Fixioneal

Package leaflet: Information for the user

FIXIONEAL

“35 Glucose 1.36% w/v /13.6 mg/ml” CLEAR-FLEX, solution for peritoneal dialysis
FIXIONEAL
“35 Glucose 2.27% w/v /22.7 mg/ml” CLEAR-FLEX, solution for peritoneal dialysis
FIXIONEAL
“35 Glucose 3.86% w/v /38.6 mg/ml” CLEAR-FLEX, solution for peritoneal dialysis
Please read all of 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 doubts, consult your doctor.
• If you experience any adverse reaction, inform your doctor. This includes any possible adverse reaction not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What FIXIONEAL is and what it is used for

FIXIONEAL is a peritoneal dialysis solution. The medicine removes water and waste products from the blood and corrects abnormal levels of various blood components. FIXIONEAL 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. FIXIONEAL may be prescribed to you if you have:
temporary or permanent kidney failure;
severe fluid retention;
significant disturbances in blood acidity or alkalinity (pH) or in blood electrolyte levels;
in some cases of drug intoxication when no other treatments are available.
FIXIONEAL has an acidity (pH value) close to that of blood, so it may be particularly suitable if you experience discomfort or pain during infusion with other, more acidic peritoneal dialysis solutions.

2. What you need to know before using FIXIONEAL

The first time, this product must be used under medical supervision.
Do not use FIXIONEAL

• If you are allergic to the active substances or to any of the other components of this medicinal product (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.

In some cases, the use of FIXIONEAL in the CLEAR-FLEX container is not recommended:

• in children requiring a fill volume of less than 1600 ml.

Warnings and precautions
Before use, you must
First mix the contents of the two chambers by opening the long seal;
Then open the short SafetyMoon seal.
If you infuse unmixed solution (the long seal between the two chambers is not opened), you may
experience abdominal pain. Immediately drain the solution, replace it with solution from a newly mixed bag, and inform your doctor immediately.
If you do not immediately drain the unmixed solution, blood levels of salts and other components may rise.
This could lead to undesirable effects such as confusion, drowsiness, and irregular heartbeat.
Inform your doctor before using FIXIONEAL.
Pay particular attention if:

• You have serious problems affecting the abdominal wall or cavity, e.g. 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, increased 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 bags you were using and give it, 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 suitable 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.
• You have elevated blood lactate levels. You are at increased risk of lactic acidosis if:
  • your blood pressure is very low
  • you have a blood infection
  • you have acute kidney failure
  • you have an inherited metabolic disorder
  • you are taking metformin (a medicine used to treat diabetes)
  • 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) should be monitored regularly. The dosage of diabetes medicines should be adjusted, especially at the beginning of peritoneal dialysis treatment or when treatment changes.
• If you have a maize (corn) allergy, which may cause hypersensitivity reactions, including severe allergic reactions called anaphylaxis. Immediately stop the infusion and drain the solution from the peritoneal cavity.
• You, possibly together with your doctor, should keep a record of your fluid balance and body weight. Your doctor will monitor your blood parameters regularly, particularly electrolytes (e.g. bicarbonate, potassium, magnesium, calcium, and phosphate), parathyroid hormone, and lipids. If you have high blood bicarbonate levels, do not use more solution than prescribed by your doctor. Symptoms of over-infusion include abdominal distension, feeling of fullness, and shortness of breath. Your doctor will regularly assess your potassium levels. If they become too low,

potassium chloride may be administered to compensate.

• Incorrect clamping or priming sequence may lead to air infusion into the peritoneal cavity, which can cause abdominal pain and/or peritonitis.
• Since a condition called encapsulating peritoneal sclerosis (EPS) is a known rare complication of peritoneal dialysis therapy, you, possibly together with your doctor, should be aware of this possible complication. EPS causes:
  • inflammation of the abdomen (belly), 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 versus benefits of using this product.

Other medicines and FIXIONEAL

• 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 certain medicines.
• Be cautious if you are using heart medicines known as cardiac glycosides (e.g. digoxin). You may:
  • need potassium and calcium supplements.
  • develop an irregular heartbeat (arrhythmia).
  • Your doctor will monitor you closely during treatment, paying particular attention to your potassium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor before using this medicine. FIXIONEAL is not
recommended during pregnancy or breastfeeding, unless otherwise directed by your
doctor.
Driving and operating machinery
This treatment may cause weakness, blurred vision, or dizziness. Under these conditions, do not
drive or operate machinery.

