Physioneal 35 glucose 3.86% p/v / 38.6 mg/ml Clear-Flex peritoneal dialysis solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PHYSIONEAL 35 Glucose 1.36% p/v / 13.6 mg/ml CLEAR-FLEX, Solution for peritoneal dialysis

PHYSIONEAL 35 Glucose 2.27% p/v / 22.7 mg/ml CLEAR-FLEX, Solution for peritoneal dialysis

PHYSIONEAL 35 Glucose 3.86% p/v / 38.6 mg/ml CLEAR-FLEX, Solution for peritoneal dialysis

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What PHYSIONEAL 35 is and what it is used for
2. What you need to know before using PHYSIONEAL 35
3. How to use PHYSIONEAL 35
4. Possible adverse 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 waste products from the blood. In addition, it 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 removed from the blood.

PHYSIONEAL 35 may be prescribed to you if you have:

• temporary or permanent kidney failure
• severe fluid retention
• severe disturbances in blood acidity or alkalinity (pH) and electrolyte levels
• certain types of drug intoxication for which no other available treatments exist.

PHYSIONEAL 35 has an acidity (pH) similar to that of blood. For this reason, it may be particularly beneficial if you experience discomfort or pain during administration of more acidic peritoneal dialysis solutions.

2. What you need to know before using PHYSIONEAL 35

Your doctor should supervise the administration of this product if it is your first time using it.

Do not use PHYSIONEAL 35

• if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).

• if you have an irreparable surgical problem affecting your abdominal wall or cavity, or an uncorrectable condition that increases the risk of abdominal infections

• if you have documented loss of peritoneal function due to severe peritoneal scarring.

Treatment with PHYSIONEAL 35 in its CLEAR FLEX container is sometimes not recommended:

• in children requiring fill volumes of 1600 ml

Warnings and precautions

Before using it, you must:

• First, mix the contents of the two chambers by opening the long seal;

• Second, open the short seal (Safety Moon).

• If the unmixed solution is infused (the long seal between the two chambers has not been opened), you may experience abdominal pain. Immediately drain the solution, use a new mixed bag, and inform your doctor right away.

• If you do not drain the unmixed solution, levels of salts or other chemicals may increase in the blood. This may cause adverse effects such as confusion, drowsiness, and irregular heartbeat.

Inform your doctor before using PHYSIONEAL 35.

Take special care:

• If you suffer from serious conditions affecting the integrity of the abdominal wall or cavity. For example, in case of hernia, chronic infection, or inflammatory disease affecting the intestines.

• If you have an aortic graft.

• If you have severe difficulty breathing.

• If you experience abdominal pain, elevated body temperature, or notice that the dialysate fluid is cloudy or contains particles. This may be a sign of peritonitis (inflamed peritoneum) or infection. Contact your healthcare team urgently. Record the batch number of the peritoneal dialysis solution bags you are using and bring it along with the drained fluid bag to your healthcare team. Your healthcare team will decide whether treatment should be stopped or corrective treatment initiated. For example, if you have an infection, your doctor may perform several tests to determine which antibiotic is most suitable for you. Your doctor may prescribe an antibiotic effective against a wide range of different bacteria until the specific infection is identified. This type of antibiotic is known as a broad-spectrum antibiotic.

• If you have high lactate levels in the blood. You are at increased risk of lactic acidosis if:

• you have a significant drop in blood pressure

• you have a blood infection

• you have acute renal failure

• you have a congenital metabolic disorder

• you are taking metformin (a medicine used to treat diabetes)

• you are taking medicines to treat HIV, particularly a group of medicines called NRTIs.

• If you have diabetes and use this solution, the dose of your medications used to regulate blood sugar levels (e.g., insulin) should be reviewed regularly. In particular, your diabetes medication dose should be adjusted when starting or changing peritoneal dialysis treatment.

• If you are allergic to corn, which may lead to hypersensitivity reactions, including severe allergic reactions known as anaphylaxis. Stop the infusion immediately and drain the solution from the peritoneal cavity.

