Physioneal 40 clear-flex

Patient Information Leaflet: Read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor. See section 4.

Table of contents:

1. What PHYSIONEAL 40 is and what it is used for
2. Important information before using PHYSIONEAL 40
3. How to use PHYSIONEAL 40
4. Possible side effects
5. How to store PHYSIONEAL 40
6. Contents of the pack and other information

1. What PHYSIONEAL 40 is and what it is used for

PHYSIONEAL 40 is a solution for peritoneal dialysis. It removes water and excess waste products from the blood. It also corrects abnormal levels of various blood components.
PHYSIONEAL 40 contains different concentrations of glucose (1.36%, 2.27%, or 3.86%). The higher the glucose concentration in the solution, the greater the amount of water that can be removed from the blood.
PHYSIONEAL 40 is used in the following conditions:

• Transient or chronic kidney failure;
• Severe fluid retention in the body;
• Severe disturbances in blood acidity or alkalinity (pH) and electrolyte levels;
• Certain types of drug poisoning, when other treatment methods cannot be used.

The pH of the PHYSIONEAL 40 solution is close to the pH of blood. Therefore, it is particularly recommended for patients who experience pain or discomfort during the filling phase when using other dialysis solutions with higher acidity.

2. Important information before using PHYSIONEAL 40

The first use of the product must be performed under medical supervision.
When NOT to use PHYSIONEAL 40

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a disorder affecting the abdominal wall or peritoneal cavity that cannot be surgically corrected or another disorder that cannot be corrected and which increases the risk of peritoneal infections;
• if the patient has documented loss of peritoneal function due to extensive peritoneal adhesions.

Sometimes the use of PHYSIONEAL 40 in the CLEAR-FLEX container is not recommended:

• in children requiring fill volumes less than 1600 ml.

Warnings and precautions
Before use:

• mix the contents of both chambers by opening the long seal;
• then open the short SafetyMoon seal;
• if an unmixed solution is infused (the long seal between chambers has not been opened), abdominal pain may occur. The solution should be drained immediately, a new bag with properly mixed solution should be used, and the physician should be contacted promptly.
• failure to drain the unmixed solution will increase blood concentrations of salts and other chemicals, leading to adverse effects such as confusion, drowsiness, and irregular heartbeat.

Before using PHYSIONEAL 40, speak with your doctor.
Exercise particular caution:

• if the patient has serious disorders affecting the abdominal wall or peritoneal cavity. For example, if the patient has a hernia, chronic inflammatory condition, or infection affecting the intestines.
• if the patient has undergone an aortic transplant;
• if the patient has significant breathing difficulties;
• if the patient experiences abdominal pain, elevated body temperature, or observes cloudiness or particles in the drained fluid. These may be signs of peritonitis or infection. Contact the medical team immediately. Record the batch number of the peritoneal dialysis bags used and present it to the medical team along with the bag containing the drained fluid. The medical team will decide whether treatment should be discontinued or appropriate therapy initiated. For example, if infection occurs, the doctor may perform certain tests to best select the appropriate antibiotic. Pending identification of the causative organism, the doctor may prescribe a broad-spectrum antibiotic effective against many types of bacteria.
• if the patient has high blood lactate levels. Increased risk of lactic acidosis may occur due to:
• severe hypotension;
• blood infection (sepsis);
• acute kidney failure;
• inherited metabolic disorders;
• use of metformin (a drug used to treat diabetes);
• use of medications used to treat HIV infection, especially drugs known as NRTIs (nucleoside reverse transcriptase inhibitors).
• in diabetic patients using this solution for dialysis, doses of glucose-regulating medications (e.g., insulin) should be monitored regularly. Doses of antidiabetic medications may require adjustment, especially at the beginning of peritoneal dialysis treatment or when changes occur in peritoneal dialysis regimen.
• in patients with corn allergy, which may cause hypersensitivity reactions, including severe allergic reactions known as anaphylaxis. Infusion should be stopped immediately and the solution drained from the peritoneal cavity.
• in patients with high blood parathyroid hormone (PTH) levels due to kidney disease. The low calcium concentration in PHYSIONEAL 40 may exacerbate hyperparathyroidism. The doctor will monitor the patient's blood parathyroid hormone levels.
• the patient—whenever possible in consultation with the doctor—should keep a written fluid and body weight balance record. The doctor will regularly monitor blood parameters, especially levels of electrolytes (e.g., bicarbonate, potassium, magnesium, calcium, and phosphates), parathyroid hormone, and lipids.
• if the patient has high blood bicarbonate levels;
• do not use a larger volume of solution than prescribed by the doctor. Symptoms of excessive infusion include abdominal distension, feeling of fullness, and shortness of breath.
• the doctor will regularly monitor the patient's potassium levels. If potassium levels drop too low, the doctor may prescribe potassium chloride supplementation.
• incorrect sequence of connection or filling may lead to air entering the peritoneal cavity, which may cause abdominal pain and/or peritonitis.
• a condition called encapsulating peritoneal sclerosis (EPS) is a known, although rare, complication of peritoneal dialysis treatment. The patient and doctor should be aware of the possibility of this complication. EPS causes:
• inflammation within the abdomen;
• thickening of intestinal walls, which may be accompanied by abdominal pain, distension, or vomiting. EPS can be fatal.

