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INFLUENZA VACCINE (SPLIT VIRION INACTIVATED)

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

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PACKAGE LEAFLET

Package leaflet: Information for the user
Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled
syringe
Quadrivalent influenza vaccine (split virion, inactivated)
This medicine is subject to additional monitoring. This will allow quick identification of new
safety information. You can help by reporting any side effects you may get. See the end of section 4
for how to report side effects.
Read all of this leaflet carefully before you or your child are vaccinated because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This vaccine has been prescribed for you or your child only. Do not pass it on to others.
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for
2.
What you need to know before you or your child use Quadrivalent Influenza Vaccine (split
virion, inactivated)
3.
How to use Quadrivalent Influenza Vaccine (split virion, inactivated)
4.
Possible side effects
5.
How to store Quadrivalent Influenza Vaccine (split virion, inactivated)
6.
Contents of the pack and other information

1.

What Quadrivalent Influenza Vaccine (split virion, inactivated) is and what it is used for

Quadrivalent Influenza Vaccine (split virion, inactivated) is a vaccine. This vaccine helps to protect
you or your child against influenza (flu). The use of Quadrivalent Influenza Vaccine (split virion,
inactivated) should be based on official recommendations.
When a person is given Quadrivalent Influenza Vaccine (split virion, inactivated), 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. Due to this potential change in circulating strains on a yearly basis, as well as the duration of
protection intended by the vaccine, vaccination is recommended every year. The greatest risk of
catching flu is during the cold months between October and March. If you or your child were not
vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you run the risk
of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated.
Quadrivalent Influenza Vaccine (split virion, inactivated) is intended to protect you or your child
against the four strains of virus contained in the vaccine about 2 to 3 weeks after the injection. In
addition, if you or your child are exposed to flu immediately before or after your vaccination, you or
your child could still develop the illness as the incubation period for flu is a few days.
The vaccine will not protect you or your child 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 use Quadrivalent Influenza Vaccine
(split virion, inactivated)

To make sure that Quadrivalent Influenza Vaccine (split virion, inactivated) 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 Quadrivalent Influenza Vaccine (split virion, inactivated):
- if you or your child are allergic to:

the active substances, or

any of the other ingredients of this vaccine (listed in section 6), or

any component that may be present in very small amounts such as eggs (ovalbumin,
chicken proteins), neomycin, formaldehyde or octoxinol-9,
- if you or your child have an illness with a high or moderate temperature or an acute illness, the
vaccination should be postponed until after you or your child have recovered.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Quadrivalent Influenza Vaccine (split virion,
inactivated).
You should tell your doctor before vaccination if you or your child have:
- a poor immune response (immunodeficiency or taking medicines affecting the immune system),
- bleeding problem or bruising easily.
Your doctor will decide if you or your child should receive the vaccine.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore
tell your doctor or nurse if you or your child fainted with a previous injection.
As with all vaccines, Quadrivalent Influenza Vaccine (split virion, inactivated) may not fully protect
all persons who are vaccinated.
If, for any reason, you or your child have a blood test within a few days following a flu vaccination,
please tell your doctor. This is because false positive blood test results have been observed in a few
patients who had recently been vaccinated.
Children
Quadrivalent Influenza Vaccine (split virion, inactivated) is not recommended for use in children
below 3 years of age.
Other medicines and Quadrivalent Influenza Vaccine (split virion, inactivated)
Tell your doctor or pharmacist if you or your child are receiving, have recently received or might
receive any other vaccines or any other medicines.
Quadrivalent Influenza Vaccine (split virion, inactivated) can be given at the same time as other
vaccines by using separate limbs.
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 using this vaccine.
Your doctor/pharmacist will be able to decide if you should receive Quadrivalent Influenza Vaccine
(split virion, inactivated).
Driving and using machines
Quadrivalent Influenza Vaccine (split virion, inactivated) has no or negligible influence on the ability
to drive or use machines.

Quadrivalent Influenza Vaccine (split virion, inactivated) contains potassium and sodium
This medicine contains less than 1 mmol potassium (39 mg) and sodium (23 mg) per dose, i.e.
essentially ‘potassium- free’ and ‘sodium- free’.
3.

How to use Quadrivalent Influenza Vaccine (split virion, inactivated)

Dosage
Adults receive one 0.5 ml dose.
Use in children
Children from 3 years to 17 years of age receive one 0.5 ml dose.
If your child is less than 9 years and has not been previously vaccinated against flu, a second dose of
0.5 ml should be given after at least 4 weeks.
How Quadrivalent Influenza Vaccine (split virion, inactivated) is given
Your doctor or nurse will administer the recommended dose of the vaccine as an injection into the
muscle or under the skin.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions
See a doctor IMMEDIATELY if you or your child experience:
Severe allergic reactions:

that may lead to medical emergency with low blood pressure, rapid, shallow breathing,
rapid heart rate and weak pulse, cold, clammy skin, dizziness, that may lead to collapse
(shock). These side effects were not observed with Quadrivalent Influenza Vaccine (split
virion, inactivated) but have been rarely reported with other vaccines given to prevent flu
(may affect up to 1 in 1,000 people).

