DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER (calcium chloride)
DELFLEX is a peritoneal dialysis solution indicated for the management of patients with acute or chronic renal failure. It is used to remove toxic substances, metabolic waste products, and excess body water while helping to maintain or restore electrolyte and acid-base balance.
How DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER Works
This solution functions through the processes of diffusion and osmosis across the peritoneal membrane. Dextrose creates an osmotic gradient that facilitates the removal of excess fluid (ultrafiltration) from the plasma into the peritoneal cavity. Simultaneously, electrolytes and metabolic waste products (such as urea and creatinine) move along concentration gradients from the blood into the dialysis solution to be drained from the body. Sodium, calcium, and magnesium help regulate systemic electrolyte levels, while lactate serves as a bicarbonate precursor to correct metabolic acidosis.
Details
- Status
- Prescription
- First Approved
- 1984-11-30
- Routes
- INTRAPERITONEAL
- Dosage Forms
- SOLUTION
Companies
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER Approval History
What DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER Treats
2 indicationsDELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Electrolyte deficiency
- Dehydration
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07550413 | 20042026 | Ph 2 | not yet recruiting | Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section |
| NCT03772990 ICARUS | 21/2019 | Ph 4 | completed | Calcium Administration in Cardiac Surgery |
| NCT05027048 CALBLOC results posted | 62206 MRTG-02-15-2022-Ansari, YIG-2020 | Ph 3 | completed | Calcium Chloride for Prevention of Blood Loss During Intrapartum Cesarean Delivery |
| NCT04153435 COCA results posted | 00002 2019-003387-46 | Ph 2 | completed | Calcium for Out-of-Hospital Cardiac Arrest |
| NCT03867383 results posted | 43076 | Ph 1, Ph 2 | completed | Calcium Chloride for Prevention of Uterine Atony During Cesarean |
| NCT01941914 | AA1310 | Ph 1 | completed | Calcium Electroporation for the Treatment of Keloids |
| NCT00955266 results posted | 2009-P-000052 | Ph 4 | terminated | A Trial of Intravenous Calcium and Myocardial Diastolic Dysfunction During Separation From Cardiopulmonary Bypass |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER is indicated for the treatment of Electrolyte deficiency; Dehydration.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.