Dianeal pd4 (glucose 3.86%). peritoneal dialysis set

Package leaflet: Information for the user

DIANEAL PD4 (glucose 1.36%) peritoneal dialysis solution; 13.6 mg/ml
DIANEAL PD4 (glucose 2.27%) peritoneal dialysis solution; 22.7 mg/ml
DIANEAL PD4 (glucose 3.86%) peritoneal dialysis solution; 38.6 mg/ml
Peritoneal dialysis solutions
Please read this leaflet carefully before using this medicine, because it
contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents:

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 pack 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 waste products from the blood. It also corrects abnormal
levels 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 greater the amount of water that can
be removed from the blood.
DIANEAL PD4 is used in the following conditions:

• Transient or permanent kidney failure;
• Significant fluid retention in the body;
• Severe disturbances in blood acidity or alkalinity and electrolyte imbalances;
• 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 agents containing calcium or
magnesium.

2. Important Information Before Using Dianeal PD4

When Dianeal PD4 Must Not Be Used

• 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 (excess acid in the blood) prior to the first administration of the solution.
• If the patient has an abdominal wall or peritoneal cavity abnormality that cannot be surgically corrected, or another irreversible condition increasing the risk of peritoneal cavity infections.
• If the patient has documented loss of peritoneal function due to extensive peritoneal adhesions.

Warnings and Precautions
Before starting treatment with Dianeal PD4, discuss this with your doctor.
Exercise particular caution:

• if the patient has serious abnormalities of the abdominal wall or peritoneal cavity, for example, a hernia or intestinal inflammatory condition.
• if the patient has undergone arterial grafting in the aortic region;
• if the patient has respiratory disorders;
• if the patient experiences abdominal pain, elevated body temperature, or observes cloudiness or particles in the drained fluid. These may be signs of peritonitis or infection. Contact the medical team immediately. Record the product batch number and present it to the medical team along with the bag containing the drained fluid. The medical team will decide whether treatment should be discontinued or corrective therapy initiated. For example, if an infection occurs, the doctor may perform certain tests to best determine the appropriate antibiotic. Until the type of infection is identified, the doctor may prescribe an antibiotic effective against many different bacteria—a broad-spectrum antibiotic.
• if the patient is at increased risk of developing severe lactic acidosis (excess acid in the blood). Increased risk of lactic acidosis may occur due to:
  • significant hypotension or sepsis, which may be associated with acute renal failure;
  • inherited metabolic disorders;
  • use of metformin (a medication used in diabetes treatment);
  • use of medications for HIV treatment, particularly drugs known as NRTIs (nucleoside reverse transcriptase inhibitors).
• in diabetic patients using this solution for dialysis, doses of glucose-regulating medications (e.g., insulin) should be monitored regularly. Dosages of antidiabetic medications may require adjustment, especially at the beginning of peritoneal dialysis treatment or when changes occur in peritoneal dialysis therapy.
• in patients allergic to corn. Infusion must be stopped immediately and the solution drained from the peritoneal cavity.
• the patient—whenever possible in consultation with the doctor—should maintain a written record of fluid balance and body weight. The doctor should regularly monitor blood parameters, particularly concentrations of:
  • electrolytes (e.g., bicarbonates, potassium, magnesium, calcium, and phosphates);
  • parathyroid hormone—responsible for maintaining calcium levels in the body;
  • blood lipids.
• if the patient has abnormally high or low blood calcium levels. This solution may affect changes in calcium concentration.
• Do not use a larger volume of solution than prescribed by the doctor. Symptoms of fluid overload include abdominal distension, a feeling of fullness, and shortness of breath.
• The doctor will regularly monitor the patient’s potassium levels. If levels drop too low, the doctor may prescribe potassium chloride to correct the deficiency.
• A condition called encapsulating peritoneal sclerosis (EPS) is a known, although rare, complication of peritoneal dialysis treatment. Both the patient and doctor should be aware of the possibility of this complication. EPS causes:
  • inflammation within the abdomen;
  • thickening of intestinal walls, possibly accompanied by abdominal pain, distension, or vomiting. EPS may lead to death.

Dianeal PD4 and Other Medicines

• Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
• If the patient is taking other medications, the doctor may need to increase their dosages. This is because peritoneal dialysis treatment may enhance the elimination of certain drugs.
• Exercise caution if the patient is taking heart medications known as cardiac glycosides (e.g., digoxin). In such patients:
  • supplementation of potassium and calcium may be required;
  • cardiac arrhythmia may occur;
  • during treatment, the patient will be under close medical supervision, with particular monitoring of potassium, calcium, and magnesium levels.

Pregnancy and Breast-Feeding
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. The doctor will decide whether treatment is appropriate in such cases.

