Patient Medication Information: uses, side effects, how to take - PRISM0CAL B22K0/0
ABOUT THIS MEDICATION
What the medication is used for:
Prism0CAL B22K0/0 is used in adults:
in the treatment of acute kidney failure:
- as replacement for fluid lost from the blood during hemofiltration or hemodiafiltration, and
- as a dialysis solution in hemodialysis or hemodiafiltration in Continuous Renal Replacement Therapy (CRRT).
- for patients suffering from high potassium (hyperkalemia) and/or high calcium (hypercalcaemia) levels in their blood.
- in case of drug poisoning with substances that can be removed by dialysis or hemofiltration.
Prism0CAL B22K0/0 should only be used under the direction of a healthcare professional competent in the treatment of acute kidney failure using hemofiltration, hemodiafiltration and hemodialysis in CRRT in a hospital setting.
What it does:
Prism0CAL B22K0/0 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 B22K0/0 should not be used in the following cases:
- Hypokalaemia (low potassium levels in your blood).
- Hypocalcaemia (low calcium levels in your blood).
What the medicinal ingredient is:
Magnesium chloride hexahydrate, Sodium hydrogen carbonate, Sodium chloride.
What the nonmedicinal ingredients are:
Carbon dioxide, water for injection, hydrochloric acid (pH adjuster).
What dosage forms 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 adult 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.
| In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
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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.
I 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)
II Push with both hands on the large compartment until the peel seal between the two compartments is entirely open. (See figure II below)
III 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)
IV The dialysis or replacement line may be connected to either of the two access ports.
IV.a 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.
IV.b If the injection port (spike connector) is used, first remove the snap-off cap. The injection port is a swabbable port. Introduce the spike through the rubber septum. Verify that the fluid is flowing freely. (See figure IV.b 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
If any of these affects you severely, tell your doctor, nurse or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor, nurse or pharmacist | Seek immediate medical help | ||
| Only if severe | In all cases | |||
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 Prism0CALB22K0/0, contact your doctor, nurse, or pharmacist.
HOW TO STORE IT
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.
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 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. |
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MORE INFORMATION
This document, plus the full prescribing information, prepared for health professionals can be found by contacting the sponsor, Vantive ULC, at: 1-800-387-8399.
Vantive and Prism0CAL are trademarks of Vantive Health Inc., or its subsidiaries.