Physioneal 40 with glucose 2.27 w/v 22.7 mg/ml

Package leaflet: Information for the user

PHYSIONEAL 40 with glucose 1.36% w/v 13.6 mg/ml, solution for peritoneal dialysis
PHYSIONEAL 40 with glucose 2.27% w/v 22.7 mg/ml, solution for peritoneal dialysis
PHYSIONEAL 40 with glucose 3.86% w/v 38.6 mg/ml, solution for peritoneal dialysis
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• 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 adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Contents of the leaflet:

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 permanent kidney failure;
• Significant 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 that 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 this medicine must be carried out under medical supervision.
When not to use PHYSIONEAL 40 solution

• If the patient is allergic to the active substances or to any of the other components 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 any other uncorrectable disorder increasing the risk of peritoneal infections.
• if the patient has documented loss of peritoneal function due to extensive peritoneal adhesions.

Warnings and precautions

Before starting treatment with PHYSIONEAL 40, discuss this with your doctor.
Exercise special caution:

• if the patient has serious disorders affecting the condition of the abdominal wall or peritoneal cavity. For example, if the patient has a hernia, or chronic inflammatory or infectious conditions affecting the intestines.
• if the patient has undergone arterial grafting in the aortic region;
• if the patient has breathing difficulties;
• if the patient experiences abdominal pain, elevated body temperature, or if the drained fluid appears cloudy, non-transparent, or contains particles. These may be signs of peritonitis or infection. Contact the medical team responsible for the patient's care immediately. Record the product batch number and present it to the medical team along with the bag containing the drained fluid. The medical team will decide whether treatment should be suspended or corrective therapy initiated. For example, in case of infection, the doctor may perform certain tests to best select the appropriate antibiotic. Until the type of infection is identified, the doctor may prescribe an antibiotic effective against many different bacteria. This is known as a broad-spectrum antibiotic.
• if the patient has high blood lactate levels. Increased risk of lactic acidosis may occur due to: o severe drop in blood pressure or blood infection (septicaemia), which may be associated with acute kidney failure; o inherited metabolic disorders; o use of metformin (a medicine used in diabetes treatment); o use of medicines for HIV treatment, particularly drugs known as NRTIs (nucleoside reverse transcriptase inhibitors).
• in diabetic patients using this solution for dialysis, doses of medications regulating blood glucose levels (e.g. insulin) should be monitored regularly. The dose of antidiabetic medications may need adjustment, especially at the beginning of peritoneal dialysis treatment or when changes occur in peritoneal dialysis therapy.
• in patients with corn allergy, which may cause hypersensitivity reactions, including severe allergic reactions called anaphylaxis. Infusion must be stopped immediately and the solution drained from the peritoneal cavity.
• if the patient has high levels of parathyroid hormone in the blood due to kidney disease. The low calcium concentration in PHYSIONEAL 40 solution may worsen hyperparathyroidism. The doctor should monitor the patient's parathyroid hormone levels.
• the patient—whenever possible in consultation with the doctor—should keep a written record of fluid balance and body weight. The doctor will regularly monitor blood parameters, especially levels of electrolytes (e.g. bicarbonates, 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 fluid overload include abdominal distension, feeling of fullness, and shortness of breath.
• the doctor will regularly monitor the patient's potassium levels. If potassium levels drop excessively, the doctor may prescribe potassium chloride to correct the deficiency.
• incorrect sequence of connections or filling may lead to air entering the peritoneal cavity, which may cause abdominal pain and/or peritonitis.
• in case of infusion of an unmixed solution, the solution must be immediately drained and a new bag with properly mixed solution administered;
• 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: o inflammation within the abdomen o thickening of intestinal walls, which may be accompanied by abdominal pain, abdominal distension, or vomiting. EPS can be life-threatening.

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

• Inform the doctor about all medicines the patient is currently taking or has 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, as peritoneal dialysis treatment may enhance the elimination of certain drugs.
• Exercise caution if the patient is taking heart medications known as cardiac glycosides (e.g. digoxin), because: o potassium and calcium supplementation may be required; o cardiac rhythm disturbances (arrhythmias) may occur; o during treatment, the patient will be under close medical supervision, with particular monitoring of 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.
The doctor will assess whether treatment is appropriate in such cases.
Driving and operating machinery
This type of treatment may cause weakness, blurred vision, or dizziness. Do not drive motor vehicles 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 use.
This medicine should always be used according to the instructions provided by the medical team specialized 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 recommend 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 assess the benefit-risk ratio before prescribing the medicine.

