Peritoneal dialysis solution Galenica Senese

Package leaflet: Information for the user

PERITONEAL DIALYSIS SOLUTION GALENICA SENESE

Please 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE is and what it is used for
2. What you need to know before being administered SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE
3. How to use SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE
4. Possible side effects
5. How to store SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE
6. Contents of the pack and other information

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

This medicinal product is a solution for blood purification through the peritoneal membrane (a lining layer of the abdominal wall and intra-abdominal organs) in patients affected by severe kidney problems (end-stage chronic renal failure). This type of blood purification is called peritoneal dialysis. This solution contains glucose, lactate, and other substances known as electrolytes.

SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE is indicated for the treatment of:

• patients with acute and chronic renal failure;
• disturbances in fluid or electrolyte (electrolyte) levels in the blood (fluid overload, electrolyte imbalance);
• intoxications by substances that can be removed from the body through dialysis.

2. What you should know before being administered PERITONEAL DIALYSIS SOLUTION

GALENICA SENESE
PERITONEAL DIALYSIS SOLUTION GALENICA SENESE MUST NOT BE ADMINISTERED TO YOU

• if you are allergic to the active substances or to any of the other ingredients of this medicine listed in section 6;
• if you suffer from lactic metabolism disorders causing a condition of acidosis (severe lactic acidosis).

Warnings and precautions
Consult your doctor or nurse before being administered PERITONEAL DIALYSIS SOLUTION GALENICA SENESE.
Peritoneal dialysis should be started cautiously if:

• you have previously suffered from abdominal disorders, such as abdominal injury or surgery, abdominal or intestinal tumors, abdominal infections, umbilical, inguinal or diaphragmatic hernias, non-healing exuding abdominal wounds (fistulas), or lesions that may cause abdominal damage such as presence of large kidney cysts;
• you have undergone aortic repair surgery with a vascular prosthesis (aortic graft);
• you suffer from severe lung disease.

Peritoneal dialysis therapy may rarely cause serious damage to the peritoneum (encapsulating peritoneal sclerosis).
If you develop inflammation of the peritoneum (peritonitis), recognizable by cloudy dialysate (peritoneal dialysis solution contaminated by bacteria), abdominal pain, fever, feeling unwell, or, in rare cases, blood poisoning, your doctor will prescribe treatment with a medicine for bacterial infections (antibiotic).
If you are at risk of lactic metabolism disorders—for example, if you suffer from acute renal failure, metabolic disturbances, or if you are taking medicines that may alter lactate levels in the blood—your doctor must monitor you before and during treatment.
You must be closely monitored for blood substances, especially if you are taking other medicines such as those affecting potassium levels in the blood (e.g. cardioactive glycosides), if you have diabetes, or if you are being treated with low-calcium solutions.
Peritoneal dialysis may lead to loss of proteins and water-soluble vitamins. An adequate diet or use of dietary supplements is recommended to prevent nutritional deficiencies.
Your doctor will periodically check your electrolyte and fluid balance, body weight (since fluid overload or excessive fluid removal may cause heart failure or shock), total blood cell count, residual kidney function, and nutritional status.
Medical staff must carefully monitor the volume of solution, as an excess (more than 5–6 liters) may cause symptoms such as abdominal pain and breathing difficulties.

Other medicines and PERITONEAL DIALYSIS SOLUTION GALENICA SENESE
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Since peritoneal dialysis may affect the action of certain medicines, your doctor may need to adjust their dosage, especially in the case of:

• medicines eliminated by dialysis,
• medicines used to treat heart conditions, such as digitalis. Your doctor will periodically check your blood potassium levels and, if necessary, take appropriate corrective measures,
• medicines affecting calcium levels, such as those containing calcium or vitamin D,
• oral medicines that lower blood sugar levels, or insulin. Your blood sugar level must be monitored regularly.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before being administered this medicine. There is insufficient information on the use of this medicine in pregnant or breastfeeding women. In such cases, PERITONEAL DIALYSIS SOLUTION GALENICA SENESE will be administered only if your doctor considers it absolutely necessary.

Driving and using machines
This medicine may cause adverse effects in patients with end-stage renal failure undergoing peritoneal dialysis, which may impair the ability to drive or operate machinery.

3. How to use SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE

This medicinal product will be administered to you by specialized healthcare personnel who will follow the instructions provided by your doctor. If you have any doubts, consult your doctor.
Your doctor will determine the method, duration, frequency of use, volume of infused fluid, and dwell time of the fluid in the peritoneal cavity. If excessive abdominal tension occurs, your doctor may reduce the volume of infused fluid.
In adults undergoing continuous ambulatory peritoneal dialysis (CAPD), generally 4 exchanges are performed per day (24 hours). Patients undergoing automated peritoneal dialysis (APD) generally perform 4–5 exchanges at night and up to 2 exchanges during the day. The fill volume depends on body size, normally ranging between 2.0 and 2.5 liters.
The choice of type of PERITONEAL DIALYSIS SOLUTION depends on the patient's weight and the amount of fluid to be removed at each exchange.

