PRISMASOL Renal replacement solution (2022)
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1. Indications and Usage
PRISMASOL and PHOXILLUM solutions are indicated in pediatric and adult patients for use as a replacement solution in Continuous Renal Replacement Therapy (CRRT) to replace plasma volume removed by ultrafiltration ...
2. Dosage and Administration
2.1 Administration Instructions Visually inspect PRISMASOL and PHOXILLUM for particulate matter and discoloration prior to administration. Administration should only be under the direction of a physician ...
3. Dosage Forms and Strengths
See Table 1 for the concentrations of the active ingredients (after mixing) in these 9 different replacement solutions [see Dosage and Administration (2.2)].
4. Contraindications
PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known hypersensitivities to these products.
5. Warnings and Precautions
5.1 Electrolyte and Volume Abnormalities PHOXILLUM and PRISMASOL solutions can affect electrolytes and volume and may result in hyperkalemia or hyperphosphatemia. Monitor hemodynamic status and fluid inputs ...
6. Adverse Reactions
The following adverse reactions have been identified during post approval use with these or other similar products and therefore may occur with use of PHOXILLUM or PRISMASOL. Because these reactions are ...
7. Drug Interactions
As with the use of other replacement solutions, blood concentrations of dialyzable drugs may be reduced by CRRT due to their removal by the hemofilter or hemodiafilter. The blood concentrations of certain ...
8.1. Pregnancy
Risk Summary PRISMASOL and PHOXILLUM are pharmacologically inactive solutions. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PRISMASOL and PHOXILLUM ...
8.2. Lactation
Risk Summary The components of PRISMASOL and PHOXILLUM solutions are excreted in human milk. Appropriate administration of PRISMASOL and PHOXILLUM solutions with monitoring of fluid, electrolyte, acid-base ...
8.4. Pediatric Use
Safety and effectiveness have been established based on published clinical data of CRRT replacement solutions with compositions similar to PRISMASOL and PHOXILLUM used in adults and two hemofiltration ...
8.5. Geriatric Use
The experience with PRISMASOL and PHOXILLUM solutions in geriatric patients has not identified novel concerns.
11. Description
PRISMASOL and PHOXILLUM solutions are clear, sterile, free of bacterial endotoxins and contain no bacteriostatic or antimicrobial agents. These solutions are used in Continuous Renal Replacement Therapies ...
12.1. Mechanism of Action
PRISMASOL and PHOXILLUM solutions are pharmacologically inactive. The electrolyte concentrations in the solutions are chosen to restore plasma levels to clinically desired concentrations or maintain plasma ...
12.3. Pharmacokinetics
The distribution of electrolytes, bicarbonate, and dextrose is determined by the patients clinical condition, metabolic status, and residual renal function. The elimination and replacement of water, electrolytes ...
16.1. How Supplied
PRISMASOL and PHOXILLUM solutions are supplied in a two-compartment bag made of polyolefin. The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze or expose to excessive heat. Do not use if precipitate has ...