Medicinal Products

ACCUSOL 35 POTASSIUM 4 mmol / L

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Main compartment A: Calcium chloride, Magnesium chloride, Sodium chloride, Potassium chloride (E508), Glucose, Small compartment B: [Sodium bicarbonate (E550i), 651], Final solution after mixing: Chloride of Calcium, Magnesium Chloride, Sodium Chloride, Potassium Chloride (E508), Glucose, [Sodium Bicarbonate (E550i), 651]
laboratory: Baxter

Solution for hemofiltration, hemodialysis and hemodiafiltration
Box of 2 Pouches (CLEAR-FLEX) of 5000 ml
All forms

Indication

Accusol 35 Potassium 4 mmol / l is indicated for the treatment of acute and chronic renal failure, as a replacement for haemofiltration and haemodiafiltration and as a dialysis solution in hemodialysis and haemodiafiltration.

Accusol 35 Potassium 4 mmol / L is primarily intended for patients with hypokalemia.

Dosage ACCUSOL 35 POTASSIUM 4 mmol / L Solution for hemofiltration, hemodialysis and haemodiafiltration Box of 2 Pouches (CLEAR-FLEX) 5000 ml

For haemofiltration, hemodialysis and haemodiafiltration.

Accusol 35 Potassium 4 mmol / l as a substitute

The amount of substitution solution to be administered to an adult patient is determined by the prescribed ultrafiltration rate and is defined individually for each case to ensure adequate fluid and electrolyte balance.

Adults:

· Chronic renal failure: 7 to 35 ml / kg / hour.

· Acute renal failure: 20 to 35 ml / kg / hour.

Seniors : as for adults.

Fluid volume recommendations may be adjusted by the attending physician based on the clinical condition of the patient.

Accusol 35 Potassium 4 mmol / l is administered into the extracorporeal bloodstream in pre- or post-dilution mode according to the doctor's prescription.

Accusol 35 Potassium 4 mmol / l as a dialysis solution

The mode and frequency of treatment, the volume of the exchange, the stasis time and the length of the dialysis session should be determined by the attending physician according to the clinical condition of the patient.

Administration mode :

· Hemodialysis: via dialysis dialysis compartment.

· Hemofiltration: via extracorporeal arterial or venous circulation.

The ready-to-use solution Accusol 35 Potassium 4 mmol / l is obtained after mixing the solution of the large compartment A and the solution of the small compartment B, after having opened the intercomparable peel weld. For more information on the use of this medicine, see the section Instructions for use, handling and disposal .

Against indications

Contraindications dependent on the solution:

· Hyperkalemia,

· Metabolic alkalosis.

Contraindications related to the technique of haemofiltration / hemodialysis and haemodiafiltration:

· Renal failure with aggravated hypercatabolism in cases where uremic symptoms are no longer relieved by hemofiltration,

· Inappropriate blood flow from vascular access,

· High risk of hemorrhage caused by systemic anticoagulation.

Adverse effects Accusol 35 Potassium

The undesirable effects indicated are the adverse effects observed in clinical trials that have been evaluated by the investigator as related to Accusol (see 1 / Clinical Studies) and those observed in the literature (see 2 / Literature Review).

To date, no adverse effects are based on post-marketing experience.

The frequencies are defined as follows:

Very common (> 1/10), common (> 1/100, 1/1000, 1/10 000, <1/1000) and very rare (<1/10 000).

1 / Clinical studies

Body System

Undesirable effect

Frequency

Linked to the procedure

Linked to the solution

Metabolism and nutrition disorders

hypoglycemia

Rare

Yes

Yes

2 / Review of the literature

The undesirable effects listed below can be observed with haemofiltration and hemodialysis solutions:

· Those related to the procedure may include: nausea, vomiting, muscle cramps, hypotension, bleeding, coagulation, infection and air embolism.

· Those related to the solution may include: metabolic alkalosis, electrolyte and / or fluid imbalances, hypophosphatemia, hypoglycemia, hypo- and hypervolemia, hypo- and hypertension.

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