EXTRANEAL

This brand name is authorized in United States. It is also authorized in Austria, Brazil, Croatia, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Japan, Lithuania, Malta, New Zealand, Romania, Singapore, South Africa, Spain, Tunisia, Turkey.

Active ingredients

The drug EXTRANEAL contains a combination of these active pharmaceutical ingredients (APIs):

1
Icodextrin
UNII 2NX48Z0A9G - ICODEXTRIN
2
UNII 451W47IQ8X - 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.

 
Read more about Sodium chloride
3
UNII TU7HW0W0QT - SODIUM LACTATE
 
Read more about Lactic acid
4
UNII M4I0D6VV5M - 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.

 
Read more about Calcium chloride
5
UNII 02F3473H9O - MAGNESIUM CHLORIDE
 
Read more about Magnesium chloride

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 EXTRANEAL Solution for peritoneal dialysis MPI, EU: SmPC Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
B05DA Isotonic solutions B Blood and blood forming organs → B05 Blood substitutes and perfusion solutions → B05D Peritoneal dialytics
Discover more medicines within B05DA

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
BR Câmara de Regulação do Mercado de Medicamentos 503206301134312, 503206302173419
EE Ravimiamet 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
ES Centro de información online de medicamentos de la AEMPS 61860
FI Lääkealan turvallisuus- ja kehittämiskeskus 086264, 086280, 147330
FR Base de données publique des médicaments 66121209
HK Department of Health Drug Office 46627
HR Agencija za lijekove i medicinske proizvode HR-H-928997385
IL מִשְׂרַד הַבְּרִיאוּת 9136
JP 医薬品医療機器総合機構 3420432A1038, 3420432A2034, 3420432A3030, 3420432A4037
LT Valstybinė vaistų kontrolės tarnyba 1006817, 1015279, 1015280, 1062003, 1062004, 1062005, 1062006, 1076660, 1076661, 1076662
MT Medicines Authority MA1277/01101
NZ Medicines and Medical Devices Safety Authority 9679
RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale 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
SG Health Sciences Authority 11220P
TN Direction de la Pharmacie et du Médicament 10193011, 10193012
TR İlaç ve Tıbbi Cihaz Kurumu 8681413880605, 8681413880612, 8681413880629, 8681413880636
US FDA, National Drug Code 0941-0679
ZA Health Products Regulatory Authority 38/34/0172

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