EXTRANEAL (ICODEXTRIN 7.5%) Icodextrin

Consumer Medicine Information

Blood glucose management with BEFORE THE USE OF • Use cardiac glycosides, such as Extraneal must be done with a EXTRANEAL digoxin. Your doctor may need to glucose-specific method to avoid FORMULA monitor your blood levels of interference resulting in calcium, potassium and unrecognised hypoglycemia. If magnesium. non-specific glucose test methods (GDH-PQQ) are used, loss of Do not use Extraneal if: Tell your doctor if you have had abdominal (stomach area): consciousness, neurological You have a known allergy to any of damage and death may occur. the ingredients listed at the end of • Surgery in the past 30 days this leaflet or to starch. • Tumors • You have a glycogen storage disease. Open wounds • Hernia WHAT IS IN THIS Additionally tell your doctor if you LEAFLET have recently had surgery on your Use during pregnancy or stomach or if you have any other breastfeeding Extraneal is not recommended if you This leaflet answers some more stomach complaints. common questions about are pregnant or breastfeeding. Your doctor should make sure that you are Extraneal. It does not contain all of Precautions: the available information. not pregnant before using Extraneal. Blood glucose measurement must be If you are of child bearing age, you All medicines have risks and done with a glucose-specific method must use a reliable method of birth benefits. Your doctor has weighed to prevent maltose interference with control while using Extraneal. the risks of you taking Extraneal test results. Since falsely elevated against the benefit they expect it will Use on the elderly glucose levels have been observed have for you. Extraneal has not been shown to with blood glucose monitoring cause different side effects or It does not take the place of talking to devices and test strips that use problems in older people than it does your doctor. glucose dehydrogenase in younger adults. If you have any concerns about pyrroloquinolinequinone (GDH Paediatric use taking the medicine, ask your doctor PQQ)-based methods, GDH PQQ- Extraneal is not recommended in or renal nurse. based methods should not be used to measure glucose levels in patients children less than 18 years. Keep this leaflet with the medicine, administered EXTRANEAL. Potential effects of this product on as you may need to read it again. Tell your doctor if you: the ability to drive vehicles or operate machinery • Have a condition that restricts Use of this product will not affect normal nutrition (you do not eat your ability to drive or operate WHAT EXTRANEAL IS well) machinery. USED FOR • Have a lung or breathing problem You will not however be able to • Have low potassium levels in drive nor operate machinery whilst Extraneal is used as a replacement your blood you are administering this product. for a single glucose exchange (e.g. • Have high calcium levels in your Dianeal product), as part of a blood Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) regimen for chronic renal failure.

