Dengvaxia MD Powder for Suspension for Injection SC

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Dengue Tetravalent Vaccine (Live, Attenuated) (see formulation on reverse side)

Available from:

Zuellig Pharma Corporation

INN (International Name):

Dengue Tetravalent Vaccine (Live, Attenuated) (see formulation on reverse side)

Pharmaceutical form:

Powder for Suspension for Injection SC

Units in package:

Type I glass vial x 4mL + 2.5mL of 0.9% Sodium Chloride solvent in a vial (box of 5's and 10's)

Manufactured by:

Sanofi Pasteur

Authorization date:

2020-12-22

Patient Information leaflet

SANOFI PASTEUR
PRODUCT INFORMATION, V1.0
323 - DENGVAXIA MD
CONFIDENTIAL/PROPRIETARY INFORMATION
PAGE 25 / 30
PACKAGE LEAFLET: INFORMATION FOR THE USER
DENGVAXIA MD, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Dengue tetravalent vaccine (live, attenuated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If you or your child get any side effects, talk to your doctor,
pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1.
What Dengvaxia MD is and what it is used for
2.
What you need to know before Dengvaxia MD is given to you or your
child
3.
How to use Dengvaxia MD
4.
Possible side effects
5.
How to store Dengvaxia MD
6.
Contents of the pack and other information
1
WHAT DENGVAXIA MD IS AND WHAT IT IS USED FOR
Dengvaxia MD is a vaccine used to help protect you or your child
against dengue disease caused by
dengue virus serotypes 1, 2, 3 and 4. Dengvaxia MD is given to adults,
adolescents and children 9
through 45 years of age living in endemic areas.
Dengvaxia MD contains dengue virus serotypes 1, 2, 3 and 4 that have
been weakened. Dengvaxia
MD works by stimulating the body’s natural defenses (immune system),
which produces its own
protection (antibodies) against the viruses that cause dengue disease.
Dengue is a viral infection transmitted to humans through the bite of
an infected _Aedes_ mosquito.
Dengue is not transmitted directly from person-to-person. Nevertheless
the virus which replicates in an
infected individual can be transmitted to other humans through
mosquito bites for 4–5 days (maximum
12 days) after the first symptoms appear.
Dengue disease results in a wide range of symptoms including fever,
headache, pain behind the eyes,
m

Summary of Product characteristics

SANOFI PASTEUR
PRODUCT INFORMATION, V1.0
323 - DENGVAXIA MD
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
MULTIDOSE PRESENTATION
SANOFI PASTEUR
PRODUCT INFORMATION, V1.0
323 - DENGVAXIA MD
CONFIDENTIAL/PROPRIETARY INFORMATION
PAGE 2 OF 30
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 (0.9% sodium chloride solution) 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 9 through 45 years of age living in endemic
areas.
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 (se