Phisioneal 40 z glukozom 2,27 v/v 22,7 mg/ml

Leaflet accompanying the packaging: information for the user

PHYSIONEAL 40 with glucose 1.36% w/v 13.6 mg/ml, peritoneal dialysis solution

PHYSIONEAL 40 with glucose 2.27% w/v 22.7 mg/ml, peritoneal dialysis solution

PHYSIONEAL 40 with glucose 3.86% w/v 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 that you can read it again if you need to.
• In case of 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 inform their doctor. See section 4.

Table of 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 packaging and other information

1. What PHYSIONEAL 40 is and what it is 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;
• significant fluid 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 medicine must be under the supervision of a doctor.

When not to use PHYSIONEAL 40 solution

• If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with PHYSIONEAL 40, you should discuss it with your doctor.
Particular caution should be exercised:

• if the patient has serious disorders affecting the abdominal wall or abdominal cavity. For example, if the patient has a hernia or chronic inflammation or infection affecting the intestines.
• if the patient has had an aortic graft;
• if the patient has breathing difficulties;
• if the patient experiences abdominal pain, elevated body temperature, or cloudiness, lack of clarity, or particles in the drained fluid. This may be a sign of peritonitis or infection. You should contact the medical team immediately. You should record the batch number of the product and show it to the medical team along with the bag of drained fluid. The medical team will decide whether to discontinue treatment or start corrective treatment. For example, if an infection occurs, the doctor may perform certain tests to select the appropriate antibiotic. Until the type of infection is determined, the doctor may recommend taking a broad-spectrum antibiotic.
• if the patient has high levels of lactate in the blood. The risk of lactic acidosis may increase due to: severe hypotension or blood infection that may be associated with acute kidney failure; congenital metabolic disorders; taking metformin (a medicine used to treat diabetes); taking medicines used to treat HIV, 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 drained from the abdominal cavity.
• if the patient has high levels of parathyroid hormone in the blood due to kidney disease. The low calcium concentration in PHYSIONEAL 40 may exacerbate hyperparathyroidism. The doctor should monitor the patient's parathyroid hormone levels in the 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 electrolyte levels (e.g., bicarbonate, potassium, magnesium, calcium, and phosphate), parathyroid hormone, and lipids.
• if the patient has high levels of bicarbonate in the blood;
• you should not use a larger volume of the solution than recommended by the doctor. Signs of overhydration include abdominal distension, feeling of fullness, and shortness of breath.
• the doctor will systematically check the patient's potassium levels. If they decrease excessively, 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.
• in the case of infusing an unmixed solution, the solution should be drained immediately and a new bag with a mixed solution used;
• encapsulating peritoneal sclerosis (EPS) is a known, though rare, complication of peritoneal dialysis. The patient and doctor should be aware of the possibility of this complication. EPS causes: inflammation in the abdominal cavity, 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 and benefits 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 enhances the elimination of some medicines.
• You should exercise caution if you are taking cardiac glycosides (e.g., digoxin), as: potassium and calcium supplements may be needed; cardiac arrhythmias may occur; during treatment, you will be under close medical supervision, especially monitoring of 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 your doctor before using this medicine.
Your doctor will assess whether treatment is appropriate in such cases.

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 use.
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 the medicine

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

Use in children and adolescents

In patients under 18 years of age, before prescribing the medicine, the doctor will assess the ratio of benefits to the risk of side effects.

Discontinuation of PHYSIONEAL 40 treatment

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

Method of administration

Before use:

• The bag should be warmed to a temperature of 37°C. For this purpose, a special heating plate should be used. The bag should never be immersed in water for warming. A microwave oven should not be used to warm the bag.
• During administration of the solution, aseptic techniques should be used, in accordance with training.
• Before starting the exchange, you should ensure that your hands and the place where the exchange will be performed are clean.
• Before opening the protective bag, you should check the type of solution, expiration date, and quantity (volume). You should lift the dialysis bag and check if it is leaking (presence of fluid in the protective bag). You should not use it if the bag is leaking.
• After removing the protective bag, you should check the packaging for leaks by strongly squeezing the bag. You should check if the plug between the chambers is broken. If the plug is broken, the solution should be discarded. You should not use the bag if you find a leak.
• You should check if the solution is clear. You should not use the bag if the solution is cloudy or contains particles. Before the exchange, you should ensure that all connections are secure.
• You should mix the contents of both chambers by breaking the plug between the chambers. You should wait until the contents of the upper chamber have completely flowed into the lower chamber. You should gently mix by pressing your hands against the walls of the lower chamber.
• You should ask your doctor in case of questions or doubts about this product or its use.
• Each bag is intended for single use only. Any unused remnants of the solution should be discarded.
• The solution must be administered within 24 hours of mixing.