3. How to use FIXIONEAL

FIXIONEAL must be administered into the peritoneal cavity. The peritoneal cavity is the space
in 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 instructed 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 need to 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 FIXIONEAL
Do not discontinue peritoneal dialysis without your doctor’s consent. Stopping treatment may lead to life-threatening consequences.

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, expiry 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 both the long and short seals are intact and not opened at any point. If either seal is open, even partially, discard the bag. Do not use the bag if leakage is 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. Mix the contents of the two chambers thoroughly by first opening the long seal, then the short seal, SafetyMoon.
• Consult your doctor if you have any questions or concerns about this medicine or its use.
• Use the 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 injectable medicines to be added directly to the FIXIONEAL bag. In this case, add the medicine through the medication port located in the large chamber before opening the long seal. Disinfect the medication port immediately before injection. Use the product immediately after adding the medicine. If in doubt, consult your doctor.

If you have used more FIXIONEAL bags than prescribed within 24 hours
If you use too many FIXIONEAL 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 further doubts about using this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause unwanted side effects, although not everyone experiences them.
Contact your doctor or peritoneal dialysis center immediately if you experience any of the following:

• Hypertension (blood pressure higher than normal),
• Swelling in the ankles or legs, puffiness around the eyes, shortness of breath, or chest pain (hypervolemia);
• Abdominal pain;
• Chills (trembling/flu-like symptoms), fever,
• Inflamed peritoneum (peritonitis).
  These are all serious side effects that may require urgent medical attention. If you experience any adverse reaction, contact your doctor or peritoneal dialysis center. This includes any adverse reaction not listed in this leaflet.

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

• Changes in certain blood values
• increased calcium (hypercalcemia)
• decreased potassium (hypokalemia), causing muscle weakness, muscle cramps, or abnormal heartbeat
• Weakness, fatigue
• Fluid retention (edema)
• 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 hernia (inguinal swelling);
• Changes in certain blood values
• lactic acidosis
• increased carbon dioxide concentration
• increased blood sugar (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 side effects related to the peritoneal procedure:

• Infection around the catheter exit site, catheter blockage.

Reporting of side effects
This includes any possible side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at 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 FIXIONEAL

• 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 packaging and bag following the abbreviation Exp. and the symbol . The expiry date refers to the last day of that month. Dispose of FIXIONEAL as indicated during your training.

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 doubts or
are unsure about anything, please consult your doctor.
What FIXIONEAL contains
The active substances in the mixed peritoneal dialysis solution are:

The excipients are water for injections, sodium hydroxide, and hydrochloric acid.
The composition in mmol/l in the mixed solution is:

Description of the appearance of FIXIONEAL and packaging contents

• FIXIONEAL is a clear, colorless, sterile peritoneal dialysis solution.
• FIXIONEAL is supplied in dual-chamber non-PVC plastic bags. The two chambers are separated by non-permanent seals. You must administer FIXIONEAL only after the solutions in both chambers have been completely mixed. Only then should you open the short seal, SafetyMoon.
• Each bag is enclosed in an outer wrapper and supplied in cardboard boxes.

Volume Number of units per box Product packaging Connector type
1.5 l 5/6 Single bag (APD) luer
1.5 l 5/6 Double bag (CAPD) luer
2.0 l 4/5 Single bag (APD) luer
2.0 l 4/5 Double bag (CAPD) luer
2.5 l 3/4 Single bag (APD) luer
2.5 l 3/4 Double bag (CAPD) luer
3.0 l 3 Single bag (APD) luer
3.0 l 3 Double bag (CAPD) luer
4.5 l 2 Single bag (APD) luer
Single bag (APD) luer/luer and Homechoice
5.0 l 2
APD set with luer
Not all pack sizes may be marketed.
For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Marketing Authorization Holder:
Vantive S.r.l.
Via del Serafico, 89 - 00142 Rome, Italy
Manufacturer:
Vantive Manufacturing Limited
Moneen Road – Castlebar – County Mayo, Ireland
Bieffe Medital S.p.A.
Via Nuova Provinciale, s/n – 23034 Grosotto, Italy
This medicinal product is authorized in the EEA Member States under the following brand 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
This Patient Information Leaflet has been last revised on:

Package leaflet: information for the user

FIXIONEAL

“40 Glucose 1.36% w/v / 13.6 mg/ml” CLEAR-FLEX, solution for peritoneal dialysis
FIXIONEAL
“40 Glucose 2.27% w/v / 22.7 mg/ml” CLEAR-FLEX, solution for peritoneal dialysis
FIXIONEAL
“40 Glucose 3.86% w/v / 38.6 mg/ml” CLEAR-FLEX, solution for peritoneal dialysis
Please read this patient information leaflet carefully before using this medicine, as 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.