Use in children and adolescents
For 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.

If you are administered more SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE than you should
If an excessive volume of this medicinal product is administered, alterations in blood volume (hypervolemia or hypovolemia), electrolyte disturbances, or increased blood sugar levels (hyperglycemia in diabetic patients) may occur.

Treatment

• In case of increased blood volume (hypervolemia), you may be administered a hypertonic peritoneal dialysis solution (with increased electrolyte content), and fluid intake may be restricted.
• In case of decreased blood volume (hypovolemia), fluids should be replenished orally or intravenously, depending on the degree of dehydration.
• Electrolyte disturbances can be managed according to the specific disturbance identified by blood testing. The most likely disturbance, decreased potassium levels, can be managed by oral potassium administration or by adding potassium chloride to the peritoneal dialysis solution as prescribed by the treating physician.
• Hyperglycemia (in diabetic patients) can be managed by adjusting the insulin dosage according to the insulin therapy regimen prescribed by the treating physician.

If you are not administered an adequate amount of SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE
You must not be administered more than the prescribed dialysate volume for each 24-hour interval to avoid the risk of potentially life-threatening consequences. If in doubt, contact your doctor.
If you have any questions about the use of this product, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur following peritoneal dialysis treatment:
Not known (frequency cannot be estimated from the available data):

• decrease in blood levels of potassium, sodium or chloride, fluid retention, increase or decrease in blood volume, dehydration, increased blood sugar levels, changes in lipid levels;
• increase or decrease in blood pressure;
• difficulty breathing (dyspnea);
• peritoneal disorders (encapsulating peritoneal sclerosis, peritonitis, cloudy peritoneal effluent, fungal peritonitis, bacterial peritonitis), vomiting, diarrhoea, nausea, constipation, abdominal disorders (pain, distension, discomfort);
• skin reactions such as Stevens-Johnson syndrome, urticaria, rash (including pruritic, erythematous and generalized rash), pruritus;
• muscle problems such as myalgia, muscle spasms, musculoskeletal pain;
• swelling due to fluid accumulation (generalized oedema), fever, malaise, pain at infusion site, 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
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 PERITONEAL DIALYSIS SOLUTION GALENICA SENESE

Medical personnel are aware of the storage conditions for this medicine.
Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C and not below 4°C. Do not freeze this medicine.
Keep the container tightly closed in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Once the outer wrapper has been removed, the medicine must be used immediately. Discard any unused portion of the solution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE Contains
Peritoneal dialysis solutions have variable compositions. The active substances are listed below.
Each 1000 ml of solution contains:

Packaging: Glucose 1.5%, Calcium 1.75 mmol/l, Lactate 35 mmol/l Bag of 2000 ml
CAPD twin bag system
Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 99.5 mmol/l 99.5 mEq/l
Glucose 83.25 mmol/l

Packaging: Glucose 1.5%, Calcium 1.75 mmol/l, Lactate 35 mmol/l, Potassium 2 mmol/l
Bag of 2000 ml CAPD twin bag system
Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Potassium 2 mmol/l 2 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 101.5 mmol/l 101.5 mEq/l
Glucose 83.25 mmol/l

Packaging: Glucose 2.5%, Calcium 1.75 mmol/l, Lactate 35 mmol/l Bag of 2000 ml
CAPD twin bag system
Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 99.5 mmol/l 99.5 mEq/l
Glucose 138.7 mmol/l

Packaging: Glucose 4%, Calcium 1.75 mmol/l, Lactate 35 mmol/l Bag of 2000 ml
CAPD twin bag system
Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 99.5 mmol/l 99.5 mEq/l
Glucose 222 mmol/l

Packaging: Glucose 1.5%, Calcium 1.75 mmol/l, Lactate 40 mmol/l Bag of 5000 ml
Sodium 133 mmol/l 133 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.25 mmol/l 0.5 mEq/l
Lactate 40 mmol/l 40 mEq/l
Chloride 97 mmol/l 97 mEq/l
Glucose 83.3 mmol/l

Packaging: Glucose 1.5%, Calcium 1.75 mmol/l, Lactate 40 mmol/l, Potassium 2 mmol/l
Bag of 5000 ml
Sodium 133 mmol/l 133 mEq/l
Potassium 2 mmol/l 2 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.25 mmol/l 0.5 mEq/l
Lactate 40 mmol/l 40 mEq/l
Chloride 99 mmol/l 99 mEq/l
Glucose 83.3 mmol/l

Packaging: Glucose 2.5%, Calcium 1.75 mmol/l, Lactate 40 mmol/l Bag of 5000 ml
Sodium 133 mmol/l 133 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.25 mmol/l 0.5 mEq/l
Lactate 40 mmol/l 40 mEq/l
Chloride 97 mmol/l 97 mEq/l
Glucose 138.9 mmol/l

