FIXIONEAL Infusion solution

Зміст інструкції

1. FIXIONEAL
   1. What is FIXIONEAL and what is it 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

FIXIONEAL

“40 Glucosio 1.36% w/v/13.6 mg/ml” CLEAR-FLEX, peritoneal dialysis solution
FIXIONEAL
“40 Glucosio 2.27% w/v/22.7 mg/ml” CLEAR-FLEX, peritoneal dialysis solution
FIXIONEAL
“40 Glucosio 3.86% w/v/38.6 mg/ml” CLEAR-FLEX, peritoneal dialysis solution
Read this leaflet carefully before you start 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 get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

• 1. What is FIXIONEAL and what it is used for
• 2. What you need to know before you use 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 is FIXIONEAL and what is it 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 concentrations of glucose (1.36%, 2.27% or 3.86%). The amount of water that can be removed from the blood is greater the higher the glucose concentration in the solution. FIXIONEAL may be prescribed to you if you have:
temporary or permanent kidney failure;
severe fluid retention;
severe alterations of acidity or alkalinity (pH) or salt levels in the blood;
in some cases of drug poisoning when other treatments are not available.
FIXIONEAL has an acidity (pH value) close to that of the 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 product must be used under the supervision of a doctor for the first time.

Do not use FIXIONEAL

• If you are allergic to the active ingredients or 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 problem 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 who require 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 open) you may
experience abdominal pain. Immediately drain the solution, replace it with the solution from a
newly mixed bag, and immediately inform your doctor
If you do not immediately drain the unmixed solution, the level of salts and
other components of the blood may increase. This could cause the onset of adverse
effects such as confusion, drowsiness, and irregular heartbeat.
Inform your doctor before using FIXIONEAL.
Pay particular attention:

• if you have severe problems affecting the abdominal wall or cavity, e.g. a hernia or chronic infection or an inflammatory condition affecting the intestine.
• If you have undergone an aortic graft.
• If you have severe breathing difficulties.
• If you experience abdominal pain, an increase in body temperature, or if you notice turbidity or particles in the drained fluid. These signals may be indicators of peritonitis (inflamed peritoneum) or infection and you should urgently contact the medical team. Note the lot number of the peritoneal dialysis solution bags you were using and deliver them to the medical team together with the drained fluid bag. They will decide whether treatment should be discontinued or whether corrective therapies should be adopted. For example, if you have an infection, the doctor may perform some tests to find out which antibiotic is best for you. Until the doctor discovers the type of infection present, they may give you an antibiotic effective for a wide range of different bacteria. This is defined as a broad-spectrum antibiotic.
• If you have a high concentration of lactate in your blood. You have a high 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 to treat HIV, particularly medicines called NRTIs.
• If you have diabetes and use this solution, the dosage of the medicines that regulate your blood sugar concentration (e.g. insulin) will need to be assessed regularly. The dosage of diabetes medicines will need to be adjusted, especially at the start of peritoneal dialysis treatment or when it undergoes changes.
• If you have an allergy to corn that may lead to 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 concentration of parathyroid hormone due to kidney failure. The low calcium concentration in FIXIONEAL 40 may worsen hyperparathyroidism. The doctor will monitor your blood parathyroid hormone concentration.
• You, possibly together with the doctor, should keep a record of fluid balance and body weight. The doctor will monitor blood parameters at regular intervals, in particular salts (e.g. bicarbonate, potassium, magnesium, calcium and phosphate), parathyroid hormone and lipids.
• If you have a high concentration of bicarbonate in your blood.
• Do not use a quantity of solution greater than that prescribed by your doctor. Symptoms of overinfusion include abdominal distension, a feeling of fullness and shortness of breath.
• The doctor will regularly assess the potassium concentration. If it should become too low, you may be given potassium chloride to compensate.
• An incorrect sequence of clamping or priming can cause air to be infused into the peritoneal cavity, which can cause abdominal pain and/or peritonitis.
• Since a condition called encapsulating peritoneal sclerosis (EPS) is a rare known complication of peritoneal dialysis therapy. You, possibly together with the 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, the doctor will assess the risk versus benefit of using this
product.

Other medicines and FIXIONEAL

• Tell 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 happens because peritoneal dialysis treatment increases the elimination of some medicines.
• Pay attention if you are using medicines for the heart, known as cardiac glycosides (e.g. digoxin). You may: o need to take potassium and calcium supplements; o develop an irregular heartbeat (arrhythmia). o the doctor will monitor you carefully during treatment, observing in particular potassium levels.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor for advice before using this medicine. FIXIONEAL is not
recommended during pregnancy or breastfeeding, unless otherwise indicated by the
doctor.

