Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
PHOXILIUM 1.2 mmol/l phosphate Solution for haemodialysis/haemofiltration.
| Pharmaceutical Form |
|---|
|
Solution for haemodialysis/haemofiltration. Clear and colourless solutions. Theoretical osmolarity: 293 mOsm/l. pH of the reconstituted solution: 7.0–8.5. |
Phoxilium is presented in a two-compartment bag. The final reconstituted solution is obtained after breaking the frangible pin or the peel seal and mixing both solutions.
1000 ml of solution in the small compartment (A) contains:
Calcium chloride, 2 H2O 3.68 g
Magnesium chloride, 6 H2O 2.44 g
1000 ml of solution in the large compartment (B) contains:
Sodium chloride 6.44 g
Sodium hydrogen carbonate 2.92 g
Potassium chloride 0.314 g
Disodium phosphate, 2 H2O 0.225 g
1000 ml of the reconstituted solution contains:
| Active substances | mmol/l | mEq/l | |
|---|---|---|---|
| Calcium | Ca2+ | 1.25 | 2.50 |
| Magnesium | Mg2+ | 0.600 | 1.20 |
| Sodium | Na+ | 140.0 | 140.0 |
| Chloride | Cl- | 115.9 | 115.9 |
| Hydrogen phosphate | HPO42- | 1.20 | 2.40 |
| Hydrogen carbonate | HCO3- | 30.0 | 30.0 |
| Potassium | K+ | 4.00 | 4.00 |
Each 1000 ml of the final reconstituted solution corresponds to 50 ml of solution A and 950 ml of solution B.
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. |
|
| 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 A: Water for injections Large compartment B: Water for injections |
The container made in polyvinyl chloride (PVC) or polyolefin 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 or a peel seal.
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 a multilayer polymer film.
Each two-compartment bag contains 5000 ml.
Package size: 2 × 5000 ml in a box.
Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
PL 00116/0708
Date of first authorisation: 15th April 2009
Date of latest renewal: 5th May 2013
| Drug | Countries | |
|---|---|---|
| PHOXILIUM | Austria, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom |
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