VAXIGRIP TETRA

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

A/DARWIN/9/2021 (H3N2)-LIKE VIRUS; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS; B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS

Dostupné z:

SANOFI ISRAEL LTD

ATC kód:

J07BB02

Forma lieku:

SUSPENSION FOR INJECTION

Zloženie:

B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS 30 MCG HA / 1 ML; A/DARWIN/9/2021 (H3N2)-LIKE VIRUS 30 MCG HA / 1 ML; B/AUSTRIA/1359417/2021 (B/VICTORIA LINEAGE)-LIKE VIRUS 30 MCG HA / 1 ML; A/VICTORIA/4897/2022 (H1N1)PDM09-LIKE VIRUS 30 MCG HA / 1 ML

Spôsob podávania:

S.C, I.M

Typ predpisu:

Required

Výrobca:

SANOFI PASTEUR, FRANCE

Terapeutické oblasti:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Terapeutické indikácie:

Vaxigrip Tetra 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 birth to less than 6 months of age following vaccination of pregnant women.The use of Vaxigrip Tetra should be based on official recommendations.

Dátum Autorizácia:

2023-02-28

Príbalový leták

רבמבונ
2019
ה
ןודנ
:
RIP TETRA
VAXIG
ארטט פירגיסקו
Suspension for Injection
ה /דבכנ ה /אפור
,ה/דבכנ ת/חקור
ל תשקבמ מ"עב לקידמ י'צידמ תרבח
לע עידוה
כדע
ו
לש אפורל ןולעה ן
תיתנועה תעפשה ןוסיח
Vaxigrip Tetra
פירגיסקו /
ארטט
.
רובע םינזה ןוכדע םג ללוכ ןולעה ןוכדע
ףרוח
2019-2020
.
:םיליעפ םירמוח
A/Brisbane/02/2018 (H1N1)pdm09 - like strain (A/Brisbane/02/2018,
IVR-190) ………..15
µ
g HA**
A/Kansas/14/2017 (H3N2) - like strain (A/Kansas/14/2017, NYMC X-327)
……………. 15 µg HA**
B/Colorado/06/2017-like strain (B/Maryland/15/2016, NYMC
BX-69A)……………….….15 µg HA**
B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild
type)............................…...15 µg HA**
Per one 0.5 ml dose
* propagated in fertilised hens’ eggs from healthy chicken flocks
** haemagglutinin
יוותה
:ה
Vaxigrip Tetra is indicated for active immunisation of adults and
children from 6 months of age
and older 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.
The use of Vaxigrip Tetra should be based on official recommendations
ןולעל ועצובש םייונישה םיניוצמ וז
העדוהב
:םינמוסמה םינוכדעל ארקמ
תפסות
–
לוחכ
הקיחמ
-
הקיחמ וק םע םודא
הרמחה
–
בוהצב :אפורל ןולעב ושענש םייתוהמה םינוכדעה
ןלהל
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus (inactivated, split) of the following strains*:
A/Brisbane/02/2018
(H1N1)pdm09
-
like
strain
(A/Brisbane/02/2018,
IVR-190)A/Michigan/45/2015
(H1N1)pdm09 - like strain (A/Michigan/45/200215, NYMC X-275) ….15
micrograms HA**
A/Kansas/14/2017
(H3N2)
-
like
strain
(A/Kansas/14/2017,
NYMC
X-327)A/Singapore/INFIMH-16-
0019/2016 (H3N2) - like strain
(A/Singapore/INFIMH-16-0019/2016,IVR-186) …

Súhrn charakteristických

1. NAME OF THE MEDICINAL PRODUCT
Vaxigrip Tetra, 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/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/2570/2019,
IVR-215)
………………………………………………………....…..……....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
2022
/2023 season.
For the full list of excipients, see Section 6.1.
Vaxigrip Tetra 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
Vaxigrip Tetra (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 birth to less than 6 months of
age following
vaccination of pregnant women (see Sections 4.