Dianeal Pd4 (glukoza 3,86%). Zestav do dializi otzhevnovei

Leaflet accompanying the packaging: Information for the user

DIANEAL PD4 (glucose 1.36%) peritoneal dialysis set; 13.6 mg/ml

DIANEAL PD4 (glucose 2.27%) peritoneal dialysis set; 22.7 mg/ml

DIANEAL PD4 (glucose 3.86%) peritoneal dialysis set; 38.6 mg/ml

Peritoneal dialysis solutions

You should carefully read the contents of the leaflet before using the medicine, because

it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet:

• 1. What DIANEAL PD4 is and what it is used for
• 2. Important information before using DIANEAL PD4
• 3. How to use DIANEAL PD4
• 4. Possible side effects
• 5. How to store DIANEAL PD4
• 6. Contents of the packaging and other information

1. What DIANEAL PD4 is and what it is used for

DIANEAL PD4 is a peritoneal dialysis solution.
It removes water and excess metabolic products from the blood. It also corrects abnormal
concentrations of various blood components. DIANEAL PD4 contains different glucose concentrations (1.36%,
2.27% or 3.86%). The higher the glucose concentration in the solution, the more water can
be removed from the blood.
DIANEAL PD4 is used in the following cases:

• transient or permanent kidney failure;
• significant water retention in the body;
• severe acid-base or electrolyte disturbances in the blood;
• certain types of drug poisoning, when other treatment methods cannot be used.

DIANEAL PD4 is particularly indicated for maintaining normal calcium and phosphate levels in
patients taking phosphate-binding preparations containing calcium or magnesium.

2. Important information before using DIANEAL PD4

When not to use DIANEAL PD4

• If the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6).
• If the patient has severe lactic acidosis (too much acid in the blood) before the first use of the solution.
• If the patient has an abdominal wall or peritoneal abnormality that cannot be surgically corrected or another disorder that cannot be corrected, which increases the risk of peritoneal infections.
• If the patient has documented loss of peritoneal function due to extensive peritoneal adhesions.

Warnings and precautions

Before starting DIANEAL PD4, you should discuss it with your doctor.
Particular caution should be exercised:

• if the patient has severe abdominal wall or peritoneal abnormalities. For example, if the patient has a hernia or intestinal inflammation.
• if the patient has had an aortic graft;
• if the patient has respiratory disorders;
• if the patient experiences abdominal pain, elevated body temperature, or cloudiness or particles in the drained fluid. This may be a sign of peritonitis or infection. You should contact the medical team immediately. You should record the product batch number and show it to the medical team along with the bag of drained fluid. The medical team will decide whether to discontinue treatment or start corrective treatment. For example, if an infection occurs, the doctor may perform certain tests to select the most appropriate antibiotic. Until the type of infection is determined, the doctor may recommend taking a broad-spectrum antibiotic.
• if the patient is at increased risk of developing severe lactic acidosis (too much acid in the blood). The increased risk of lactic acidosis may occur due to:
• severe hypotension or sepsis, which may be associated with acute kidney failure;
• congenital metabolic disorders;
• taking metformin (a medicine used to treat diabetes);
• taking HIV medications, especially those called NRTIs (nucleoside reverse transcriptase inhibitors).
• in diabetic patients using this dialysis solution, blood glucose levels (e.g., insulin) should be systematically checked. The dose of antidiabetic medications may need to be adjusted, especially at the start of peritoneal dialysis treatment or in case of changes in peritoneal dialysis treatment.
• in patients with corn allergies. The infusion should be stopped immediately and the solution drained from the peritoneal cavity.
• the patient - if possible in agreement with the doctor - should keep a written record of fluid and body weight balance. The doctor should regularly check blood parameters, especially concentrations of:
• electrolytes (e.g., bicarbonate, potassium, magnesium, calcium, and phosphates);
• parathyroid hormone - responsible for maintaining calcium levels in the body;
• lipids in the blood.
• if the patient has too high or too low calcium levels in the blood. This solution may affect changes in calcium levels.
• You should not use more of the solution than prescribed by your doctor. Signs of overhydration include abdominal distension, feeling of fullness, and shortness of breath.
• The doctor will regularly check the patient's potassium levels. If they drop too low, the doctor may prescribe potassium chloride to supplement the deficiency.
• A disease called encapsulating peritoneal sclerosis (EPS) is a known, although rare, complication of peritoneal dialysis treatment. The patient and doctor should be aware of the possibility of this complication. EPS causes:
• inflammation in the abdominal cavity;
• thickening of the intestinal walls, which may be accompanied by abdominal pain, abdominal distension, or vomiting. EPS can lead to death.

DIANEAL PD4 and other medicines

• You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
• If you are taking other medicines, your doctor may need to increase their doses. This is because peritoneal dialysis treatment increases the elimination of some medicines.
• You should exercise caution if you are taking cardiac glycosides (e.g., digoxin). In this case:
• potassium and calcium supplements may be necessary;
• heart rhythm disturbances (arrhythmias) may occur;
• during treatment, the patient will be under close medical supervision, especially with regard to potassium, calcium, and magnesium levels.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine. The doctor will decide whether treatment is appropriate in this case.

