FLUARIX 15/15/15mc Microgram Suspension for Injection

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED NIB-74XP DERIVED FROM A/CHRISTCHURCH/16/2010, A/HONG KONG/4801/2014 (H3N2) - LIKE STRAIN (A/HONG KONG/4801/2014, NYMC X-263B), B/BRISBANE/60/2008 - LIKE STRAIN (B/BRISBANE/60/2008)

Saatavilla:

GlaxoSmithKline (Ireland) Limited

ATC-koodi:

J07BB02

INN (Kansainvälinen yleisnimi):

A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED NIB-74XP DERIVED FROM A/CHRISTCHURCH/16/2010, A/HONG KONG/4801/2014 (H3N2) - L

Annos:

15/15/15mc Microgram

Lääkemuoto:

Suspension for Injection

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

Influenza vaccines

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1998-04-03

Pakkausseloste

Reason for update: 2016/17 Strain update
Agency Approval Date: 16/6/2016
Text Date: 11/04/2016
Text Issue 11 Draft No.1
SPC Issue 5 Draft No.1
- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUARIX® SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Influenza vaccine (split virion, inactivated)
FOR USE DURING THE 2016/2017 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.
What Fluarix is and what it is used for
2.
What you need to know before you or your child receives Fluarix
3.
How Fluarix is given
4.
Possible side effects
5.
How to store Fluarix
6.
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 f

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fluarix suspension for injection in a prefilled syringe
Influenza vaccine (split virion, inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 fertilized hens’ eggs from healthy chicken flocks
**
haemagglutinin
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern hemisphere) and EU
recommendation for the 2016/2017 season.
Excipients with known effect
This product contains approximately 3.75 mg of sodium chloride and
approximately 1.3 mg of disodium phosphate
dodecahydrate per dose (see section 4.4).
This product contains approximately 0.2 mg of potassium dihydrogen
phosphate and
approximately 0.1 mg of potassium chloride per dose (see section 4.4).
Fluarix may contain traces of eggs (such as ovalbumin, chicken
proteins), formaldehyde,
gentamicin sulphate and sodium deoxycholate which are used during the
manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe.
The suspension is colourless to slightly opalescent.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Fluarix is indicated in adults and children from 6 months of age.
The use of Fluarix should be based on official recommendations.
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