Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CYD DENGUE VIRUS SEROTYPE 1; CYD DENGUE VIRUS SEROTYPE 2; CYD DENGUE VIRUS SEROTYPE 3; CYD DENGUE VIRUS SEROTYPE 4
AVENTIS PHARMA - Indonesia
CYD DENGUE VIRUS SEROTYPE 1; CYD DENGUE VIRUS SEROTYPE 2; CYD DENGUE VIRUS SEROTYPE 3; CYD DENGUE VIRUS SEROTYPE 4
4,5-6,0 LOG 10 CCID50/DOSE
SERBUK INJEKSI
VIAL (1 DOSE) + 0,5 ML OF SOLVENT IN A PREFILLED SYRINGE WITH 2 S...
SANOFI PASTEUR - France
2019-02-15
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 Preberite celoten dokument