Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands
Hemosol B0 solution for haemodialysis/haemofiltration.
| Pharmaceutical Form |
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Solution for haemodialysis/haemofiltration. Clear and colourless reconstituted solution. Theoretical Osmolarity: 287 mOsm/l |
Hemosol B0 consists of a two compartment PVC bag containing the electrolyte solution in the small compartment (compartment A) and the buffer solution in the large compartment (compartment B).
1000 ml of electrolyte solution (smallcompartment A) contains: active substances:
| Calcium chloride, 2H2O | 5,145 g |
| Magnesium chloride, 6H2O | 2,033 g |
| Lactic acid | 5,4 g |
1000 ml of buffer solution (large compartment B) contains: active substances:
| Sodium hydrogen carbonate | 3,09 g |
| Sodium chloride | 6,45 g |
The small and the large compartments are mixed to give one reconstituted solution whose ionic composition is:
| in mmol/l | in mEq/l | |
| Calcium Ca2+ | 1,75 | 3,50 |
| Magnesium Mg2+ | 0,5 | 1,0 |
| Sodium Na+ | 140 | 140 |
| Chloride Cl- | 109,5 | 109,5 |
| Lactate | 3 | 3 |
| Hydrogen carbonate HCO3- | 32 | 32 |
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. |
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| Lactic acid |
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| Magnesium chloride |
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| 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 |
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In the small compartment A: Water for injections In the large compartment B: Water for injections, Carbon dioxide |
The container made in Polyvinyl chloride (PVC) is a two-compartment bag. The 5000 ml bag is comprised of a small compartment (250 ml) and a large compartment (4750 ml). The two compartments are separated by a frangible pin.
The large compartment B is fitted with an injection connector (or spike connector) made of polycarbonate (PC), which is closed with a rubber disc covered by a cap as well as a luer connector (PC) with a frangible pin (PC) or a valve made of silicone rubber for the connection of the bag with a suitable replacement solution line or dialysis line.
The bag is over wrapped with a transparent overwrap made of multilayer polymer film.
Each two-compartment bag contains 5000 ml.
Package size: 2 × 5000 ml in a box.
Baxter Holding B.V., Kobaltweg 49, 3542CE Utrecht, Netherlands
PA2299/051/001
Date of first authorisation:11 June 1999
Date of last renewal: 15 October 2014
| Drug | Countries | |
|---|---|---|
| HEMOSOL | Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, New Zealand, United Kingdom, South Africa |
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