EFLUELDA

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

A/MICHIGAN/45/2015 (H1N1)PDM09 – LIKE STRAIN; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE); B/PHUKET/3073/2013 LIKE STRAIN

Disponible depuis:

SANOFI ISRAEL LTD

Code ATC:

J07BB02

forme pharmaceutique:

SUSPENSION FOR INJECTION

Composition:

B/PHUKET/3073/2013 LIKE STRAIN 60 MCG / 0.7 ML; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) 60 MCG / 0.7 ML; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS 60 MCG / 0.7 ML; A/MICHIGAN/45/2015 (H1N1)PDM09 – LIKE STRAIN 60 MCG / 0.7 ML

Mode d'administration:

S.C, I.M

Type d'ordonnance:

Required

Fabriqué par:

SANOFI PASTEUR, USA

Domaine thérapeutique:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

indications thérapeutiques:

Active immunisation in adults 65 years of age and older for the prevention of influenza disease. בקשה לשינוי משטר מינון: 9/3/2022Active immunisation in adults 60 years of age and older for the prevention of influenza disease.

Date de l'autorisation:

2022-02-03

Résumé des caractéristiques du produit

_EFLU-SPC-12.23 V10.0 _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efluelda , suspension for injection in pre-filled syringe
Quadrivalent influenza vaccine (split virion, inactivated), 60
micrograms HA/strain
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) 60 micrograms HA**
A/Darwin/9/2021(H3N2)-like
strain
(A/Darwin/9/2021, SAN-010) 60 micrograms HA**
B/Austria/1359417/2021-like strain (B/Michigan/01/2021, wild type) 60
micrograms HA**
B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type)
............ 60 micrograms HA**
Per 0.7 ml dose
*
propagated in embryonated chicken eggs
**
haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU
decision for the 2023/2024 season.
Efluelda may contain traces of eggs, such as ovalbumin, formaldehyde
which are used during
the manufacturing process (see Section 4.3).
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Suspension for injection, in a pre-filled syringe
Efluelda, after shaking gently, is a colourless opalescent liquid.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Efluelda is indicated for active immunisation in adults 65 years of
age and older for the
prevention of influenza disease.
The use of Efluelda should be based in accordance with official
recommendations on
vaccination against influenza.
4.2
Posology and method of administration
Posology
In adults 65 years of age and older: one dose of 0.7 ml.
_Paediatric population _
The safety and effectiveness of Efluelda in children less than 18
years of age have not
been established.
Method of administration
The preferred route of administration for this vaccine is
intramuscular although it may also be
given subcutaneously.
The recommended site for intramuscular injection is the deltoid
region. The vaccine should
not be injected into the gluteal region, or into areas where there may
be a