After use, you should check if the drained fluid is not cloudy.

Compatibility with other medicines

Your doctor may prescribe other medicines in the form of injections, which should be added directly to the PHYSIONEAL 40 bag. In such a case, you should add the medicine through the port intended for this purpose, located on the small chamber, before breaking the plug between the chambers. After adding the medicine, you should use the product immediately. In case of doubts, you should consult your doctor.

Use of a larger amount of PHYSIONEAL 40 bags than recommended in 24 hours

If too much PHYSIONEAL 40 solution is administered, the following may occur:

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

• Hypertension (blood pressure higher than usual)
• Hyperolemia: swollen ankles or legs, eyelid edema, shortness of breath, or chest pain
• Abdominal pain
• Chills (flu-like symptoms), fever
• Peritonitis. These are serious side effects. Immediate medical intervention may be required.

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or the center performing the peritoneal dialysis treatment.
Frequently (occurring in 1 in 10 people):

• Changes in blood test results:
• increased calcium levels (hypercalcemia)
• decreased potassium levels (hypokalemia), which may cause muscle weakness, muscle tremors, or cardiac arrhythmias
• increased bicarbonate levels (alkalosis)
• weakness, fatigue
• fluid retention (edema)
• weight gain

Less frequently (occurring in 1 in 100 people):

• decreased volume of fluid removed during dialysis
• fainting, dizziness, or headache
• cloudiness of the drained peritoneal fluid, abdominal pain
• peritoneal bleeding, abscess, edema, 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 mass)
• changes in blood test results:
• lactic acidosis
• increased carbon dioxide levels
• increased glucose levels (hyperglycemia)
• increased white blood cell count (eosinophilia)
• sleep disorders
• low blood pressure (hypotension)
• cough
• muscle and bone pain
• facial or throat edema
• 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 the leaflet, you should inform 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
PL 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 out of sight and reach of children.
• Store in the original packaging.
• Do not store at a temperature below 4°C.
• Do not use this medicine after the expiration date stated on the carton and on the bag after the words "Exp. date" and the symbol . The expiration date refers to the last day of the given 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 additional questions or doubts, you should consult your doctor.

What PHYSIONEAL 40 contains

Active substances in the peritoneal dialysis solution after mixing:
Other ingredients are water for injection and carbon dioxide.
Composition of the solution after mixingin mmol/l:

1.36% 2.27% 3.86%

Glucose anhydrous (mmol/l)
75.5
126
214
Sodium (mmol/l)
Calcium (mmol/l)
Magnesium (mmol/l)
Chloride (mmol/l)
Bicarbonate (mmol/l)
Lactate (mmol/l)
132
1.25
0.25
95
25
15

What PHYSIONEAL 40 looks like and what the packaging contains

• PHYSIONEAL 40 solution is a clear, colorless, sterile peritoneal dialysis solution.
• PHYSIONEAL 40 solution is in a dual-chamber bag with PCW. Both chambers are separated by a permanent weld. PHYSIONEAL 40 should only be administered after complete mixing of the contents of both chambers.
• Each bag is packaged in a protective bag and supplied in cardboard boxes.

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

2.5 l - 4 bags in the packaging - double dual-chamber bag - Luer-type connector
2.5 l - 5 bags in the packaging - single dual-chamber bag - Luer-type connector
2.5 l - 5 bags in the packaging - double dual-chamber bag - Luer-type connector
Not all types of bags and packaging sizes may be marketed.

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
Date of last update of the leaflet:July 2024
Vantive and Physioneal are trademarks of Vantive Health Inc. or its subsidiaries.