Influvac Tetra, suspension for injection in pre-filled syringe (influenza vaccine, surface antigen, inactivated)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215) ; A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021, IVR-228); B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE); B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type)

Available from:

Viatris Healthcare Limited

ATC code:

J07BB; J07BB02

INN (International Name):

A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215) ; A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021, IVR-228); B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE); B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type)

Pharmaceutical form:

Suspension for injection in pre-filled syringe

Therapeutic area:

Influenza vaccines; influenza, inactivated, split virus or surface antigen

Authorization status:

Marketed

Authorization date:

2017-08-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
INFLUVAC 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 Tetra is and what it is used for
2.
What you need to know before you or your child use Influvac Tetra
3.
How to use Influvac Tetra
4.
Possible side effects
5.
How to store Influvac Tetra
6.
Contents of the pack and other information
1.
WHAT INFLUVAC TETRA IS AND WHAT IT IS USED FOR
Influvac 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
Tetra is indicated in adults and children from
6 months of age. The use of Influvac Tetra should be based on official
recommendations.
When a person is given the vaccine Influvac 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 be vaccinated up until the spring since you or
your child run the risk of catching flu until then.
Your doctor will be a

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2023
CRN00DWPG
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Influvac 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 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 Tetra is indicated in adults and children from 6 months of
age.
The use of Influvac 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 sa