swelling most apparent in the head and neck, including the face, lips, tongue, throat or
any other part of the body and which may cause difficulty in swallowing or breathing
(angioedema).
Allergic reactions such as skin reactions that may spread throughout the body including itching,
hives, rash, redness.
These side effects are rare (may affect up to 1 in 1,000 people) except itching (pruritus) that
may be more frequent (may affect up to 1 in 100 people).
Other side effects reported in adults and elderly
Very common (may affect more than 1 in 10 people)
Headache, muscular pain (myalgia), generally feeling unwell (malaise) (1), injection site pain.
Common (may affect up to 1 in 10 people)
Fever (2), shivering, injection site reactions: redness, swelling, hardness (induration).
Uncommon (may affect up to 1 in 100 people)
Dizziness (3), diarrhoea, feeling seek (nausea) (4), fatigue, injection site reactions: bruising
(ecchymosis), itching (pruritus), warmth
Hot flush: observed in elderly only.
Swelling of the glands in the neck, armpit or groin (lymphadenopathy): observed in adults only.

Rare (may affect up to 1 in 1000 people)
Anomalies in the perception of touch, pain, heat and cold (paraesthesia), sleepiness, increased
sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness
Joint pain (arthralgia), injection site discomfort: observed in adults only.
(1)

Common in elderly

(2)

Uncommon in elderly

(3)

Rare in adults

(4)

Rare in elderly

Other side effects reported in children from 3 to 17 years of age
Very common (may affect more than 1 in 10 people)
Headache, muscular pain (myalgia), generally feeling unwell (malaise), shivering (5), injection
site reactions: pain, swelling, redness (5), hardness (induration) (5).
Common (may affect up to 1 in 10 people)
Fever, injection site bruising (ecchymosis).
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age
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):
reported in one child of 3 years of age
Moaning, restlessness
Dizziness, diarrhoea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, injection
site warmth.
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age
Diarrhoea, injection site itching (pruritus).
(5)

Common in 9 to 17 years of age

In children from 3 to 8 years of age who receive 2 doses, side effects are similar after the first and after
the second dose.
When observed, side effects generally occurred within the first 3 days following vaccination and
resolved spontaneously within 1 to 3 days after onset. The intensity of observed side effects was mild.
Overall, side effects were generally less frequent in elderly than in adults and children from 3 to 17
years of age.
The following side effects have been reported after administration of Inactivated Influenza Vaccine
(Split Virion) BP. These side effects may occur with Quadrivalent Influenza Vaccine (split virion,
inactivated):
Pain situated on the nerve route (neuralgia), fits (convulsions), 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)
Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in
temporary kidney problems.
Reporting of side effects
If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.You can also report side effects directly via the national
reporting system (see details below). By reporting side effects you can help provide more information
on the safety of this medicine.
Ireland
Health Products Regulatory Authority (HPRA): HPRA Pharmacovigilance, Earlsfort Terrace, IRL Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:
medsafety@hpra.ie.
United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA): Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
5.

How to store Quadrivalent Influenza Vaccine (split virion, inactivated)

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 label and 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. Keep the syringe in the outer carton 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 Quadrivalent Influenza Vaccine (split virion, inactivated) contains
-

The active substances are: Influenza virus (inactivated, split) of the following strains*:

A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)
.................................................................................................................................. 15 micrograms HA**
A/Texas/50/2012 (H3N2) - like strain (A/Texas/50/2012, NYMC X223A)............ 15 micrograms HA**
B/Massachusetts/2/2012 (Yamagata lineage) ....................................................... 15 micrograms HA**
B/Brisbane/60/2008 (Victoria lineage) .................................................................. 15 micrograms HA**
Per 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO (World Health Organisation) recommendations (Northern
hemisphere) and EU decision for the 2014/2015 season.
The other ingredients are: a buffer solution containing sodium chloride, potassium chloride,
disodium phosphate dihydrate, potassium dihydrogen phosphate, and water for injections.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol9 may be present in very small amounts (see section 2).

What Quadrivalent Influenza Vaccine (split virion, inactivated) looks like and contents of the
pack
The vaccine, after shaking gently, is a colourless opalescent liquid.
Quadrivalent Influenza Vaccine (split virion, inactivated) is a suspension for injection presented in a
pre-filled syringe of 0.5 ml, with attached needle or without needle, in box of 1, 10 or 20. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder in the UK is:
Sanofi Pasteur MSD Limited
Mallards Reach
Bridge Avenue
Maidenhead
SL6 1QP
The Marketing Authorisation Holder in Ireland is:
Sanofi Pasteur MSD Limited
Block A, Second floor
Cookstown Court
Old Belgard Road
Tallaght
Dublin 24
The Manufacturer is:
Sanofi Pasteur - 1541 avenue Marcel Mérieux - 69280 Marcy l'Etoile - France
Sanofi Pasteur - Parc Industriel d'Incarville - 27100 Val de Reuil - France
Sanofi Aventis Zrt. - Campona utca 1. (Harbor Park) - 1225 Budapest - Hungary

This leaflet was last revised in 06/2016.

----------------------------------------------------------------------------------------------------------------------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 reaction following the administration of the vaccine.
The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
The vaccine should not be used if foreign particles are present in the suspension.
It should not be mixed with other medicinal products in the same syringe.
This vaccine is not to be injected directly into a blood vessel.
See also section 3. How to use Quadrivalent Influenza Vaccine (split virion, inactivated)

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