Influvac Sub-unit, suspension for injection (influenza vaccine, surface antigen, inactivated)

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215) ; A/Cambodia/e0826360/2020 (H3N2)-like strain (A/Cambodia/e0826360/2020, IVR-224); B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Disponibil de la:

Mylan IRE Healthcare Limited

Codul ATC:

J07BB; J07BB02

INN (nume internaţional):

A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019, IVR-215) ; A/Cambodia/e0826360/2020 (H3N2)-like strain (A/Cambodia/e0826360/2020, IVR-224); B/Washington/02/2019-like strain (B/Washington/02/2019, wild type)

Dozare:

0.5 microgram(s)

Forma farmaceutică:

Suspension for injection in pre-filled syringe

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

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

Statutul autorizaţiei:

Marketed

Data de autorizare:

1998-05-01

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE USER
2021/2022 season
INFLUVAC® SUB-UNIT
SUSPENSION FOR INJECTION
Influenza vaccine (surface antigen, inactivated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED, BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU AND 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. 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 Influvac is and what it is used for
2
What you need to know before you or your child use Influvac
3
How to use Influvac
4
Possible side effects
5
How to store Influvac
6
Contents of the pack and other information
1. WHAT INFLUVAC IS AND WHAT IT IS USED FOR
Influvac is a vaccine. This vaccine helps to protect you or your child
against influenza (flu), particularly in people
who run a high risk of associated complications. The use of Influvac
should be based on official recommendations.
When a person is given the vaccine Influvac, 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 runs the risk of catching flu until then.
Your doctor will be able to recommend the best time to be vaccinated.
Influvac will protect you or your child against the three strains of
virus contained in the vaccine fro

Caracteristicilor produsului

Health Products Regulatory Authority
07 September 2021
CRN00CHPP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Influvac Sub-unit, suspension for injection (influenza vaccine,
surface antigen, inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following strains*:
- A/Victoria/2570/2019 (H1N1)pdm09-like strain
(A/Victoria/2570/2019, IVR-215)
15 micrograms HA **
- A/Cambodia/e0826360/2020 (H3N2)-like strain
(A/Cambodia/e0826360/2020, IVR-224)
15 micrograms HA **
-B/Washington/02/2019-like strain
(B/Washington/02/2019, 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 2021/2022 season.
For a full list of excipients see section 6.1.
Influvac 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 prefilled syringe;
a colourless clear liquid, filled in single-dose syringes
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac is indicated in adults and children from 6 months of age.
The use of Influvac 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 ml may be given, for detailed
instructions on administering a 0.25 ml or 0.5 ml dose, see section
6.6. The dose given should be in accordance with existing
national recommendations.
For children, who have not previously b