DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER (calcium chloride)
DELFLEX is a peritoneal dialysis solution indicated for patients with chronic renal failure. It is used to remove toxic substances, metabolic waste products, and excess body water that the kidneys can no longer filter. This solution is administered into the peritoneal cavity to help maintain electrolyte and fluid balance in patients undergoing CAPD (Continuous Ambulatory Peritoneal Dialysis) or CCPD (Continuous Cycling Peritoneal Dialysis).
How DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER Works
DELFLEX works through the processes of diffusion and osmosis across the peritoneal membrane. The high concentration of Dextrose creates an osmotic gradient that draws excess water (ultrafiltration) from the patient's plasma into the peritoneal cavity. Simultaneously, metabolic waste products and toxins move from the blood into the dialysis solution via diffusion. The specific concentrations of electrolytes (sodium, chloride, magnesium, and calcium) help normalize the patient's serum electrolyte levels, while the absence of potassium allows for the removal of excess potassium from the body.
Details
- Status
- Prescription
- First Approved
- 1992-08-19
- Routes
- INTRAPERITONEAL
- Dosage Forms
- SOLUTION
Companies
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER Approval History
What DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER Treats
2 indicationsDELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Water deficiency
- Electrolyte deficiency
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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 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER is indicated for the treatment of Water deficiency; Electrolyte deficiency.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.