Manufacturer
Hikma Farmaceutica (Portugal) S.A.(PORTUGAL)
Registraction Number
MAL22076001ACRZ
Contents:
• Each vial contains 100 mg of remdesivir in lyophilized (freeze-dried) form.
• Excipients include 3 g of betadex sulfobutyl ether sodium, and may contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
• Contains no preservatives.
Indications:
• Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing.
• It is used for both hospitalized and non-hospitalized patients with mild-to-moderate COVID-19 who are at high risk for progression to severe COVID-19.
Instuctions:
• Reconstitution: Reconstitute each vial with 19 mL of Sterile Water for Injection.
• Dilution: Further dilute the reconstituted solution in 100 mL or 250 mL of 0.9% Sodium Chloride Injection prior to intravenous infusion.
• Administration: Administer via intravenous infusion over 30 to 120 minutes.
• Storage: After reconstitution, use immediately. The diluted solution can be stored up to 24 hours at room temperature (20°C to 25°C) or 48 hours at refrigerated temperature (2°C to 8°C).
• Dosage: For adults and pediatric patients (12 years and older, weighing at least 40 kg), the recommended dosage is a single loading dose of 200 mg on Day 1, followed by once-daily maintenance doses of 100 mg from Day 2.
Malaysia
