Physioneal: detailed information

“40 Glucose 1.36% p/v/13.6 mg/ml”, Peritoneal dialysis solution
“40 Glucose 2.27% p/v/22.7 mg/ml”, Peritoneal dialysis solution
“40 Glucose 3.86% p/v/38.6 mg/ml”, Peritoneal dialysis solution
Read this leaflet carefully before 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 side effects, inform your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

What PHYSIONEAL 40 is and what it is used for
What you need to know before using PHYSIONEAL 40
How to use PHYSIONEAL 40
Possible side effects
How to store PHYSIONEAL 40
Contents of the pack and other information

1. What PHYSIONEAL 40 is and what it is used for

PHYSIONEAL 40 is a peritoneal dialysis solution. The medicine removes water and waste products from the blood and 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 that can be 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 blood acidity or alkalinity (pH) or in blood electrolyte levels;
in some cases of drug intoxication when no other treatments are available.

PHYSIONEAL 40 has an acidity (pH value) close to that of blood, and is therefore particularly suitable if you experience discomfort or pain during infusion with more acidic peritoneal dialysis solutions.

2. What you need to know before using PHYSIONEAL 40

The first time, the product must be used under medical supervision.
DO NOT use PHYSIONEAL 40

If you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
If you have a surgically uncorrectable problem affecting the 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 significant peritoneal scarring.

Warnings and precautions
Contact your doctor before using PHYSIONEAL 40.
Pay particular attention if:
you have severe problems affecting the abdominal wall or cavity, such as a hernia, chronic infection, or an inflammatory condition of the intestine.
You have had an aortic graft.
You have severe respiratory difficulties.
You experience abdominal pain, an increase in body temperature, or notice cloudiness or particles in the drained fluid. These signs may indicate peritonitis (inflamed peritoneum) or infection, and you must contact your medical team urgently. Note down the batch number of the peritoneal dialysis solution bags you were using and give them, together with the bag of drained fluid, to your medical team. They will decide whether treatment should be stopped or corrective therapies initiated. For example, if you have an infection, your doctor may perform tests to determine the most appropriate antibiotic for you. Until the type of infection is identified, you may be given an antibiotic effective against a wide range of different bacteria. This is known as a broad-spectrum antibiotic.
If you have a high level of lactate in your blood. You are at increased risk of lactic acidosis if:
o your blood pressure is very low
o you have a blood infection
o you have acute kidney failure
o you have an inherited metabolic disorder
o you are taking metformin (a medicine used to treat diabetes)
o you are taking medicines for the treatment of HIV, particularly medicines called NRTIs
If you have diabetes and use this solution, the dosage of your blood sugar-regulating medicines (e.g. insulin) must be regularly assessed. The dosage of diabetes medicines should be adjusted, especially at the beginning of peritoneal dialysis treatment or when changes are made to the treatment.
If you are allergic to maize (corn) starch, which may cause hypersensitivity reactions, including severe allergic reactions called anaphylaxis. Immediately stop the infusion and drain the solution from the peritoneal cavity.
If you have a high blood level of parathyroid hormone due to your kidney failure.
The low calcium concentration in PHYSIONEAL 40 may worsen hyperparathyroidism. Your doctor will monitor your blood parathyroid hormone levels.
You, possibly together with your doctor, should keep careful records of body weight and fluid balance. Your doctor will monitor your blood parameters at regular intervals, particularly electrolytes (e.g. bicarbonate, potassium, magnesium, calcium, and phosphate), parathyroid hormone, and lipids.
If you have a high level of bicarbonate in your blood.
Do not use a volume of solution greater than that prescribed by your doctor. Symptoms of over-infusion include abdominal distension, sensation of fullness, and shortness of breath.
Your doctor will regularly assess your potassium levels. If they become too low, you may be given potassium chloride to compensate.
Incorrect clamping or priming sequences may lead to air infusion into the peritoneal cavity, which may cause abdominal pain and/or peritonitis.
If you have infused unmixed solution, immediately drain the solution and use a freshly mixed solution.
Since a condition called encapsulating peritoneal sclerosis (EPS) is a rare known complication of peritoneal dialysis therapy, you, possibly together with your doctor, should be aware of this possible complication. EPS causes:
o inflammation of the abdomen (stomach)
o thickening of the intestine, 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 risks and benefits of using this product.
Other medicines and PHYSIONEAL 40

Inform your doctor if you are taking, have recently taken, or might take any other medicines.
If you are taking other medicines, your doctor may need to increase their dosage. This is because peritoneal dialysis treatment increases the elimination of some medicines. Pay particular attention if you are taking heart medicines called cardiac glycosides (e.g. digoxin). You may: o require potassium and calcium supplements o develop an irregular heartbeat (arrhythmia) o need to be closely monitored throughout treatment, with particular attention to potassium levels.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, consult your doctor before using this medicine. Your doctor will confirm whether this treatment is suitable for you.
Driving and using machines
This treatment may cause weakness, blurred vision, or dizziness. Under these conditions, do not drive or operate machinery.

3. How to use PHYSIONEAL 40

PHYSIONEAL 40 must be infused into the peritoneal cavity. The peritoneal cavity is the space
within the abdomen (belly) between the skin and the peritoneum. The peritoneum is the membrane surrounding the internal organs,
such as the intestines and liver.
Not for intravenous use.
Always use this medicine exactly as directed by your peritoneal dialysis healthcare team. If in doubt, consult your doctor.
Discard the bag if it is damaged.

Dosage and frequency
Your doctor will prescribe the most 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 stop treatment with PHYSIONEAL 40
Do not stop peritoneal dialysis without your doctor’s approval. Stopping treatment may lead to life-threatening consequences.

