IXIARO

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

JAPANESE ENCEPHALITIS PURIFIED INACTIVATED VACCINE

Доступно од:

KAMADA LTD, ISRAEL

АТЦ код:

J07BA02

Фармацеутски облик:

SUSPENSION FOR INJECTION

Састав:

JAPANESE ENCEPHALITIS PURIFIED INACTIVATED VACCINE 6 AU / 0.5 ML

Пут администрације:

I.M

Тип рецептора:

Required

Произведен од:

VALNEVA SCOTLAND LTD, UK

Терапеутска област:

ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS

Терапеутске индикације:

Ixiaro is indicated for active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Ixiaro should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.

Датум одобрења:

2016-04-30

Информативни летак

HEAD OFFICE 2 Holtzman St., Science Park, P.O. Box 4081, Rehovot,
7670402, Israel | Tel. [phone] | Fax. [phone] PLANT Kibbutz Beit Kama, M.P Negev 8532500, Israel | Tel.
[phone] | Fax. [phone]
רבמצד
8
201
,ה/דבכנ ת/חקור ,ה/אפור ןוכדיע לע עידוהל תשקבמ עדהמק תרבח
עדימ
:רישכתה רובע ,ןלהל טרופמכ
IXIARO ;
וראיסקיא
SUSPENSION FOR INJECTION IM
ןוישירל םאתהב םיליעפ םיביכרמ
:
JAPANESE ENCEPHALITIS PURIFIED INACTIVATED VACCINE 6 AU / 0.5 ML
:היוותה
Ixiaro is indicated for active immunization against Japanese
encephalitis in adults,
adolescents, children and infants aged 2 months and older.
Ixiaro should be considered for use in individuals at risk of exposure
through travel or in the
course of their occupation.
יונישה תוהמ
םי
: רטשמ ןוכדיע
ה
ןונימ .תואירבה דרשמ רושיאב ,
יעסב ןכדוע אפורל ןולעה
ף
4.2
םאתהב
םיפיעסה ונכדוע ףסונב .
4.8
ו
-
5.1
)
םהבש םיפיעסה יתת קר ןלהל םיטרופמ
ושענ
רקיע
םייונישה
שדח טסקט .
הצוח וקב ושענ תוקיחמ ;יתחת וקב שגדומ
ושגדוה תורמחה .
בוהצב
:(
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS (18-65 YEARS OF AGE)_ _
The primary vaccination series consists of two separate doses of 0.5
ml each, according to the following
conventional schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
Rapid schedule Adults 18-65 years of age:
Persons aged 18-65 years can be vaccinated in a rapid schedule as
follows:
First dose at Day 0.
Second dose: 7 days after first dose.
With both schedules, primary immunisation should be completed at least
one week prior to potential
exposure to Japanese encephalitis virus (JEV) (see section 4.4).
It is recommended that vaccinees who received the first dose of IXIARO
complete the primary 2-dose
vaccination course with IXIARO.
If the primary i

Карактеристике производа

PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
IXIARO suspension for injection
Japanese encephalitis vaccine (inactivated, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (0.5 ml) of IXIARO contains:
Japanese encephalitis virus strain SA
14
-14-2 (inactivated)
1,2
6 AU
3
corresponding to a potency of ≤ 460 ng ED50
1
produced in Vero cells
2
adsorbed on aluminium hydroxide, hydrated (approximately 0.25
milligrams Al
3+
)
3
Antigen Units
Excipients with known effect:
This medicine contains potassium, less than 1mmol/dose and sodium,
less than 1mmol/dose.
Phosphate Buffered Saline 0.0067 M (in PO4) has the following saline
composition: NaCl – 9 mg/mL
KH2PO4 – 0.144
mg/mL Na2HPO4 –
0.795 mg/mL
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear liquid with a white precipitate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IXIARO is indicated for active immunisation against Japanese
encephalitis in adults, adolescents,
children and infants aged 2 months and older.
IXIARO should be considered for use in individuals at risk of exposure
through travel or in the
course of their occupation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS
(18-65 YEARS OF AGE)
_ _
The primary vaccination series consists of two separate doses of 0.5
ml each, according to the
following conventional schedule:
First dose at Day 0.
Second dose: 28 days after first dose.
Rapid schedule Adults 18-65 years of age:
Persons aged 18-65 years can be vaccinated in a rapid schedule as
follows:
First dose at Day 0.
Second dose: 7 days after first dose.
With both schedules, primary immunisation should be completed at least
one week prior to
potential exposure to Japanese encephalitis virus (JEV) (see section
4.4).
It is recommended that vaccinees who received the first dose of IXIARO
complete the primary
2-dose vaccination course with IXIARO.
If the primary immunization of two injections is not completed, full
protection against the disease
might not be achie