Extraneal Zestav do dializi otzhevnovei

Package Leaflet: Information for the User

EXTRANEAL Peritoneal Dialysis System

Peritoneal Dialysis Solution

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is EXTRANEAL and what is it used for
• 2. Important information before using EXTRANEAL
• 3. How to use EXTRANEAL
• 4. Possible side effects
• 5. How to store EXTRANEAL
• 6. Contents of the pack and other information

1. WHAT IS EXTRANEAL AND WHAT IS IT USED FOR

EXTRANEAL is a peritoneal dialysis solution. The peritoneal cavity is the space inside the abdomen, between the layers of the peritoneum. The peritoneum is a membrane that lines the internal organs, such as the intestines and liver. EXTRANEAL solution is introduced into the peritoneal cavity, from where it removes water and waste products from the blood. It also corrects abnormal concentrations of various blood components. Your doctor may prescribe EXTRANEAL if:

• you are an adult with permanent kidney failure requiring peritoneal dialysis;
• the use of conventional peritoneal dialysis solutions containing glucose does not result in the removal of sufficient amounts of water.

2. IMPORTANT INFORMATION BEFORE USING EXTRANEAL

During the first use of this medicine, the patient must remain under medical supervision.

When not to use EXTRANEAL

• if you are allergic to icodextrin, starch or its derivatives (e.g. corn starch) or any of the other ingredients of EXTRANEAL;
• if you have intolerance to maltose or isomaltose (a sugar derived from starch);
• if you have a disease characterized by abnormal glycogen storage;
• if you have had severe lactic acidosis (too much acid in the blood) in the past;
• if you have a non-resectable abdominal wall or abdominal cavity defect or uncorrectable conditions that increase the risk of intra-abdominal infections;
• if you have documented loss of peritoneal function due to severe peritoneal fibrosis.

Warnings and precautions

Before starting EXTRANEAL, discuss it with your doctor.

• if you are elderly. There is a risk of dehydration.
• if you have diabetes and are using this solution for the first time. You may need to adjust your insulin dose.
• if you need to measure your blood glucose levels (e.g. due to diabetes). Your doctor will advise which test kit to use (see "Other types of interactions").
• if you are at increased risk of developing severe lactic acidosis (too much acid in the blood). The increased risk of lactic acidosis may occur due to:
• severe hypotension or blood infection that may be associated with acute kidney failure;
• inborn metabolic disorders;
• taking metformin (a medicine used to treat diabetes);
• taking HIV medications, especially those called NRTIs (nucleoside reverse transcriptase inhibitors).
• if you experience abdominal pain or notice cloudiness, lack of clarity or sediment in the drained fluid. These may be symptoms of peritonitis or infection. You should contact your healthcare team immediately. You should note the batch number and take the bag with the drained fluid with you. The doctors will decide whether to discontinue treatment or initiate corrective treatment. For example, in the case of an infection, the doctor may order certain tests to determine the best antibiotic. Before determining the type of infection, the doctor may administer a broad-spectrum antibiotic.
• during peritoneal dialysis, the body may lose protein, amino acids, vitamins. Your doctor will decide when they need to be supplemented.
• if you have abdominal wall or abdominal cavity diseases, such as hernia or chronic infections or inflammation of the intestines.
• if you have an aortic vascular prosthesis.
• if you have severe lung disease, such as pulmonary emphysema.
• if you have breathing difficulties.
• if you have conditions that exclude normal nutrition.
• if you have potassium deficiency.

You should also consider that:

• Encapsulating Peritoneal Sclerosis (EPS) is a known, rare complication of peritoneal dialysis treatment. The patient and doctor should be aware of the possibility of this complication. EPS causes:
• inflammation of the abdominal cavity;
• development of a layer of fibrotic tissue that covers and binds the organs, making it difficult for them to move naturally. In rare cases, this has been fatal.
• the patient - and possibly the doctor - should record data on fluid balance and body weight. The doctor will regularly check blood parameters;
• the doctor will regularly check potassium levels. If the level is too low, the doctor may administer potassium chloride to supplement it.

Sometimes, the use of this medicine is not recommended, for example:

• if you have acute kidney disease;

Children
The safety and efficacy of EXTRANEAL in children under 18 years of age have not been established.

