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VIAL ( Powder for concentrate for solution for infusion)
Day 1: 200 mg. day 2-5: 100 mg.
Treatment of COVID-19 in adults and in adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)
Hypersensitivity to the active substance or to any of the excipients
Hypersensitivity reactions including infusion-related and anaphylactic reactions have been observed during and following administration. Monitor patients for hypersensitivity reactions during and following administration. Transaminase elevations have been observed in patients.
Liver function should be determined in all patients prior to starting remdesivir and should be monitored while receiving it as clinically appropriate.
All patients should have eGFR determined prior to starting remdesivir and while receiving it as clinically appropriate. Remdesivir should not be used in patients with eGFR < 30 mL/min.
See prescribing information for full details.
Rash, headache, nausea, transaminases increase, prolonged prothrombin time. See prescribing information for full details.
Concomitant use of remdesivir with chloroquine phosphate or hydroxychloroquine sulphate is not recommended. See prescribing information for full details.
Pregnancy and Lactation
Pregnancy: There are no or limited amount of data from the use of remdesivir in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Remdesivir should not be used during pregnancy unless the clinical condition of the women requires treatment with it. Women of child-bearing potential have to use effective contraception during treatment.
Lactation: It is unknown whether remdesivir is excreted in human milk or the effects on the breast-fed infant, or the effects on milk production.
General supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with remdesivir.
The expiry date of the product is indicated on the packaging materials.
Reconstituted and diluted solution for infusion:
After reconstitution dilute immediately.
Store diluted remdesivir solution for infusion up to 4 hours at room temperature (20°C to 25°C) or 24 hours in a refrigerator (2°C – 8°C). Dilute within the same day as administration.
Special precautions for disposal and other handling
Prepare solution for infusion under aseptic conditions and on the same day as administration. Remdesivir should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. Should either be observed, the solution should be discarded and fresh solution prepared.
Remdesivir must be reconstituted with 19 mL sterile water for injections and diluted in sodium chloride 9 mg/mL (0.9%) solution for injection before being administered via intravenous infusion over 30 to 120 minutes.
Preparation of remdesivir solution for infusion.
Remove the required number of single-use vial(s) from storage. For each vial:
Aseptically reconstitute remdesivir powder for concentrate for solution for infusion by addition of 19 mL of sterile water for injections using a suitably sized syringe and needle per vial.
Discard the vial if a vacuum does not pull the sterile water for injections into the vial.
Only use sterile water for injection to reconstitute remdesivir powder.
Immediately shake the vial for 30 seconds.
Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
If the contents of the vial are not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
Inspect the vial to ensure the container closure is free from defects and the solution is free of particulate matter.
Dilute immediately after reconstitution.
Care should be taken to prevent inadvertent microbial contamination. As there is no preservative or bacteriostatic agent present in this product, aseptic technique must be used in preparation of the final parenteral solution. It is always recommended to administer IV medicines immediately after preparation when possible.
For : Recommended dilution instructions – Reconstituted remdesivir powder for concentrate for solution for infusion: See prescribing information for full details.