• You, likely together with your doctor, will keep a record of your fluid balance and body weight. Your doctor will monitor your blood parameters at regular intervals, particularly levels of electrolytes (e.g., bicarbonate, potassium, magnesium, calcium, and phosphate), parathyroid hormone, and lipids.

• If you have high levels of bicarbonate in the blood.

• Do not use more solution than prescribed by your doctor. Symptoms of overdose include abdominal distension, stomach heaviness, and difficulty breathing.

• Your doctor will check your potassium levels regularly. If levels drop significantly, you may be given potassium chloride to compensate.

• Improper priming or clamping sequence may result in air infusion into the peritoneal cavity, which may cause abdominal pain and/or peritonitis.

• Due to a disorder called encapsulating peritoneal sclerosis (EPS), a known but rare complication of peritoneal dialysis therapy, you, likely together with your doctor, should be aware of this possible complication. EPS causes:

  • inflammation of the abdomen (belly)
  • thickening of the intestines, which may be associated with abdominal pain, abdominal distension, or vomiting. EPS can be fatal.

Children

If you are under 18 years of age, your doctor will evaluate the benefit-risk ratio of using this product.

Use of other medicines and PHYSIONEAL 35

• Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

• If you are taking other medicines, your doctor may need to increase your dose, as peritoneal dialysis treatment increases the removal of certain medicines.

• Be cautious if you are taking heart medications called cardiac glycosides (e.g., digoxin), as you may:

  • require potassium and calcium supplements
  • develop disturbances in heart rhythm (arrhythmia).
  • Your doctor will perform close monitoring during treatment, especially of your potassium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The use of Physioneal during pregnancy or breastfeeding is not recommended unless advised by your doctor.

Driving and use of machines

This treatment may cause weakness, blurred vision, or dizziness. Do not drive or operate machinery if affected.

3. How to use PHYSIONEAL 35

PHYSIONEAL 35 must be administered into your peritoneal cavity. This cavity is located in the abdomen (belly), between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs such as the intestines or liver.

Do not use by intravenous route.

Follow exactly the administration instructions for this medicine provided by your peritoneal dialysis medical team. If in doubt, consult them again.

If the bag is damaged, it must be discarded.

Dosage and frequency

Your doctor will determine the appropriate glucose concentration and the number of bags you should use each day.

Use in children and adolescents

If you are under 18 years of age, your doctor will carefully evaluate the prescription of this medicine.

If you interrupt treatment with PHYSIONEAL 35

Do not interrupt peritoneal dialysis without your doctor's consent. Stopping treatment may have harmful consequences for your life.

Method of administration

Before use,

• Warm the bag to 37°C. Use the heating plate specifically designed for this purpose. Never immerse the bag in water to warm it. Do not use a microwave oven to heat the bag.

• You must use an aseptic technique throughout the administration of the solution, as you have been taught.

• Before performing an exchange, make sure to wash your hands and the area where you will perform the exchange.

• Before opening the overpouch, check that it is the correct solution, the expiration date, and the quantity (volume). Lift the bag to check for leaks (excess liquid in the overpouch). Do not use the bag if you detect any leaks.

• After removing the overpouch, check for signs of leaks by firmly pressing the bag. Check that neither the long nor short seals are open at any point. Discard the bag if either seal is open, even partially. Do not use the bag if you detect any leak.

• Check that the solution is clear and transparent. 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 two chambers carefully by first breaking the long seal and then the short seal (Safety Moon).

• Consult your doctor if you have any questions or doubts about this product or its use.

• Use each bag only once. Discard any unused solution.

• The solution must be administered within 24 hours after mixing.

After use, check that the drained fluid is not cloudy.

Compatibility with other medicines

Your doctor may prescribe other injectable medicines to be added directly to the PHYSIONEAL 35 bag. In this case, add the medicine through the medication addition site located in the large chamber, before opening the long seal. Disinfect the medication addition site immediately before performing the injection. Use the product immediately after adding the medicine. Consult your doctor if you are unsure.

