EXTRANEAL Solution for peritoneal dialysis Ref.[50603] Active ingredients: Calcium chloride Lactic acid Magnesium chloride Sodium chloride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Product name and form

EXTRANEAL (Icodextrin 7.5%).

Solution for peritoneal dialysis.

Pharmaceutical Form

Solution for peritoneal dialysis.

Extraneal is a sterile, clear, colorless solution.

Qualitative and quantitative composition

A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution.

Icodextrin75 g/L
Sodium Chloride5.4 g/L
Sodium S-Lactate4.5 g/L
Calcium Chloride0.257 g/L
Magnesium Chloride0.051 g/L

Theoretical osmolarity: 284 (milliosmoles per litre)
Theoretical osmolality: 301 (milliosmoles per kg)

Electrolyte solution content per 1000 ml:

Sodium133 mmol/L
Calcium1.75 mmol/L
Magnesium0.25 mmol/L
Chloride96 mmol/L
Lactate40 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
Sodium hydroxide or
Hydrochloric acid q.s. to required pH.

Pack sizes and marketing

Flexible PVC container holding 1.5, 2.0 or 2.5 litres.

1.5 L8 units per box Single bag Sy II (luer connector)
1.5 L8 units per box Single bag Sy III (spike connector)
1.5 L8 units per box Twin bag Sy II (luer connector)
1.5 L8 units per box Twin bag Sy III (spike connector)
1.5 L6 units per box Single bag Sy II (luer connector)
1.5 L6 units per box Single bag Sy III (spike connector)
1.5 L6 units per box Twin bag Sy II (luer connector)
1.5 L6 units per box Twin bag Sy III (spike connector)
2.0 L8 units per box Single bag Sy II (luer connector)
2.0 L8 units per box Single bag Sy III (spike connector)
2.0 L8 units per box Twin bag Sy II (luer connector)
2.0 L8 units per box Twin bag Sy III (spike connector)
2.0 L6 units per box Single bag Sy II (luer connector)
2.0 L6 units per box Single bag Sy III (spike connector)
2.0 L6 units per box Twin bag Sy II (luer connector)
2.0 L6 units per box Twin bag Sy III (spike connector)
2.5 L5 units per box Single bag Sy II (luer connector)
2.5 L5 units per box Single bag Sy III (spike connector)
2.5 L5 units per box Twin bag Sy II (luer connector)
2.5 L5 units per box Twin bag Sy III (spike connector)
2.5 L5 units per box Single bag Sy II (luer connector)
2.5 L5 units per box Single bag Sy III (spike connector)
2.5 L5 units per box Twin bag Sy II (luer connector)
2.5 L5 units per box Twin bag Sy III (spike connector)
2.5 L4 units per box Single bag Sy II (luer connector)
2.5 L4 units per box Single bag Sy III (spike connector)
2.5 L4 units per box Twin bag Sy II (luer connector)
2.5 L4 units per box Twin bag Sy III (spike connector)

Not all pack sizes may be marketed.

Marketing authorization holder

Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom

Marketing authorization dates and numbers

PL 00116/0266

06/01/2012

Drugs

Drug Countries
EXTRANEAL Austria, Brazil, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, New Zealand, Romania, Singapore, Tunisia, Turkey, United States, South Africa

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