Patient information leaflet contents:

1. What FIXIONEAL is and what it is used for
2. What you need to know before using FIXIONEAL
3. How to use FIXIONEAL
4. Possible side effects
5. How to store FIXIONEAL
6. Package contents and other information

1. What FIXIONEAL is and what it is used for

FIXIONEAL is a peritoneal dialysis solution. The medicine removes water and waste products from the blood and corrects abnormal levels of various blood components. FIXIONEAL 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.
FIXIONEAL may be prescribed to you if you have:
temporary or permanent kidney failure;
severe fluid retention;
significant disturbances in blood acidity or alkalinity (pH) or electrolyte levels;
in some cases of drug intoxication when no other treatments are available.
FIXIONEAL has an acidity (pH value) close to that of blood, so it may be particularly suitable if you experience discomfort or pain during infusion with other, more acidic peritoneal dialysis solutions.

2. What you should know before using FIXIONEAL

The first time, the product must be used under medical supervision.
Do not use FIXIONEAL

• 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.

In some cases, the use of FIXIONEAL in the CLEAR-FLEX container is not recommended:

• in children requiring a fill volume of less than 1600 ml.

Warnings and precautions
Before use, you must:
First mix the contents of the two chambers by opening the long seal;
Then open the short SafetyMoon seal.
If you infuse unmixed solution (the long seal between the two chambers is not opened), you may
experience abdominal pain. Immediately drain the solution, replace it with a newly mixed bag, and inform your doctor immediately.
If you do not immediately drain the unmixed solution, blood levels of salts and other components may rise.
This could lead to undesirable effects such as confusion, drowsiness, and irregular heartbeat.
Inform your doctor before using FIXIONEAL.
Exercise particular caution:

• if you have serious problems affecting the abdominal wall or cavity, e.g. a hernia, chronic infection, or an inflammatory condition of the intestine.
• If you have had an aortic graft.
• If you have severe respiratory difficulties.
• If you experience abdominal pain, increased 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. Record the batch number of the peritoneal dialysis solution bags you were using and provide it, together with the drained fluid bag, 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 high blood lactate levels. You are at increased risk of lactic acidosis if:
  • your blood pressure is very low
  • you have a blood infection
  • you have acute renal failure
  • you have an inherited metabolic disorder
  • you are taking metformin (a medicine used to treat diabetes)
  • you are taking medicines for HIV treatment, 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 evaluated. The dosage of diabetes medicines should be adjusted, especially at the beginning of peritoneal dialysis treatment or when treatment changes.
• If you are allergic to corn, 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 high blood levels of parathyroid hormone due to renal failure. The low calcium concentration in FIXIONEAL 40 may worsen hyperparathyroidism. Your doctor will monitor your blood parathyroid hormone levels.
• You, possibly together with your doctor, should keep a record of your fluid balance and body weight. Your doctor will monitor your blood parameters at regular intervals, particularly salts (e.g. bicarbonate, potassium, magnesium, calcium, and phosphate), parathyroid hormone, and lipids.
• If you have high blood bicarbonate levels.
• Do not use a volume of solution greater than that prescribed by your doctor. Symptoms of over-infusion include abdominal distension, feeling 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 sequence of clamping or priming may result in air infusion into the peritoneal cavity, which may cause abdominal pain and/or peritonitis.
• Since a condition called encapsulating peritoneal sclerosis (EPS) is a known rare complication of peritoneal dialysis therapy, you, possibly together with your doctor, should be aware of this potential complication. EPS causes:
  • inflammation of the abdomen (belly)
  • 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 risk versus benefit of using this
product.
Other medicines and FIXIONEAL

• 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.
• Be cautious if you are using medicines for the heart, known as cardiac glycosides (e.g. digoxin). You may:
  o need potassium and calcium supplements;
  o develop an irregular heartbeat (arrhythmia).
  o require close monitoring by your doctor, particularly regarding potassium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding,
please consult your doctor before using this medicine. FIXIONEAL is not
recommended during pregnancy or breastfeeding, unless otherwise directed by your
doctor.
Driving and use of machines

