Patient leaflet - Polithera solution for Peritoneal Dialysis

1. WHAT POLITHERA SOLUTION FOR PERITONEAL DIALYSIS IS AND WHAT IT IS USED FOR

Polithera Solution for peritoneal dialysis is a solution for peritoneal dialysis. The peritoneal cavity is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. The Polithera Solution for peritoneal dialysis solution is placed into the peritoneal cavity where it removes water and waste products from your blood. It also corrects abnormal levels of different blood components.

Polithera Solution for peritoneal dialysis may be prescribed for you if:

you are an adult with permanent kidney failure which needs peritoneal dialysis.
standard glucose peritoneal dialysis solutions alone cannot remove sufficient water

2. WHAT YOU NEED TO KNOW BEFORE YOU USE POLITHERA SOLUTION FOR PERITONEAL DIALYSIS

Your doctor must supervise you the first time you use this product.

Do not use Polithera Solution for peritoneal dialysis

if you are allergic to icodextrin, starch derivatives (e.g. maize starch) or any of the other ingredients of this medicine (listed in section 6).
if you are intolerant to maltose or isomaltose (sugar coming from starch)
if you have glycogen storage disease
if you already have severe lactic acidosis (too much acid in the blood)
if you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases 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 using Polithera Solution for peritoneal dialysis

if you are elderly. There is a risk of dehydration
if you are diabetic and using this solution for the first time.
You may need to adjust your insulin dose
if you need to test your blood glucose level (for example if you are diabetic). Your doctor will advise you on which test kit to use (see “Other forms of interactions”)
if you have a high risk of severe lactic acidosis (too much acid in the blood). You are at increased risk of lactic acidosis if:
- you have profoundly low blood pressure
- you have a blood-infection
- you have acute severe kidney failure
- you have an inherited metabolic disease
- you are taking metformin (a medicine used to treat diabetes)
- you are taking medicines to treat HIV, especially medicines called NRTIs
if you experience abdominal pain or notice cloudiness, haziness or particles in the drained fluid.
This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and bring it along with the drained fluid bag to your medical team. The doctor will decide if the treatment should be stopped or any corrective treatment started. For example, if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, he may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.
during peritoneal dialysis your body may lose protein, amino acids and vitamins. Your doctor will know if these need to be replaced
if you have problems affecting your abdominal wall or cavity. For example, if you have a hernia or a chronic infectious or inflammatory condition affecting your intestines
if you had aortic graft placement
if you have severe lung disease, e.g. emphysema
if you have breathing difficulties
if you have disorders precluding normal nutrition
if you have a potassium deficiency

You should also take into account that:

a disorder called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You - together with your doctor - should be aware of this possible complication. EPS causes:
- inflammation in your abdomen (belly)
- the growth of sheets of fibrous tissue that cover and bind your organs and affect their normal movement. Rarely this has been fatal
  - you - possibly together with your doctor - should keep a record of your fluid balance and of your body weight. Your doctor will monitor your blood parameters at regular intervals
  - your doctor will check your potassium levels regularly. If they fall too low, he may give you some potassium chloride to compensate.

Sometimes treatment with this medicine is not recommended, such as if:

you have acute kidney disease.

Children and adolescent

The safety and efficacy of Polithera Solution for peritoneal dialysis in children less than 18 years old has not been demonstrated.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before starting treatment with this medicine. If you are pregnant, you will receive this medicine only if your doctor considers it absolutely necessary for your recovery. [Polithera Solution for peritoneal dialysis] should only be given to pregnant women after careful consideration.

At therapeutic doses of Polithera Solution for peritoneal dialysis no effects on the breastfed newborns/infants are anticipated. Nevertheless, breast-feeding is not recommended if you need peritoneal dialysis in that time.

Driving and using machines

This treatment may cause fatigue, weakness, blurred vision or dizziness. Do not drive or operate machines if you are affected.

3. HOW TO USE POLITHERA SOLUTION FOR PERITONEAL DIALYSIS

Always use this medicine exactly as your doctor has told you.

Check with your doctor if you are not sure.

Polithera Solution for peritoneal dialysis is indicated as a once-daily exchange for the long (6 to 16 hour) dwell during continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) for the management of end-stage renal disease. Polithera Solution for peritoneal dialysis is to be administered into your peritoneal cavity. The peritoneal cavity is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver.

Always use this medicine exactly as instructed by the medical team specialized in peritoneal dialysis. Check with your doctor if you are not sure.

