INFLUVAC TETRA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

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

Available from:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC code:

J07BB02

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

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

Administration route:

S.C, I.M

Prescription type:

Required

Manufactured by:

ABBOTT BIOLOGICAL B.V., THE NETHERLANDS

Therapeutic area:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Therapeutic indications:

Prophylaxis of influenza, especially those who run an increased risk of associated complications. Influvac Tetra is indicated in adults and children from 6 months of age.

Authorization date:

2019-06-26

Patient Information leaflet

Attidim Science Park, Bldg 4,
P.O.B 58099
Tel Aviv 61580
Israel
T: [phone]
F: [phone]
טסוגוא
2022
יאופר תווצ
,ה/דבכנ
ןודנה
:
INFLUVAC TETRA IS INDICATED FOR AGE 6 MONTH AND ABOVE
עידוהל תדבכתמ מ"עב תיאופר תודבעמ טובא
לע היוותה תפסות ןוסיחה ןתמל ליגמ םידליל
6
םישדוח ,הלעמו
רישכתל
Influvac Tetra
.
הרטט קאבולפניא
לעב ןוסיח אוה
4
.תירוע תת הקרזהב ףיחרתכ ןתינה םינז תינכדעה היוותהה רישכתל
הניה : INDICATIONS:
Prophylaxis of influenza, especially those who run an increased risk
of
associated complications.
Influvac Tetra is indicated in adults and children from 6 months of
age. POSOLOGY:
Adults: 0.5 ml.
Paediatric population:
Children from 6 months to 17 years of age: 0.5 ml.
Children less than 9 years of age, who have not previously been
vaccinated with a seasonal influenza vaccine: a second dose of 0.5 ml
should be given after an interval of at least 4 weeks.
Infants less than 6 months of age: the safety and efficacy of Influvac
Tetra have not been established.
הרוטרפמטב רוריקב ןסחואמ תויהל ךירצ
הרטט קאבולפניא רישכתה
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2-8º
.
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.ןתמהו ןוסחיאה תוארוה לע דיפקהל שי
ל
ףסונ עדימ
רישכתה תודוא
ןכדועמה אפורל ןולעב ןייעל שי
.
תואירבה דרשמ רתאב תופורתה רגאמל
ותאלעה ךרוצל תואירבה דרשמל חלשנ ןולעה
,
הינפ י"ע ספדומ ולבקל ןתינו
עב תויאופר תודבעמ טובא ,םושירה לעבל
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וגורטס תרפא
הנוממ תחקור

Summary of Product characteristics

_ _
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INFLUVAC TETRA
3
202
/
2
202
1.
NAME OF THE MEDICINAL PRODUCT
Influvac Tetra, suspension for injection in pre-filled syringe 0.5 ml
(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/Darwin/9/2021 (H3N2)-like strain
(A/Darwin/9/2021, SAN-010)
15 micrograms HA **
- B/Austria/1359417/2021-like strain
(B/Austria/1359417/2021, BVR-26)
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 World Health Organisation (WHO)
recommendation (northern
hemisphere) and EU recommendation for the 2022/2023 season.
For a full list of excipients see section 6.1.
Influvac 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.
_ _
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac Tetra is indicated in adults and children from 6 months of
age..
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
_ _
Paediatric population
Children from 6 months to 17 years of age: 0.5 ml.
Children less than 9 years of age, who have not previously been
vaccinated with a seasonal influenza
vaccine: a second dose of 0.5 ml should be given after an interval of
at least 4 weeks.
_ _
_ _
_ _
2/9
Infants less than 6 months of age: the safety and efficacy of Influvac
Tetra have not been
established.
Method of Administration
Immun