INFLUVAC TETRA

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

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

থেকে পাওয়া:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

এটিসি কোড:

J07BB02

ফার্মাসিউটিকাল ফর্ম:

SUSPENSION FOR INJECTION

রচনা:

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

প্রশাসন রুট:

S.C, I.M

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

ABBOTT BIOLOGICAL B.V., THE NETHERLANDS

Therapeutic area:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

থেরাপিউটিক ইঙ্গিত:

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.

অনুমোদন তারিখ:

2019-06-26

তথ্য লিফলেট

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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רישכתה תודוא
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ותאלעה ךרוצל תואירבה דרשמל חלשנ ןולעה
,
הינפ י"ע ספדומ ולבקל ןתינו
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הנוממ תחקור

পণ্য বৈশিষ্ট্য

_ _
_ _
_ _
1/9
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