Driving and using machines

This type of treatment may cause weakness, blurred vision, or dizziness. You should not drive vehicles or operate machinery if you experience such symptoms.

3. How to use DIANEAL PD4

DIANEAL PD4 is intended for administration into the peritoneal cavity. This is the space in the abdominal cavity (abdomen) between the skin and the peritoneum. The peritoneum is a membrane surrounding the internal organs, such as the intestines and liver.
This solution is not intended for intravenous use.
You should always use this medicine according to the instructions of the medical team specializing in peritoneal dialysis. In case of doubts, you should consult a doctor.
Incorrect sequence of connection or filling may lead to air entering the peritoneal cavity, which can cause abdominal pain and/or peritonitis.
If the bag is damaged, it must be discarded.

In what doses and how often to use the medicine

The doctor will recommend the appropriate glucose concentration and the number of bags for daily use.

Discontinuation of DIANEAL PD4

You should not discontinue peritoneal dialysis without your doctor's consent. Discontinuation of treatment may have life-threatening consequences.

Method of administration

Before use:

• The bag should be warmed to 37°C. For this purpose, a specially designed heating plate should be used. The bag should not be immersed in water. A microwave oven should not be used to heat the solution.
• The outer bag should be removed and the solution applied immediately.
• Check if the solution is clear. Do not use the bag if the solution is not clear.
• Each bag is intended for single use only. Any unused solution should be discarded.

During administration of the solution, you should follow aseptic procedures, in accordance with training.
After use, check if the drained fluid is not cloudy.

Compatibility with other medicines

You should always check the compatibility of medicines added to DIANEAL PD4.
The doctor may prescribe other medicines in a form intended for injection, which are to be added directly to the DIANEAL PD4 bag. In this case, the medicine should be added through the designated place at the bottom of the bag. After adding the medicine, the product should be used immediately. In case of doubts, you should consult your doctor again.

Using more than the recommended amount of DIANEAL PD4 bags within 24 hours

If too much DIANEAL PD4 solution is administered, the following may occur:

• abdominal distension;
• feeling of fullness and/or
• shortness of breath. You should contact your doctor immediately. The doctor will recommend further action.

In case of any further doubts related to the use of the medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should immediately inform your doctor or the peritoneal dialysis treatment center:

• high blood pressure (hypertension);
• swollen ankles or feet, puffy eyes, shortness of breath, or chest pain (hyperolemia);
• a serious disease characterized by the formation of blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome);
• abdominal pain;
• fever;
• peritonitis. These are serious side effects that require immediate medical attention.

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or the peritoneal dialysis treatment center.
Side effects that have been reported (occurring in an unknown number of patients treated with DIANEAL PD4):

• changes in blood test results:
• decreased potassium levels (hypokalemia), which may cause muscle weakness, muscle tremors, or heart rhythm disturbances;
• decreased sodium levels (hyponatremia), which may cause fatigue, coma, confusion, or nausea;
• decreased chloride levels (hypochloremia), which may cause fatigue, coma, confusion, or nausea;
• pain at the infusion site;
• nausea, vomiting, diarrhea, constipation, dehydration (thirst, dry mouth);
• decreased blood volume (hypovolemia);
• low blood pressure (hypotension);
• muscle cramps, muscle and bone pain;
• fluid retention (edema);
• abdominal distension or discomfort;
• fainting;
• skin disorders, such as hives, rashes, and itching;
• shortness of breath.

Other side effects related to the peritoneal dialysis procedure
(occurring in an unknown number of patients treated with DIANEAL PD4):

• infection around the catheter exit site, catheter obstruction.

Reporting side effects

If you experience any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store DIANEAL PD4

• The medicine should be stored out of sight and reach of children.
• Store in the original packaging.
• Store at a temperature below 25°C.
• Use immediately, discard any unused remains.
• Do not use this medicine after the expiry date, which is stated on the carton and on the bag after the words "Exp. date" and the symbol . The expiry date refers to the last day of the month stated.

DIANEAL PD4 should be disposed of in accordance with the instructions provided during training.

6. Contents of the packaging and other information

This leaflet does not contain all the information about the medicine. If you have any additional questions or doubts, you should consult your doctor.

What DIANEAL PD4 contains

DIANEAL PD4 is available as a solution containing 3 different glucose concentrations.
The composition of the solutions is as follows:

The other ingredient is water for injection.

What DIANEAL PD4 looks like and what the packaging contains

DIANEAL PD4 is packaged in plastic bags of various capacities.
The solution in the bags is clear and colorless.
Each bag is packaged in an outer bag and supplied in cardboard boxes.
Volume
Package type
1.5 l
Single and double bags
2.0 l
Single and double bags
2.5 l
Single and double bags
3.0 l
Single and double bags
5.0 l
Single and double bags
To obtain more detailed information, you should contact the marketing authorization holder:

Marketing authorization holder

Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw

Manufacturer

Vantive Manufacturing Limited
Moneen Road
Castlebar - County Mayo
Ireland
Date of last revision of the leaflet:May 2024
Baxter and Dianeal are trademarks of Baxter International Inc.