Peritoneal dialysis solution FME: detailed information

Package leaflet: Information for the patient

PERITONEAL DIALYSIS SOLUTION FME

1.5%, 1.75 mmol/l, 35 mmol/l peritoneal dialysis solution
4.5%, 1.75 mmol/l, 35 mmol/l peritoneal dialysis solution
2.3%, 1.75 mmol/l, 35 mmol/l peritoneal dialysis solution
Glucose, Calcium, (L)-Lactate
Please read this leaflet carefully before you are given 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What SOLUZIONE PER DIALISI PERITONEALE FME is and what it is used for
What you need to know before you are given SOLUZIONE PER DIALISI PERITONEALE FME
How to use SOLUZIONE PER DIALISI PERITONEALE FME
Possible side effects
How to store SOLUZIONE PER DIALISI PERITONEALE FME
Contents of the pack and other information

1. What SOLUZIONE PER DIALISI PERITONEALE FME is and what it is used for

Peritoneal dialysis solutions are preparations for intraperitoneal use, containing electrolytes in concentrations similar to those found in plasma (except for glucose and lactate).
They are indicated for the treatment of acute and chronic renal failure associated with fluid overload or electrolyte imbalance.
They are also indicated for the treatment of intoxications caused by dialyzable substances.

2. What you should know before being administered SOLUZIONE PER DIALISI PERITONEALE FME

PERITONEAL DIALYSIS SOLUTION FME
You must not be administered PERITONEAL DIALYSIS SOLUTION FME

if you are allergic to Glucose, Calcium, (L)-Lactate, or any of the other components of this medicine (listed in section 6).
if you have pre-existing severe lactic acidosis

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are administered PERITONEAL DIALYSIS
SOLUTION FME.
Peritoneal dialysis should be administered with caution if you have:

Abdominal conditions, including rupture of the peritoneal membrane and diaphragm following surgery, congenital abnormalities or trauma until complete healing, abdominal tumors, infection of the abdominal wall, hernias, fecal fistula or colostomy, polycystic kidneys with large cysts, or other conditions compromising the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity;
Other conditions including aortic graft implantation and severe pulmonary disease.

Encapsulating peritoneal sclerosis (EPS) is considered a known, although rare, complication of
peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions,
including patients using PERITONEAL DIALYSIS SOLUTIONS as part of their PD therapy.
If you develop peritonitis, the choice and dosage of antibiotics should be based, whenever possible, on
the results of identification studies and sensitivity testing of isolated organisms. Before
identification of the causative organisms, broad-spectrum antibiotics may be indicated.
If you have conditions known to increase the risk of lactic acidosis (e.g., acute renal failure, congenital
metabolic disorders, treatment with medications such as metformin and nucleoside/nucleotide reverse transcriptase inhibitors – NRTIs), you should be monitored for lactic acidosis before starting therapy and during treatment with peritoneal dialysis solutions containing lactate.
When prescribing the solution to be used, consider possible interactions between dialysis treatment and therapy for other pre-existing diseases.
If you are receiving cardiac glycosides, your serum potassium levels must be closely monitored.
If you are a diabetic with azotemia, careful monitoring of insulin requirements is necessary during and after dialysis with dextrose-containing solutions.
Your fluid balance must be closely monitored, and your body weight should be carefully tracked to avoid over- or under-hydration, which may lead to serious consequences including congestive heart failure, fluid depletion, and shock.
During peritoneal dialysis, significant losses of proteins, amino acids, and water-soluble vitamins may occur. Replenishment therapy may be required when necessary.
If you are being treated with low-calcium solutions, calcium levels should be monitored to assess for the development of hypocalcemia or worsening of hypercalcemia. In such cases, your doctor should consider adjusting the dosage of phosphate binders and/or vitamin D and/or vitamin D analogs.
Due to the risk of overfilling, the use of 5- or 6-liter solutions in a single exchange is not recommended, either in CAPD (continuous ambulatory peritoneal dialysis) or in APD (automated peritoneal dialysis).
Overfilling of peritoneal dialysis solutions into the peritoneal cavity may present as abdominal distension/abdominal pain and/or dyspnea.
In case of overfilling with Peritoneal Dialysis Solution FME, drain the solution from the peritoneal cavity.
Excessive use of peritoneal dialysis solutions with high glucose concentration during peritoneal dialysis treatment may cause excessive fluid removal.
Your serum electrolyte levels (particularly bicarbonate, potassium, magnesium, calcium, and phosphate) and hematological and biochemical parameters (including parathyroid hormone) should be periodically checked.
If you are not diabetic, blood glucose levels may vary widely, likely due to glucose intolerance caused by uremia. The risk of developing hyperglycemia is proportionally increased if you are diabetic and uremic.
If you are diabetic, blood glucose levels should be regularly monitored and insulin dosage or other antihyperglycemic medications should be adjusted accordingly.
a transfer set connecting the bag to the patient's catheter (transfer line).
The "Lineo" connector, which may be part of the Y-transfer line connected to the double bag, contains povidone-iodine ointment.
Detailed instructions for the peritoneal dialysis exchange procedure are available through training at specialized centers and in the package leaflet.
The medicine, once the outer wrapper has been removed, must be used immediately.
Other medicines and PERITONEAL DIALYSIS SOLUTION FME
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted with PERITONEAL DIALYSIS SOLUTION FME. The blood concentration of dialyzable drugs may be reduced during dialysis. If necessary, dosages
If you are on digitalis therapy, plasma potassium levels should be frequently assessed to prevent the risk of cardiac arrest.
Addition of drugs to the solution should only be performed upon medical prescription and carefully evaluated.
The relatively low pH of the solution may require the addition of sodium bicarbonate for correction.
To prevent fibrin deposition in the catheter, heparin may be added to the dialysis solution.
If you are diabetic, insulin administration may be necessary during peritoneal dialysis to correct hyperglycemia; in such cases, the drug should be administered intraperitoneally.
Before adding other medicines, their compatibility with PERITONEAL DIALYSIS SOLUTION FME must be verified. The solution should be inspected immediately after addition of medicines.
In vitro studies have demonstrated stability of the following antimicrobials when mixed with the medicine:
amphotericin B, ampicillin, azlocillin, cephradine, cefazolin, cephapirin, cefotaxime, ceftazidime,
ceftriaxone, ciprofloxacin, clindamycin, co-trimoxazole, deferoxamine, erythromycin, gentamicin,
linezolid, mezlocillin, miconazole, moxifloxacin, nafcillin, ofloxacin, penicillin G, piperacillin,
teicoplanin, ticarcillin, tobramycin, and vancomycin.
However, aminoglycosides should not be mixed with penicillins due to their chemical incompatibility.
Pregnancy and breastfeeding
Driving and use of machines
If you suffer from end-stage renal failure and are undergoing peritoneal dialysis, you may experience side effects that could impair your ability to drive vehicles or operate machinery.

