MULTIBIC Solution for haemodialysis/haemofiltration Ref.[50679] Active ingredients: Calcium chloride Glucose Magnesium chloride Potassium chloride Sodium bicarbonate Sodium chloride

Source: Marketing Authorisation Holder  Revision Year: 2017  Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Product name and form

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

Solution for haemodialysis/haemofiltration.

The ready-to-use solution is clear and colourless.

Theoretical osmolarity:

multiBic potassium-free 292 mOsm/l
multiBic 2 mmol/l potassium 296 mOsm/l
multiBic 3 mmol/l potassium 298 mOsm/l
multiBic 4 mmol/l potassium 300 mOsm/l

pH ≈ 7.4

Qualitative and quantitative composition

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.

BEFORE MIXING: 1000 ml solution contain:

Acidic electrolyte, glucose solution (small compartment):

 multiBic potassium-freemultiBic 2 mmol/l potassiummultiBic 3 mmol/l potassiummultiBic 4 mmol/l potassium
Potassium chloride- 2.982 g4.473 g5.964 g
Calcium chloride dihydrate4.410 g4.410 g4.410 g4.410 g
Magnesium chloride hexahydrate2.033 g2.033 g2.033 g2.033 g
Glucose monohydrate22.00 g22.00 g22.00 g22.00 g
(Glucose) (20.00 g) (20.00 g) (20.00 g) (20.00 g)
K+0 mmol/l40 mmol/l60 mmol/l80 mmol/l
Ca2+30 mmol/l30 mmol/l30 mmol/l30 mmol/l
Mg2+10 mmol/l10 mmol/l10 mmol/l10 mmol/l
Cl-82 mmol/l122 mmol/l142 mmol/l162 mmol/l
Glucose111 mmol/l111 mmol/l111 mmol/l111 mmol/l

Alkaline hydrogen carbonate solution (large compartment):

 multiBic potassium-freemultiBic 2 mmol/l potassiummultiBic 3 mmol/l potassiummultiBic 4 mmol/l potassium
Sodium chloride6.453 g6.453 g6.453 g6.453 g
Sodium hydrogen carbonate3.104 g3.104 g3.104 g3.104 g
Na+147 mmol/l147 mmol/l147 mmol/l147 mmol/l
Cl-110 mmol/l110 mmol/l110 mmol/l110 mmol/l
HCO3-37 mmol/l37 mmol/l37 mmol/l37 mmol/l

AFTER MIXING: 1000 ml of the ready-to-use solution contain:

 multiBic potassium-freemultiBic 2 mmol/l potassiummultiBic 3 mmol/l potassiummultiBic 4 mmol/l potassium
Potassium chloride- 0.1491 g0.2237 g0.2982 g
Sodium chloride6.136 g6.136 g6.136 g6.136 g
Sodium hydrogen carbonate2.940 g2.940 g2.940 g2.940 g
Calcium chloride dihydrate0.2205 g0.2205 g0.2205 g0.2205 g
Magnesium chloride hexahydrate0.1017 g0.1017 g0.1017 g0.1017 g
Glucose monohydrate1.100 g1.100 g1.100 g1.100 g
(Glucose) (1.000 g) (1.000 g) (1.000 g) (1.000 g)
K+0 mmol/l2.0 mmol/l3.0 mmol/l4.0 mmol/l
Na+140 mmol/l140 mmol/l140 mmol/l140 mmol/l
Ca2+1.5 mmol/l1.5 mmol/l1.5 mmol/l1.5 mmol/l
Mg2+0.50 mmol/l0.50 mmol/l0.50 mmol/l0.50 mmol/l
Cl-109 mmol/l111 mmol/l112 mmol/l113 mmol/l
HCO3-35 mmol/l35 mmol/l35 mmol/l35 mmol/l
Glucose5.55 mmol/l5.55 mmol/l5.55 mmol/l5.55 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
Hydrochloric acid 25%

Large compartment:

Water for injections
Carbon dioxide
Sodium dihydrogen phosphate dihydrate

Pack sizes and marketing

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.

Marketing authorization holder

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg v.d.H., Germany

Drugs

Drug Countries
MULTIBIC Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Lithuania, Singapore, Turkey, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.