EXTRANEAL (ICODEXTRIN 7.5%) Published by MIMS October 2014 1 Interaction with other medicines How to use Extraneal Duration of treatment, if limitable: Treatment with cardiac glycosides Formula properly This will be determined by your may be affected if taken whilst using doctor. Extraneal. Your doctor will carefully What to do if more than 1 dose is monitor your blood to determine if How much to use: missed: dialysis is affecting the level of drugs Please contact your doctor for further in your system. Your doctor will decide the dosage of Extraneal. For adult patients of advice. Blood Glucose Testing normal body size, the instilled How should treatment be stopped, It should be noted that Extraneal may volume should not exceed 2.0 litres. if treatment may lead to interfere with the measurement of If this causes stomach pain a smaller withdrawal or other adverse blood glucose by certain testing kits volume should be used. events: (including the test strips). A falsely Extraneal should not cause symptoms high glucose might be found. If you How is Extraneal given: of withdrawal. If you suffer from an need to test your blood glucose, your adverse event, your doctor may physician will advise you on which Extraneal should be introduced into decide to discontinue Extraneal kit to use. your peritoneal cavity in around 10- treatment. 20 minutes at a rate that you find Special Warnings: most comfortable. It is recommended that Extraneal remains in your body There have been reported deaths for between 6 and 12 hours in CAPD Side Effects associated with hypoglycaemia and and 14-16 hours in APD. Drainage of hypoglycaemic incidents that have the fluid is by gravity at a rate Undesirable effects of peritoneal resulted in permanent neurological comfortable for you. The drained dialysis include procedure and damage. This is a result of falsely fluid should be checked for visible solution related problems. high blood glucose readings due to matter and cloudiness. If cloudy, the interaction between Icodextrin consult your doctor or renal nurse. Procedure related side effects and its by-products and glucometers include: abdominal pain, bleeding, To do your EXTRANEAL exchange, that use pyrroloquinolinequinone peritonitis, infection around the you should follow the steps learned (GDH-PQQ) for measuring blood catheter and catheter blockage. glucose. Blood glucose measurement in your peritoneal dialysis training. It Solution related side effects include: in patients receiving EXTRANEAL is very important that you follow the electrolyte and fluid imbalances, must be done with a glucose specific steps shown to you in your peritoneal blood volume changes, blood method (monitor and test strips) to dialysis training. All surfaces and pressure changes, muscle cramping avoid interference by maltose, connecting parts must be clean to and rashes. released from EXTRANEAL. avoid serious infection. If you need Glucose dehydrogenase more help or have any questions you Potential effects of female and male pyrroloquinolinequinone (GDH should contact your dialysis centre or fertility are unknown. doctor. PQQ)-based methods must not be Should you suffer any of the above used. The manufacturer(s) of the Make sure that the solution is clear or any other side effects please monitor and test strips should be and does not contain particles. Do inform your doctor or renal nurse. contacted to determine if Icodextrin not use bags that are cloudy, leaking or maltose causes interference or or that contain particles. falsely elevated glucose results. The bag of Extraneal may be warmed Extraneal should not be used if you to body temperature prior to use, OVERDOSE have been diagnosed with acute renal using a warming device designed for failure. the purpose. The bag should not be You should not use more than one immersed in water nor should it be bag of Extraneal per 24 hours. If you microwaved in order to warm. have repetitively used more than one Frequency of administration and if bag per 24 hours, you should consult applicable most appropriate time your doctor as it may affect levels of to administer Extraneal: Icodextrin metabolites in your blood. This product is designed to replace The doctor will ultimately decide if one of your daily glucose exchanges. any corrective treatment is necessary. Extraneal is recommended for use overnight in CAPD and during the day APD.

EXTRANEAL (ICODEXTRIN 7.5%) Published by MIMS October 2014 2 STORAGE Where do you go for further CONDITIONS information You should consult your doctor to Extraneal has a shelf life of 2 years at discuss any aspect of your treatment. temperatures below 30°C.

The product should not be stored Manufacturer below 4°C. Extraneal is manufactured in Do not use the product after the Australia by expiry date shown on the product Baxter Healthcare Pty Ltd., label. 1 Baxter Drive, Keep out of reach of children. Old Toongabbie, NSW 2146, The product should be used once Australia. only. Any unused portion of dialysate Australian Registration should be discarded. Number Extraneal (Icodextrin 7.5%) AUST R: • Single Bag 91344 PRODUCT • DESCRIPTION Twin Bag 91430 This leaflet was prepared in November 1998. What Extraneal looks like Latest revision: 21 September 2011

Extraneal is a sterile solution for 88-19-01-086B intra-peritoneal administration. It is Baxter Extraneal and Dianeal are in a flexible plastic container with or registered trademarks of Baxter without a second plastic bag attached International Inc. for drainage. It is available in the following bag size: 2.5 litres.

Ingredients

The active ingredients and excipients of Extraneal formulated in each one litre are listed below. Active Constituents • Icodextrin - 75g • Sodium Chloride - 5.4g • Sodium Lactate - 4.5g • Calcium Chloride - 257mg • Magnesium Chloride - 51mg Other Ingredients • Water for injections - q.s. • Sodium Hydroxide - For pH adjustment • Hydrochloric Acid - For pH adjustment

EXTRANEAL (ICODEXTRIN 7.5%) Published by MIMS October 2014 3