AGRIPPAL S1

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

A/BRISBANE/02/2018(H1N1)PDM09-LIKE VIRUS; A/KANSAS/14/2017 (H3N2) LIKE VIRUS; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE); B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS

Dostupné z:

NEOPHARM SCIENTIFIC LTD

ATC kód:

J07BB02

Forma lieku:

SUSPENSION FOR INJECTION

Zloženie:

B/PHUKET/3073/2013 (B/YAMAGATA LINEAGE)-LIKE VIRUS 15 MCG / 0.5 ML; B/COLORADO/06/2017- LIKE VIRUS (B/VICTORIA/2/87 LINEAGE) 15 MCG / 0.5 ML; A/KANSAS/14/2017 (H3N2) LIKE VIRUS 15 MCG / 0.5 ML; A/BRISBANE/02/2018(H1N1)PDM09-LIKE VIRUS 15 MCG / 0.5 ML

Spôsob podávania:

I.M, DEEP S.C.

Typ predpisu:

Required

Výrobca:

SEQIRUS VACCINES LTD, UK

Terapeutické skupiny:

INFLUENZA, PURIFIED ANTIGEN

Terapeutické oblasti:

INFLUENZA, INACTIVATED, SPLIT VIRUS OR SURFACE ANTIGEN

Terapeutické indikácie:

Prophylaxis of influenza.

Dátum Autorizácia:

2019-09-08

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
AGRIPPAL™ S1
1.
NAME OF THE MEDICINAL PRODUCT
AGRIPPAL S1, Suspension for injection in pre-filled syringe
Influenza Vaccine
Surface Antigen, Inactivated
(2017/2018 SEASON)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase),
of strains*:
A/Michigan/45/2015 (H1N1)pdm09
-like strain
(A/Singapore/GP1908/2015, IVR-180)
15 micrograms HA**
A/Hong Kong/4801/2014 (H3N2)-like strain
(A/Hong Kong/4801/2014, NYMC X-263B)
15 micrograms HA**
B/Brisbane/60/2008-like strain
(B/Brisbane/60/2008, wild type)
15 micrograms HA**
* propagated in fertilized hens’ eggs from healthy chicken flocks
** haemagglutinin
For one dose of 0.5ml
This vaccine complies with the WHO recommendations (Northern
Hemisphere) and EU decision for the
2017/2018 season.
AGRIPPAL S1
may contain traces of eggs such as ovalbumin or chicken proteins,
kanamycin and
neomycin
sulphate,
formaldehyde,
cetyltrimethylammonium
bromide
(CTAB),
polysorbate
80
and
barium sulphate which are used during the manufacturing process (see
section 4.3).
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
The vaccine appears as a clear liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza, especially in those who run an increased
risk of associated complications.
AGRIPPAL S1
is indicated in adults and children from 6 months of age.
The use of
AGRIPPAL S1
should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: 0.5 ml.
_Paediatric population _
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. The dose given should be in accordance with the existing
national recommendation.
For children who have not previously been vaccinated, a second dose
should be given after an interval of
at least 4 weeks.
Children less than 6 months: the safety and efficacy of