Supemtek

Երկիր: Եվրոպական Միություն

Լեզու: անգլերեն

Աղբյուրը: EMA (European Medicines Agency)

Ակտիվ բաղադրիչ:

Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant

Հասանելի է:

Sanofi Pasteur

ATC կոդը:

J07BB02

INN (Միջազգային անվանումը):

Quadrivalent influenza vaccine (recombinant, prepared in cell culture)

Թերապեւտիկ խումբ:

Vaccines

Թերապեւտիկ տարածք:

Influenza, Human

Թերապեւտիկ ցուցումներ:

Supemtek is indicated for active immunization for the prevention of influenza disease in adults.Supemtek should be used in accordance with official recommendations.

Ապրանքի ամփոփագիր:

Revision: 3

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2020-11-16

Տեղեկատվական թերթիկ

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET – INFORMATION FOR THE USER
SUPEMTEK
SOLUTION FOR INJECTION
Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)
▼
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side affects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE THIS MEDICINE
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, nurse or
pharmacist.
-
This vaccine has been prescribed for you only. Do not pass it on to
others.
-
If you 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 Supemtek is and what it is used for
2.
What you need to know before you receive Supemtek
3.
How Supemtek is given
4.
Possible side effects
5.
How to store Supemtek
6.
Contents of the pack and other information
1.
WHAT SUPEMTEK IS AND WHAT IT IS USED FOR
Supemtek is a vaccine
for adults who are 18 years of age and older. This vaccine helps to
protect
you against flu (influenza). Supemtek is egg-free because of the
technology used to produce it.
HOW SUPEMTEK WORKS
When a person is given Supemtek, the body’s natural defence (the
immune system) produces
protection against the influenza virus. None of the ingredients in the
vaccine can cause flu.
As with all vaccines, Supemtek may not fully protect all persons who
are vaccinated.
WHEN TO HAVE A FLU VACCINE
Flu can spread very fast.
•
It is caused by different types of flu virus that can change every
year. This is why you might
need to be vaccinated every year.
•
The greatest risk of catching flu is during the cold months between
October and March.
•
If you were not vaccinated in the autumn, it is still sensible to be
vaccinated up until the spring
since you r

Ապրանքի հատկությունները

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
Supemtek solution for injection in pre-filled syringe
Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Influenza virus haemagglutinin (HA) proteins, of the following
strains*:
A/XXXXXX (H1N1).................................. 45 micrograms HA
A/XXXXXX (H3N2).................................. 45 micrograms HA
B/XXXXXX ............................................... 45 micrograms
HA
B/XXXXXX ............................................... 45 micrograms
HA
*
produced by recombinant DNA technology using a baculovirus expression
system in a
continuous insect cell line that is derived from Sf9 cells of the fall
armyworm,
_Spodoptera _
_frugiperda._
This vaccine complies with the World Health Organization (WHO)
recommendation (Northern
Hemisphere) and EU recommendation for the XXXX/XXXX season.
Supemtek may contain traces of octylphenol ethoxylate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe (injection).
Clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Supemtek is indicated for active immunization for the prevention of
influenza disease in adults.
Supemtek should be used in accordance with official recommendations.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
One dose of 0.5 mL.
_Paediatric population _
Safety and efficacy of Supemtek have not yet been established in
individuals below 18 years of age.
Method of administration:
For intramuscular injection only. The preferred site is in the deltoid
muscle.
The vaccine must not be injected intravascularly and must not be mixed
with othe