Fluarix suspension for injection in pre filled syringe

Riik: Malta

keel: inglise

Allikas: Malta Medicines Authority

Toimeaine:

A, CALIFORNIA, H, B, BRISBANE, VICTORIA LINEAGE, LIKE STRAIN, MEDI

Saadav alates:

Smithkline Beecham Limited 980, Great West Road, Brentford Middlesex TW8 9GS, United Kingdom

ATC kood:

J07BB02

INN (Rahvusvaheline Nimetus):

A/CALIFORNIA/7/2009 (H1N1) 15 µg B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030) 15 µg

Ravimvorm:

SUSPENSION FOR INJECTION

Koostis:

A/CALIFORNIA/7/2009 (H1N1) 15 µg B/BRISBANE/60/2008 (VICTORIA LINEAGE)-LIKE STRAIN (B/BRISBANE/60/2008, MEDI 228030) 15 µg

Retsepti tüüp:

POM

Terapeutiline ala:

VACCINES

Volitamisolek:

Withdrawn

Loa andmise kuupäev:

2006-05-09

Infovoldik

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUARIX SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE
Influenza vaccine (split virion, inactivated) 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 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 IS 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 vacci

Toote omadused

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluarix® suspension for injection in a pre-filled 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 (e.g. ovalbumin and 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.
Page 2 of 8
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml
_ _
_Paediatric population _
Children from 36 months onwards: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited.
Dosages of 0.25 ml or 0.5