Patient Medication Information: uses, side effects, how to take - Prismasol 4
ABOUT THIS MEDICATION
What the medication is used for:
PrismaSOL 4
- Is used by your doctor (or healthcare professional) in the treatment of acute kidney disease as solution for hemofiltration or hemodiafiltration (as replacement for fluid lost from the blood passing through a filter) and hemodialysis or hemodiafiltration (the blood flows on one side of a dialysis membrane while a hemodialysis solution flows on the other side of the membrane) in Continuous Renal Replacement Therapy (CRRT).
- Is indicated particularly in patients who are normokalaemic (anormal potassium concentration in your blood.
- May also be used in case of drug poisoning with dialysable or filterable substances.
What it does:
PrismaSOL 4 is a solution for hemofiltration, hemodiafiltration and hemodialysis in Continuous Renal Replacement Therapy. These techniques aim at normalising the composition of the blood.
When it should not be used:
PrismaSOL 4 should not be used in the following cases:
- Hyperkalaemia (a high concentration of potassium in your blood)
- Metabolic alkalosis (a process that primarily raises the plasma bicarbonate concentration)
- Hypersensitivity to PrismaSOL 4
Hemofiltration/ dialysis should not be used in the following cases:
- Kidney failure with pronounced hypercatabolism (abnormally increased destructive breakdown of complex substances in the body), if the uraemic symptoms (symptoms caused by high concentration of urea in your blood) cannot be corrected with hemofiltration,
Insufficient arterial (blood) pressure in the vascular access (catheter area),
- Systemic anticoagulation (reduced clotting of your blood), if there is a high risk of hemorrhage (bleeding).
What the medicinal ingredients are:
Calcium chloride dihydrate, Glucose anhydrous, Lactic acid solution 90% w/w, Magnesium chloride hexahydrate, Potassium chloride, Sodium bicarbonate, Sodium chloride.
What the important nonmedicinal ingredients are:
Carbon dioxide
Water for Injection
What dosage forms it comes in:
Solution for hemofiltration and for hemodialysis.
WARNINGS AND PRECAUTIONS
The solution should be used only by, or under the direction of, a physician competent in renal failure treatments using hemofiltration, hemodiafiltration and hemodialysis.
Before and during treatment, your blood condition will be checked, e.g. your acid-base balance and concentrations of salts in the blood (electrolytes).
Your blood glucose concentration should be closely monitored, especially if you are diabetic.
Solutions containing dextrose should be used with caution in patients with known allergy to corn or corn products.
Tell your doctor if you are pregnant, planning to become pregnant or nursing.
The product will be checked to ensure that all seals are intact and the reconstituted solution is clear and free of precipitate.
INTERACTIONS WITH THIS MEDICATION
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The blood concentration of some of your other medicines may be reduced during the treatment. Your doctor will decide if your medication should be changed.
In particular tell your doctor if you are taking:
- Digitalis. The risk of digitalis (medicine for treatment of certain heart conditions)-induced cardiac arrhythmia (irregular or rapid beating of the heart) is increased during hypokalaemia (low concentration of potassium in your blood).
- Vitamin D and other Vitamin D analogues, as well as medicinal products containing calcium(e.g. calcium chloride or calcium gluconate used for maintenance of calcium homeostasis, in CRRT patients receiving citrate anticoagulation) can increase the risk of hypercalcaemia (a high concentration of calcium in your blood).
- Additional sodium bicarbonate [or buffer source]
IMPORTANT: PLEASE READ
contained in the CRRT fluids or in other fluids administered during therapy may increase the risk of metabolic alkalosis (a process that primarily raises the plasma bicarbonate concentration).
- When citrate is used as an anticoagulant, it contributes to the overall buffer load and can reduce plasma calcium levels.
PROPER USE OF THIS MEDICATION
Usual dose:
PrismaSOL 4 is used as a replacement solution and/or dialysate.
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 PrismaSOL 4 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.
The approximate range of flow rates for the replacement solution in hemofiltration and hemodiafiltration are:
Adults: 500 - 3000 mL/h
Children: 1000 - 4000 mL/h/1.73m2
(including adolescents to 18 years)
The approximate range of flow rates for the dialysate solution in continuous hemodialysis and continuous hemodiafiltration are:
Adults: 500 - 2500 mL/h
Children: 1000 - 4000 mL/h/1.73m2
(including adolescents to 18 years)
Overdose:
Your fluid balance, electrolyte and acid-base balance will be carefully monitored.
Overdose could lead to severe consequences, such as congestive heart failure, electrolyte or acid-base disturbances.
If you have any further questions on the use of this product, please ask your doctor or pharmacist.
Missed Dose:
Not applicable as continuous treatment.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, PrismaSOL 4 can cause side effects, although not everybody gets them.
The following undesirable effects related to the solution are conceivable: Hyper- or hypohydration (abnormally high or low volume of water in your body), electrolyte imbalance (salt in your blood) disturbances, hypophosphataemia (abnormally low concentration of phosphate in your blood), hyperglycaemia (abnormally high concentration of glucose in your blood) and metabolic alkalosis (a process that primarily raises the plasma bicarbonate concentration).
Some undesirable effects related to the dialysis treatments can occur, such as nausea, vomiting, muscle cramps and hypotension (low blood pressure).
Other adverse reactions reported with similar products include hypotension, acid–base balance disorders, electrolyte imbalance, fluid imbalance and increased ionized calcium.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOW TO STORE IT
Keep out of the reach of children.
Store between 4ºC and 30ºC. Do not refrigerate. Protect from freezing.
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 24 hours at 22o C.
The solution may be heated to no more than 37°C to enhance patient comfort. Warming of PrismaSOL 4 prior to use should be done before reconstitution with dry heat only (e.g., 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. After heating, verify that the solution is clear and without particles. Use immediately after mixing, or before the in-use storage directions above have expired, then discards the remaining solution. Storage conditions prior to use are the responsibility of the user.
Do not use after the expired date printed on the label and the packaging.
REPORTING SIDE EFFECTS
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document, plus the full prescribing information, prepared for health professionals can be found at: by contacting the sponsor, Vantive ULC, at: 1-800-387-8399
Vantive and PrismaSOL are trademarks of Vantive Health Inc., or its subsidiaries.