Source: Marketing Authorisation Holder Revision Year: 2017 Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany
multiBic potassium-free solution for haemodialysis/haemofiltration.
multiBic 2 mmol/l potassium solution for haemodialysis/haemofiltration.
multiBic 3 mmol/l potassium solution for haemodialysis/haemofiltration.
multiBic 4 mmol/l potassium solution for haemodialysis/haemofiltration.
| Pharmaceutical Form |
|---|
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Solution for haemodialysis/haemofiltration. The ready-to-use solution is clear and colourless. Theoretical osmolarity: multiBic potassium-free 292 mOsm/l pH ≈ 7.4 |
multiBic potassium-free/2/3/4 mmol/l potassium is provided in a two-compartment bag with 4750 ml of an alkaline hydrogen carbonate solution in one compartment and 250 ml of an acidic electrolyte, glucose solution in the other compartment.
Acidic electrolyte, glucose solution (small compartment):
| multiBic potassium-free | multiBic 2 mmol/l potassium | multiBic 3 mmol/l potassium | multiBic 4 mmol/l potassium | |
|---|---|---|---|---|
| Potassium chloride | - | 2.982 g | 4.473 g | 5.964 g |
| Calcium chloride dihydrate | 4.410 g | 4.410 g | 4.410 g | 4.410 g |
| Magnesium chloride hexahydrate | 2.033 g | 2.033 g | 2.033 g | 2.033 g |
| Glucose monohydrate | 22.00 g | 22.00 g | 22.00 g | 22.00 g |
| (Glucose) | (20.00 g) | (20.00 g) | (20.00 g) | (20.00 g) |
| K+ | 0 mmol/l | 40 mmol/l | 60 mmol/l | 80 mmol/l |
| Ca2+ | 30 mmol/l | 30 mmol/l | 30 mmol/l | 30 mmol/l |
| Mg2+ | 10 mmol/l | 10 mmol/l | 10 mmol/l | 10 mmol/l |
| Cl- | 82 mmol/l | 122 mmol/l | 142 mmol/l | 162 mmol/l |
| Glucose | 111 mmol/l | 111 mmol/l | 111 mmol/l | 111 mmol/l |
Alkaline hydrogen carbonate solution (large compartment):
| multiBic potassium-free | multiBic 2 mmol/l potassium | multiBic 3 mmol/l potassium | multiBic 4 mmol/l potassium | |
|---|---|---|---|---|
| Sodium chloride | 6.453 g | 6.453 g | 6.453 g | 6.453 g |
| Sodium hydrogen carbonate | 3.104 g | 3.104 g | 3.104 g | 3.104 g |
| Na+ | 147 mmol/l | 147 mmol/l | 147 mmol/l | 147 mmol/l |
| Cl- | 110 mmol/l | 110 mmol/l | 110 mmol/l | 110 mmol/l |
| HCO3- | 37 mmol/l | 37 mmol/l | 37 mmol/l | 37 mmol/l |
| multiBic potassium-free | multiBic 2 mmol/l potassium | multiBic 3 mmol/l potassium | multiBic 4 mmol/l potassium | |
|---|---|---|---|---|
| Potassium chloride | - | 0.1491 g | 0.2237 g | 0.2982 g |
| Sodium chloride | 6.136 g | 6.136 g | 6.136 g | 6.136 g |
| Sodium hydrogen carbonate | 2.940 g | 2.940 g | 2.940 g | 2.940 g |
| Calcium chloride dihydrate | 0.2205 g | 0.2205 g | 0.2205 g | 0.2205 g |
| Magnesium chloride hexahydrate | 0.1017 g | 0.1017 g | 0.1017 g | 0.1017 g |
| Glucose monohydrate | 1.100 g | 1.100 g | 1.100 g | 1.100 g |
| (Glucose) | (1.000 g) | (1.000 g) | (1.000 g) | (1.000 g) |
| K+ | 0 mmol/l | 2.0 mmol/l | 3.0 mmol/l | 4.0 mmol/l |
| Na+ | 140 mmol/l | 140 mmol/l | 140 mmol/l | 140 mmol/l |
| Ca2+ | 1.5 mmol/l | 1.5 mmol/l | 1.5 mmol/l | 1.5 mmol/l |
| Mg2+ | 0.50 mmol/l | 0.50 mmol/l | 0.50 mmol/l | 0.50 mmol/l |
| Cl- | 109 mmol/l | 111 mmol/l | 112 mmol/l | 113 mmol/l |
| HCO3- | 35 mmol/l | 35 mmol/l | 35 mmol/l | 35 mmol/l |
| Glucose | 5.55 mmol/l | 5.55 mmol/l | 5.55 mmol/l | 5.55 mmol/l |
For the full list of excipients, see section 6.1.
| 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 |
|---|
|
Small compartment: Water for injections Large compartment: Water for injections |
Double chamber bag with 4750 ml (alkaline hydrogen carbonate solution) + 250 ml (acidic electrolyte, glucose solution) = 5000 ml (ready-to-use solution).
The foil used for the bag is made of polyethylene-terephthalate, SiOx, polyamide, and polyolefine.
Each bag is equipped with a HF-connector, a Luer-lock-connector and an injection port, and is covered by a protective foil.
Pack size: 2 bags of 5000 ml.
Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany
| Drug | Countries | |
|---|---|---|
| MULTIBIC | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Lithuania, Singapore, Turkey, United Kingdom |
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