Rabies Vaccine Inactivated (freeze dried) powder lyophilized for solution for injection and solvent

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

purified rabies antigen

متاح من:

Serum Institute of India Pvt Ltd.

ATC رمز:

J07BG01

INN (الاسم الدولي):

purified rabies antigen

جرعة:

2,5IU/ml

الشكل الصيدلاني:

powder lyophilized for solution for injection and solvent

الوحدات في الحزمة:

(1) glass vial and (1) solvent in ampoule 1ml, (5) glass vials and (5) solvent in ampoules 1ml, (50) glass vials, (50) solvent in ampoules 1ml

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2019-08-08

خصائص المنتج

@
sеrчm
Inýtitute
of
India
Pvt-
Ltd.
Rabieý
vассiпс
Inactivated
(Freeze-Dried)
S!mmаlY ofProduct
characteristicý
1.
NAME
оF
тнЕ MnDlcINAL
PRODUсT
Proprietaly
Name:
Rabies
vaccine
lnactivated
(Freeze_Dried)
Non-Ploprietary
Name.,
Rabies
Vaccine
lnactivated
(Гrееzе-Driеd)
Rabies
vaccine
lnactivated
(Frееzе
dried)
iS а
stelile,
purified
inactivated
Rabjes
vaccine
pfepaled
оп
чеrо
ce]ls,
Rabies
vaccine
Inactivated iý
freeze
dlied
аtrd
is
ргочidеd
\rith
diluent
(l
dose
of
роwdег
in
visl
and
1
ml
of diluent
in
ampoule).
The vaccine
has the
арреаrапсе
of
а White
dry
cake. The
vaccine сопfогms
to
the
World
Health
organization
(W.H.o.)
rеqчirеmепts.
2.
QUALITЛTIVE
AND
QUANTITATIVE
COMPOSITION
васh
dose
of
l
ml
contains:
3.
PHARMAсEUTIсAL
FORM
LyophiIizcd
vaccine
1о
beIeconstifut9d
With
Diluent-Sterile
water
fоI Injeations
I.P,
D€ýc.ipt;o!]
оftеr
гесоislitчtiоп:'Сlеаг
colorless
solution.
4.
CLINICAL
PARTICULARS
4.1.
?herapeutic
indicationý
Rabies
vaccino
Inactivated
(Fre9ze-Dried)
iý
indicated
fог
the
ргечбпtiоп
of
rabieý in сhildrеп
and
аdцlls,
lt сап
Ье
used
befo.e
оr
аftсrехроsurе,
as а
рrimаrу
immчпizаtiол
оr
as а
boosteгdose.
а)
Рrе-Ехроsцrc
prophylaxis
Рге-ехроsчге
vaccination
should
Ье offered
to
subjects
at hi8h
risk
of
contamination
Ьу
the
ýpecification
Active/
Non-
aGtive
Rеаsоп
fог
iпсlчsiоп
Purified
Rabies
Antigen
(Rabies
чirчs
Pitrran_Moore
stгаiп
З2l8_
vERo
adapted
and
дояtr
оп
vею
cells,
inactivaLed
Ьу
using
В
propiolactone)
Not
less
than 2.5
lU
ln-ho!se
Active
Immunogen
Glycine
40
mg
IP/BP/Ph.Eur
Non-active
StabiIizer
ýucrose
40 mg
ВРДh.ЕчI
Non_active
stabilizer
HsA
10
g
IP/BP/Ph.E
чг/
USP/In-
house
Non-active
stabilizer
Su!пmаlа
ofProduct
с
h
aracteristicý
Rabies
vдссiпе
Inactivated
(Freeze-)ried)
ýеrчm
Institute
of
India
Pvt
Ltd.
rabies
virus.
This
vaccination
is
partioularly
rесоmmепdеd
fог_чеtеri