Physioneal 35 clear-flex

Package leaflet: Information for the user

PHYSIONEAL 35 CLEAR-FLEX, glucose 13.6 mg/ml, solution for peritoneal dialysis
PHYSIONEAL 35 CLEAR-FLEX, glucose 22.7 mg/ml, solution for peritoneal dialysis
PHYSIONEAL 35 CLEAR-FLEX, glucose 38.6 mg/ml, solution for peritoneal dialysis
Please read carefully the entire leaflet 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.

Leaflet contents:

1. What PHYSIONEAL 35 is and what it is used for
2. Important information before using PHYSIONEAL 35
3. How to use PHYSIONEAL 35
4. Possible side effects
5. How to store PHYSIONEAL 35
6. Contents of the pack and other information

1. What PHYSIONEAL 35 is and what it is used for

PHYSIONEAL 35 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 35 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 35 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 acidity (i.e., pH) of the PHYSIONEAL 35 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, more acidic dialysis solutions.

2. Important information before using PHYSIONEAL 35

The first use of this product must be performed under medical supervision.
When NOT to use PHYSIONEAL 35

• 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 an abdominal wall or peritoneal cavity disorder that cannot be surgically corrected, or any other disorder that cannot be corrected and increases the risk of peritoneal cavity infections;
• if the patient has documented loss of peritoneal function due to extensive peritoneal adhesions.

Sometimes the use of PHYSIONEAL 35 in the CLEAR-FLEX container is not recommended:

• in children requiring fill volumes less than 1600 ml.

Warnings and precautions
Before use, the following must be done:

• mix the contents of both chambers by opening the long seal;
• then open the SafetyMoon short seal;
• if an unmixed solution is infused (the long seal between chambers has not been opened), the patient may experience abdominal pain. The solution should be drained immediately, a new bag with properly mixed solution should be used, and the physician should be contacted without delay.
• failure to drain an unmixed solution will lead to increased blood concentrations of salts and other chemicals, causing adverse effects such as confusion, drowsiness, and irregular heartbeat.

Before using PHYSIONEAL 35, speak with your doctor.
Exercise particular caution:

• if the patient has serious conditions 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 graft;
• if the patient has significant difficulty breathing;
• 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 dialysis solution 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 an infection occurs, 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:
• severe drop in blood pressure;
• blood infection (sepsis);
• acute kidney failure;
• inherited metabolic disorders;
• use of metformin (a drug used in diabetes treatment);
• use of drugs used to treat HIV infection, especially drugs called NRTIs (nucleoside reverse transcriptase inhibitors).
• in diabetic patients using this dialysis solution, doses of blood glucose-regulating medications (e.g. insulin) should be monitored regularly. Doses 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 should be stopped immediately and the solution drained from the peritoneal cavity.
• the patient, if possible in consultation with the physician, should keep a written record of fluid balance and body weight. The physician 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 physician. Symptoms of excessive infusion include abdominal distension, feeling of fullness, and shortness of breath.
• the physician will regularly monitor the patient's potassium levels. If potassium levels drop too low, the physician may prescribe potassium chloride to correct the deficiency.
• incorrect connection or filling sequence 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 physician 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, abdominal distension, or vomiting. EPS can be fatal.

Children
The physician will assess the risk versus benefit of using this medicine in patients under 18 years of age.
PHYSIONEAL 35 and other medicines

• Inform the physician about all medicines currently used or recently taken by the patient, as well as any medicines the patient plans to take.
• If the patient is taking other medicines, the physician 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 called 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, particularly with regard 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 physician before using this medicine. PHYSIONEAL is not recommended during pregnancy or breastfeeding unless the physician decides otherwise.
Driving and operating machinery
This type of treatment may cause fatigue, blurred vision, or dizziness. Do not drive or operate machinery if experiencing such symptoms.

3. How to use PHYSIONEAL 35

PHYSIONEAL 35 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 must always be used in accordance with 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 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 physician will carefully evaluate the possibility of using this medicine.

Discontinuation of PHYSIONEAL 35 treatment
Do not discontinue peritoneal dialysis without your doctor's approval. Stopping treatment may have life-threatening consequences.

Method of administration
Before use:

• Warm the bag to a temperature of 37°C. A special heating plate should be used for this purpose. 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 hands and the area where the exchange will be performed are clean.
• Before opening the protective bag, check the solution type, expiration date, and quantity (volume). Lift the dialysis bag 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 whether 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 an exchange, ensure that all connections are secure.
• Mix the contents of both chambers thoroughly by first opening the long seal, then the short SafetyMoon seal.
• Consult your doctor in case of any questions or doubts regarding this medicine or its method of 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 medicines in injectable form to be added directly to the PHYSIONEAL 35 bag. In such cases, add the medicine via the medication addition port located on the large chamber before opening the long seal. Disinfect the medication addition port immediately before injection. After adding the medicine, the product should be used immediately. In case of doubt, consult your doctor.

Use of more than the recommended number of PHYSIONEAL 35 bags within 24 hours
If an excessive amount of PHYSIONEAL 35 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. In case of 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 everyone 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: swelling of the 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 those not listed in this leaflet, inform your doctor or contact the centre managing your peritoneal dialysis treatment.
Common (occurring in 1 out of 10 people)

• Changes in blood test results:
• increased calcium levels (hypercalcemia);
• decreased potassium levels (hypokalemia), which may cause muscle weakness, muscle twitching, or heart rhythm disturbances;
• Weakness, fatigue;
• Fluid retention (edema);
• Increased body weight.

Uncommon (occurring in 1 out of 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 flatulence, thirst, dry mouth;
• Abdominal distension or inflammation, shoulder pain, hernia (inguinal swelling);
• Changes in blood test results:
• lactic acidosis,
• increased carbon dioxide levels,
• increased glucose levels (hyperglycemia),
• 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 related to the peritoneal dialysis procedure

• Infection around the catheter exit site, catheter blockage.

Reporting of adverse reactions
If any adverse reactions occur that are not listed in this leaflet, 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
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store PHYSIONEAL 35

• Keep this 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:” and the symbol . The expiry date refers to the last day of the stated month.

PHYSIONEAL 35 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 35 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 35 CLEAR-FLEX looks like and contents of the pack

• PHYSIONEAL 35 is a clear, colourless, sterile dialysis solution for peritoneal dialysis.
• PHYSIONEAL 35 is supplied in a dual-chamber non-PVC bag. The two chambers are separated by temporary seals. PHYSIONEAL 35 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 per Configuration of product Type of connector
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.
For further information, contact the local representative of the Marketing Authorisation Holder:
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Manufacturer
Baxter Healthcare S.A. 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 35 CLEAR-FLEX
Italy: FIXIONEAL 35
Baxter, Physioneal and Clear-Flex are trademarks of Baxter International Inc.