2 mmol / l potassium hemodialysis fluid / hemofiltration fluid
Calcium chloride dihydrate / Magnesium chloride hexahydrate / Glucose monohydrate / Lactic acid solution, 90% w / w / Sodium chloride / Potassium chloride / Sodium bicarbonate
What Prismasol® is and what it is used for
Prismacolor contains the active substances calcium chloride dihydrate, magnesium chloride hexahydrate, glucose monohydrate, lactic acid solution 90% w / w, sodium chloride, potassium chloride, and sodium bicarbonate.
Prismacolor is used in the treatment of renal failure as a solution in continuous hemofiltration or hemodiafiltration (as a replacement for the fluid that the blood loses as it passes through a filter) and continuous hemodialysis or hemodiafiltration (the blood circulates on one side of the dialysis membrane while the hemodialysis fluid circulates on the other side of membrane et).
The solution can also be used in drug poisoning of dialyzable or filterable substances.
Prismacolor 2 mmol / l potassium is especially indicated for patients with a tendency to hyperkalemia (high levels of potassium in the blood).
What you need to know before using Prismasol®
Do not use Prismasol 2 mmol / l potassium in:
- allergy to any of the active substances or any of the other ingredients of this medicine (listed in section 6)
- low level of potassium in the blood ( hypokalaemia )
- high level of bicarbonate in the blood ( metabolic alkalosis ).
The presence of maize antigen in Prismasol cannot be ruled out.
Do not use haemofiltration/dialysis if:
- you have kidney failure with pronounced hypercatabolism (abnormally increased catabolism ) and the uremic symptoms (symptoms caused by high levels of urea in the blood) can not be corrected with hemofiltration
- you have insufficient arterial pressure in the vessel access
- you have systemic anticoagulation (decreased coagulation capacity) and there is a high risk of bleeding.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Prismasol. The solution should only be used by, or under the supervision of, physicians competent in the treatment of renal failures such as hemofiltration, hemodiafiltration, or continuous hemodialysis.
Before and during treatment, the hemodynamic status will be checked, for example, the acid-base balance and the level of electrolytes (salts in the blood) will be monitored, including all fluid you receive ( intravenous infusion ) and which you produce (urine production), including fluid that is not directly related to the treatment.
Blood sugar levels should be closely monitored, especially if you have diabetes.
Other medicines and Prismasol®
Talk to your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Blood levels of other medicines may be reduced during treatment. The doctor decides if the medication needs to be corrected.
Your doctor needs to know if you are using:
- Digitalis preparations (for the treatment of certain heart diseases), as digitalis increases the risk of cardiac arrhythmia (the heart beats irregularly or quickly) in case of hypokalaemia (low potassium content in the blood).
- Vitamin D and calcium-containing medicines may increase the risk of hypercalcemia (high blood calcium).
- Any addition of sodium bicarbonate (or another buffer source) may increase the risk of metabolic alkalosis (excess bicarbonate in the blood).
- When citrate is used as an anticoagulant (as a protective additive in dialysis equipment), it may lower plasma calcium levels.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. It is up to the doctor to decide if you should be treated with Prismasol when you are pregnant or breastfeeding.
Driving and using machines
Prismacolor is not known to affect your ability to drive or use machines.
How to use Prismasol®
Method of administration: For intravenous use and hemodialysis.
The operating instructions can be found in the section “The following information is intended only for healthcare professionals” below.
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The volume of Prismasol to be used varies depending on your clinical condition and desired fluid balance. Dosage one is therefore the responsibility of the treating physician.
If you think you have used too much Prismasol®
Your fluid, electrolyte, and acid-base balance will be closely monitored.
If an overdose is unlikely to occur, your doctor will take the necessary corrective action and adjust your dose.
Overdose can result in:
- too much fluid in the blood
- elevated bicarbonate level in the blood ( metabolic alkalosis )
- and/or decreased salt levels in the blood ( hypophosphatemia, hypokalemia ). Overdose can have serious consequences such as heart failure, and electrolyte or acid-base disorders.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:
Has been reported: occurs in an unknown number of users
- Changes in salt levels in the blood (disturbed electrolyte balance such as hypophosphatemia, hypokalaemia )
- Increased level of bicarbonate in blood plasma ( metabolic alkalosis ) or decreased level of bicarbonate in blood plasma (metabolic acidosis )
- The abnormally high or low fluid level in the body (hyper- or hypovolemia )
- Abnormally high level of glucose in the blood (hyperglycemia)
- Nausea
- Vomiting
- Muscle cramps
- Hypotension (low blood pressure ).
How to store Prismasol®
Keep this medicine out of the sight and reach of children.
Store at least + 4 ° C.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. or EXP. The expiration date is the last day of the specified month.
For the reconstituted solution, chemical and physical in-use stability have been demonstrated for 24 hours at 22 ° C. If not used immediately, in-use storage times and conditions before administration are the responsibility of the user and should not exceed 24 hours, including treatment time.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are
Before mixing
| Calcium chloride dihydrate | 5.145 g |
| Magnesium chloride hexahydrate | 2,033 g |
| Glucose | 22,000 g |
| (S) – lactic acid | 5,400 g |
| Sodium chloride | 6,450 g |
| Sodium bicarbonate | 3,090 g |
| Potassium chloride | 0.157 g |
After mixing
| mmol / l | mEq / l | ||
|---|---|---|---|
| Calcium | Ca 2+ | 1.75 | 3.50 |
| Magnesium | Mg 2+ | 0.50 | 1.00 |
| Sodium | Na + | 140.00 | 140.00 |
| Chloride | Cl – | 111.50 | 111.50 |
| Lactate | 3.00 | 3.00 | |
| Hydrocarbonate | HCO 3 – | 32.00 | 32.00 |
| Potassium | K + | 2.00 | 2.00 |
| Glucose | 6.10 | ||
| Theoretical osmolarity | 297 mOsm / l |
The other ingredients are: carbon dioxide (E290), water for injections
the pH of the reconstituted solution: 7.0-8.5
What the medicine looks like and the contents of the pack
Prismacolor is packed in a two-chamber bag with electrolyte solution in the smaller chamber A and buffer solution in the larger chamber B. The ready-mixed solution is obtained by opening the so-called peel-seal closure and mixing the two solutions. The reconstituted solution is clear and pale yellow. Each bag (A + B) contains 5000 ml of replacement solution for haemofiltration and hemodialysis. The bag has an outer packaging of transparent film.
Each box contains two bags and a package leaflet.
Marketing Authorisation Holder
Baxter Holding BV
Kobaltweg 49
3542CE Utrecht
Netherlands
Manufacturer
Bieffe Medital SpA, Via Stelvio 94, 23035 Sondalo (SO), Italy
Baxter Healthcare SA, Moneen Road, Castlebar, County Mayo, F23 XR63, Ireland
Local representative
Baxter Medical AB
Box 63
164 94 Kista