Fluarix Tetra vaccine suspension for injection 0.5ml pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Influenza virus split virion

Available from:

GlaxoSmithKline UK Ltd

ATC code:

J07BB02

INN (International Name):

Influenza virus split virion

Pharmaceutical form:

Suspension for injection

Administration route:

Intramuscular

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 14040000; GTIN: 5000123114115 5000123114221

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUARIX TETRA SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
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 START
RECEIVING THIS VACCINE 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 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 get any side effects, talk to your doctor. This
includes any possible side effects not
listed in this leaflet. See section 4.
This leaflet has been written assuming the person receiving the
vaccine is reading it, but it can be given to
adolescents and children so you may be reading it for your child.
WHAT IS IN THIS LEAFLET
1.
What Fluarix Tetra is and what it is used for
2.
What you need to know before you use Fluarix Tetra
3.
How Fluarix Tetra is given
4.
Possible side effects
5.
How to store Fluarix Tetra
6.
Contents of the pack and other information
1.
WHAT FLUARIX TETRA IS AND WHAT IT IS USED FOR
Fluarix Tetra is a vaccine. This vaccine helps to protect you against
influenza (flu), particularly in subjects who
run a high risk of associated complications. The use of Fluarix Tetra
should be based on official
recommendations.
When a person is given the vaccine Fluarix Tetra, 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 might need to be vaccinated every year. The
greatest risk of catching flu is during
the

Summary of Product characteristics

OBJECT 1
FLUARIX TETRA
Summary of Product Characteristics Updated 29-Jan-2018 |
GlaxoSmithKline UK
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Fluarix Tetra▼suspension for injection in pre-filled syringe
Influenza vaccine (split virion, inactivated)
2. Qualitative and quantitative composition
Influenza virus (inactivated, split) of the following strains*:
A/MICHIGAN/45/2015 (H1N1)PDM09 - LIKE STRAIN (A/SINGAPORE/GP1908/2015,
IVR-180)
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**
B/PHUKET/3073/2013 - LIKE STRAIN (B/PHUKET/3073/2013, 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 2017/2018 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 Tetra 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 pre-filled syringe.
The suspension is colourless and slightly opalescent.
4. Clinical particulars
4.1 Therapeutic indications
Fluarix Tetra is indicated for active immunisation of adults and
c