DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER (calcium chloride) · VANTIVE US HLTHCARE
DIANEAL PD-2 with Dextrose is a peritoneal dialysis solution indicated for the management of patients with acute or chronic renal failure. It is administered intraperitoneally to remove metabolic waste products and toxic substances from the body and to assist in the regulation of fluid and electrolyte balance when kidney function is inadequate.
How DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER Works
DIANEAL PD-2 functions through the processes of diffusion and osmosis across the peritoneal membrane. Dextrose in the solution creates an osmotic gradient that draws excess water (ultrafiltrate) from the patient's plasma into the peritoneal cavity. Simultaneously, metabolic waste products (such as urea and creatinine) and electrolytes move along concentration gradients between the capillary blood and the dialysis solution. This allows for the clearance of toxins and the correction of electrolyte imbalances. Sodium, chloride, calcium, and magnesium are included to maintain or normalize plasma levels, while lactate serves as a bicarbonate precursor to correct metabolic acidosis.
Details
- Status
- Prescription
- First Approved
- 1978-09-27
- Routes
- INTRAPERITONEAL
- Dosage Forms
- SOLUTION
Companies
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER Approval History
What DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER Treats
2 indicationsDIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
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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.
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients. Ringer’s Injection is indicated for use as a source of water and electrolytes in adults and pediatric patients.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.