EXTRANEAL and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• If you are taking other medicines, your doctor may increase their dose, as peritoneal dialysis increases the elimination of certain medicines.
• Patients taking heart medicines called cardiac glycosides (e.g. digoxin) should be cautious. The heart medicine may be less effective or its toxicity may be increased. In the patient:
• potassium and calcium levels may need to be supplemented;
• heart rhythm disturbances (arrhythmia) may develop. During treatment, the doctor will carefully monitor the patient's condition, especially potassium levels.

Other types of interactions

EXTRANEAL interferes with blood glucose measurement using certain test kits. If blood glucose measurement is necessary, make sure the test kit used is specific for glucose. Your doctor will advise which test kit to use.
Using an inappropriate test may give a falsely high blood glucose reading. This may cause too much insulin to be administered, leading to hypoglycemia (low blood glucose), which can cause loss of consciousness, coma, neurological damage, and death. Additionally, a falsely high blood glucose reading may also mask actual hypoglycemia, which, if left untreated, can have similar effects.
For up to two weeks after stopping EXTRANEAL, blood glucose measurements may give falsely high results. If you are hospitalized, you should inform your doctors about the possibility of this interaction, and they will ensure that the test kit used is specific for glucose.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. EXTRANEAL is not recommended during pregnancy or breastfeeding, unless your doctor decides otherwise.

Driving and using machines

This type of treatment may cause fatigue, weakness, blurred vision, or dizziness. Do not drive or operate machinery if you experience these symptoms.

3. HOW TO USE EXTRANEAL

EXTRANEAL is intended for administration into the peritoneal cavity, which is located in the abdomen, between the layers of the peritoneum. The peritoneum is a membrane that surrounds the internal organs, such as the intestines and liver.
This medicine should always be used exactly as directed by the medical staff specializing in peritoneal dialysis. If you have any questions or doubts, ask your doctor.

Recommended dose is

• One bag per day during the longest dwell exchange, i.e.
• at night in the case of continuous ambulatory peritoneal dialysis (CAPD);
• during the day in the case of automated peritoneal dialysis (APD).
• The recommended volume should be administered over a period of 10 to 20 minutes.
• The dwell time of EXTRANEAL is 6-12 hours in CAPD and 14-16 hours in APD.

Method of administration

Before use,

• Warm the bag to a temperature of 37°C. Use heating plates specifically designed for this purpose. Never immerse the bag in water to heat it.
• During administration of the solution, use aseptic techniques, as per training.
• Before starting the exchange, make sure your hands and the area where the exchange will be performed are clean.
• Before opening the protective bag, check the type of solution, expiration date, and quantity (volume). Lift the dialysis bag and check for leaks (presence of fluid in the protective bag). Do not use if the bag is leaking.
• After removing the protective bag, check the container for leaks by firmly squeezing the bag. Do not use if the bag is leaking.
• Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.
• Before starting the exchange, make sure all connections are secure.
• You should ask your doctor if you have any questions or doubts about this product or its use.

The bag can only be used once. Any unused solution should be discarded.
After use, check if the drained fluid is not cloudy.

Compatibility with other medicines

Your doctor may prescribe other medicines to be administered by injection directly into the EXTRANEAL fluid bag. You should then add the medicine through the medication port (valve) located at the bottom of the bag. The product should be used immediately after adding the medicine. If you have any doubts, ask your doctor.

In case of administration of more than one EXTRANEAL bag in 24 hours

If you take too much EXTRANEAL, you may experience:

• abdominal swelling;
• a feeling of fullness and/or
• shortness of breath.

You should contact your doctor immediately. Your doctor will advise you on what to do.

Discontinuation of EXTRANEAL

You should not stop peritoneal dialysis without your doctor's consent. Stopping treatment may cause life-threatening effects.

4. POSSIBLE SIDE EFFECTS

Like all medicines, EXTRANEAL can cause side effects, although not everybody gets them.
If you experience any side effects, including those not listed in this package leaflet, tell your doctor.
If you experience any of the following side effects, tell your doctor or contact the peritoneal dialysis center immediately:

• hypertension (high blood pressure);
• edema of the ankles or feet, swollen eyes, shortness of breath or chest pain (hypervolemia);
• hypersensitivity (allergic reaction), which may manifest as swelling of the face, throat, or swelling around the eyes (angioedema);
• abdominal pain;
• chills (chills/flu-like symptoms). These may be symptoms of serious side effects. You may need urgent medical attention.

