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EXTRANEAL (ICODEXTRIN is a brand name for Sodium Chloride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions,…
Verbatim from this product's MHRA label. Tap a section to expand.
e. in CAPD usually overnight and in APD for the long daytime dwell. • The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the physician. Adults By intraperitoneal administration limited to a single exchange in each 24 hour-period, as part of a CAPD or APD regimen.
The volume to be instilled should be given over a period of approximately 10 to 20 minutes at a rate which the patient finds comfortable. 0 L. 5 L may be used. If the instilled volume causes discomfort due to abdominal tension the instilled volume should be reduced.
The recommended dwell time is between 6 and 12 hours in CAPD and 14-16 hours in APD. Drainage of the fluid is by gravity at a rate comfortable for the patient. Older people As for Adults. Paediatric population The safety and efficacy of Extraneal in children aged less than 18 years has not been established.
No data are available.
Administration:
Precautions to be taken before handling or administering the medicinal product • EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection. • Peritoneal dialysis solutions may be warmed in the overpouch to 37°C to enhance patient comfort.
However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort. • Aseptic technique should be employed throughout the peritoneal dialysis procedure.
• Do not administer if the solution is discoloured, cloudy, contains particulate matter or shows evidence of leakage, or if seals are not intact. 4). • For single use only
Undesirable effects which occurred in patients treated with Extraneal from the clinical trials and post marketing are listed below. Extraneal associated skin reactions, including rash and pruritus, are generally mildor moderate in severity.
Occasionally, these rashes have been associated with exfoliation. In the event of this occurring and depending on the severity, Extraneal should be withdrawn at least temporarily.
Frequency is based upon the following scale:
Very Common (≥1/10); Common (≥1/100-<1/10), Uncommon (≥1/1,000-<1/100), Rare (≥1/10,000-<1/1,000), Very Rare (<1/10,000), not known (cannot be estimated from the available data). 4). ** Hypersensitivity-type reactions have been reported in patients using Extraneal including bronchospasm, hypotension, rash, pruritus and urticaria Other undesirable effects of peritoneal dialysis related to the procedure: fungal peritonitis, bacterial peritonitis, catheter site infection, catheter related infection and catheter related complication.
4). 4). g. hypokalaemia, hypocalcaemia and hypercalcaemia). 4). Fatigue was often reported spontaneously and in literature as an undesirable effect related to the procedure. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard
• Patients with diabetes mellitus often need additional insulin in order to maintain glycaemic control during Peritoneal Dialysis (PD). Transfer from glucose based PD solution to Extraneal may necessitate an adjustment of the usual insulin dosage.
Insulin can be administered intraperitoneally. • Blood glucose measurement must be done with a glucose specific method to prevent maltose interference. Glucose dehydrogenase pyrroloquinolinequinone (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 GDH-PQQ, 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 that of test strips, to determine if the system is appropriate for use with EXTRANEAL (icodextrin).
g. maize starch) and/or icodextrin • maltose or isomaltose intolerance • glycogen storage disease • pre-existing severe lactic acidocis • uncorrectable mechanical defects that prevent effective PD or increase the risk of infection • documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sodium Chloride in United Kingdom.
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To avoid improper insulin administration, educate patients to alert healthcare providers of this interaction whenever they are admitted to the hospital. • Peritoneal dialysis should be done with caution in patients with: 1) abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, from congenital anomalies or trauma until healing is complete, abdominal tumours, abdominal wall infection, hernias, faecal fistula, colostomy or iliostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity; and 2) other conditions including recent aortic graft replacement and severe pulmonary disease.
• Encapsulating peritoneal sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including some patients using EXTRANEAL as part of their PD therapy.
Infrequently, fatal outcomes have been reported with EXTRANEAL. , severe hypotension, sepsis, acute renal failure, inborn errors of metabolism, treatment with drugs such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] should be monitored for occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions.
• When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. Serum potassium levels should be monitored carefully in patients treated with cardiac glycosides.
8). In case of peritoneal reactions, the patient should keep the icodextrin drained fluid bag along with its batch number, and contact the medical team for analysis of the drained fluid bag. The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of infection or aseptic peritonitis.
Patients should be asked to inform their physician if this occurs and appropriate microbiological samples should be drawn. The initiation of antibiotic treatment should be a clinical decision based on whether or not infection is suspected.
If other possible reasons for cloudy fluid have been excluded, Extraneal should be stopped and the result of this action evaluated. If Extraneal is stopped and the fluid becomes clear afterwards, Extraneal should not be reintroduced unless under close supervision.
If by re- challenging with Extraneal, the cloudy fluid recurs then this patient should not be prescribed Extraneal again. Alternative peritoneal dialysis therapy should be initiated and the patient should be kept under close supervision.
• If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broadspectrum antibiotics may be indicated.
• Rarely, serious hypersensitivity reactions to Extraneal have been reported such as toxic epidermal necrolysis, angioedema, erythema multiforme and vasculitis. Anaphylactic/anaphylactoid reactions may occur. Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected hypersensitivity reaction develop.
Appropriate therapeutic countermeasures must be instituted as clinically indicated. • Extraneal is not recommended in patients with acute renal failure. • Protein, amino acids, water-soluble vitamins and other medicines may be lost during peritoneal […]