Remdesivir INN

Composition : Each vial contains Remdesivir INN 100mg as lyophilized powder.

Indication : Emergency use Authorization (EUA) of Remdesivir is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. Remdesivir should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

Dosage and administration : General Information: • Adult and pediatric patients (>28 days old) must have an eGFR determined and full-term neonates (>7 days to <_28 days old) must have serum creatinine determined before dosing of Remdesivir. • Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and while receiving Remdesivir.

• Remdesivir should be administered via intravenous (IV) infusion only. Do not administer as an intramuscular (IM) injection. For Detail Please see PDF File.

Use in pregnancy and lactation : There is no adequate and well-controlled studies in pregnant women. Remdesivir should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for viral transmission to SARS-CoV-2-negative infants and adverse reactions from the drug in breastfeeding infants, the developmental and health benefits of

breast feeding should be considered along with the mother’s clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.

Packing: Each combipack contains one vial of lyophilized powder of Remdesivir INN 100 mg and two ampoules of 10ml water for injection BP.

Prescribing Description

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