The recommended dose is:

One bag per day during the longest dwell period, i.e.:
- overnight in continuous ambulatory peritoneal dialysis (CAPD)
- during the day in automated peritoneal dialysis (APD).
Take between 10-20 minutes to instill the solution.
The dwell time with Polithera Solution for peritoneal dialysis is between 6-12 hours in CAPD and between 14-16 hours in APD.

Method of administration

Before use:

Warm the bag to 37°C. Use the warming plate specially designed for this purpose. Never immerse in water to warm the bag.
Use aseptic technique throughout the administration of the solution as you have been trained.
Prior to beginning an exchange, ensure you clean your hands and the area where your exchange will be performed.
Prior to opening the overpouch, check for the correct solution type, amount (volume) and expiration date. Lift the dialysate bag to check for any leaks (excess fluid in the overpouch). Do not use the bag if leaks are discovered.
After removing the overpouch, inspect the container for signs of leakage by pressing firmly on the bag. Do not use the bag if leaks are discovered.
Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.
Ensure all connections are secure before beginning the exchange.
Ask your doctor or nurse if you have questions or concerns about this product or how to use it.
Use each bag only once. Discard any unused remaining solution.
After use, check that the drained fluid is not cloudy.
This solution is not to be used for intravenous infusion.

Compatibility with other drugs

Your doctor may prescribe you other injectable drugs to be added directly into the Polithera Solution for peritoneal dialysis bag. In that situation, add the drug through the medication site located at the bottom of the bag. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.

Package leaflet: Information for the user

If you use more than one bag of Polithera Solution for peritoneal dialysis in 24 hours

If you use too much Polithera Solution for peritoneal dialysis you may get abdominal distension a feeling of fullness and/or a shortness of breath.

Contact your doctor immediately. The doctor will tell you what to do.

If you stop using Polithera Solution for peritoneal dialysis

Do not pause or stop the treatment without the agreement of your doctor. If you stop the treatment it may have life-threatening consequences. If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you notice any side effects, consult your doctor or dialysis center. This also includes any possible side effects not listed in this leaflet.

If any of the following side effects occur, tell your doctor or dialysis center immediately:

Hypertension.
Swollen ankles or legs, puffy eyes, shortness of breath or chest pain (hypervolemia).
Hypersensitivity (allergic reaction) which may include swelling of face, throat or around the eyes (angioedema).
Abdominal pain.
Chills (shivering/flu-like symptoms).

These could be signs of serious side effects. You may need urgent medical attention. Common: may affect up to 1 in 10 people in patients using Polithera Solution for peritoneal dialysis:

Redness and scaling of the skin, rash, itching.
Feeling lightheaded, dizzy, or thirst (dehydration).
Decreased blood volume (hypovolemia).
Abnormal laboratory tests.
Weakness, headache, fatigue.
Swollen ankles or legs.
Low blood pressure (hypotension).
Ringing in the ears (tinnitus).

Other side effects related to the peritoneal dialysis procedure or common to all peritoneal dialysis solutions:

Cloudy solution drained from the peritoneal cavity, stomach-ache.
Peritoneal bleeding, pus, swelling, pain or infection around the exit site of your catheter, catheter blockage, injury, interaction with the catheter.
Faintness, cold sweats, hunger, confusion, possibly unconsciousness and seizures due to low blood sugar (hypoglycaemia). It may in some develop into a serious side effect. Talk to your doctor.
Shock or coma caused by low concentration of sugar in blood.
Frequent urination, thirst, fatigue due to high blood sugar (blood glucose). It may in some develop into a serious side effect. Talk to your doctor.
Nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhoea, flatulence, disorder of the stomach or intestines such as blockage in your intestine, gastric ulcer, abdominal pain, indigestion.
Abdominal swelling, hernia of the abdominal cavity (this causes a lump in the groin).
Modification of your blood tests.
Abnormal liver function test.
Weight increase or decrease.
Pain, fever, malaise.
Heart disease, faster heartbeat, shortness of breath or chest pain.
Anemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness); increase or decrease of white blood cell count; reduction in blood platelets, which increases risk of bleeding or bruising.
Numbness, tingling, burning sensation.
Involuntary movements (hyperkinesia).
Blurred vision.
Loss of the sense of taste.
Fluid on the lungs (pulmonary oedema), shortness of breath, difficulty in breathing or wheezing, cough, hiccups.
Kidney pain.
Nail disorder.
Skin disorders such as hives (urticaria), psoriasis, skin ulcer, eczema, dry skin, skin discoloration, blistering of the skin, allergic or contact dermatitis, rashes and itching.
Rashes may be itchy with red spots covered with bumps or shedding of the skin. The following three severe types of skin reaction may occur:
- Toxic epidermal necrolysis (TEN). This causes:
  - a red rash over many parts of the body
  - shedding of the outer layer of skin.
- Erythema multiforme. An allergic skin reaction causing spots, red welts or purple or blistered areas. It can also affect the mouth, eyes and other moist body surfaces.
- Vasculitis. Inflammation of certain blood vessels within the body. Clinical symptoms
  will depend on the part of the body involved but may be characterized on the skin as red or violet spots or welts or have symptoms similar to an allergic reaction, including rash, joint pain and fever.
Muscle cramps, pain in bones, joints, muscles, back and neck.
Dizziness, possible fainting when changing from lying to sitting or from sitting to standing position due to low blood pressure (orthostatic hypotension).
Peritonitis (inflamed peritoneum) including peritonitis caused by fungal or bacterial infection.
Infections including flu syndrome, boils.
Abnormal thinking, anxiety, nervousness.

