Influvac sub-unit Tetra, suspension for injection in pre-filled syringe 15mcg/0.5ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

INFLUENZA VACCINE, SPLIT VIRION, INACTIVATED

Available from:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

J07BB02

INN (International Name):

INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg

Pharmaceutical form:

SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Composition:

INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) 15 µg

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Authorised

Authorization date:

2017-07-21

Patient Information leaflet

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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)
2021/2022 season
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you or your
child may get. See the end of section 4 for
how to report side effects.
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

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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
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/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 **
- 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.
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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 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, filled in single-dose syringes.
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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.
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