Driving and Operating Machinery
This type of treatment may cause weakness, blurred vision, or dizziness. Do not drive motor vehicles or operate machinery if experiencing such symptoms.

3. How to use DIANEAL PD4

DIANEAL PD4 is intended for administration into the peritoneal cavity. This is the space within the abdominal cavity (abdomen) located between the skin and the peritoneum. The peritoneum is the membrane surrounding internal organs such as the intestines and liver.
This solution is not intended for intravenous use.
Always use this medicine exactly as instructed by the medical team specialising in peritoneal dialysis. In case of doubt, contact your doctor.
Incorrect connection or filling sequence may lead to air entering the peritoneal cavity, which could cause abdominal pain and/or peritonitis.
If the bag is damaged, it must be discarded.

Dosage and frequency of use
Your doctor will recommend the appropriate glucose concentration and number of bags for daily use.

Discontinuing treatment with DIANEAL PD4
Do not discontinue peritoneal dialysis without consulting your doctor. Stopping treatment may have life-threatening consequences.

Method of administration
Before administration:

• Warm the bag to 37°C using a specially designed heating plate. Do not immerse the bag in water. Do not use a microwave oven to heat the solution.
• Remove the outer bag and use the solution immediately.
• Check whether the solution is clear and transparent. Do not use the bag if the solution is not clear.
• Each bag is for single use only. Any unused portion of the solution must be discarded.

During administration, maintain aseptic technique as instructed during training.
After use, check whether the drained fluid is cloudy.

Compatibility with other medicines
Always verify compatibility of drugs added to DIANEAL PD4.
Your doctor may prescribe additional medicines in injectable form to be added directly to the DIANEAL PD4 bag. In such cases, add the medicine through the designated site at the bottom of the bag. After adding the medicine, use the product immediately. If in doubt, contact your doctor again.

Use of more DIANEAL PD4 bags than recommended within 24 hours
If too much DIANEAL PD4 solution is administered, the following may occur:

• Abdominal distension;
• A feeling of fullness and/or
• Shortness of breath.

Contact your doctor immediately. Your doctor will advise on further management.

If you have any further doubts regarding the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, inform your doctor or the centre managing your peritoneal dialysis treatment immediately:

• blood pressure higher than usual (hypertension);
• swollen ankles or legs, puffiness around the eyes, breathlessness or chest pain (hypervolemia);
• a serious illness characterised by blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome);
• abdominal pain;
• fever;
• peritonitis. These are serious adverse reactions requiring immediate medical attention.

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or contact the centre managing your peritoneal dialysis treatment.
Adverse reactions reported (occurring in an unknown number of patients treated with
DIANEAL PD4):

• changes in blood test results:
  • decreased potassium levels (hypokalaemia), which may cause muscle weakness, muscle twitching or irregular heartbeat;
  • decreased sodium levels (hyponatraemia), which may cause fatigue, drowsiness, confusion or nausea;
  • decreased chloride levels (hypochloraemia), which may cause fatigue, drowsiness, confusion or nausea;
• pain at the infusion site;
• nausea, vomiting, diarrhoea, constipation, dehydration (thirst, dry mouth);
• reduced blood volume (hypovolaemia);
• low blood pressure (hypotension);
• muscle cramps, muscle and bone pain;
• fluid retention (oedema);
• abdominal distension or discomfort;
• fainting;
• skin reactions such as urticaria, rash and itching;
• breathlessness.

Other adverse reactions associated with the peritoneal dialysis procedure
(occurring in an unknown number of patients treated with DIANEAL PD4):

• infection around the catheter exit site, catheter blockage.

Reporting of adverse reactions
If any adverse reactions not listed in this leaflet occur, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store DIANEAL PD4

• Keep the medicine out of the sight and reach of children.
• Store in the original packaging.
• Store below 25 °C.
• Use immediately; discard any unused portions.
• Do not use this medicine after the expiry date stated on the cardboard box and on the bag following the words "Expiry:" and the symbol . The expiry date refers to the last day of the stated month.

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

6. Contents of the pack and other information

This leaflet does not contain all information about the medicine. If you have any further questions or
doubts, please 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 component is water for injections.
What DIANEAL PD4 looks like and contents of the pack
DIANEAL PD4 is packed in plastic bags of various volumes.
The solution in the bags is clear and colourless.
Each bag is packed 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
Marketing Authorisation Holder
Vantive Belgium SRL,
Boulevard d’Angleterre 2,
1420 Braine-l’Alleud,
Belgium
Manufacturer
Vantive Manufacturing Limited
Moneen Road
Castlebar - County Mayo
Ireland
Vantive and Dianeal are trademarks of Vantive Health LLC or its affiliates.