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PRISMASOL is a brand name for Calcium Chloride, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations The rate at which PrismaSOL 4 is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of replacement solution and/or dialysate to be administered will depend on desired intensity (dose) of the treatment.
The solution should be prescribed and administration (dose, infusion rate and cumulative volume) should be established only by a physician experienced in critical care medicine and CRRT. 2 mmol/L may be added to PrismaSOL 4. Use sodium phosphate if adding phosphate to the bag.
73 m2 Commonly used flow rates in adults are approximately 2000 to 2500 mL/h which correspond to a daily fluid volume of approximately 48 to 60 L. PrismaSOL 4 has an osmolarity of 301 mOsmol/L. Missed Dose Not relevant, since PrismaSOL 4 is administered continuously.
Administration Intravenous use for hemofiltration (and part of hemodiafiltration) and dialysis transmembrane use for hemodialysis. PrismaSOL 4 is used as a replacement solution and/or dialysate. PrismaSOL 4when used as replacement solution, is administered into the extra-corporeal circuit before (pre-dilution) or after (post-dilution) the hemofilter or hemodiafilter Use only with appropriate extracorporeal renal replacement equipment.
6 °F) to enhance patient comfort. , heating pad, warming plate). Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort. PrismaSOL 4 Page 9 of 22 PrismaSOL 4 should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Do not administer unless the solution is clear and the seal is intact.
Reconstitution:
The solution in the small compartment A is added to the solution in the large compartment B after breaking the frangible pin or peel seal immediately before use to obtain the clear reconstituted solution with a slightly yellow color (see SPECIAL HANDLING INSTRUCTIONS.
OVERDOSAGE Overdose with PrismaSOL 4 should not occur if the procedure is carried out correctly and the fluid balance, electrolyte and acid-base balance of the patient are carefully monitored. However, overdose can result in fluid overload in patients with renal failure.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Calcium Chloride in Canada.
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) may occur in the event of an overdose. Stop administration promptly. There is no specific antidote for overdose. The risk can be minimized by close monitoring during treatment. Overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acid- base disturbances.
For management of suspected overdose, please contact the regional poison centre. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action PrismaSOL 4 is pharmacologically inactive. The sodium, potassium, calcium, magnesium, chloride ions and glucose are present at concentrations similar to physiological levels in plasma.
The solution is used to replace water and electrolytes removed during hemofiltration and hemodiafiltration or to serve as a suitable exchange medium for use during hemodiafiltration or hemodialysis in CRRT. Bicarbonate is used as an alkalising buffer.
Glucose is intended to help normalise glucose balance. Pharmacodynamics No factor affects the pharmacodynamic response. Pharmacokinetics Not relevant, since the drug substances are pharmacologically inactive and are present at concentrations similar to physiological plasma levels.
PrismaSOL 4 Page 10 of 22 Special Populations and Conditions Not relevant, since the pharmacokinetics are not modified with specific population and conditions. STORAGE AND STABILITY Store between 4°C and 30°C. Do not refrigerate. Protect from freezing.
Chemical and physical in-use stability of the reconstituted solutions has been demonstrated for 24 hours at 22o C. If not used immediately in-use storage times and conditions prior to use are the responsibility of the user and should not normally be longer than 24 hours including the duration of the treatment.
Do not use if container is damaged or if solution is not clear. PrismaSOL 4 Page 11 of 22 SPECIAL HANDLING INSTRUCTIONS Aseptic technique should be used throughout the handling and administration to the patient: Use only if the overwrap is not damaged, all seals are intact, frangible pin or peel seal is not broken, and the solution is clear.
Press bag firmly to test for any leakage. If leakage is discovered, discard the solution immediately since sterility can no longer be assured. Do not remove unit from over wrap until ready for use. The reconstituted solution should be used immediately (not to exceed 24 hours).
The reconstituted solution is for single use only. Discard any unused portion. If a frangible pin separates the two compartments of the bag the following instructions for use should be followed: I Remove the over wrap from the bag and the sheet between the folded compartments immediately before use.
Open the seal by breaking the frangible pin between the two compartments of the bag. The frangible pin will remain in the bag. II Make sure all the fluid from the small compartment A is transferred into the large compartment B. III Rinse the small compartment A twice by pressing the […]