Packaging: Glucose 4%, Calcium 1.75 mmol/l, Lactate 40 mmol/l Bag of 5000 ml
Sodium 133 mmol/l 133 mEq/l
Calcium 1.75 mmol/l 3.5 mEq/l
Magnesium 0.25 mmol/l 0.5 mEq/l
Lactate 40 mmol/l 40 mEq/l
Chloride 97 mmol/l 97 mEq/l
Glucose 222 mmol/l

Packaging: Glucose 1.4%, Calcium 1.3 mmol/l, Lactate 35 mmol/l Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Calcium 1.3 mmol/l 2.6 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 98.6 mmol/l 98.6 mEq/l
Glucose 77.78 mmol/l

Packaging: Glucose 2.4%, Calcium 1.3 mmol/l, Lactate 35 mmol/l Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Calcium 1.3 mmol/l 2.6 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 98.6 mmol/l 98.6 mEq/l
Glucose 133.3 mmol/l

Packaging: Glucose 4%, Calcium 1.3 mmol/l, Lactate 35 mmol/l Bag of 5000 ml
Sodium 130 mmol/l 130 mEq/l
Calcium 1.3 mmol/l 2.6 mEq/l
Magnesium 0.5 mmol/l 1 mEq/l
Lactate 35 mmol/l 35 mEq/l
Chloride 98.6 mmol/l 98.6 mEq/l
Glucose 222 mmol/l

The other component is water for injections.

Description of the Appearance of SOLUZIONE PER DIALISI PERITONEALE GALENICA SENESE and Package Contents
The package contains a peritoneal dialysis solution in a CAPD twin bag system of 2000 ml or in a bag of 5000 ml.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351
53014 Monteroni d'Arbia (SI), Italy

The following information is intended exclusively for healthcare professionals:

Warnings and Precautions for Use
Due to the risk of overfilling, the use of 5- or 6-liter solutions in a single exchange is not recommended, either in CAPD or APD.
Overfilling of peritoneal dialysis solutions into the peritoneal cavity may manifest as abdominal distension/pain and/or dyspnea.
In case of overfilling with peritoneal dialysis solutions, the solution must be drained from the peritoneal cavity.

Excessive use of peritoneal dialysis solutions with high glucose concentration during peritoneal dialysis treatment may result in excessive fluid removal from the patient. Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium, and phosphate), hematological and biochemical parameters (including parathyroid hormone) should be periodically monitored. In non-diabetic patients, blood glucose levels vary widely, likely due to glucose intolerance caused by uremia. The risk of developing hyperglycemia is proportionally increased in diabetic and uremic patients. In diabetic patients, blood glucose levels must be regularly monitored, and insulin dosage or other antihyperglycemic medications should be adjusted accordingly.

Intraperitoneal administration requires the use of a special catheter and a connecting set between the bag and the patient's catheter (transfer line).
The "Lineo" connector, which may be part of the Y-type transfer line connected to the dual bag, contains povidone-iodine ointment.

Instructions for Use:

• Peritoneal dialysis solutions must be administered exclusively via the intraperitoneal route. They must not be administered intravenously.
• Peritoneal dialysis solutions may be warmed to 37°C within their outer protective packaging to improve patient comfort. This should be done using dry heat (e.g., a heating pad or warming plate). To avoid the risk of injury or discomfort to the patient, do not heat the solutions in water or microwave ovens.
• During the entire bag exchange procedure, care must be taken to avoid contamination of the solution with bacteria or other microorganisms.
• The solution must not be administered if it appears cloudy or discolored, contains particles, shows signs of leakage, or if the seals are not intact.
• Check the drained fluid bag for the presence of fibrin or turbidity, which could be signs suggestive of peritonitis.
• Each container is for single use only: any unused solution must be discarded by medical personnel.

Interactions with Other Medicinal Products and Other Forms of Interaction
No interaction studies have been conducted with SOLUZIONI PER DIALISI PERITONEALE GALENICA SENESE.
Addition of medicinal products to the solution may only be performed upon medical indication and must be carefully evaluated.
The relatively low pH of the solution may require correction with sodium bicarbonate.
To prevent fibrin deposition in the catheter, heparin may be added to the dialysis solution.
During peritoneal dialysis of diabetic patients, insulin administration may be necessary to correct hyperglycemia; in such cases, the drug may be administered intraperitoneally.

Incompatibilities
No formal compatibility studies have been performed. Before adding other medicinal products, their compatibility with SOLUZIONI PER DIALISI PERITONEALE GALENICA SENESE must be verified. The solution must be used immediately after addition of medicinal products.
In vitro studies have demonstrated stability of the following antimicrobial agents when mixed: amphotericin B, ampicillin, azlocillin, cephradine, cefazolin, cefepime, 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 must not be mixed with penicillins due to their chemical incompatibility.