3. How to use FIXIONEAL

FIXIONEAL must be administered into the peritoneal cavity. The peritoneal cavity is the space
in the abdomen (belly) between the skin and the peritoneum. The peritoneum is the membrane surrounding the internal organs,
such as the intestine and the liver.
Not for intravenous use.
Always use this medicine exactly as instructed by your peritoneal dialysis medical 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 need to 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 FIXIONEAL
Do not stop peritoneal dialysis without your doctor’s approval. Stopping treatment may have 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 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, expiry date, and quantity (volume) are correct. Lift the dialysis bag to check for leaks (excess fluid in the outer protective bag). Do not use the bag if you detect any leaks.
After removing the outer protective bag, check that the container shows no signs of leakage by firmly pressing on the bag. Check that both the long and short seals are intact and not opened at any point. If either seal is open, even partially, discard the bag. Do not use the bag if you detect any leaks.
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.
Mix the contents of the two chambers thoroughly by first opening the long seal and then the short seal, SafetyMoon.
Consult your doctor if you have any questions or concerns about this medicine or its use.
Use the 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 injectable medicines to be added directly to the FIXIONEAL bag. In this case, add the medicine through the medication port located in the large chamber before opening the long seal. Disinfect the medication port immediately before injection. Use the product immediately after adding the medicine. If in doubt, consult your doctor.

If you have used more FIXIONEAL bags than prescribed within 24 hours
If you use too many FIXIONEAL 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 further doubts about using this product, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or peritoneal dialysis centre immediately if you experience any of the
following:

• Hypertension (blood pressure higher than normal),
• Swelling in the ankles or legs, swelling around the eyes, shortness of breath or chest pain (hypervolemia);
• Abdominal pain;
• Chills (trembling/influenza-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 (hypercalcemia), decreased potassium (hypokalemia) causing muscle weakness, muscle cramps or abnormal heartbeat, increased bicarbonate concentration (alkalosis)
• Weakness, fatigue
• Fluid retention (edema)
• 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 hernia (inguinal swelling);
• Changes in certain blood values:
  • lactic acidosis
  • increased carbon dioxide concentration
  • increased blood sugar (hyperglycemia)
  • increased white blood cell count (eosinophilia)
• Difficulty sleeping
• Low blood pressure (hypotension)
• Cough
• Muscle or bone pain
• Swelling of the face or throat
• 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 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 FIXIONEAL

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 packaging and on the bag after the abbreviation Exp. and the symbol . The expiry date refers to the last day of that month.
Dispose of FIXIONEAL as instructed 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, consult your doctor.
What FIXIONEAL contains
The active substances in the mixed peritoneal dialysis solution are:

The excipients are water for injections, sodium hydroxide and hydrochloric acid.
The composition in mmol/l in the mixed solution is:

Description of the appearance of FIXIONEAL and contents of the pack

• FIXIONEAL is a clear, colourless, sterile peritoneal dialysis solution.
• FIXIONEAL is packed in non-PVC plastic dual-chamber bags. The two chambers are separated by non-permanent seals. You must administer FIXIONEAL only after the solutions in both chambers have been completely mixed. Only thereafter should you open the short seal, SafetyMoon.
• Each bag is packed in an outer wrapper and supplied in cardboard boxes.

Volume | Number of units per box | Packaging type | Connector type
--- | --- | --- | ---
1.5 l | 5/6 | Single bag (APD) | luer
1.5 l | 5/6 | Double bag (CAPD) | luer
2.0 l | 4/5 | Single bag (APD) | luer
2.0 l | 4/5 | Double bag (CAPD) | luer
2.5 l | 3/4 | Single bag (APD) | luer
2.5 l | 3/4 | Double bag (CAPD) | luer
3.0 l | 3 | Single bag (APD) | luer
3.0 l | 3 | Double bag (CAPD) | luer
4.5 l | 2 | Single bag (APD) | luer
| | Single bag (APD) | luer/luer and Homechoice
5.0 l | 2 | | APD set with luer

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 Roma, Italy

Manufacturer:
Vantive Manufacturing Limited
Moneen Road – Castlebar – County Mayo, Ireland
Bieffe Medital S.p.A.
Via Nuova Provinciale, s/n – 23034 Grosotto, Italy

This medicinal product is authorised in the EEA Member States under the following trade 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 40 CLEAR-FLEX

Italy: FIXIONEAL 40

This Patient Information Leaflet was last reviewed on: