Influvac sub-unit Tetra, suspension for injection in pre-filled syringe

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

זמין מ:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

קוד ATC:

J07BB02

INN (שם בינלאומי):

INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg

טופס פרצבטיות:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

הרכב:

INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg

סוג מרשם:

POM

איזור תרפויטי:

VACCINES

מצב אישור:

Authorised

תאריך אישור:

2017-07-21

עלון מידע

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PACKAGE LEAFLET: INFORMATION FOR THE USER
_INFLUVAC SUB-UNIT TETRA_, SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
Influenza vaccine (surface antigen, inactivated)
2023/2024 season
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED, 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, pharmacist or
nurse.
-
This vaccine has been prescribed for you or your child. Do not pass it
on to others.
-
If you or your child 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
_Influvac Sub-unit Tetra_
is and what it is used for
2
What you need to know before you or your child use
_Influvac Sub-unit Tetra_
3
How to use
_Influvac Sub-unit Tetra_
4
Possible side effects
5
How to store
_Influvac Sub-unit Tetra_
6
Contents of the pack and other information
1. WHAT _INFLUVAC SUB-UNIT TETRA_ IS AND WHAT IT IS USED FOR
_Influvac Sub-unit Tetra_
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.
_Influvac Sub-unit Tetra_
is indicated in
adults and children from 6 months of age. The use of
_Influvac Sub-unit Tetra_
should be based on official
recommendations.
When a person is given the vaccine
_Influvac Sub-unit 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 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

מאפייני מוצר

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1.
NAME OF THE MEDICINAL PRODUCT
_Influvac Sub-unit Tetra_
, suspension for injection in pre-filled syringe
(influenza vaccine, surface antigen, inactivated).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following
strains*:
- A/Victoria/4897/2022 (H1N1)pdm09-like strain
(A/Victoria/4897/2022, IVR-238)
15 micrograms HA **
- A/Darwin/9/2021 (H3N2)-like strain
(A/Darwin/9/2021, SAN-010)
15 micrograms HA **
- B/Austria/1359417/2021-like strain
(B/Austria/1359417/2021, BVR-26)
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 fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin.
_ _
This vaccine complies with the World Health Organisation (WHO)
recommendation (northern
hemisphere) and EU recommendation for the 2023/2024 season.
For a full list of excipients see section 6.1.
_Influvac Sub-unit Tetra_
may contain traces of eggs (such as ovalbumin, chicken proteins),
formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or
gentamicin, which are used
during the manufacturing process (see section 4.3).
3. PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
A colourless clear liquid.
_ _
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
_Influvac Sub-unit Tetra_
is indicated in adults and children from 6 months of age.
The use of
_Influvac Sub-unit Tetra_
should be based on official recommendations.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
_Paediatric population _
Children from 6 months to 17 years of age: 0.5 ml.
Children less than 9 years of age, who have not previously been
vaccinated with a seasonal influenza
vaccine: a second dose of 0.5 ml should be given after an interval of
at least 4 weeks.
Infants less than 6 months of age: the safety and efficacy of
_Influvac Sub-unit Tetr