INFLUVAC

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN; A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN; B/WASHINGTON/02/2019 (B/VICTORIA LINEAGE)-LIKE VIRUS

Available from:

ABBOTT MEDICAL LABORATORIES LTD, ISRAEL

ATC code:

J07BB02

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

B/WASHINGTON/02/2019 (B/VICTORIA LINEAGE)-LIKE VIRUS 15 MCG/DOSE / 0.5 ML; A/CAMBODIA/E0826360/2020 (H3N2)-LIKE STRAIN 15 MCG / 0.5 ML; A/VICTORIA/2570/2019 (H1N1)PDM09-LIKE STRAIN 15 MCG / 0.5 ML

Administration route:

I.M, DEEP S.C.

Prescription type:

Required

Manufactured by:

ABBOTT BIOLOGICAL B.V., THE NETHERLANDS

Therapeutic group:

INFLUENZA, INACTIVATED, WHOLE VIRUS

Therapeutic area:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Therapeutic indications:

Influenza virus vaccine.

Authorization date:

2023-05-31

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור רשוא
–
61.5 ךיראת
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םושירה רפסמו תילגנאב רישכת םש
:
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-
22645
-
66
-
INFLUVAC, 033
םושירה לעב םש
בא
ו
מ"עב תויאופר תודבעמ ט
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
Prophylaxis of influenza; especially those
who run an increased risk of associated
complications.
Influvac is indicated in adults and children
from 6 months of age.
The use of Influvac should be based on
official recommendations.
Vaccination is particularly recommended for
the following categories of patients,
depending on national immunization
policies:
-
Persons aged ≥ 65 years, regardless
their health condition.
-
Adults and children with chronic
disorders of the pulmonary or
cardiovascular systems, including
asthma.
-
Adults and children with chronic
metabolic diseases such as diabetes
mellitus.
-
Adults and children with chronic
renal dysfunction.
-
Adults and children with
immunodeficiencies due to disease
or immunosuppressant medication
(e.g., cytostatics or corticosteroids)
or radiotherapy.
-
Children and teenagers (6 months –
18 years) who receive long-term
acetylsalicylic acid containing
medication, and might therefore be
at risk for developing Reye’s
syndrome following an influenza
infection.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those
who run an increased risk of associated
complications.
Influvac is indicated in adults and children
from 6 months of age.
The use of Influvac should be based on
official recommendations.
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL
WARNINGS AN

Summary of Product characteristics

_ _
_ _
1/6
INFLUVAC
®
2020/2021
1.
NAME OF THE MEDICINAL PRODUCT
Influvac, suspension for injection (influenza vaccine, surface
antigen, inactivated).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (inactivated) (haemagglutinin and
neuraminidase) of the following
strains*:
- A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like
strain
(A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
15 micrograms HA **
-A/Hong Kong/2671/2019 (H3N2)-like strain
(A/Hong Kong/2671/2019, IVR-208)
15 micrograms HA **
-B/Washington/02/2019-like strain
(B/Washington/02/2019, 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 2020/2021 season.
For a full list of excipients see section 6.1.
Influvac 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 prefilled syringes;
A colourless clear liquid, filled in single-dose syringes.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially those who run an increased risk
of associated complications.
Influvac is indicated in adults and children from 6 months of age.
The use of Influvac should be based on official recommendations.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
_ _
Paediatric population
_ _
_ _
_ _
2/6
Children from 36 months onwards: 0.5 ml.
Children from 6 months to 35 months: Clinical data are limited.
Dosages of 0.25 ml or 0.5 ml may be
given, for detailed instructions on administering a 0.25 ml or 0.5 ml
dose, see section 6.6. The dose given
should be in accordance with existing national recommendations.
For children who have not previously been vaccinated, a second dose
should be giv