Children
The doctor will assess the risks versus benefits of using this medicine in patients under 18
years of age.
PHYSIONEAL 40 and other medicines

• Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
• If the patient is taking other medicines, the doctor may need to increase their doses, because peritoneal dialysis treatment increases the elimination of certain drugs.
• Exercise caution if the patient is taking heart medications known as cardiac glycosides (e.g., digoxin), because:
• potassium and calcium supplementation may be required;
• cardiac arrhythmias may occur;
• during treatment, the patient will be under close medical supervision, with particular attention to potassium levels.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine. PHYSIONEAL is not recommended during pregnancy or breastfeeding unless otherwise decided by the doctor.
Driving and operating machinery
This type of treatment may cause weakness, blurred vision, or dizziness. Do not drive or operate machinery if experiencing such symptoms.

3. How to use PHYSIONEAL 40

PHYSIONEAL 40 is intended for administration into the peritoneal cavity. This is the space within the abdominal cavity (abdomen) located between the skin and the peritoneum. The peritoneum is the membrane surrounding internal organs such as the intestines and liver.
This solution is not intended for intravenous administration.
This medicine should always be used according to the instructions provided by the medical team specializing in peritoneal dialysis. In case of doubt, consult your doctor.
If the bag is damaged, it must be discarded.

Dosage and frequency of administration
Your doctor will determine the appropriate glucose concentration and the number of bags to be used daily.

Use in children and adolescents
In patients under 18 years of age, the doctor will carefully assess the suitability of using this medicine.

Discontinuing treatment with PHYSIONEAL 40
Do not stop peritoneal dialysis without consulting your doctor. Discontinuation of treatment may have life-threatening consequences.

Method of administration
Before use:

• Warm the bag to a temperature of 37°C using a special heating pad. Never immerse the bag in water. Do not use a microwave oven to heat the bag.
• During administration of the solution, aseptic techniques must be followed as instructed during training.
• Before starting an exchange, ensure that your hands and the area where the exchange will be performed are clean.
• Before opening the protective bag, check the solution type, expiry date, and quantity (volume). Hold the dialysis bag upright and check for leakage (excess fluid in the protective bag). Do not use if the bag is leaking.
• After removing the protective bag, check the container for leakage by firmly squeezing the bag. Check that both the long and short seals are completely closed. If either seal is open, even partially, discard the bag. Do not use the bag if leakage is detected.
• Check whether the solution is clear. Do not use the bag if the solution is cloudy or contains particles.
• Before starting the exchange, ensure that all connections are secure.
• Mix the contents of both compartments thoroughly by first opening the long seal, then the short SafetyMoon seal.
• Consult your doctor if you have any questions or doubts regarding this medicine or its method of administration.
• Each bag is for single use only. Any unused portion of the solution must be discarded.
• The solution must be administered within 24 hours after mixing. After use, check whether the drained fluid is cloudy.

Compatibility with other medicines
Your doctor may prescribe additional medications in injectable form to be added directly to the PHYSIONEAL 40 bag. In such cases, the medication should be added through the medication addition site located on the large compartment, immediately before opening the long seal. The medication addition site must be disinfected immediately before injection. After adding the medication, the product should be used immediately. In case of doubt, consult your doctor.

Use of more than the recommended number of PHYSIONEAL 40 bags within 24 hours
If an excessive amount of PHYSIONEAL 40 is administered, the following may occur:

• abdominal distension;
• sensation of fullness, and/or
• shortness of breath.

Contact your doctor immediately. The doctor will advise on further management. If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the symptoms listed below occur, contact your doctor or the centre managing your peritoneal dialysis treatment immediately:

• Hypertension (blood pressure higher than usual);
• Hypervolaemia: swelling of the ankles or legs, swelling of the eyelids, shortness of breath or chest pain;
• Abdominal pain;
• Chills (flu-like symptoms), fever;
• Peritonitis. These are serious adverse reactions. Immediate medical intervention may be required.

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or contact the centre managing your peritoneal dialysis treatment.
Common (affects 1 in 10 people)

• Changes in blood test results:
• increased calcium levels (hypercalcaemia);
• decreased potassium levels (hypokalaemia), which may cause muscle weakness, muscle twitching or heart rhythm disturbances;
• increased bicarbonate levels (metabolic alkalosis);
• Weakness, fatigue;
• Fluid retention (oedema);
• Weight gain.

Uncommon (affects 1 in 100 people)

• Reduced volume of fluid drained during dialysis;
• Fainting, dizziness or headache;
• Cloudy dialysate effluent, abdominal pain;
• Bleeding from the peritoneum, discharge, swelling or pain at the catheter exit site, catheter blockage;
• Nausea, loss of appetite, indigestion, bloating with increased flatus, thirst, dry mouth;
• Distension or inflammation in the abdominal area, shoulder pain, hernia (inguinal swelling);
• Changes in blood test results:
• lactic acidosis,
• increased carbon dioxide levels,
• increased blood sugar levels (hyperglycaemia),
• increased white blood cell count (eosinophilia);
• Sleep disturbances;
• Low blood pressure (hypotension);
• Cough;
• Muscle and bone pain;
• Facial or throat swelling;
• Rash.

Other adverse reactions associated with the peritoneal dialysis procedure

• Infection around the catheter exit site, catheter blockage.

Reporting of adverse reactions
If any adverse reactions not listed in this leaflet occur, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine PHYSIONEAL 40

• Keep the medicine out of the sight and reach of children.
• Do not store at temperatures below 4°C.
• Do not use this medicine after the expiry date stated on the carton and bag following “Expiry date” and the symbol . The expiry date refers to the last day of the stated month.

PHYSIONEAL 40 must be disposed of in accordance with the instructions provided during training.

6. Contents of the pack and other information

This leaflet does not contain all information about the medicine. If you have any questions or
doubts, please consult your doctor.
What the medicine PHYSIONEAL 40 contains
Active substances in the peritoneal dialysis solution after mixing:

The other ingredients are: water for injections, sodium hydroxide, hydrochloric acid.
Composition of the solution after mixing in mmol/l:

What PHYSIONEAL 40 CLEAR-FLEX looks like and contents of the pack

• PHYSIONEAL 40 is a clear, colourless, sterile dialysis solution for peritoneal dialysis.
• PHYSIONEAL 40 is supplied in a dual-chamber, non-PVC bag. The two chambers are separated by temporary seals. PHYSIONEAL 40 must only be administered after complete mixing of the contents of both chambers. Only then should the short SafetyMoon seal be opened.
• Each bag is packed in a protective overwrap and supplied in cardboard boxes.

Volume Number of bags in Configuration of the product Type of connector
the box (connectors)
1.5 l 5 / 6 Single bag Luer
(ADO)
1.5 l 5 / 6 Double bag Luer
(CADO)
2.0 l 4 / 5 Single bag Luer
(ADO)
2.0 l 4 / 5 Double bag Luer
(CADO)
2.5 l 3 / 4 Single bag Luer
(ADO)
2.5 l 3 / 4 Double bag Luer
(CADO)
3.0 l 3 Single bag Luer
(ADO)
3.0 l 3 Double bag Luer
(CADO)
4.5 l 2 Single bag Luer
(ADO)
5.0 l 2 Single bag Luer/Luer and
(ADO) Homechoice set for
ADO Luer
Not all connector types and pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturer
Vantive Manufacturing Limited Bieffe Medital S.p.A
Moneen Road Via Nuova Provinciale
Castlebar 23034 Grosotto
County Mayo Italy
Ireland

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom: PHYSIONEAL 40 CLEAR-FLEX
Italy: FIXIONEAL 40

Vantive, Physioneal and Clear-Flex are trademarks of Vantive Health Inc. or its affiliates.