3. How to use SOLUZIONE PER DIALISI PERITONEALE FME

Dosing
The type of therapy, treatment frequency, exchange volume, dwell time in the
peritoneal cavity, and duration of dialysis must be determined and supervised by the prescribing physician.

If you are undergoing continuous ambulatory peritoneal dialysis (CAPD), you will generally perform 4 exchanges per day (24 hours). If you are undergoing automated peritoneal dialysis (APD), you will generally perform 4–5 exchanges at night and up to 2 exchanges during the day. The fill volume depends on body size, normally between 2.0 and 2.5 litres.
In paediatric patients (from neonates up to adolescents aged 18 years), the recommended fill volume is 800 to 1400 ml/m² per exchange, up to a maximum of 2000 ml as tolerated. In children under 2 years of age, fill volumes of 500 to 1000 ml/m² are recommended.

Administration

Peritoneal dialysis solutions are for intraperitoneal use only. Not for intravenous use.
Peritoneal dialysis solutions may be warmed to 37°C inside their outer protective packaging for your comfort. This should be done using dry heat (e.g. a heating pad or warming plate). To avoid possible injury or discomfort, do not use water baths or microwave ovens to warm the solution.
An aseptic technique must be used throughout the bag exchange procedure.
Do not administer the solution if it appears cloudy or discoloured, contains particles, shows signs of leakage, or if the seals are not intact.
Check that the drained fluid does not contain fibrin or appear turbid, as these may be signs suggestive of peritonitis.
For a single administration: any unused solution must be discarded. It is recommended to select a peritoneal dialysis solution with a lower dextrose (glucose) concentration as your weight approaches your dry weight (i.e. your ideal weight). To avoid the risk of severe dehydration and hypovolaemia and to limit protein loss, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity compatible with the amount of fluid to be removed at each exchange.

If you are given more SOLUZIONE PERITONEALE FME than you should receive
Consequences
Hypervolaemia, hypovolaemia, electrolyte disturbances, or (in diabetic patients) hyperglycaemia.
Treatment

Hypervolaemia: use of hypertonic peritoneal dialysis solution and restriction of fluid intake.
Hypovolaemia: rehydration orally or intravenously, depending on the degree of dehydration.
Electrolyte disturbances: these will be managed according to the specific disturbance identified by blood testing. The most likely disturbance, hypokalaemia, can be managed by oral potassium supplementation or by adding potassium chloride to the peritoneal dialysis solution as prescribed by your physician. If you are diabetic, hyperglycaemia can be managed by adjusting your insulin dosage.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The possible side effects are listed below, classified by frequency:

Hypokalaemia, Fluid retention, Hypervolaemia, Hypovolaemia, Hyponatraemia, Dehydration, Hypochloraemia, Hyperglycaemia, Dyslipidaemia
Hypertension, Hypotension
Dyspnoea
Sclerosing encapsulating peritonitis, Peritonitis, Turbid peritoneal effluent, Vomiting, Diarrhoea, Nausea, Constipation, Abdominal pain, Abdominal distension, Abdominal discomfort
Stevens-Johnson syndrome, Urticaria, Rash (including pruritic, erythematous and generalized rash), Pruritus
Myalgia, Muscle spasms, Musculoskeletal pain
Generalized oedema, Pyrexia, Malaise, Infusion site pain

Other side effects related to peritoneal dialysis procedure include:

fungal peritonitis
bacterial peritonitis
catheter site infection
catheter-related complications.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse. You can also report side effects directly via
http://www.agenziafarmaco.gov.it/it/responsabili.it. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLUZIONE PER DIALISI PERITONEALE FME

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp." The expiry date refers to the last day of that month.
The expiry date applies to the product stored in its original, unopened packaging and properly conserved.

