Страна: Сингапур
Език: английски
Източник: HSA (Health Sciences Authority)
CYD Dengue Virus Serotype 1; CYD Dengue Virus Serotype 2; CYD Dengue Virus Serotype 3; CYD Dengue Virus Serotype 4
SANOFI-AVENTIS SINGAPORE PTE. LTD.
J07BX
INJECTION, POWDER, FOR SUSPENSION
CYD Dengue Virus Serotype 1 4.5 - 6.0 log10 CCID50/dose; CYD Dengue Virus Serotype 2 4.5 - 6.0 log10 CCID50/dose; CYD Dengue Virus Serotype 3 4.5 - 6.0 log10 CCID50/dose; CYD Dengue Virus Serotype 4 4.5 - 6.0 log10 CCID50/dose
SUBCUTANEOUS
Prescription Only
Sanofi Pasteur (VDR) (Drug Product and Diluent)
ACTIVE
2016-10-11
SANOFI PASTEUR PRODUCT INFORMATION 323 - DENGVAXIA MD 1 NAME OF THE MEDICINAL PRODUCT Dengvaxia MD, powder and solvent for suspension for injection. Dengue tetravalent vaccine (live, attenuated). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, one dose (0.5 mL) contains: CYD dengue virus serotype 1 * .....................................................................4.5 - 6.0 log 10 CCID 50 /dose ** CYD dengue virus serotype 2 * .....................................................................4.5 - 6.0 log 10 CCID 50 /dose ** CYD dengue virus serotype 3 * .....................................................................4.5 - 6.0 log 10 CCID 50 /dose ** CYD dengue virus serotype 4 * .....................................................................4.5 - 6.0 log 10 CCID 50 /dose ** * Produced in serum-free Vero cells by recombinant DNA technology ** CCID 50 : 50% Cell Culture Infectious Dose. No adjuvants and no preservatives are added. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for suspension for injection. 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dengvaxia MD is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 12 through 45 years of age living in endemic areas (see Section 4.2). 4.2 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 intervals. If flexibility in the vaccination schedule is necessary, a time window of +/- 20 days is acceptable (see Section 5.1). PAGE 1 OF 19 SANOFI PASTEUR PRODUCT INFORMATION 323 - DENGVAXIA MD _Paediatric population_ The vaccination schedule and dose are the same for adults and for the paediatric population. Прочетете целия документ