Arexvy 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

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Full Prescribing Info

Description

Powder and suspension for suspension for injection.
The powder is white.
The suspension is an opalescent, colourless to pale brownish liquid.
After reconstitution, one dose (0.5 mL) contains: RSVPreF3¹ antigen^2,3 120 micrograms.
¹Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation = RSVPreF3.
²RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology ³adjuvanted with AS01E containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 25 micrograms.
3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 25 micrograms.
Excipients/Inactive Ingredients: Powder (RSVPreF3 antigen): Trehalose dihydrate, Polysorbate 80 (E 433), Potassium dihydrogen phosphate (E 340), Dipotassium phosphate (E 340).
Suspension (AS01E Adjuvant System): Dioleoyl phosphatidylcholine (E 322), Cholesterol, Sodium chloride, Anhydrous disodium phosphate (E 339), Potassium dihydrogen phosphate (E 340), Water for injections.

respiratory syncytial virus vaccine

Manufacturer:

GlaxoSmithKline Biologicals

Distributor:

GlaxoSmithKline