PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER (calcium chloride)
PRISMASOL BGK 2/3.5 is a specialized replacement solution indicated for use in adult and pediatric patients undergoing Continuous Renal Replacement Therapy (CRRT). It is used to replace water and electrolytes (including sodium, potassium, and calcium) and to provide glucose and bicarbonate to maintain fluid, electrolyte, and acid-base balance in patients with acute kidney injury or drug poisoning.
How PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER Works
Prismasol BGK 2/3.5 functions as a replacement fluid during extracorporeal blood treatment. During CRRT, the patient’s blood is filtered, removing water and solutes; Prismasol is infused to replace necessary volume and essential electrolytes. Sodium and chloride maintain osmotic pressure, while potassium and calcium replace ions lost during filtration to support cardiac and neuromuscular function. The bicarbonate in the solution acts as a buffering agent to correct metabolic acidosis, and glucose provides a caloric source and helps maintain blood sugar levels during treatment.
Details
- Status
- Prescription
- First Approved
- 2006-10-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER Approval History
What PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER Treats
2 indicationsPRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Water loss
- Electrolyte imbalance
PRISMASOL BGK 2/3.5 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.
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER is indicated for the treatment of Water loss; Electrolyte imbalance.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.