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

Website at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. HOW TO STORE POLITHERA SOLUTION FOR PERITONEAL DIALYSIS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package.

Do not refrigerate or freeze.

The product should be used immediately after the outer bag is removed. Dispose of Polithera Solution for peritoneal dialysis in the way you have been trained. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

What Polithera Solution for peritoneal dialysis contains

The active substance are:

Icodextrin 75 mg/ml (75 g/L)

Sodium Chloride 5.4 mg/ml (5.4 g/L)

Sodium S-Lactate 4.5 mg/ml (4.5 g/L)

Calcium Chloride Dihydrate 0.257 mg/ml (0.257 g/L) Magnesium Chloride Hexahydrate 0.051 mg/ml (0.051 g/L) Theoretical osmolarity: 284 (milliosmoles per litre)

Theoretical osmolality: 301 (milliosmoles per kg)

Electrolyte solution content per 1000 ml (1 L):

Sodium 133 mmol/L

Calcium 1.75 mmol/L

Magnesium 0.25 mmol/L

Chloride 96 mmol/L

Lactate 40 mmol/L pH = 5 to 6

The other ingredients are water for injections, sodium hydroxide or hydrochloric acid.

What Polithera Solution for peritoneal dialysis looks like and contents of the pack

Polithera Solution for peritoneal dialysis is a sterile, colourless or slightly yellowish solution. Polithera is presented in the following two packaging:

2.0 litres polypropilene plastic bag containing the solution and 3.0 litres drainage empty polypropilene plastic bag with connection tubing.

Both bags and their connection are introduced into a protective two-layer film made of polypropylene and polyamide overpouch and supplied in carton boxes containing 4 bags. 2.0 litres polypropylene plastic bag containing the solution introduced into a protective two-layer film made of polypropylene and polyamide overpouch and supplied in carton boxes containing 4 bags.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Vivisol S.r.l.

Via Gerolamo Borgazzi 27, 20900 Monza (MB), Italy

Manufacturer

Infomed Fluids S.r.l.

Bd. Pallady Theodor 50, 032266 Bucuresti-Sector 3, Romania

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: Austria: Polithera 7.5% Peritonealdialyselösung

Belgium: Polithera 7,5 % solution pour dialyse péritonéale

Denmark: Polithera Peritonealdialysevæske 75 mg/ml

Germany: Polithera Peritonealdialyselösung

Icodextrin 75 g/L, Natriumchlorid 5,4 g/L, Natrium-(S)-Lactat 4,5 g/L, Calciumchlorid-Dihydrat 0,257 g/L, Magnesiumchlorid-Hexahydrat 0,051 g/L Italy: Icothera

Netherlands: Polithera 7.5%, Oplossing voor peritoneale dialys

Poland: Polithera

Romania: Polithera soluţie pentru dializă peritoneală

Spain: Polithera (Icodextrina 7,5%), Solución para diálisis peritoneal Sweden: Polithera, peritonealdialysvätska

United Kingdom: Polithera Solution for peritoneal dialysis

This leaflet was last revised in 01/2025

Other sources of information

Leaflet could be provided in an alternative format (large print) at specific request received from the patient.

The patient can request the Leaflet either in electronic format (PDF), indicating an email address to receive it, or in paper format, indicating their Name and Surname and the postal address at which to receive the material by using the following website: https://www.vivisol.com/ under the section “Contact us”.

Active substances	Magnesium chloride hexahydrate, Calcium chloride dihydrate, Sodium chloride
Marketing authorisation	PL 52631/0001

Polithera solution for Peritoneal Dialysis – patient leaflet, side effects, dosage