DENGVAXIA

Riik: Indoneesia

keel: indoneesia

Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Toimeaine:

CYD DENGUE VIRUS SEROTYPE 1; CYD DENGUE VIRUS SEROTYPE 2; CYD DENGUE VIRUS SEROTYPE 3; CYD DENGUE VIRUS SEROTYPE 4

Saadav alates:

AVENTIS PHARMA - Indonesia

INN (Rahvusvaheline Nimetus):

CYD DENGUE VIRUS SEROTYPE 1; CYD DENGUE VIRUS SEROTYPE 2; CYD DENGUE VIRUS SEROTYPE 3; CYD DENGUE VIRUS SEROTYPE 4

Annus:

4,5-6,0 LOG 10 CCID50/DOSE

Ravimvorm:

SERBUK INJEKSI

Ühikuid pakis:

VIAL (1 DOSE) + 0,5 ML OF SOLVENT IN A PREFILLED SYRINGE WITH 2 S...

Valmistatud:

SANOFI PASTEUR - France

Loa andmise kuupäev:

2019-02-15

Toote omadused

DENGVAXIA
Dengue tetravalent vaccine (live, attenuated)
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
CYD dengue virus serotype 1
*
.....................................................................
4.8 - 6.0 log
10
CCID
50
/dose
**
CYD dengue virus serotype 2
*
.....................................................................
4.8 - 6.0 log
10
CCID
50
/dose
**
CYD dengue virus serotype 3
*
.....................................................................
4.8 - 6.0 log
10
CCID
50
/dose
**
CYD dengue virus serotype 4
*
.....................................................................
4.8 - 6.0 log
10
CCID
50
/dose
**
*
Produced in serum-free Vero cells by recombinant DNA technology
**
CCID
50
: 50% Cell Culture Infectious Dose.
Excipients with known effect: (see section Special Warnings and
Precautions)
Phenylalanine………………41 micrograms
Sorbitol…………….……….9.38 milligrams
LIST OF EXCIPIENTS:
Powder:
Essential
amino
acids
including
L-Phenylalanine,
Non-essential
amino
acids,
L-Arginine
hydrochloride, Sucrose. D-Trehalose dehydrate, D-Sorbitol. Trometamol,
Urea, Hydrochloric acid and
Sodium hydroxide for pH adjustment
Solvent for reconstitution:
Sodium chloride, Water for injections
No adjuvants and no preservatives are added.
DESCRIPTION
Prior to reconstitution, the vaccine is a white, homogenous,
freeze-dried powder with possible
retraction at the base, and may form a ring-shaped cake.
The solvent is a clear, colorless liquid.
THERAPEUTIC INDICATION
Dengvaxia is indicated for reducing the risk of the event and severity
of dengue disease caused by
dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 16 years
of age living in endemic areas
who have previously been infected with dengue virus (seropositive).
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Primary vaccination _
The primary vaccination schedule consists of 3 injections of one
reconstituted dose (0.5 mL) to be
administered at 6-month interv