporting of side effects
If you or your child get any side effects, talk to your doctor or pharmacist This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via
Ireland
HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Fax: +353 1 6762517. Website:
www.hpra.ie; email: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store Fluarix
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package in order to protect from light.
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.
6. Contents of the pack and other information
What Fluarix contains
-

The active substance is: Influenza virus (inactivated, split) of the following strains *:

A/California/7/2009 (H1N1) pdm09-like strain (A/Christchurch/16/2010, NIB-74xp)
15 micrograms HA **
A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)
15 micrograms HA**
B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)

15 micrograms HA**

per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with World Health Organisation (WHO) recommendations (northern hemisphere)
and EU recommendation for the 2016/2017 season.
-

The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium
dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, α-tocopheryl
hydrogen succinate, polysorbate 80, octoxinol 10 and water for injections.

What Fluarix looks like and contents of the pack
Fluarix is a suspension for injection presented in a pre-filled syringe with fixed or separate or without
needles in the following pack sizes:
- with fixed needle: pack sizes of 1, 10 or 20
- with 1 separate needle: pack sizes of 1, 10 or 20
- with 2 separate needles: pack size of 1
- without needle: pack sizes of 1, 10 or 20
Not all pack sizes may be marketed.

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Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
In the UK: SmithKline Beecham Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT
In Ireland: GlaxoSmithKline (Ireland) Ltd., 12 Riverwalk, Citywest Business Campus, Dublin 24,
Ireland
Manufacturer:
GlaxoSmithKline Biologics, Branch of SmithKline Beecham Pharma GmbH & Co. KG, Zirkusstrasse 40,
D-01069, Dresden, Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Member State
Austria, Bulgaria, Cyprus, Croatia, Czech
Republic, Denmark, Estonia, Finland,
France, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Malta,
The Netherlands, Norway, Poland,
Portugal, Romania, Slovenia, Slovakia,
Spain, Sweden, UK
Belgium, Luxemburg
Germany

Name

Fluarix

α-RIX
Influsplit SSW

Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Fluarix
Reference number
10592/0118
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last updated in May 2016
Fluarix is a registered trade mark of the GSK group of companies
 2016 GSK group of companies. All rights reserved.

------------------------------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily
available in case of an anaphylactic event following the administration of the vaccine.
Immunisation should be carried out by intramuscular or deep subcutaneous injection.
Fluarix should under no circumstances be administered intravascularly.

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Fluarix may be given at the same time as other vaccines. Immunisation should be carried out on
separate limbs.
The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
When a dose of 0.5 ml is indicated, the entire contents of the syringe should be injected.
Instructions for administration of 0.25 ml of the vaccine for use in children from 6 months to 35 months
When a dose of 0.25 ml is indicated, the pre-filled syringe should be held in upright position and half of
the volume should be eliminated until the stopper reaches the marking line printed on the syringe. The
remaining volume of 0.25 ml should be injected.

Instructions for administration of the vaccine presented in pre-filled syringe without a fixed needle
To attach the needle to the syringe, refer to picture 1.
Picture 1

Needle protector

Needle

Syringe

Syringe plunger
Syringe barrel
Syringe cap

1. Holding the syringe barrel in one hand (avoid holding the syringe plunger), unscrew the syringe cap
by twisting it anticlockwise.
2. To attach the needle to the syringe, twist the needle clockwise into the syringe until you feel it lock.
(see picture)
3. Remove the needle protector, which on occasion can be a little stiff.
4. Administer the vaccine.

Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.
This leaflet was last updated in May 2016
Fluarix is a registered trade mark of the GSK group of companies
 2016 GSK group of companies. All rights reserved.

-7-

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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