Details for: PRISM0CAL B22K0/0
Company: BAXTER CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02441691 | PRISM0CAL B22K0/0 | MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE | 3.05 G / L; 7.14 G / L; 2.12 G / L | SOLUTION | DIALYSIS |
| 02441691 | PRISM0CAL B22K0/0 | MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE | 3.05 G / L; 7.14 G / L; 2.12 G / L | 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)
What the medicinal ingredient is
Magnesium chloride hexahydrate, Sodium hydrogen carbonate, Sodium chloride.
What the non-medicinal ingredients are
Carbon dioxide, water for injection, hydrochloric acid (pH adjuster).
What dosage form it comes in
Solution for hemodialysis, hemofiltration and hemodiafiltration.
Warnings and precautions
Before and during treatment, your blood condition will be
checked, e.g. your acid-base balance, concentrations of
salts in the blood (electrolytes) and sugar levels (glucose).
Tell your doctor if you are pregnant, planning to become
pregnant or nursing.
There is no adequate data for the use of Prism0CAL
B22/K0/0 in patients less than16 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 (medicine for treatment of certain heart conditions).
- Additional buffer substitution (e.g. sodium hydrogen carbonate).
Proper use of this medication
Usual Dose
The volume of solution used will depend on your clinical condition and the target fluid balance. The dose volume is therefore at the discretion of the responsible physician.
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:
Prism0CALB22/K0/0 will be checked before use to ensure
that all seals are intact and the reconstituted solution is
clear, colorless and free of precipitate.
The solution in the small compartment is added to the
solution in the large compartment after opening the peel
seal.
INSTRUCTION FOR USE:
Remove the overwrap from the bag immediately before
use. Aseptic technique should be used throughout
administration to the patient. The solution should be used
immediately after opening to avoid microbiological
contamination.
Use only if the overwrap is not damaged, all seals are
intact, 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.
- Open the seal by holding the small compartment with both hands and squeezing 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 either of the two access ports.
-
- If the luer connector is used, remove the cap with a
twist and pull motion, and connect the male luer
connector on the dialysis or replacement line to the
female luer connector 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 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 solution will stop. The luer connector is a needle-less and swabbable port. - If the injection port (spike connector) is used, first remove the snap-off cap. Introduce the spike through the rubber septum. Verify that the fluid is flowing freely. (See figure IV.b below)
- If the luer connector is used, remove the cap with a
twist and pull motion, and connect the male luer
connector on the dialysis or replacement line to the
female luer connector 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 fluid is flowing freely. (See figure
IV.a below)
The introduction and mixing of additives must always be performed prior to connecting the solution bag to the extracorporeal circuit.
Side effects and what to do about them
Side effects may include:
- nausea, vomiting
- muscle cramps
| 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 | ✔ |
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 22°C.
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