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

Method of administration
Before use:

• Warm the bag to 37°C using a special heating pad. Never immerse the bag in water for warming. Do not use a microwave oven to heat the bag.
• During administration, aseptic techniques must be followed as instructed during training.
• Before starting the exchange, ensure that your hands and the area where the procedure will be performed are clean.
• Before opening the protective bag, check the solution type, expiry date, and quantity (volume). Lift the dialysis bag and check for leakage (presence of fluid inside the protective bag). Do not use if the bag is leaking.
• After removing the protective bag, check the bag for leakage by firmly squeezing it. Check whether the seal between the chambers is intact. If the seal is broken, discard the solution. 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 the exchange, ensure all connections are secure.
• Mix the contents of both chambers by breaking the seal between them. Wait until the entire contents of the upper chamber have completely drained into the lower chamber. Gently mix by pressing on the walls of the lower chamber with your hands.
• Consult your doctor if you have any questions or doubts regarding this product or its use.
• Each bag is for single use only. Any unused 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 other injectable medicines to be added directly to the PHYSIONEAL 40 bag. In such cases, add the medicine through the designated injection site on the small chamber before breaking the seal between the chambers. After adding the medicine, the product should be used immediately. In case of doubt, consult your doctor.

Use of more bags of PHYSIONEAL 40 than recommended within 24 hours
If too much PHYSIONEAL 40 solution is administered, the following may occur:

• Abdominal distension;
• Feeling 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 the 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)
• Hypervolemia: swollen ankles or legs, eyelid swelling, 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 (occurring in 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)
  • Increased body weight

Uncommon (occurring in 1 in 100 people):

• Reduced volume of fluid drained during dialysis
• Fainting, dizziness or headache
• Cloudy dialysate fluid drained from the peritoneum, 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
• Abdominal distension or inflammation, shoulder pain, abdominal hernia (inguinal lump)
• 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 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 PHYSIONEAL 40

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

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

6. Contents of the package and other information

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

Other ingredients are water for injections and carbon dioxide.
Composition of the solution after mixing, in mmol/l:
1.36% 2.27% 3.86%
Anhydrous glucose (mmol/l) 75.5 126 214
Sodium (mmol/l) 132
Calcium (mmol/l) 1.25
Magnesium (mmol/l) 0.25
Chloride (mmol/l) 95
Bicarbonate (mmol/l) 25
Lactate (mmol/l) 15

What PHYSIONEAL 40 looks like and contents of the pack

• PHYSIONEAL 40 solution is a clear, colourless, sterile dialysis solution for peritoneal dialysis.
• PHYSIONEAL 40 is contained in a dual-chamber bag made of PVC. The two chambers are separated by a permanent seal. PHYSIONEAL 40 must only be administered after complete mixing of the contents of both chambers.
• Each bag is packed in a protective outer bag and supplied in cardboard boxes.

1.5 l - 1 bag in pack - single dual-chamber bag - Luer connector
1.5 l - 1 bag in pack - double dual-chamber bag - Luer connector
1.5 l - 5 bags in pack - single dual-chamber bag - Luer connector
1.5 l - 5 bags in pack - double dual-chamber bag - Luer connector
1.5 l - 6 bags in pack - single dual-chamber bag - Luer connector
1.5 l - 6 bags in pack - double dual-chamber bag - Luer connector
2.0 l - 1 bag in pack - single dual-chamber bag - Luer connector
2.0 l - 1 bag in pack - double dual-chamber bag - Luer connector
2.0 l - 4 bags in pack - single dual-chamber bag - Luer connector
2.0 l - 4 bags in pack - double dual-chamber bag - Luer connector
2.0 l - 5 bags in pack - single dual-chamber bag - Luer connector
2.0 l - 5 bags in pack - double dual-chamber bag - Luer connector
2.5 l - 1 bag in pack - single dual-chamber bag - Luer connector
2.5 l - 1 bag in pack - double dual-chamber bag - Luer connector
2.5 l - 4 bags in pack - single dual-chamber bag - Luer connector
2.5 l - 4 bags in pack - double dual-chamber bag - Luer connector
2.5 l - 5 bags in pack - single dual-chamber bag - Luer connector
2.5 l - 5 bags in pack - double dual-chamber bag - Luer connector

Not all bag 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
Moneen Road, Castlebar
County Mayo
Ireland

Vantive and Physioneal are trademarks of Vantive Health LLC or its affiliates.