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
Accusol 35 Potassium 4 mmol/l.
Solution for haemofiltration, haemodialysis and haemodiafiltration
| Pharmaceutical Form |
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Solution for haemofiltration, haemodialysis and haemodiafiltration. Accusol 35 is a sterile, non pyrogenic, clear and colourless solution. |
| Composition | Per 1000 ml Accusol 35 |
|---|---|
| Large chamber 'A' | |
| Calcium chloride dihydrate | 0.343 g |
| Magnesium chloride hexahydrate | 0.136 g |
| Sodium chloride | 7.52 g |
| Potassium chloride | 0.398 g |
| Glucose monohydrate | 1.47 g |
| Small chamber 'B' | |
| Sodium bicarbonate | 13.4 g |
| Final solution after mixing | Per 1000 ml Accusol 35 | Calcium chloride dihydrate | 0.257 g | Magnesium chloride hexahydrate | 0.102 g | Sodium chloride | 6.12 g | Potassium chloride | 0.298 g | Glucose anhydrous | 1.0 g | Sodium bicarbonate | 2.94 g |
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Equivalent to the following ionic composition:
| Ionic Composition of Final Solution | Per 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 anhydrous | 5.55 mmol |
| Bicarbonate (HCO3-) | 35 mmol |
| Theoretical osmolarity | 300 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. |
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| 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. |
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| Magnesium chloride |
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| 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. |
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| Sodium bicarbonate |
Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. |
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| 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 |
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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.
Nikkiso Belgium, Industriepark 6, 3300 Tienen, Belgium, Tel (Belgium): +32 (0)16 781770, Tel (Ireland): +353 1800 939112
PA 2021/2/2
| Drug | Countries | |
|---|---|---|
| ACCUSOL | Austria, Spain, France, Ireland, Poland, United Kingdom |
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