Source: Υπουργείο Υγείας (CY) Revision Year: 2021 Publisher: Gambro Lundia AB, Magistratsvägen 16, 226 43 Lund, Sweden
Biphozyl – Solution for haemodialysis / haemofiltration.
| Pharmaceutical Form |
|---|
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Solution for haemodialysis / haemofiltration. Clear and colourless solution. Theoretical osmolarity: 290 mOsm/l |
Biphozyl is presented in a two-compartment bag. The final reconstituted solution is obtained after opening the peel seal and mixing the contents of the two compartments.
Composition in the small compartment:
Magnesium chloride hexahydrate: 3.05 g/l
Composition in the large compartment:
Sodium chloride: 7.01 g/l
Sodium hydrogen carbonate: 2.12 g/l
Potassium chloride: 0.314 g/l
Disodium phosphate dihydrate: 0.187 g/l
Composition of the reconstituted solution:
| Active substances | mmol/l | mEq/l |
|---|---|---|
| Sodium Na+ | 140 | 140 |
| Potassium K+ | 4 | 4 |
| Magnesium Mg2+ | 0.75 | 1.5 |
| Chloride Cl- | 122 | 122 |
| Hydrogen phosphate HPO42- | 1 | 2 |
| Hydrogen carbonate HCO3- | 22 | 22 |
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| 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. |
|
| Sodium phosphate |
|
| List of Excipients |
|---|
|
Small compartment: Water for injections, Dilute hydrochloric acid (for pH adjustment) E507 Large compartment: Water for injections, Carbon dioxide (for pH adjustment) E290 |
The container is a two-compartment bag made of a multilayer film containing polyolefins and elastomers. 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 peel seal. The bag is fitted with an injection connector (or spike connector) made of polycarbonate (PC) and a luer connector (PC) with a valve made of silicone rubber for the connection with a suitable solution line. The bag is overwrapped with a transparent overwrap made of polymer film.
Pack size: 2 × 5000 ml in a box.
Gambro Lundia AB, Magistratsvägen 16, 226 43 Lund, Sweden
| Drug | Countries | |
|---|---|---|
| BIPHOZYL | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Poland, Romania, Singapore, Turkey |
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