Description

EXTRANEAL-PD_Solutions-Datasheet

This abbreviated summary of product characteristics is intended for international use. Please note that it may differ from the licensed SPC in the country where you are practicing. Therefore, please always consult your country specific SPC or package leaflet.

NAME OF THE MEDICINAL PRODUCT

Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis

QUALITATIVE AND QUANTITATIVE COMPOSITION

A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution. Icodextrin 75.0 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 The pH of the solution is 5.0 to 6.0

Theoretical osmolarity

284 (milliosmoles per litre)

301 (milliosmoles per kg)

List of excipients: Water for injections, Sodium Hydroxide or Hydrochloric acid q.s to required pH.

THERAPEUTIC INDICATIONS

Extraneal is recommended as a once daily replacement for a single glucose exchange as part of an automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on APD therapy in such patients.

CONTRA-INDICATIONS

Extraneal should not be used in patients with: a known allergy to starch based polymers/or icodextrin, maltose or isomaltose intolerance, glycogen storage disease, preexisting severe lactic acidosis, uncorrectable mechanical defects that prevent effective PD or increase the risk of infection or documented loss of peritoneal function or extensive adhesions that compromise peritoneal function

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Patients with diabetes mellitus often need additional insulin in order to maintain glycemic control during Peritoneal Dialysis (PD). Transfer from glucose based PD solution to Extraneal may necessitate an adjustment of the usual insulin dosage. Initial results show that insulin is minimally absorbed from Extraneal in Clear Flex bags compared with PVC bags, so dosage adjustments may be also necessary and special attention is advised in this situation. Insulin can be administered intraperitoneally. Blood glucose measurement must be done with a glucose specific method to prevent maltose interference. Glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) or glucose-dye-oxidoreductase (GDO)-based methods should not be used. Also, the use of some glucose monitors and test strips using glucose dehydrogenase flavin-adenine dinucleotide (GDH-FAD) methodology has resulted in falsely elevated glucose readings due to the presence of maltose. The manufacturer(s) of the monitor and test strips should be contacted to determine if icodextrin or maltose causes interference or falsely elevated glucose results. If GDH-PQQ-, GDO- or GDH-FAD-based methods are used, using Extraneal may cause a falsely high glucose reading, which could result in the administration of more insulin than needed. Administration of more insulin than needed has caused hypoglycaemia, which has resulted in loss of consciousness, coma, neurological damage and death. Additionally, falsely elevated blood glucose measurements due to maltose interference may mask true hypoglycaemia and allow it to go untreated with similar consequences. Falsely elevated glucose levels may be measured up to two weeks following cessation of Extraneal (icodextrin) therapy when GDH-PQQ-, GDO- or GDH-FAD-based blood glucose monitors and test strips are used. Because GDHPQQ-, GDO- or GDH-FAD-based blood glucose monitors may be used in hospital settings, it is important that the health care providers of peritoneal dialysis patients using Extraneal (icodextrin) carefully review the product information of the blood glucose testing system, including the information of test strips, to determine if the system is appropriate for use with Extraneal (icodextrin). To avoid improper insulin administration, educate patients to alert health care providers of this interaction, whenever they are admitted to the hospital.