DENGVAXIA(Dengue Tetravalent Vaccine, Live)Suspension for Subcutaneous Injection(二)
ministration with Other Vaccines
7.2 Immunosuppressive Treatments
7.3 Drug/Laboratory Test Interactions
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NON-CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Efficacy
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are
not listed.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
DENGVAXIA® (Dengue Tetravalent Vaccine, Live) is a vaccine indicated for the prevention ofdengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved foruse in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infectionand living in endemic areas.
Limitations of use
DENGVAXIA is not approved for use in individuals not previously infected by any denguevirus serotype or for whom this information is unknown. Those not previously infected areat increased risk for severe dengue disease when vaccinated and subsequently infected withdengue virus. [See Warnings and Precautions (5.1).]
Previous dengue infection can beassessed through a medical record of a previous laboratory-confirmed dengue infection orthrough serological testing prior to vaccination.
The safety and effectiveness of DENGVAXIA have not been established in individualsliving in dengue non-endemic areas who travel to dengue endemic areas.
2 DOSAGE AND ADMINISTRATION
For subcutaneous use only.
2.1 Dose
Three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12).
2.2 Preparation
The package contains a vial of lyophilized vaccine antigen and a vial of saline diluent (0.4%NaCl).
After removing the “flip-off” caps, cleanse the lyophilized vaccine antigen and diluent vialstoppers with a suitable germicide. Do not remove the vial stoppers or metal seals holding themin place.
To reconstitute DENGVAXIA, use a sterile needle and syringe to withdraw 0.6 mL from thediluent vial and inject it into the vial of the lyophilized vaccine antigen. Swirl the vial gently.
Changing needles between withdrawing the vaccine from the vial and injecting it into a recipientis not necessary unless the needle has been damaged or contaminated.
Figure 1
Insert the syringe needle
through the stopper of the
vial of diluent and
withdraw 0.6 mL liquid
content.
Figure 2
Insert the syringe needle
through the stopper of the
vial of lyophilized
vaccine antigen and
inject the liquid into the
vial.
Figure 3
Swirl vial gently. The syringe
needle is not removed while
swirling the vial.
Figure 4
After reconstitution,
withdraw 0.5 mL.
DENGVAXIA should be
used immediately after
reconstitution.
After reconstitution, the suspension is colorless and may develop trace amounts of white totranslucent endogenous proteinaceous particles. [See Description (11).]
Parenteral drug products should be inspected visually for particulate matter and discolorationprior to administration, whenever solution and container permit. Disc |
