VIVOTIF

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VIABLE SALMONELLA TYPHI TY21A CELLS

متاح من:

KAMADA LTD, ISRAEL

الشكل الصيدلاني:

GASTRO RESISTANT HARD CAPSULE

تركيب:

VIABLE SALMONELLA TYPHI TY21A CELLS

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

EMERGENT BIOSOLUTIONS BERNA GMBH, SWITZERLAND

الخصائص العلاجية:

Vivotif is indicated for active oral immunisation against typhoid fever, caused by Salmonella enterica serovar Typhi, (S. Typhi), in adults and children aged five years and older.This vaccine should be used in accordance with official recommendations

تاريخ الترخيص:

2021-05-04

نشرة المعلومات

ﺔﻴﺒﻧﺎﺠﻟا ضاﺮﻋﻷا .4
نــم شــهدنت لا .ينلمعتــسلما ضــعب
ىدــل ةــيبناج
ً
اــضارعأ ببــسي دــق فــيتوڤيڤ
لماعتــسإ نإ ،ءاود لكــب ماــك
.اهنم
ً
ايأ نياعت لاأ زئاجلا نم ،ةيبناجلا
ضارعلأا ةئماق
لــعف دودر :ةــيلاتلا ةيرــطخلا
ةــيبناجلا ضارــعلأا نــم سياــقت
تــنك اذإ رﻮــﻔﻟا ﲆــﻋ ﺐــﻴﺒﻄﻟا
ﱃإ ﻪــﺟﻮﺘﻟا ﺐــﺠﻳ
مدــلا طــغض في
ً
اــضافخنإ وأ/و ســفنتلا في
ً
اــقيضو ةرــجنحلا وأ هــجولا خاــفتنإ
ببــست يــتلا ةيرــطخ ةيــسسحت
.ءماغإو
:ىرخأ ةيبناج ضارعأ
نطبلا في ملاآ
نايثغ
تاؤيقت
لاهسإ
ةنوخس
عادص
دلجلا رارمحإ
ةكح ،عفترمو زراب وأ رمحأ حفط ،حفط
،دلجلا في جيهت
فعض
ةماع ةكعوب روعشلا
فاجترإ
قاهرإ
ل
ّ
منت
راود
تلاضعلا وأ لصافلما في لمأ
رهظلا في لمأ
ةخفن ،نطبلا في تازاغ ،ماعطلل ةيهشلا
ةلق
ازنإولفنلإاب هيبش ضرم ﺮــﻛﺬﻳ لم ﻲــﺒﻧﺎﺟ ضﺮــﻋ ﻦــﻣ
نيﺎــﻌﺗ ﺎــﻣﺪﻨﻋ وأ ﺔــﻴﺒﻧﺎﺠﻟا
ضاﺮــﻋﻷا ىﺪــﺣإ ﺖــﻤﻗﺎﻔﺗ اذإ
،ﻲــﺒﻧﺎﺟ ضﺮــﻋ ﺮــﻬﻇ اذإ
.ﺐﻴﺒﻄﻟا ةرﺎﺸﺘﺳإ ﻚﻴﻠﻋ ،ةﴩﻨﻟا
هﺬﻫ ﰲ
ﺔﻴﺒﻧﺎﺟ ضاﺮﻋأ ﻦﻋ ﻎﻴﻠﺒﺘﻟا
ضارــعأ نــع غــيلبت» طــبارلا لىــع
طــغضلا ةطــساوب ةــحصلا ةرازوــل
ةــيبناج ضارــعأ نــع غــيلبتلا
ناكــملإاب
(www.health.gov.il)
ةــحصلا ةرازو عــقولم ةيــسيئرلا
ةــحفصلا لىــع دوــجو�

خصائص المنتج

1.
NAME OF THE MEDICINAL PRODUCT
Vivotif
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains not less than 2x10
9
CFU of viable Salmonella Typhi Ty21a cells (also known as
_Salmonella enterica_
serovar Typhi , abbr.
_S_
. Typhi).
Excipients with known effect: lactose, sucrose.
For the full list of excipients , see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant hard capsules.
The capsules are bicoloured: the capsule cap is opaque orange and the
capsule body is opaque white.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Vivotif is indicated for active oral immunisation against typhoid
fever, caused by Salmonella
enterica serovar Typhi, (S. Typhi), in adults and children aged five
years and older.
This vaccine should be used in accordance with official
recommendations.
4.2
Posology and method of administration
Posology
One capsule of Vivotif is taken on each of Days 1, 3 and 5.
Complete vaccination comprises the ingestion of three capsules as
described above. The optimal
immune response may not be achieved unless the entire vaccination
schedule is completed.
Protection against typhoid fever commences approximately seven to ten
days after ingesting the third
dose of vaccine. The entire vaccination schedule should be completed
at least one week prior to travel
to an endemic area.
_Revaccination _
Revaccination is recommended at three years following the most recent
vaccination for all individuals.
Revaccination comprises the ingestion of three capsules on Days 1, 3,
and 5, as for the original
vaccination schedule.
_Paediatric Population _
Vivotif is not indicated for children under 5 years of age.
The posology in children is the same as in adults. Safety and efficacy
in children under five years of
age have not been established.
Method of administration
One capsule of Vivotif is taken with cold or lukewarm water
(temperature not more than 37°C) on an
empty stomach and at least one hour before the next meal. The vaccine
capsule should not be chewed
and should be swallowed as soon as possible