METHOD OF ADMINISTRATION
Before use,
Warm the bag to 37°C. Use a heating plate specifically designed for this purpose. Never immerse the product in water. Never use a microwave oven to heat the solution.
Use an aseptic technique throughout the entire administration of the solution, as instructed.
Before starting the exchange procedure, ensure that your hands and the area where the exchange will take place are clean.
Before removing the outer protective bag, check that the solution type, expiration date, and quantity (volume) are correct. Lift the dialysis bag to verify that there are no leaks (excess fluid in the outer protective bag). Do not use the bag if leaks are detected.
After removing the outer protective bag, check that the container shows no signs of leakage by firmly pressing on the bag. Check that the break cone between the two chambers is intact. If the break cone is already open, discard the bag. Do not use the bag if any leaks are detected.
Check that the solution is clear. Do not use the bag if the solution is cloudy or contains particles.
Before starting the exchange, ensure that all connections are secure.
Thoroughly mix the contents of the two chambers by breaking the break cone between them.
Wait until the upper chamber has completely emptied into the lower chamber.
Gently mix by pressing on the walls of the lower chamber with both hands.
Consult your doctor if you have any questions or concerns about this medicine or its use.
Use each bag only once. Discard any unused solution.
The solution must be infused 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 40 bag. In this case, add the medicine through the medication site located in the small chamber before breaking the break cone between the two chambers. Use the product immediately after adding the medicine. If in doubt, consult your doctor.

If you have used more PHYSIONEAL 40 bags than prescribed within 24 hours
If you use too many PHYSIONEAL 40 bags, you may experience:

abdominal distension
feeling of fullness, and/or
shortness of breath

Contact your doctor immediately. They will advise you on what to do. If you have any further doubts about the use of this product, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor or peritoneal dialysis centre immediately if you experience any of the following:
High blood pressure (hypertension),
Swelling of the ankles or legs, eye puffiness, difficulty breathing or chest pain (hypervolemia);
Abdominal pain;
Chills (shivering/flu-like symptoms), fever;
Inflamed peritoneum (peritonitis).

These are all serious side effects which may require urgent medical attention.
If you experience any side effect, contact your doctor or peritoneal dialysis centre. This includes any side effect not listed in this leaflet.

Common (may affect up to 1 in 10 people):
Changes in certain blood values
increased calcium (hypercalcaemia)
decreased potassium (hypokalaemia), which may cause muscle weakness, muscle cramps or abnormal heartbeat
increased bicarbonate concentration (alkalosis)
Weakness, fatigue
Fluid retention (oedema)
Weight gain

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

Reduced fluid removal during dialysis;
Feeling faint, dizziness or headache;
Cloudy solution drained from the peritoneum, stomach pain;
Peritoneal bleeding, pus, swelling or pain around the catheter exit site, catheter blockage;
Nausea, loss of appetite, indigestion, flatulence, thirst, dry mouth;
Abdominal distension or inflammation, shoulder pain, abdominal wall hernia (inguinal swelling);
Changes in certain blood values
- lactic acidosis
- increased carbon dioxide concentration
- increased blood sugar (hyperglycaemia)
- increased white blood cell count (eosinophilia)
Difficulty sleeping
Low blood pressure (hypotension)
Cough
Muscle or bone pain
Facial or throat swelling
Rash

Other side effects related to the peritoneal procedure:

Infection around the catheter exit site, catheter blockage.

Reporting of side effects
If you experience any side effect, tell your doctor. This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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. The date is stated on the packaging label and on the bag after the abbreviation Exp. and the symbol . The expiry date refers to the last day of that month.
Dispose of PHYSIONEAL 40 as indicated during your training.

6. Contents of the pack and other information

This leaflet does not contain all the information about this medicine. If you have any doubts or are
unsure about anything, please consult your doctor.
What PHYSIONEAL 40 contains
The active substances in the mixed peritoneal dialysis solution are:

	1.36%	2.27%	3.86%
Glucose monohydrate (g/l)	15.0	25.0	42.5
equivalent to anhydrous glucose (g/l)	13.6	22.7	38.6
Sodium chloride (g/l)	5.38
Calcium chloride dihydrate (g/l)	0.184
Magnesium chloride hexahydrate (g/l)	0.051
Sodium bicarbonate (g/l)	2.10
Sodium S-Lactate solution (g/l)	1.68

The excipients are water for injections and carbon dioxide.
The composition in mmol/l of the final solution after mixing is:

	1.36%	2.27%	3.86%
Anhydrous glucose (mmol/l)	75.5	126	214
Sodium (mmol/l)	132
Calcium (mmol/l)	1.25
Magnesium (mmol/l)	0.25
Chloride (mmol/l)	95
Bicarbonate (mmol/l)	25
Lactate (mmol/l)	15

Description of the appearance of PHYSIONEAL 40 and contents of the pack

PHYSIONEAL 40 is a clear, colourless, sterile peritoneal dialysis solution.
PHYSIONEAL 40 is packed in double-chamber PVC bags. The two chambers are separated by a permanent seal. You must only infuse PHYSIONEAL 40 after the solutions in both chambers have been completely mixed.
Each bag is packed in an outer wrapper and supplied in cardboard boxes.

Not all pack sizes may be marketed.
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Marketing Authorisation Holder:
Vantive S.r.l.
Via del Serafico, 89 - 00142 Rome, Italy
Manufacturer:
Vantive Manufacturing Limited, Moneen Road – Castlebar – County Mayo, Ireland
or
Bieffe Medital SpA, Via Nuova Provinciale - 23034 Grosotto, Italy
This Patient Information Leaflet was last revised on