DENGVAXIA MD POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CYD Dengue Virus Serotype 1; CYD Dengue Virus Serotype 2; CYD Dengue Virus Serotype 3; CYD Dengue Virus Serotype 4

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

J07BX

Pharmaceutical form:

INJECTION, POWDER, FOR SUSPENSION

Composition:

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

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Sanofi Pasteur (VDR) (Drug Product and Diluent)

Authorization status:

ACTIVE

Authorization date:

2016-10-11

Summary of Product characteristics

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.