Physioneal 40 glucose 3.86% p/v / 38.6 mg/ml solution for peritoneal dialysis

Patient Information Leaflet

Introduction

Patient Information Leaflet

PHYSIONEAL 40 Glucose 1.36% p/v / 13.6 mg/ml, Solution for peritoneal dialysis

PHYSIONEAL 40 Glucose 2.27% p/v / 22.7 mg/ml, Solution for peritoneal dialysis

PHYSIONEAL 40 Glucose 3.86% p/v / 38.6 mg/ml, Solution for peritoneal dialysis

Read the entire leaflet carefully before starting to use this medicine, because it contains important information for you.

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

Leaflet Contents:

1. What PHYSIONEAL 40 is and what it is used for
2. What you need to know 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 waste products from the blood. In addition, it corrects abnormal levels of various blood components.

PHYSIONEAL 40 contains different glucose concentrations (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 40 may be prescribed for you if you have:

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

The solution PHYSIONEAL 40 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 40

Your doctor must supervise the administration of this product if it is the first time you are using it.

Do not use PHYSIONEAL 40

• 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 any surgically uncorrectable problems 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.

Warnings and precautions

Talk to your doctor before starting to use PHYSIONEAL 40.

Take special care:

• Inform your doctor 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 bowel disease.
• If you have an aortic graft.
• If you have severe breathing difficulties.
• If you experience abdominal pain, elevated body temperature, or notice that the dialysate fluid is cloudy or contains particles. These may be signs of peritonitis (inflamed peritoneum) or infection. Contact your medical 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 medical team. Your medical team will decide whether treatment should be interrupted or corrective treatment initiated. For example, if you have an infection, your doctor may perform several tests to determine which antibiotic is most appropriate for you. Your doctor may give you 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 levels of lactate in your blood. You are at increased risk of lactic acidosis if:
  • you have severely low blood pressure,
  • you have a blood infection (sepsis),
  • 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 for HIV, especially a class of medicines called NRTIs.
• If you have diabetes and are using 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 dosage should be adjusted when starting or changing peritoneal dialysis treatment.
• If you have a corn allergy that may lead to hypersensitivity reactions, including severe allergic reactions known as anaphylaxis. Immediately stop administration and drain the solution from the peritoneal cavity.
• If you have high levels of parathyroid hormone in your blood due to kidney impairment. The low calcium content of PHYSIONEAL 40 may worsen your hyperparathyroidism. Your doctor will monitor your blood parathyroid hormone levels.
• 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 your 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 regularly check your potassium levels. If levels become too low, you may be given potassium chloride to correct it.
• Improper sequence during priming or clamping may result in air being infused into the peritoneal cavity, which could cause abdominal pain and/or peritonitis.
• If you administer an unmixed solution, you must immediately drain (empty) the solution and use a new, properly mixed bag.
• Due to a condition called encapsulating peritoneal sclerosis (EPS), a known but rare complication of peritoneal dialysis therapy, you and your doctor should be aware of this potential complication. EPS may cause:
  • inflammation of the abdomen (belly),
  • thickening of the intestines, which may be associated with abdominal pain, abdominal distension, or vomiting. In rare cases, 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 PHYSIONEAL 40 with other medicines

• Inform your doctor if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.
• If you are taking other medicines, your doctor may need to increase your dose, as peritoneal dialysis treatment increases the elimination 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 closely monitor you during treatment, especially 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. 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 40

PHYSIONEAL 40 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 intravenously.

Always follow exactly the administration instructions for this medicine given 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 whether to prescribe this medicine.

If you interrupt treatment with PHYSIONEAL 40

Do not stop peritoneal dialysis without your doctor's approval. Interrupting treatment may have harmful consequences for your life.

Method of administration

Before use:

• Warm the bag to 37°C using a heating plate specifically designed for this purpose. Never immerse the bag in water to warm it. Never use a microwave oven to heat the bag.

• You must use an aseptic technique throughout the administration of the solution, as previously 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). Hold the bag up 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 leakage by firmly pressing the bag. Check that the breakable seal separating the two chambers is intact. If the seal is broken, discard the bag. Do not use the bag if any leakage is detected.

• 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.

• Carefully mix the two chambers by breaking the breakable seal located between them. Wait until the upper chamber has completely emptied into the lower chamber. Then carefully mix the solution by pressing both hands against the walls of the lower chamber.

  • 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 injectable medicines to be added directly to the PHYSIONEAL 40 bag. In this case, add the medicine through the medication addition site located in the small chamber, before breaking the seal between the two chambers. Use the product immediately after adding the medicine. Consult your doctor if you are unsure.

If you use more PHYSIONEAL 40 bags than you should within 24 hours

If you receive an excessive dose of PHYSIONEAL 40, you may experience:

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences 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
  • increased bicarbonate levels (alkalosis)
• 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 solution 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 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, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of PHYSIONEAL 40

• Keep this 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 label of the outer packaging and on the bag, following the abbreviation EXP and the symbol . The expiry date refers to the last day of the month indicated.

Dispose of PHYSIONEAL 40 as instructed.

Medicines should 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 pack and other information

This patient information 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 40

The mixed peritoneal dialysis solution contains the following active substances:

The other components are: water for injections and carbon dioxide.

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

Appearance of the product and contents of the container

PHYSIONEAL 40 is a colorless, transparent, sterile solution for peritoneal dialysis.

• PHYSIONEAL 40 is packed in a dual-chamber PVC bag. The two chambers are separated by a permanent seal. You must only administer PHYSIONEAL 40 when the solutions from both chambers are completely mixed.
• Each bag is enclosed in an overpouch and supplied in a cardboard box.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Vantive Health, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo 2

46394 Ribarroja del Turia (Valencia), Spain

Manufacturer

Vantive Manufacturing Limited

Moneen Road

Castlebar

County Mayo – Ireland

or

Bieffe Medital SpA

Via Nuova Provinciale

23034 Grosotto

Italy

Date of the most recent review of this leaflet: November 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/

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