Dengvaxia Description

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Full Prescribing Info

Description

After reconstitution, one dose (0.5 mL) contains: CYD dengue virus serotype 1^* 4.8 - 6.0 log₁₀ CCID₅₀/dose^**; CYD dengue virus serotype 2^* 4.8 - 6.0 log₁₀ CCID₅₀/dose^**; CYD dengue virus serotype 3^* 4.8 - 6.0 log₁₀ CCID₅₀/dose^**; CYD dengue virus serotype 4^* 4.8 - 6.0 log₁₀ CCID₅₀/dose^**.
^* Produced in serum-free Vero cells by recombinant DNA technology.
^** CCID₅₀: 50% Cell Culture Infectious Dose.
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.
Excipients with known effect: (see Precautions) Phenylalanine 41 micrograms; Sorbitol 9.38 milligrams.
Excipients/Inactive Ingredients: Powder: Essential amino acids including L-Phenylalanine, Non-essential amino acids, L-Arginine hydrochloride, Sucrose, D-Trehalose dehydrate, D-Sorbitol, Trometamol, Urea, Hydrochloric acid and Sodium hydroxide for pH adjustment.
Solvent for reconstitution: Sodium chloride, Water for injections.
No adjuvants and no preservatives are added.

Manufacturer:

Kalventis Sinergi Farma