Qdenga Description

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Description

The solvent is a clear, colourless solution.
Prior to reconstitution, the vaccine is a white to off-white coloured freeze-dried powder (compact cake).
After reconstitution, 1 dose (0.5 mL) contains: Dengue virus serotype 1 (live, attenuated)^*: ≥3.3 log10 PFU^**/dose.
Dengue virus serotype 2 (live, attenuated)^#: ≥2.7 log10 PFU^**/dose.
Dengue virus serotype 3 (live, attenuated)^*: ≥4.0 log10 PFU^**/dose.
Dengue virus serotype 4 (live, attenuated)^*: ≥4.5 log10 PFU^**/dose.
^*Produced in Vero cells by recombinant DNA technology. Genes of serotype-specific surface proteins engineered into dengue type 2 backbone. This product contains genetically modified organisms (GMOs).
^#Produced in Vero cells by recombinant DNA technology.
^**PFU = Plaque-forming units.
Excipients/Inactive Ingredients: Powder: α,α-Trehalose dihydrate, Poloxamer 407, Human serum albumin, Potassium dihydrogen phosphate, Disodium hydrogen phosphate, Potassium chloride, Sodium chloride.
Solvent: Sodium chloride, Water for injections.

Manufacturer:

Takeda

Distributor:

Zuellig Pharma