This brand name is authorized in Austria, Brazil, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, New Zealand, Romania, Singapore, Tunisia, Turkey, United States, South Africa
The drug EXTRANEAL contains a combination of these active pharmaceutical ingredients (APIs):
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1
Icodextrin
UNII 2NX48Z0A9G - ICODEXTRIN
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2
Sodium chloride
UNII 451W47IQ8X - SODIUM CHLORIDE
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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. |
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3
Lactic acid
UNII TU7HW0W0QT - SODIUM LACTATE
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4
Calcium chloride
UNII M4I0D6VV5M - CALCIUM CHLORIDE
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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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5
Magnesium chloride
UNII 02F3473H9O - MAGNESIUM CHLORIDE
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Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| EXTRANEAL Solution for peritoneal dialysis | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| B05DA | Isotonic solutions | B Blood and blood forming organs → B05 Blood substitutes and perfusion solutions → B05D Peritoneal dialytics |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 503206301134312, 503206302173419 |
| Country: EE | Ravimiamet | Identifier(s): 1010170, 1067666, 1067677, 1669002, 1669013, 1669024, 1669035, 1669046, 1669057, 1669068, 1669079, 1669080, 1669091, 1734173, 1734184, 1734195, 1734207, 1734229, 1734230, 1734241, 1734252, 1734263, 1734274, 1734285, 1734296, 1734308, 1734319, 1734320, 1734331, 1734342, 1734353, 1734454, 1734465, 1734476, 1734487, 1734498, 1734500, 1734511, 1734522, 1734533, 1734544, 1734735, 1734746 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 61860 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 086264, 086280, 147330 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 66121209 |
| Country: HK | Department of Health Drug Office | Identifier(s): 46627 |
| Country: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-928997385 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 9136 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 3420432A1038, 3420432A2034, 3420432A3030, 3420432A4037 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1006817, 1015279, 1015280, 1062003, 1062004, 1062005, 1062006, 1076660, 1076661, 1076662 |
| Country: MT | Medicines Authority | Identifier(s): MA1277/01101 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 9679 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67135001, W67135002, W67135003, W67135004, W67135005, W67135006, W67135007, W67135008, W67135009, W67135010, W67135011, W67135012, W67135013, W67135014, W67135015, W67135016, W67135017, W67135018, W67135019, W67135020, W67135021, W67135022, W67135023, W67135024, W67135025, W67135026, W67135027, W67135028, W67135029, W67135030, W67135031 |
| Country: SG | Health Sciences Authority | Identifier(s): 11220P |
| Country: TN | Direction de la Pharmacie et du Médicament | Identifier(s): 10193011, 10193012 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8681413880605, 8681413880612, 8681413880629, 8681413880636 |
| Country: US | FDA, National Drug Code | Identifier(s): 0941-0679 |
| Country: ZA | Health Products Regulatory Authority | Identifier(s): 38/34/0172 |
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