DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER (dextrose)
This solution is used as an anticoagulant during the preparation of Platelet Rich Plasma (PRP) products. It is specifically designed for use with medical devices that process blood outside the body. Healthcare providers use it to prevent blood from clotting while it is being handled by these specialized preparation systems.
How DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Works
The solution works by binding to free calcium within the blood, which is a necessary component for the natural clotting process. By removing available calcium, the solution effectively halts the clotting cascade during extracorporeal processing. It also contains citric acid to regulate pH and dextrose to maintain the solution's isotonicity.
Details
- Status
- Prescription
- First Approved
- 1988-02-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Approval History
What DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Treats
2 indicationsDEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Extracorporeal anticoagulation
- Platelet Rich Plasma (PRP) preparation
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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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
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07494084 | R01HL177106 R01HL177106 | Ph 4 | not yet recruiting | Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance |
| NCT04895358 | 3475-B49 MK-3475-B49, KEYNOTE-B49 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) |
| NCT05264727 | 22-000306 R01DK116231 | Ph 4 | active not recruiting | Glucagon Suppression by Hyperglycemia in the Presence and Absence of Amino Acid Infusion |
| NCT04020601 | Pro00092897 | Ph 2, Ph 3 | terminated | The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty |
| NCT02471690 | MDCO-ORI-15-01 | Ph 1 | completed | Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers |
| NCT03095651 results posted | 5160-002 MK-5160-002 | Ph 1 | completed | Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002) |
| NCT02269735 | 2640-001 | Ph 1 | completed | A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) |
| NCT00578669 results posted | PHI0710-002 1R01DA023190 | Ph 3 | completed | Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms |
| NCT01547364 | SweetCaudal | Ph 2 | completed | Caudal Epidural Injection of Dextrose For Low Back Pain |
| NCT02984098 40%D-N-PP | POSDRU/159.5/S/133377 | Ph 4 | completed | 40% Orally Administered Dextrose Gel is More Effective Than 25% Dextrose |
| NCT02185729 TPN1 results posted | IRB00007543 | Ph 2, Ph 3 | completed | Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers |
| NCT00878878 results posted | GE-191-004 | Ph 4 | completed | Evaluate Effect of Optison on Pulmonary Artery Systolic Pressure (PASP) and Pulmonary Vascular Resistance (PVR). |
| NCT01326611 | rö05053781128 | Ph 4 | completed | Efficacy of Clarithromycin Treatment in Prevention of Chronic Lung Disease in Premature Infants |
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.
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER is indicated for the treatment of Extracorporeal anticoagulation; Platelet Rich Plasma (PRP) preparation.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.