Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
Calcium Chloride (UNII: M4I0D6VV5M) (Calcium Cation - UNII:2M83C4R6ZB, Chloride Ion - UNII:Q32ZN48698), Magnesium Chloride (UNII: 02F3473H9O) (Magnesium Cation - UNII:T6V3LHY838, Chloride Ion - UNII:Q32ZN48698), Dextrose monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK), Lactic Acid (UNII: 33X04XA5AT) (Lactic Acid - UNII:33X04XA5AT), Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37, Chloride Ion - UNII:Q32ZN48698), Sodium Bicarbonate (UNII: 8MDF5V39QO) (Sodium Cation -
Gambro Renal Products
Calcium Chloride
Calcium Chloride 0.139 g in 1 L
INTRAVENOUS
PRESCRIPTION DRUG
There is no known contraindication to the use of PrismaSol solution. Pregnancy Category C. PrismaSol solution is a replacement solution of electrolytes, bicarbonate and dextrose and is pharmacologically inactive. Animal reproduction studies have not been conducted with PrismaSol solution. While there are no adequate and well controlled studies in pregnant women, appropriate administration of PrismaSol solution with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to cause fetal harm, or affect reproductive capacity. Maintenance of normal acid-base balance is important for fetal well being. PrismaSol solution is a replacement solution of electrolytes, bicarbonate and dextrose and is pharmacologically inactive. The components of PrismaSol solution are excreted in human milk. Appropriate administration of PrismaSol solution with monitoring of fluid, electrolyte, acid-base and glucose balance, is not expected to harm a nursing infant. Safety and effectiveness have been established
PrismaSol solution is supplied in a two compartment bag made of polyolefin. Polyolefin does not contain the chemical component di-2-ethyl hexyl phthalate (DEHP). The 5000 mL bag is composed of a small compartment (250 mL) and a large compartment (4750 mL). The two compartments are separated by a peel seal. The bag is overwrapped with a transparent overwrap. Not all formulations may be marketed. Storage conditions Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature] Do not freeze or expose to excessive heat. Do not use if precipitate has formed or if container seals have been damaged.
New Drug Application
PRISMASOL BGK0/2.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, AND SODIUM BICARBONATE SOLUTION PRISMASOL BGK4/2.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION PRISMASOL BGK2/3.5- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION PRISMASOL BGK2/0- MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION PRISMASOL B22GK4/0- MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION PRISMASOL BK0/0/1.2- MAGNESIUM CHLORIDE, LACTIC ACID, SODIUM CHLORIDE, AND SODIUM BICARBONATE SOLUTION PRISMASOL BGK4/0/1.2- MAGNESIUM CHLORIDE, DEXTROSE MONOHYDRATE, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDE SOLUTION GAMBRO RENAL PRODUCTS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PRISMASOL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRISMASOL SOLUTION. PRISM ASO L SOLUTION, FOR INTRAVENOUS ADMINISTRATION. INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE PrismaSol solution is indicated: (1) As a replacement solution in Continuous Renal Replacement Therapy (CRRT) In case of drug poisoning when CRRT is used DOSAGE AND ADMINISTRATION The mode of therapy, solute formulations, flow rates and length of therapy should be selected by the physician responsible for managing treatment depending on the clinical condition of the patient as well as the patient's fluid, electrolyte, acid base and glucose balance. (2) DOSAGE FORMS AND STRENGTHS 1000 mL of the reconstituted PrismaSol solution contains (in mEq/L except where noted): (3) BGK 0/2.5 BGK 4/2.5 BGK 2/3.5 BGK 2/0 Ca 2.5 2.5 3.5 0 HCO 32 32 32 32 K 0 4.0 2.0 2.0 Mg 1.5 1.5 1.0 1.0 Na 140 140 140 140 Cl 10 Olvassa el a teljes dokumentumot