Regiocit
Generic name: sodium chloride, sodium citrate
Dosage form: injection, solution
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Emergency Use Authorization (EUA) for Regiocit (Sodium Chloride and Sodium Citrate Renal Replacement and Regional Anticoagulant Solution)
FACT SHEET FOR HEALTHCARE PROVIDERS
Regiocit
(Sodium Chloride and Sodium Citrate Renal Replacement and Regional Anticoagulant solution) For continuous renal replacement therapy
For extracorporeal use only
Emergency Use Authorization for the United States
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Regiocit: a replacement solution that contains citrate for Regional Citrate Anticoagulation (RCA) of the extracorporeal circuit. Regiocit has been authorized for emergency use as a replacement solution in adult patients treated with Continuous Renal Replacement Therapy (CRRT), and for whom RCA is appropriate, during the COVID-19 pandemic. Regiocit is intended for use in a critical care setting. Regiocit is intended to be used in continuous venovenous hemofiltration (CVVH) and continuous venovenous hemodiafiltration (CVVHDF) modalities. Use of Regiocit is limited to healthcare providers and/or institutions that Baxter has qualified to administer Regiocit for these emergency uses.
Regiocit has been authorized by FDA for emergency use. Regiocit is not FDA-approved.
Regiocit is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of Regiocit under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
The scope of the EUA is as follows:
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- Regiocit will be used as a replacement solution only in adult patients being treated with CRRT and for whom RCA is appropriate.
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- Regiocit will be administered only by a licensed healthcare provider in a critical care setting.
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- Regiocit will available for use only in facilities that Baxter Healthcare Corporation has qualified and provided appropriate training on the use of Regiocit.
Product Description
Regiocit is a sterile, replacement solution intended for use in adult patients being treated with CRRT and for whom RCA is appropriate. Regiocit, contains physiological concentrations of sodium (140 mmol/l), chloride (86 mmol/l), and a low concentration of citrate (18 mmol/L).
