Vaxigrip suspension for injection in prefilled syringe.Influenza vaccine (split virion, inactivated)

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Medicines Authority

Δραστική ουσία:

INFLUENZA VACCINE, SPLIT VIRION, INACTIVATED

Διαθέσιμο από:

Sanofi Pasteur 14 Espace Henry Vallée , 69007 Lyon, France

Φαρμακολογική κατηγορία (ATC):

J07BB02

INN (Διεθνής Όνομα):

INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg

Φαρμακοτεχνική μορφή:

SUSPENSION FOR INJECTION

Σύνθεση:

INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

VACCINES

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2007-01-18

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
VAXIGRIP, SUSPENSION FOR INJECTION IN PREFILLED SYRINGE.
Influenza vaccine (split virion, inactivated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVE
THIS VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU OR YOUR CHILD
-
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 or
pharmacist. This includes any
possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Vaxigrip is and what it is used for
2.
What you need to know before you or your child use Vaxigrip
3.
How to use Vaxigrip
4.
Possible side effects
5.
How to store Vaxigrip
6.
Contents of the pack and other information
1.
WHAT VAXIGRIP IS AND WHAT IT IS USED FOR
Vaxigrip is a vaccine.
This vaccine helps to protect you or your child against influenza
(flu). The use of Vaxigrip should be
based on official recommendations.
When a person is given the vaccine Vaxigrip, 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 were
not vaccinated in the autumn, it is still sensible to be vaccinated up
until the spring since you or your
child run the risk of catching flu until then. Your doctor will be
able to recommend the best time to be
vaccinated.
Vaxigrip is intended to 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

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
VAXIGRIP, suspension for injection in prefilled 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/Michigan/45/2015, NYMC
X-275) ................
..........................................................................................................................
15 micrograms HA**
•
A/Singapore/INFIMH-16-0019/2016 (H3N2) - like strain
(A/Singapore/INFIMH-16-0019/2016,
IVR-186)
...........................................................................................................
15 micrograms HA**
•
B/Colorado/06/2017 - like strain (B/Maryland/15/2016, NYMC BX-69A)
..... 15 micrograms HA**
Per 0.5 ml dose
*
propagated in fertilised hens’ eggs from healthy chicken flocks
**
haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the
2018/2019 season.
For the full list of excipients, see Section 6.1.
VAXIGRIP may contain traces of eggs, such as ovalbumin, and of
neomycin, formaldehyde and octoxinol-
9, which are used during the manufacturing process (see Section 4.3).
3.
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and
opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza.
VAXIGRIP is indicated in adults and children from 6 months of age.
The use of VAXIGRIP 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: 0.25 ml. Clinical data are
limited. See Section 6.6 for more
information on administration of 0.25 ml dose.
If this is required by national recommendations, 0.5 ml may be given.
For children less than 9 years who have not previously bee