Dengvaxia
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
04-01-2024
Summary of Product characteristics
(SPC)
04-01-2024
Public Assessment Report
(PAR)
26-01-2022
Active ingredient:
chimeric yellow fever dengue virus serotype 1 (live, attenuated), chimeric yellow fever dengue virus serotype 2 (live, attenuated), chimeric yellow fever dengue virus serotype 3 (live, attenuated), chimeric yellow fever dengue virus serotype 4 (live, attenuated)
Available from:
Sanofi Pasteur
ATC code:
J07BX
INN (International Name):
dengue tetravalent vaccine (live, attenuated)
Therapeutic group:
Vaccines
Therapeutic area:
Dengue
Therapeutic indications:
Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection (see sections 4.2, 4.4 and 4.8).The use of Dengvaxia should be in accordance with official recommendations.
Product summary:
Revision: 5
Authorization status:
Authorised
Authorization date:
2018-12-12
Patient Information leaflet
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
DENGVAXIA, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN
PRE-FILLED SYRINGE
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 is and what it is used for
2.
What you need to know before you or your child use Dengvaxia
3.
How to use Dengvaxia
4.
Possible side effects
5.
How to store Dengvaxia
6.
Contents of the pack and other information
1.
WHAT DENGVAXIA IS AND WHAT IT IS USED FOR
Dengvaxia is a vaccine. It is used to help protect you or your child
against "dengue disease" caused by
dengue virus serotypes 1, 2, 3 and 4. It contains versions of these 4
varieties of the virus that have
been weakened so that they cannot cause the disease.
Dengvaxia is given to adults, young people and children (from 6 to 45
years of age) with prior dengue
virus infection confirmed by a test (also see sections 2 and 3).
Dengvaxia should be used according to official recommendations.
HOW THE VACCINE WORKS
Dengvaxia stimulates the body’s natural defences (immune system), to
produce antibodies that will
help protect against the viruses that cause dengue disease if the body
is exposed to them in the future.
WHAT IS DENGUE AND DENGUE DISEASE?
Dengue is a viral infection which spreads through the bite of an
infected
_Aedes_
mosquito. The virus
from an infected person can spread to other people through mosquito
bites for about 4 to 5 days
(maximum 12 days) after the first symptoms appear. Dengue is not
transmitted direc
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Summary of Product characteristics
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dengvaxia, powder and solvent for suspension for injection in
pre-filled syringe
dengue tetravalent vaccine (live, attenuated)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5 mL) contains:
Chimeric yellow fever dengue virus serotype 1 (live, attenuated)*
........... 4.5 - 6.0 log
10
CCID
50
/dose**
Chimeric yellow fever dengue virus serotype 2 (live, attenuated)*
........... 4.5 - 6.0 log
10
CCID
50
/dose**
Chimeric yellow fever dengue virus serotype 3 (live, attenuated)*
........... 4.5 - 6.0 log
10
CCID
50
/dose**
Chimeric yellow fever dengue virus serotype 4 (live, attenuated)*
........... 4.5 - 6.0 log
10
CCID
50
/dose**
*Produced in Vero cells by recombinant DNA technology. This product
contains genetically modified
organisms (GMOs).
**CCID
50
: 50% Cell Culture Infectious Dose.
Excipients with known effect
One dose (0.5 mL) contains 41 micrograms of phenylalanine and 9.38
milligrams of sorbitol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
White, homogenous, freeze-dried powder with possible retraction at the
base (ring-shaped cake
possible).
The solvent is a clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dengvaxia is indicated for the prevention of dengue disease caused by
dengue virus serotypes 1, 2, 3
and 4 in individuals 6 to 45 years of age with test-confirmed previous
dengue infection (see sections
4.2, 4.4 and 4.8).
The use of Dengvaxia should be in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ _
_Children and adults 6 to 45 years of age _
The vaccination schedule consists of 3 injections of one reconstituted
dose (0.5 mL) to be
administered at 6-month intervals.
_Booster dose _
The added value of and appropriate timing for booster dose(s) have not
been established. Current
available data are included in section 5.1.
3
_Paedia
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