Storage conditions
Do not store above 25°C.
Do not refrigerate or freeze.
Keep in the original packaging to protect the medicine from light. Keep the container tightly closed.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

Peritoneal dialysis solutions have variable compositions.
The active substances are Sodium, Potassium, Calcium, Magnesium, Lactate, Chloride, and Glucose in the following compositions per 1000 ml of solution:

Formulation and system | Glucose monohydrate (≡ anhydrous glucose) | Calcium chloride dihydrate | Sodium chloride | (L)-Lactate | Magnesium chloride hexahydrate | Water for injections
--- | --- | --- | --- | --- | --- | ---
Glucose 1.5%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 16.5 g (≡ 15.0 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
6 bags of 1500 ml CAPD stay safe
Glucose 1.5%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 16.5 g (≡ 15.0 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
4 bags of 2000 ml CAPD stay safe
Glucose 1.5%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 16.5 g (≡ 15.0 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
4 bags of 2500 ml CAPD stay safe
Glucose 2.3%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 25.0 g (≡ 22.73 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
6 bags of 1500 ml CAPD stay safe
Glucose 2.3%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 25.0 g (≡ 22.73 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
4 bags of 2000 ml CAPD stay safe
Glucose 2.3%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 25.0 g (≡ 22.73 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
4 bags of 2500 ml CAPD stay safe
Glucose 4.25%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 46.75 g (≡ 42.5 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
6 bags of 1500 ml CAPD stay safe
Glucose 4.25%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 46.75 g (≡ 42.5 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
4 bags of 2000 ml CAPD stay safe
Glucose 4.25%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 46.75 g (≡ 42.5 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
4 bags of 2500 ml CAPD stay safe
Glucose 1.5%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 16.5 g (≡ 15.0 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
2 bags of 5000 ml APD sleep safe
Glucose 2.3%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 25.0 g (≡ 22.73 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
2 bags of 5000 ml APD sleep safe
Glucose 4.25%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 46.75 g (≡ 42.5 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
2 bags of 5000 ml APD sleep safe
Glucose 1.5%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 16.5 g (≡ 15.0 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
2 bags of 5000 ml APD safe lock
Glucose 2.3%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 25.0 g (≡ 22.73 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
2 bags of 5000 ml APD safe lock
Glucose 4.25%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 46.75 g (≡ 42.5 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml
2 bags of 5000 ml APD safe lock
Glucose 1.5%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l” | 16.5 g (≡ 15.0 g) | 0.2573 g | 3.925 g | 5.786 g | 0.1017 g | q.s. to 1000 ml

Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l" 4 bags of 2000 ml CAPD safe lock	15.0 g)	g		g		1000 ml
Glucose 2.3%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l" 4 bags of 2000 ml CAPD safe lock	25.0 g (≡ 22.73 g)	0.2573 g	3.925 g	5.786 g	0.1017 g	q.s. to 1000 ml
Glucose 4.25%, Calcium 1.75 mmol/l, (L)-lactate 35 mmol/l" 4 bags of 2000 ml CAPD safe lock	46.75 g (≡ 42.5 g)	0.2573 g	3.925 g	5.786 g	0.1017 g	q.s. to 1000 ml

The other components are:
Hydrochloric acid, Sodium hydroxide, Water for injections
For the composition of the pack, see the bag label
pH between 5.0 and 6.5 units
Theoretical osmolarity: depends on the specific formulation
For the qualitative and quantitative composition of the specific formulation, please refer to
the label of the bag to which this summary of product characteristics refers.
Description of the appearance of SOLUZIONE PER DIALISI PERITONEALE FME
Peritoneal dialysis solution.
stay•safe system:
Presentation and contents of bags per pack.
The system consists of a double bag for containing the solution, made of non-PVC plastic material (multilayer polyolefin film), a polyolefin tubing system, disc connector with rotatable clamp (polypropylene), and a drainage bag made of multilayer polyolefin film.
sleep•safe system:
Presentation and contents of bags per pack.
The system consists of a single bag for containing the solution, made of non-PVC plastic material (multilayer polyolefin film), a polyolefin tubing system, bag connector also made of polyolefin, and injection site made of polyolefin/synthetic rubber.
Safe lock system
The standard system consists of a single PVC bag containing the solution.
The "Safe lock" connector is made of polycarbonate. The injection site is made of polycarbonate and synthetic rubber.
Marketing Authorization Holder
Fresenius Medical Care Deutschland GmbH
61346 Bad Homburg
Germany
Manufacturer
Fresenius Medical Care Deutschland GmbH
Werk St. Wendel, D-66606 St. Wendel, Germany
Germany