VAXIGRIP

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS; 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 VIRUS (B/YAMAGATA/16/88 LINEAGE)

Available from:

MEDICI MEDICAL LTD, ISRAEL

ATC code:

J07BB01

Pharmaceutical form:

SUSPENSION FOR INJECTION

Composition:

B/PHUKET/3073/2013 - LIKE VIRUS (B/YAMAGATA/16/88 LINEAGE) 15 MCG/DOSE; A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS 15 MCG/DOSE; A/SINGAPORE/INFIMH-16-0019/2016 (H3N2) - LIKE VIRUS 15 MCG/DOSE; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) 15 MCG/DOSE

Administration route:

I.M, DEEP S.C.

Prescription type:

Required

Manufactured by:

SANOFI PASTEUR, FRANCE

Therapeutic group:

INFLUENZA, INACTIVATED, WHOLE VIRUS

Therapeutic area:

INFLUENZA, INACTIVATED, WHOLE VIRUS

Therapeutic indications:

For the prevention of influenza.

Authorization date:

2012-11-30

Patient Information leaflet

_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
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_______________ ךיראת
05.06.16
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ש םושירה רפסמו תילגנאב רישכת ם
____
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031 -05 -21760 -00
_
VAXIGRIP
םושירה לעב םש
_
מ"עב לקידמ יצידמ
___________________________________
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
2
. QUALITIVE AND QUANTITIVE COMPOSITION יוניש בכרה
21.6-21.7

A/California/7/2009 (H1N1)pdm09– like virus
….15 micrograms HA**

A/Hong Kong/4801/2014 (H3N2) -like virus
15 micrograms HA**

B/Brisbane/60/2008 –like virus
15 micrograms HA**
4.1
TERAPEUTIC INDICATIONS תפסות
טסקט
VAXIGRIP is indicated in adults and children from 6
months of age.
4.2
POSOLOGY AND METHOD OF
תפסות
ןוכדעו
טסקט POSOLOGY
Adults: 0.5 ml.
ADMINISTRATION
_Paediatric population _
Children aged 36 months onwards: 0.5 ml.
Children aged 6 to 35 months: 0.25 ml. Clinical data
are limited. See Section 6.6 for more information on
administration of the 0.25 ml dose.
A 0.5 ml dose may be given, if this is required by
national recommendations.
For children aged less than 9 years who have not
previously been vaccinated, a second dose should be
given after an interval of at least 4 weeks.
Children aged less than
6 months: the safety and
efficacy of VAXIGRIP in children aged less than 6
months
have
not
been
established.
No
data
are
available. METHOD OF ADMINISTRATION
To
be
administered
via
intramuscular
or
deep
subcutaneous route.
For adults and children from 36 months of age: the preferred
site for intramuscular injection is the deltoid muscle.
35 months of age: the preferred

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
VAXIGRIP, suspension for injection in prefilled syringe.
Influenza vaccine (split virion, inactivated).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Split influenza virus*, inactivated containing antigens equivalent to
the following strains:
•
A/California/7/2009 (H1N1)pdm09– like virus ….15 micrograms HA**
•
A/Hong Kong/4801/2014 (H3N2) -like virus 15 micrograms HA**
•
B/Brisbane/60/2008 –like virus 15 micrograms HA**
per 0.5 ml dose.
*
propagated in fertilized hens’ eggs from healthy chicken flocks
**
haemagglutinin
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the 2016-2017 season.
For a full list of excipients, see section 6.1 .
VAXIGRIP may contain traces of eggs, such as ovalbumin, traces of
neomycin, of formaldehyde and of octoxinol-9, which are used during
the manufacturing
process (see Section 4.3.).
3
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe.
The vaccine, after shaking gently, is a slightly whitish and
opalescent liquid.
4
CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS
For the prevention of influenza.
VAXIGRIP is indicated in adults and children from 6 months of age.
The use of VAXIGRIP should be based on official recommendations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY
Adults: 0.5 ml.
Paediatric population
Children aged 36 months onwards: 0.5 ml.
Children aged 6 to 35 months: 0.25 ml. Clinical data are limited. See
Section 6.6 for more information on administration of the 0.25 ml
dose.
A 0.5 ml dose may be given, if this is required by national
recommendations.
For children aged less than 9 years who have not previously been
vaccinated, a second dose should be given after an interval of at
least 4 weeks.
Children aged less than 6 months: the safety and efficacy of VAXIGRIP
in children aged less than 6 months have not been established. No data
are available.
METHOD OF ADMINISTRATION
To be administered via intramuscular or deep subcutaneous route.
For adults and children from 3