ACCUSOL 35 POTASSIUM Solution for haemofiltration, haemodialysis and haemodiafiltration Ref.[50646] Active ingredients: Calcium chloride Glucose Magnesium chloride Potassium chloride Sodium bicarbonate Sodium chloride

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Nikkiso Belgium, Industriepark 6, 3300 Tienen, Belgium, Tel (Belgium): +32 (0)16 781770, Tel (Ireland): +353 1800 939112

Product name and form

Accusol 35 Potassium 4 mmol/l.

Solution for haemofiltration, haemodialysis and haemodiafiltration

Pharmaceutical Form

Solution for haemofiltration, haemodialysis and haemodiafiltration.

Accusol 35 is a sterile, non pyrogenic, clear and colourless solution.

Qualitative and quantitative composition

CompositionPer 1000 ml
Accusol 35
Large chamber 'A'
Calcium chloride dihydrate0.343 g
Magnesium chloride hexahydrate0.136 g
Sodium chloride7.52 g
Potassium chloride0.398 g
Glucose monohydrate1.47 g
Small chamber 'B'
Sodium bicarbonate13.4 g
Final solution after mixingPer 1000 ml
Accusol 35
Calcium chloride dihydrate0.257 gMagnesium chloride hexahydrate0.102 gSodium chloride6.12 gPotassium chloride0.298 gGlucose anhydrous1.0 gSodium bicarbonate2.94 g

Equivalent to the following ionic composition:

Ionic Composition of Final SolutionPer 1000 ml
Accusol 35
Calcium (Ca++) 1.75 mmol
Magnesium (Mg++) 0.5 mmol
Sodium (Na+) 140 mmol
Potassium (K+) 4 mmol
Chloride (Cl-) 113.3 mmol
Glucose anhydrous5.55 mmol
Bicarbonate (HCO3-) 35 mmol
Theoretical osmolarity300 mOsm/l

The 5000 ml of final solution results from mixing 3750 ml of solution ‘A’ with 1250 ml of solution ‘B’.

The pH of the final solution is between 7.0-7.5

The number “35” in the name specifies the buffer concentration of the solution (bicarbonate = 35mmol/l).

Active Ingredient Description
Calcium chloride

Calcium is the most abundant mineral in the body, and is an essential body electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonin, and by the activated form of vitamin D. Calcium is a structural component of bones and teeth. It is also required for blood clotting, neurotransmitter release, muscle contraction and normal heartbeat.

Glucose

Glucose is frequently used in both adults and children to restore blood glucose concentrations in the treatment of hypoglycaemia resulting from insulin excess or from other causes. The metabolism of glucose is an energy source for the body.

Magnesium chloride
Potassium chloride

Potassium plays a vital physiological role in maintenance of normal electrical excitability of nerve and muscle. It is also important in the genesis and correction of imbalances of acid-base metabolism.

Sodium bicarbonate

Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

Sodium chloride

Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue.

List of Excipients

Pack sizes and marketing

Accusol 35 is stored in a non-PVC two-chamber bag made of a coextruded film of Polypropylene, Polyamide and a blend of Polypropylene, SEBS and Polyethylene (Clear-Flex). A long-seal (interchamber seal) separates the two chambers.

The large chamber ‘A’ is fitted with a medication port and the small chamber ‘B’ is fitted with an access port for connection to a suitable administration set. A short SafetyMoon seal (seal near access port) needs to be opened to allow administration of the mixed solution.

The two-chamber bag is presented in a protective transparent overpouch made of copolymers. The volume of the container after mixing is 5000 ml (3750 ml in the large chamber and 1250 ml in the small chamber).

Accusol 35 is available as 2 × 5000 ml per box.

Marketing authorization holder

Nikkiso Belgium, Industriepark 6, 3300 Tienen, Belgium, Tel (Belgium): +32 (0)16 781770, Tel (Ireland): +353 1800 939112

Marketing authorization dates and numbers

PA 2021/2/2

Drugs

Drug Countries
ACCUSOL Austria, Spain, France, Ireland, Poland, United Kingdom

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