Details for: PRISM0CAL
Company: BAXTER CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02274876 | PRISM0CAL | MAGNESIUM CHLORIDE; SODIUM CHLORIDE; LACTIC ACID; SODIUM BICARBONATE | 0.108 G / 1000 ML; 6.449 G / 1000 ML; 0.284 G / 1000 ML; 58.8 G / 1000 ML | SOLUTION | DIALYSIS |
| 02274876 | PRISM0CAL | MAGNESIUM CHLORIDE; SODIUM CHLORIDE; LACTIC ACID; SODIUM BICARBONATE | 0.108 G / 1000 ML; 6.449 G / 1000 ML; 0.284 G / 1000 ML; 58.8 G / 1000 ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Prism0CAL is used in adults:
- in the treatment of acute kidney disease
- as replacement solution for fluid lost from the blood during hemofiltration or hemodiafiltration
- as a dialysis solution in hemodialysis or hemodiafiltration in Continuous Renal Replacement Therapy (CRRT).
- for patients suffering from high potassium and/or calcium level in your blood (hyperkalaemic and/or hypercalcaemic).
- in case of drug poisoning with substances that can be removed by dialysis or hemofiltration
What it does
Prism0CAL is a solution used to replace water and electrolytes removed during hemofiltration, hemodiafiltration and hemodialysis in Continuous Renal Replacement Therapy.
When it should not be used
Prism0CAL should not be used in the following cases:
- Hypokalaemia (a low concentration of potassium in your blood)
- Hypocalcaemia (a low concentration of calcium in your blood)
- Metabolic alkalosis (a process that primarily raises the plasma bicarbonate concentration)
- Hypersensitivity to Prism0CAL
- Kidney failure with pronounced hypercatabolism (abnormally increased destructive breakdown of complex substances on 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 (cathether area),
- Systemic anticoagulation (reduced clotting of your blood), if there is a high risk of hemorrhage (bleeding).
What the medicinal ingredient is
Lactic acid solution 90% w/w, Magnesium chloride hexahydrate, Sodium bicarbonate, Sodium chloride.
What the non-medicinal ingredients are
Carbon dioxide
Water for Injections
What dosage form it comes in
Solution for hemodialysis, hemofiltration and hemodiafiltration
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) and sugar levels (glucose)
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.
There is no adequate data for the use of Prism0CAL in patients
less than 16 years of age or over the age of 65
Interactions with this medication
As with most medicines, interactions with other drugs are
possible. Tell your doctor, nurse, or pharmacist about all the
medicines you take, including drugs prescribed by other doctors,
vitamins, minerals, natural supplements, or alternative medicines.
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).
- Additional sodium bicarbonate [or buffer source] 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
Prism0CAL is used as a replacement solution and/or dialysate. The rate at which Prism0CAL is administered depends on the blood concentration of electrolytes, acid-base balance, fluid balance and overall clinical condition of the patient. The volume of Prism0CAL replacement solution and/or dialysate to be administered will also 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.
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.
Continuation of CRRT allows for removal of excess fluid and
correction of electrolyte abnormalities.
Reconstitution:
Prism0CAL will be checked before use to ensure that all seals are
intact and the reconstituted solution is clear, colourless and free of
precipitate
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 reconstituted solution.
INSTRUCTION FOR USE:
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 is for single use only and should be used
immediately (not to exceed 24 hours). Discard any unused
portion.
If a frangible pin separates the two compartments of the bag the
following instructions for use should be followed:
- Remove the over wrap from the bag and the sheet between the folded compartments immediately before use and discard any other packaging materials. Open the seal by breaking the frangible pin between the two compartments of the bag. The frangible pin will remain in the bag
- Make sure all the fluid from the small compartment A is transferred into the large compartment B.
- Rinse the small compartment A twice by pressing the mixed solution back into the small compartment A and then back into the large compartment B.
- When the small compartment A is empty: shake the large compartment B so that contents mix completely. The solution is now ready for use and can be hung on the equipment. The bag should hang in all three hanging holes when used. The dialysis or replacement line may be connected to the luer access or the injection port.
-
- If the luer access is used, using aseptic technique, remove the cap with a twist and pull motion and connect the male luer lock on the dialysis or replacement line to the female luer receptor on the bag: tighten using a push and twist motion. Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the fluid is flowing freely. (See figure V.a below). When the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop. The luer port is a needle-less and swabbable port.
- If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely. (See figure V.b below)
If a peel seal separates the two compartments of the bag the following instructions for use should be followed:
- Remove the overwrap from the bag immediately before use and discard any other packaging materials. Open the seal by holding the small compartment with both hands and squeeze it until an opening is created in the peel seal between the two compartments. (See figure I below)
- Push with both hands on the large compartment until the peel seal between the two compartments is entirely open. (See figure II below)
- Secure complete mixing of the solution by shaking the bag gently. The solution is now ready for use, and can be hung on the equipment. (See figure III below)
- The dialysis or replacement line may be connected to the luer access or the injection port.
-
- If the luer access is used, using aseptic technique, remove the cap with a twist and pull motion and connect the male luer lock on the dialysis or replacement line to the female luer receptor on the bag using a push and twist motion. Ensure that the connection is fully seated and tighten. The connector is now open. Verify that the the fluid is flowing freely. (See figure IV.a below). When the dialysis or replacement line is disconnected from the luer connector, the connector will close and the flow of the solution will stop. The luer port is a needle-less and swabbable port.
- If the injection port is used, first remove the snap-off cap. Then introduce the spike through the rubber septum. Verify that the fluid is flowing freely. (See figure IV.b below)
Side effects and what to do about them
Side effects may include:
- nausea, vomiting
- muscle cramps
- hypotension
- acid–base balance disorders
- fluid imbalance
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Seek immediate medical help |
|---|---|---|---|
| Low Blood Pressure:
dizziness, fainting,
lightheadedness May occur when you go from lying or sitting to standing up. |
✔ | ||
| Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat | ✔ | ||
| Abnormally high volume of water in your body: swelling in the hands, ankles, feet or stomach, shortness of breath especially when lying down, fast heartbeat | ✔ | ||
| Abnormally low volume of water in your body: dry mouth, cold, clammy and pale skin, rapid breathing and heartbeat, weakness, decreased or absent urine output, sweating, confusion, unconsciousness | ✔ | ||
| Low levels of phosphate in your blood: muscle cramps, numbness and tingling around the mouth, shortness of breath, nausea, vomiting, trouble sleeping | ✔ | ||
| Metabolic alkalosis: rapid breathing and heartbeat, headache, confusion, weakness, nausea, vomiting | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking Prism0CAL, contact your doctor, nurse, or pharmacist.
How to store
Keep out of the reach and sight 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 Prism0CAL 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.
Do not use after the expired date printed on the label and the
packaging.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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 by contacting the sponsor,
Baxter Corporation, at: 1-800-387-8399
This leaflet was prepared by Baxter Corporation
Baxter and Prism0CAL are trademarks of Baxter International
Inc., or its subsidiaries.
Last revised: March 20, 2019