Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
EXTRANEAL (Icodextrin 7.5%).
Solution for peritoneal dialysis.
| Pharmaceutical Form |
|---|
|
Solution for peritoneal dialysis. Extraneal is a sterile, clear, colorless solution. |
A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution.
| Icodextrin | 75 g/L |
| Sodium Chloride | 5.4 g/L |
| Sodium S-Lactate | 4.5 g/L |
| Calcium Chloride | 0.257 g/L |
| Magnesium Chloride | 0.051 g/L |
Theoretical osmolarity: 284 (milliosmoles per litre)
Theoretical osmolality: 301 (milliosmoles per kg)
Electrolyte solution content per 1000 ml:
| Sodium | 133 mmol/L |
| Calcium | 1.75 mmol/L |
| Magnesium | 0.25 mmol/L |
| Chloride | 96 mmol/L |
| Lactate | 40 mmol/L |
pH = 5 to 6
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. |
|
| Lactic acid |
|
|
| Magnesium chloride |
|
|
| 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 |
|---|
|
Water for injections |
Flexible PVC container holding 1.5, 2.0 or 2.5 litres.
| 1.5 L | 8 units per box Single bag Sy II (luer connector) |
| 1.5 L | 8 units per box Single bag Sy III (spike connector) |
| 1.5 L | 8 units per box Twin bag Sy II (luer connector) |
| 1.5 L | 8 units per box Twin bag Sy III (spike connector) |
| 1.5 L | 6 units per box Single bag Sy II (luer connector) |
| 1.5 L | 6 units per box Single bag Sy III (spike connector) |
| 1.5 L | 6 units per box Twin bag Sy II (luer connector) |
| 1.5 L | 6 units per box Twin bag Sy III (spike connector) |
| 2.0 L | 8 units per box Single bag Sy II (luer connector) |
| 2.0 L | 8 units per box Single bag Sy III (spike connector) |
| 2.0 L | 8 units per box Twin bag Sy II (luer connector) |
| 2.0 L | 8 units per box Twin bag Sy III (spike connector) |
| 2.0 L | 6 units per box Single bag Sy II (luer connector) |
| 2.0 L | 6 units per box Single bag Sy III (spike connector) |
| 2.0 L | 6 units per box Twin bag Sy II (luer connector) |
| 2.0 L | 6 units per box Twin bag Sy III (spike connector) |
| 2.5 L | 5 units per box Single bag Sy II (luer connector) |
| 2.5 L | 5 units per box Single bag Sy III (spike connector) |
| 2.5 L | 5 units per box Twin bag Sy II (luer connector) |
| 2.5 L | 5 units per box Twin bag Sy III (spike connector) |
| 2.5 L | 5 units per box Single bag Sy II (luer connector) |
| 2.5 L | 5 units per box Single bag Sy III (spike connector) |
| 2.5 L | 5 units per box Twin bag Sy II (luer connector) |
| 2.5 L | 5 units per box Twin bag Sy III (spike connector) |
| 2.5 L | 4 units per box Single bag Sy II (luer connector) |
| 2.5 L | 4 units per box Single bag Sy III (spike connector) |
| 2.5 L | 4 units per box Twin bag Sy II (luer connector) |
| 2.5 L | 4 units per box Twin bag Sy III (spike connector) |
Not all pack sizes may be marketed.
Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom
PL 00116/0266
06/01/2012
| Drug | Countries | |
|---|---|---|
| EXTRANEAL | Austria, Brazil, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, New Zealand, Romania, Singapore, Tunisia, Turkey, United States, South Africa |
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