Euvichol-Plus Suspension Oral Cholera Vaccine

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

V.CHOLERAE INABA 48 CLASSICAL BIOTYPE,; V.CHOLERAE INABA 6973 EL TOR BIOTYPE,; V.CHOLERAE OGAWA 50 CLASSICAL BIOTYPE,; V.CHOLERAE OGAWA 50 CLASSICAL BIOTYPE,; Vibrio Cholerae 0139, Strain 4260 B, Inactivated

متاح من:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (الاسم الدولي):

V.CHOLERAE INABA 48 CLASSICAL BIOTYPE,; V.CHOLERAE INABA 6973 EL TOR BIOTYPE,; V.CHOLERAE OGAWA 50 CLASSICAL BIOTYPE,; V.CHOLERAE OGAWA 50 CLASSICAL BIOTYPE,; Vibrio Cholerae 0139, Strain 4260 B, Inactivated

الوحدات في الحزمة:

50 Units; 5 Units; 10 Units

المصنعة من قبل:

Eubiologics Co., Ltd

نشرة المعلومات

Not applicable

خصائص المنتج

Euvichol-Plus Suspension Oral Cholera Vaccine
Vibrio cholerae O1 Inaba Cairo 48 (H eat inactivated)
Vibrio cholerae O1 Inaba Phil 6973 El Tor(Formalin inactivated)
Vibrio cholerae O1 Ogawa Cairo 50 (Formalin inactivated)
Vibrio cholerae O1 Ogawa Cairo 50 (Heat inactivated)
Vibrio cholerae O139 4260B (Formalin inactivated)
P
roduct Name
Euvichol-Plus Suspension Oral Cholera Vaccine
P
roduct Description
A plastic tube filled with a yellow to yellowish suspension consists of inactivated V. cholerae Composit
ion
One dose (1.5 mL) contains:
Active ingredients:
V. cholerae O 1 Inaba Cairo 48 classical biotype, Heat inactivated…………..300 L.E.U
V. cholerae O 1 Inaba Phil 6973 El Tor biotype , Formalin inactivated …… …600
L.E.U
V. cholerae O1 O gawa Cairo 50 classical biotype, Formali n inactivated……300
L.E.U
V. cholerae
O1 O gawa Cairo 50 cl assical biotype, Heat inactivated………...300 L.E.U
V. cholerae O139 4260B, Formalin inactivated …………………………\
…..600 L.E.U
I
ndication
Euvichol- plus is indicated for active immuniz ation against Vibrio cholerae but the efficacy
against Vibrio cholerae serogroup O139 was not demonstrated.
The vaccine can be administered to anyone above the age of 1 year. Data for the safety and
efficacy of the vaccine in infants (less than 1 year of age) is not available. The earliest onset of
protection can be expected 7 -10 days after the completion of the primary series of the vaccine.
R
ecommended Dosage
Two doses of vaccines should be given at an interval of two weeks.
R
oute of Administration
Th e vaccine is only recommended for oral administration.
C
ontraindications - The vaccine should not be administered to persons with either known hypersensitivity to
any component of the vaccine, or having shown signs of severe reaction due to the
previously t aken dose.