Common side effects (occurring in 1 in 10 people) in patients using EXTRANEAL:
include:

• redness and peeling of the skin, rash, itching (pruritus);
• feeling of emptiness in the head or dizziness, thirst (dehydration);
• decreased blood volume (hypovolemia);
• abnormal laboratory test results;
• weakness, headache, feeling of fatigue;
• edema of the ankles or feet;
• low blood pressure (hypotension);
• ringing in the ears;

Other side effects related to peritoneal dialysis or occurring frequently after administration of other peritoneal dialysis solutions:
include:

• cloudy drained fluid from the peritoneum, abdominal pain;
• peritoneal bleeding, presence of pus, swelling, pain, or infection around the catheter exit site, catheter blockage, injury, interactions related to the presence of the catheter;
• low blood sugar (hypoglycemia);
• shock or coma caused by low blood sugar;
• high blood sugar (hyperglycemia);
• nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhea, bloating (gas), gastrointestinal disorders such as intestinal obstruction, stomach ulcer, gastritis, indigestion;
• abdominal swelling, hernia in the abdominal cavity (causing lumps in the groin);
• changes in blood test results;
• abnormal liver function test results;
• weight gain or loss;
• pain, fever, malaise;
• heart disease, rapid heartbeat, shortness of breath, or chest pain;
• anemia (reduced red blood cell count, which can cause pale skin and shortness of breath and weakness); increased or decreased white blood cell count; decreased platelet count, which increases the risk of bleeding or bruising;
• numbness, tingling, or burning sensation;
• hyperkinesia (increased movement and inability to remain still);
• blurred vision;
• loss of taste;
• fluid in the lungs (pulmonary edema), shortness of breath, difficulty breathing, or wheezing, cough, hiccups;
• kidney pain;
• nail disorders;
• skin disorders such as hives, psoriasis, skin ulcers, rash, dry skin, skin discoloration, blistering of the skin, allergic or contact dermatitis, rash, or itching;
• rash with possible itching, with red spots covered with bumps or with peeling of the skin. Three types of severe skin reactions may occur:
• toxic epidermal necrolysis (TEN). It causes:
• red rash on many parts of the body
• peeling of the outer layer of the skin
• erythema multiforme. An allergic skin reaction characterized by spots with red borders or areas in purple color, or covered with blisters. It may also affect the mouth, eyes, and other moist surfaces of the body;
• vasculitis. Inflammation of some blood vessels. Clinical symptoms depend on the part of the body affected, but may appear on the skin as red or purple bumps or spots, or have a similar appearance to an allergic reaction, including rash, joint pain, and fever.
• muscle cramps, bone pain, joint pain, muscle pain, back pain, neck pain;
• drop in blood pressure when standing up (orthostatic hypotension);
• peritonitis, including peritonitis caused by fungal or bacterial infections;
• infections, including flu-like syndrome, or boils;
• disorders of thinking, anxiety, nervousness.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE EXTRANEAL

• Store out of sight and reach of children.
• Store in the original packaging.
• Do not store below 4°C.
• Do not use EXTRANEAL after the expiration date. The expiration date is stated on the carton and on the bag, after the term "Exp. date" and the symbol . The expiration date refers to the last day of the given month.
• EXTRANEAL should be disposed of in accordance with the instructions received during training.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The package leaflet does not contain all the information about the medicine. If you have any further questions or doubts, ask your doctor.

What EXTRANEAL contains

The active substances of the medicine are:
Other ingredients of the medicine are:

• water for injection;
• sodium hydroxide or hydrochloric acid.

What EXTRANEAL looks like and what the pack contains

• EXTRANEAL is packaged in flexible plastic bags with a capacity of 1.5 liters, 2.0 liters, or 2.5 liters.
• The solution in the bags is clear and colorless.
• Each bag is placed in an outer protective bag and is supplied in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Vantive Belgium SRL
Boulevard d’Angleterre 2
1420 Braine-l’Alleud
Belgium

Manufacturer

Vantive Manufacturing Limited
Moneen Road
Castlebar, County Mayo
Ireland
Date of last revision of the package leaflet:July 2024
Vantive and Extraneal are trademarks of Vantive Health Inc. or its affiliates.