Driving and operating machinery

3. How to use FIXIONEAL

FIXIONEAL must be administered into the peritoneal cavity. The peritoneal cavity is the cavity
in the abdomen (stomach) between the skin and the peritoneum. The peritoneum is the membrane around the internal organs,
such as the intestine and the liver.
Not for intravenous use.
Always use this medicine exactly as directed by the healthcare team specializing in
peritoneal dialysis. If you are unsure, ask your doctor.
Discard the bag if it is damaged.

How much and how often
The doctor will prescribe the most suitable 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, the doctor will carefully assess the prescription of this medicine.

If you stop using FIXIONEAL
Do not stop peritoneal dialysis without your doctor's consent. Stopping treatment may
have consequences that are life-threatening.

METHOD OF ADMINISTRATION
Before use,
Warm the bag to 37°C. To do this, 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 aseptic technique during the entire administration of the solution, according to the instructions
received.
Before starting the exchange procedure, make sure your hands and the area where the exchange will be
performed are clean.
Before removing the outer protective bag, verify the correctness of the type of solution, the
expiry date and the quantity (volume). Lift the dialysate bag to check for
leaks (excess liquid 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 pressing firmly on the bag. Verify that both the long and short
seals are not open at any point. If one of the seals is open, even partially, discard the
bag. Do not use the bag if you detect leaks.
Verify that the solution is clear. Do not use the bag if the solution is cloudy or contains
particles.
Before starting the exchange, make sure all connections are secure.
Thoroughly mix the contents of the two chambers, first opening the long seal and then
the short seal, SafetyMoon.
Contact your doctor if you have any questions or concerns about this medicine or how to use it.
Use the bag only once. Discard any unused solution residue.
The solution must be infused within 24 hours of mixing.
After use, check that the drained liquid is not cloudy.

Compatibility with other medicines
Your doctor may prescribe other injectable medicines to be added directly into the bag of
FIXIONEAL. In this case, add the medicine through the medication site located in the large
chamber before opening the long seal. Disinfect the medication site immediately before
the injection. Use the product immediately after adding the medicine. If you are unsure,
ask your doctor.

If you have used more FIXIONEAL bags than you shouldin 24 hours
If you take too much FIXIONEAL, 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 questions about the use
of this product, ask 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 any of the following occur:

• Hypertension (blood pressure higher than normal),
• Swelling of the ankles or legs, eye swelling, shortness of breath or chest pain (hypervolemia);
• Abdominal pain;
• Chills (trembling/flu-like symptoms), fever,
• Inflamed peritoneum (peritonitis). These are all serious side effects for which you may need urgent medical attention.

If you experience any side effect, tell your doctor or the peritoneal dialysis centre. This includes any side effect not listed in this leaflet.
Common (may affect up to 1 in 10 people):

• Changes in some blood values increased calcium (hypercalcemia) decreased potassium (hypokalaemia) which causes 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):

• Decreased fluid removal during dialysis;
• Feeling of fainting, dizziness or headache;
• Cloudy fluid 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 (groin swelling)
• Changes in some blood values
• lactic acidosis
• increased carbon dioxide concentration
• increased 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
• Skin rash

Other side effects related to the peritoneal procedure:

• Infection around the catheter exit site, catheter blockage.

Reporting of side effects
If you get any side effects, tell your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 a temperature below 4 °C.
Do not use this medicine after the expiration date stated on the package label and on the bag after the abbreviation Scad.and the symbol . The expiration 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

if you are not sure about something, ask your doctor.

What FIXIONEAL contains
The active ingredients 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 mixedsolution is:

Description of the appearance of FIXIONEAL and contents of the pack

• FIXIONEAL is a clear, colorless and sterile peritoneal dialysis solution.

• FIXIONEAL is packaged in two-chamber non-PVC plastic bags. The two chambers are separated by non-permanent seals. You must only infuse FIXIONEAL when the solutions in the two chambers are completely mixed. Only then should you open the short seal, SafetyMoon.
• Each bag is packaged 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
5.0 l 2
Single bag (APD) luer/luer and Homechoice
APD set with luer
Not all pack sizes may be marketed.
For further information on this medicine, contact the local representative of the marketing authorization holder:

Marketing authorization holder:
Vantive S.r.l.
Via del Serafico, 89 - 00142 Rome

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 Member States of the EEA 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 leaflet was last revised: