Phisioneal 40 Clear-flex

Leaflet accompanying the packaging: information for the user

PHYSIONEAL 40 CLEAR-FLEX, glucose 13.6 mg/ml, peritoneal dialysis solution

PHYSIONEAL 40 CLEAR-FLEX, glucose 22.7 mg/ml, peritoneal dialysis solution

PHYSIONEAL 40 CLEAR-FLEX, glucose 38.6 mg/ml, peritoneal dialysis solution

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. See section 4.

Table of contents of the leaflet:

• 1. What is PHYSIONEAL 40 and what is it 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 packaging and other information

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

PHYSIONEAL 40 is a peritoneal dialysis solution. 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 more water can be removed from the blood. PHYSIONEAL 40 is used in the following cases:

• transient or permanent kidney failure;
• severe water retention in the body;
• severe acid-base or electrolyte disturbances in the blood;
• certain types of drug poisoning, when other treatment methods cannot be used.

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

2. Important information before using PHYSIONEAL 40

The first use of the product must be under the supervision of a doctor.

When not to use PHYSIONEAL 40

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

• in children requiring filling volumes less than 1600 ml.

Warnings and precautions

Before use:

• mix the contents of both compartments by opening the long weld;
• then open the short SafetyMoon weld;
• not draining the unmixed solution will cause an increase in the concentration of salts and other chemicals in the blood. This will cause side effects such as confusion, drowsiness, and irregular heart rhythm.

Before using PHYSIONEAL 40, you should talk to your doctor. You should be particularly careful:

• severe drop in blood pressure;
• blood infection;
• acute kidney failure;
• congenital metabolic disorders;
• taking metformin (a medicine used to treat diabetes);
• taking medicines used to treat HIV infection, especially those called NRTIs (nucleoside reverse transcriptase inhibitors).
• in patients with diabetes using this peritoneal dialysis solution, the doses of medicines regulating blood glucose levels (e.g., insulin) should be systematically checked. The dose of antidiabetic medicines may need to be adjusted, especially at the beginning of peritoneal dialysis treatment or in case of changes in peritoneal dialysis treatment.
• in patients with a corn allergy, which can cause hypersensitivity reactions, including severe allergic reactions called anaphylaxis. The infusion should be stopped immediately and the solution should be drained from the abdominal cavity.
• in patients with high parathyroid hormone levels in the blood due to kidney disease. The low calcium level in PHYSIONEAL 40 may exacerbate hyperparathyroidism. The doctor will check the parathyroid hormone level in the patient's blood.
• the patient - if possible in agreement with the doctor - should keep a written record of fluid and body weight balance. The doctor will systematically check the patient's blood parameters, especially the levels of salts (e.g., bicarbonate, potassium, magnesium, calcium, and phosphates), parathyroid hormone, and lipids.
• you should not use a larger volume of solution than recommended by the doctor. Symptoms of excessive infusion include abdominal distension, feeling of fullness, and shortness of breath.
• the doctor will systematically check the patient's potassium level. If it decreases too much, the doctor may prescribe potassium chloride to supplement the deficiency.
• improper connection or filling sequence can lead to air entering the abdominal cavity, which can cause abdominal pain and/or peritonitis.
• a disease called encapsulating peritoneal sclerosis (EPS) is a known, though rare, complication of peritoneal dialysis treatment. The patient and doctor should be aware of the possibility of this complication. EPS causes:
• inflammation in the abdominal area;
• thickening of the intestinal walls, which may be accompanied by abdominal pain, abdominal distension, or vomiting. EPS can be fatal.

Children
The doctor will assess the risk versus benefit of using this medicine in patients under 18 years of age.

PHYSIONEAL 40 and other medicines

• You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
• If you are taking other medicines, your doctor may need to increase their doses, as peritoneal dialysis treatment increases the excretion of some medicines.
• You should be careful if you are taking cardiac glycosides (e.g., digoxin), as:
• potassium and calcium supplements may be needed;
• heart rhythm disturbances (arrhythmia) may occur;
• during treatment, the patient will be under close medical supervision, especially with regard to potassium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor before using this medicine. PHYSIONEAL is not recommended for use during pregnancy or breastfeeding, unless the doctor decides otherwise.

Driving and using machines

This type of treatment can cause weakness, blurred vision, or dizziness. You should not drive vehicles or operate machinery if you experience such symptoms.

3. How to use PHYSIONEAL 40

PHYSIONEAL 40 is intended for administration into the peritoneal cavity. This is the space in the abdominal cavity (abdomen) between the skin and the peritoneum. The peritoneum is a membrane surrounding the internal organs, such as the intestines and liver.
This solution is not intended for intravenous administration.
This medicine should always be used in accordance with the instructions of the medical team specializing in peritoneal dialysis. In case of doubts, you should consult a doctor.
In case of bag damage, it should be discarded.

In what doses and how often to use PHYSIONEAL 40

The doctor will recommend the appropriate glucose concentration and number of bags for daily use.

Use in children and adolescents

In patients under 18 years of age, the doctor will assess the possibility of using this medicine with due care.

Discontinuation of PHYSIONEAL 40

You should not stop peritoneal dialysis without the doctor's consent. Discontinuation of treatment may have life-threatening consequences.

Method of administration

Before use:

• Warm the bag to a temperature of 37°C. For this purpose, a special heating plate should be used. The bag should never be immersed in water. A microwave oven should not be used to heat the bag.
• During administration of the solution, aseptic techniques should be used, in accordance with training.
• Before starting the exchange, make sure your hands and the place 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 if it is leaking (excess 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. Check if the long and short welds are completely closed. If any of the welds are open, even partially, the bag should be discarded. Do not use the bag if leakage is detected.
• Check if 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.
• Mix the contents of both compartments thoroughly by opening the long weld first, and then the short SafetyMoon weld.
• You should consult a doctor in case of any questions or doubts about this medicine or its use.
• Each bag is intended for single use only. Any unused solution should be discarded.
• The solution must be administered within 24 hours of mixing. After use, check if the drained fluid is not cloudy.

Compatibility with other medicines

The doctor may prescribe other medicines in a form intended for injection, to be added directly to the PHYSIONEAL 40 bag. In such a case, the medicine should be added through the medication addition site, located on the large compartment, before opening the long weld. The medication addition site should be disinfected immediately before injection. After adding the medicine, the product should be used immediately. In case of doubts, you should consult a doctor.

Use of more than the recommended number of PHYSIONEAL 40 bags within 24 hours

In case of administration of too much PHYSIONEAL 40, the following may occur:

• abdominal distension;
• feeling of fullness and/or
• shortness of breath. You should contact your doctor immediately. The doctor will recommend further action. In case of any further doubts related to the use of the medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should immediately inform your doctor or the center performing peritoneal dialysis treatment:

• hypertension (blood pressure higher than usual);
• hyperolemia: 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 side effects. Immediate medical intervention may be necessary.

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or contact the center performing peritoneal dialysis treatment.

Frequent (occurring in 1 in 10 people)

• Changes in blood test results:
• increased calcium levels (hypercalcemia);
• decreased potassium levels (hypokalemia), which can cause muscle weakness, muscle tremors, or heart rhythm disturbances;
• increased bicarbonate levels (alkalosis);
• Weakness, fatigue;
• Fluid retention (edema);
• Weight gain.

Uncommon (occurring in 1 in 100 people)

• decreased volume of fluid removed during dialysis;
• fainting, dizziness, or headache;
• cloudiness of the solution drained from the peritoneum, abdominal pain;
• bleeding from the peritoneum, pus, swelling, or pain at the catheter exit site, catheter obstruction;
• nausea, loss of appetite, indigestion, bloating with gas, thirst, dry mouth;
• abdominal distension or inflammation, shoulder pain, abdominal hernia (inguinal lump);
• changes in blood test results:
• lactic acidosis,
• increased carbon dioxide content,
• increased sugar levels (hyperglycemia),
• increased white blood cell count (eosinophilia);
• sleep disorders;
• low blood pressure (hypotension);
• cough;
• muscle and bone pain;
• swelling of the face or throat;
• rash.

Other side effects related to the peritoneal dialysis procedure

• infection around the catheter exit site, catheter obstruction.

Reporting side effects

If you experience any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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 PHYSIONEAL 40

• The medicine should be stored in a place invisible and inaccessible to children.
• Do not store at a temperature below 4°C.
• Do not use this medicine after the expiration date stated on the box and on the bag after "EXP" and the symbol . The expiration date refers to the last day of the specified month.

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

6. Contents of the packaging and other information

This leaflet does not contain all the information about the medicine. If you have any questions or doubts, you should consult a doctor.

What PHYSIONEAL 40 contains

Active substances in the peritoneal dialysis solution after mixing:

Other ingredients are: water for injections, sodium hydroxide, hydrochloric acid.
Composition of the solution after mixingin mmol/l:

What PHYSIONEAL 40 CLEAR-FLEX looks like and what the packaging contains

• PHYSIONEAL 40 is a clear, colorless, and sterile peritoneal dialysis solution.
• PHYSIONEAL 40 is in a two-compartment bag, not containing PVC. The two compartments are separated by non-permanent welds. PHYSIONEAL 40 should only be administered after thorough mixing of the contents of both compartments. Only then should the short SafetyMoon weld be opened.
• Each bag is packaged in a protective bag and delivered in cardboard boxes.

Volume
Number of bags in
the box
Product configuration
Connector type
(connectors)
1.5 l
5 / 6
Single bag
(ADO)
Luer
1.5 l
5 / 6
Double bag
(CADO)
Luer
2.0 l
4 / 5
Single bag
(ADO)
Luer
2.0 l
4 / 5
Double bag
(CADO)
Luer
2.5 l
3 / 4
Single bag
(ADO)
Luer
2.5 l
3 / 4
Double bag
(CADO)
Luer
3.0 l
3
Single bag
(ADO)
Luer
3.0 l
3
Double bag
(CADO)
Luer
4.5 l
2
Single bag
(ADO)
Luer
Luer/Luer and
Homechoice set for
ADO Luer
5.0 l
2
Single bag
(ADO)
Not all types of connectors and packaging sizes must be on the market.

Marketing authorization holder and manufacturer

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
Bieffe Medital S.p.A
Via Nuova Provinciale
23034 Grosotto
Italy

This medicinal product is authorized for marketing in the Member States of 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
Date of leaflet approval:July 2024
Vantive, Physioneal, and Clear-Flex are trademarks of Vantive Health Inc. or its subsidiaries.