If you use more PHYSIONEAL 35 bags than you should within 24 hours

If you receive an excessive dose of PHYSIONEAL 35, you may experience:

• abdominal distension
• stomach heaviness and/or
• difficulty breathing.

Contact your doctor immediately. They will advise you what to do.

If you have any other questions about the use of this product, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following conditions, contact your doctor or your peritoneal dialysis unit immediately:

• Hypertension (blood pressure above normal levels).
• Swelling of the ankles or legs, puffy eyes, difficulty breathing, or chest pain (hypervolemia).
• Abdominal pain.
• Chills (flu-like symptoms), fever.
• Inflamed peritoneum (peritonitis).

All of these are serious adverse effects. You may require urgent medical attention.

If you notice any adverse effect, inform your doctor or your peritoneal dialysis unit. This includes any adverse effect, even if it is not listed in this leaflet.

Common (may affect up to 1 in 10 people):

• Changes in your blood parameters:
  • increased calcium levels (hypercalcemia)
  • decreased potassium levels (hypokalemia), which may cause muscle weakness, muscle cramps, or changes in heart rhythm.
• Weakness, fatigue.
• Fluid retention (edema).
• Weight gain.

Uncommon (may affect up to 1 in 100 people):

• Reduced fluid removal during dialysis.

• Fainting, dizziness, or headache.

• Cloudy dialysis fluid drained from the peritoneum, stomach pain.

• Peritoneal bleeding, pus, swelling or pain around the catheter exit site, and catheter blockage.

• Nausea, loss of appetite, indigestion, flatulence (gas), thirst, and dry mouth.

• Abdominal distension or swelling, shoulder pain, abdominal wall hernia (bulge in the groin).

• Changes in your blood parameters:

  • lactic acidosis
  • increased carbon dioxide levels
  • increased blood sugar levels (hyperglycemia)
  • increased white blood cell count (eosinophilia).

• Difficulty sleeping.

• Low blood pressure (hypotension).

• Cough.

• Muscle or bone pain.

• Facial or throat swelling.

• Skin rash.

Other adverse effects related to the peritoneal dialysis procedure:

• Infection around the catheter exit site, catheter blockage.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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. The expiry date is stated on the label of the outer packaging and on the bag after the abbreviation EXP and the symbol ?. The expiry date refers to the last day of the month indicated.

Dispose of PHYSIONEAL 35 as instructed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

This leaflet does not contain all the information about this medicine. If you have any questions or are unsure about anything, ask your doctor.

Composition of PHYSIONEAL 35

The mixed peritoneal dialysis solution contains the following active substances:

The other components are: water for injections, sodium hydroxide, and hydrochloric acid.

The composition in mmol/l of the mixed solution is:

Appearance of the product and contents of the pack

PHYSIONEAL 35 is a colorless, clear, sterile solution for peritoneal dialysis.

PHYSIONEAL 35 is packed in a PVC-free plastic bag with two chambers. The two chambers are separated by non-permanent seals. You should only infuse PHYSIONEAL 35 after the solutions in both chambers have been completely mixed. Only at that moment should you open the short seal (Safety Moon).

Each bag is enclosed in an overpouch and supplied in a cardboard box.

Some pack sizes may not be marketed.

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Marketing Authorization Holder

Vantive Health, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia)

Spain

Manufacturer

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Germany, Austria, Belgium, Bulgaria, Cyprus, Croatia, Denmark, Slovakia, Slovenia, Spain, Estonia, Finland, France, Greece, Netherlands, Hungary, Ireland, Iceland, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, Romania, Sweden: PHYSIONEAL 35 CLEAR-FLEX

Italy: FIXIONEAL 35

Date of the most recent review of this leaflet: April 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Vantive, Physioneal and Clear-Flex are registered trademarks of Vantive Health LLC or its affiliates