Quadrivalent Influenza Vaccine (split virion, inactivated), suspension for injection in pre-filled syringe Quadrivalent influenza vaccine (split virion, inactivated)

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238; A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021, IVR-228); B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type); B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)

Mevcut itibaren:

Sanofi Pasteur

ATC kodu:

J07BB; J07BB02

INN (International Adı):

A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238; A/Darwin/9/2021 (H3N2) - like strain (A/Darwin/9/2021, IVR-228); B/Austria/1359417/2021 - like strain (B/Michigan/01/2021, wild type); B/PHUKET/3073/2013 -LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE)

Doz:

15 microgram(s)

Farmasötik formu:

Suspension for injection in pre-filled syringe

Reçete türü:

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

Terapötik alanı:

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

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2016-07-15

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED),
SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Quadrivalent influenza vaccine (split virion, inactivated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD ARE
VACCINATED 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, pharmacist or
nurse.
-
This vaccine has been prescribed for you or your child only. 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 Quadrivalent Influenza Vaccine (split virion, inactivated) is and
what it is used for
2.
What you need to know before you or your child use Quadrivalent
Influenza Vaccine
(split virion, inactivated)
3.
How to use Quadrivalent Influenza Vaccine (split virion, inactivated)
4.
Possible side effects
5.
How to store Quadrivalent Influenza Vaccine (split virion,
inactivated)
6.
Contents of the pack and other information
1.
WHAT QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED) IS AND
WHAT IT IS USED FOR
Quadrivalent Influenza Vaccine (split virion, inactivated) is a
vaccine. This vaccine administered to
you or your child from 6 months of age helps to protect you or your
child against influenza (flu).
When a person is given Quadrivalent Influenza Vaccine (split virion,
inactivated), the immune system
(the body’s natural defence system) will produce its own protection
(antibodies) against the disease.
When given during pregnancy the vaccine helps to protect the pregnant
women but also helps to
protect her baby from birth to less than 6 months of age through the
transmission of protection from
mother to baby during pregnancy (see also Sections 2 and 3).
None of the ingredients in the vaccine can cause flu.
The use of Quadrivalent Influenza Vaccine (split virion, inactiva

Ürün özellikleri

Health Products Regulatory Authority
22 August 2023
CRN00DM8T
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Quadrivalent Influenza Vaccine (split virion, inactivated), suspension
for injection in pre-filled syringe Quadrivalent influenza
vaccine (split virion, inactivated)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) 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,
IVR-228)……………………………………......................….................15
micrograms HA**
B/Austria/1359417/2021 - like strain
(B/Michigan/01/2021, 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
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the 2021/2022 season.
For the full list of excipients, see Section 6.1.
Quadrivalent Influenza Vaccine (split virion, inactivated) may contain
traces of eggs, such as ovalbumin, and of neomycin,
formaldehyde and octoxinol-9, which are used during the manufacturing
process (see Section 4.3).
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine, after shaking gently, is a colourless opalescent liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Quadrivalent Influenza Vaccine (split virion, inactivated) is
indicated for the prevention of influenza disease caused by the two
influenza A virus subtypes and the two influenza B virus types
contained in the vaccine for:

active immunisation of adults, including pregnant women, and children
from 6 months of age and older,

passive protection of infant(s) from bir