Nutrineal Pd4 (z 1,1% roztvorem aminokvasuv)

Leaflet attached to the packaging: Information for the user

Nutrineal PD4 (with 1.1% amino acid solution) peritoneal dialysis solution

You should read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor if you have any further doubts.
• If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, you should tell your doctor.

Table of contents of the leaflet:

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

1. What is Nutrineal and what is it used for

Nutrineal is a peritoneal dialysis solution that does not contain glucose. It allows for the removal of excess water and waste products from the blood, as well as correcting abnormalities in various blood components.
Nutrineal may be prescribed in the following cases:

• if the patient has kidney failure requiring peritoneal dialysis;
• especially if the patient is malnourished.

2. Important information before using Nutrineal

The attending physician will assess whether Nutrineal is a suitable solution for the patient's treatment with peritoneal dialysis. The physician will take into account all factors obtained from the patient's medical history that could exclude the use of peritoneal dialysis solutions.

When not to use Nutrineal

Nutrineal must not be used in the following cases:

• if the patient is allergic to any amino acid or any other component of this medicine (listed in section 6);
• if the blood urea concentration is above 38 mmol/l;
• if the patient has a disorder affecting the metabolism of any amino acid;
• if the blood potassium level is too low;
• if the patient has symptoms of uremia, such as loss of appetite, nausea, or vomiting;
• if the blood bicarbonate level is too low;
• if the patient has liver failure;
• if the patient has severe lactic acidosis (high acid levels in the blood);
• if the patient has abnormalities affecting the abdominal wall or abdominal cavity that cannot be surgically removed or disorders that increase the risk of abdominal infections.

Warnings and precautions

You should consult a doctor:

• If the patient experiences: loss of appetite, nausea, or vomiting. The doctor may decide to reduce the number of exchanges with Nutrineal or discontinue treatment with Nutrineal.
• If the patient experiences abdominal pain or cloudiness, lack of clarity, or particles in the drained fluid. This may be a sign of peritonitis or infection. You should contact the medical team immediately. You should note the batch number of the product 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 determine the most appropriate antibiotic. Until the type of infection is determined, the doctor may recommend taking a broad-spectrum antibiotic.
• If the patient experiences an allergic reaction (hypersensitivity reaction) - see also section 4. The doctor may decide to discontinue treatment with Nutrineal.
• During peritoneal dialysis, there may be a loss of proteins, amino acids, and vitamins from the body. The doctor will assess whether this will require supplementation.
• If the patient has abnormalities affecting the abdominal wall or abdominal cavity. For example, if the patient has a hernia or chronic inflammation or infection affecting the intestines.
• If the patient has had an aortic graft.
• If the patient has severe lung disease, such as pulmonary emphysema.
• If the patient has breathing difficulties.
• If the patient is taking insulin or other medications for hyperglycemia correction. The doctor may decide to adjust the dose of these medications.
• If the patient is undergoing secondary treatment for hyperparathyroidism, the doctor will decide whether to use a dialysis solution with low calcium content.
• You should also consider that a condition called encapsulating peritoneal sclerosis (EPS) is a known, 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;
• an increase in fibrous tissue, which covers and connects the internal organs and disrupts their normal movement. In rare cases, this can be fatal.
• The doctor will regularly check the patient's potassium levels. If they drop to very low values, the doctor may administer potassium chloride to correct the deficiency.
• The doctor will provide the patient with detailed information about individual precautions. The doctor will regularly check the results of blood tests and ensure that they are appropriate during treatment.
• The patient - if possible in agreement with the doctor - should keep a written record of protein intake in the diet, fluid balance, and body weight.

Other medicines and Nutrineal

• 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 be cautious if you are taking heart medications known as cardiac glycosides (e.g., digoxin). These medications may not be as effective or their toxicity may be greater. The patient may:
• need to supplement potassium and calcium;
• experience heart rhythm disturbances (arrhythmias). During treatment, the patient will be under close medical supervision, especially monitoring potassium, calcium, and magnesium levels.

Pregnancy and breastfeeding

Nutrineal is not recommended during pregnancy or breastfeeding, unless the doctor recommends otherwise.

Driving and using machines

This type of treatment may cause weakness, malaise, or decreased fluid volume in the body (hypovolemia). You should not drive vehicles or operate machinery if you experience these symptoms.

3. How to use Nutrineal

Nutrineal 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 that surrounds the internal organs such as the intestines and liver.
Nutrineal is not intended for intravenous use.
You should always use this medicine according to the instructions of the medical team specializing in peritoneal dialysis. If you have any doubts, you should contact them.
In case of damage, you should discard the bag.

In what doses and how often is the medicine used

The correct amount of bags that the patient must use will be prescribed by the doctor. Usually, this amount ranges from one 2.0-liter bag to one 2.5-liter bag per day.

Use in children and adolescents

If the patient is under 18 years old, the doctor will carefully assess the recommendation to use Nutrineal.
If there is no improvement in nutritional status after 3 months, the doctor will reassess the treatment method.

Method of administration

Before use:

• you should warm the bag to a temperature of 37°C. For this purpose, you should use a heating plate specially designed for this purpose. Never immerse the bag in water to warm it. Never use a microwave to heat the solution;
• you should remove the outer protective bag and use it immediately;
• you should only use it when the solution is clear and the packaging is undamaged;
• each bag is intended for single use only;
• any unused solution should be discarded.

During the entire procedure of administering the solution, you should use aseptic techniques, in accordance with training.

Compatibility with other medicines

The doctor may prescribe other medicines in the form of injections, added directly to the Nutrineal bag. In such a case, you should add the medicine through the port for adding medicine. After adding the medicine, you should use the product immediately. If you have any doubts, you should contact the doctor again.

Using more than one Nutrineal bag in 24 hours

If too much Nutrineal fluid is administered, the following may occur:

• abdominal swelling;
• a feeling of fullness.

You should contact the doctor immediately. The doctor will recommend further action.

Discontinuing Nutrineal

You should not discontinue peritoneal dialysis without the doctor's consent. Discontinuing treatment may be life-threatening.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor.
If you experience any of the following symptoms, you should immediately inform your doctor or the center performing peritoneal dialysis:

• abdominal pain

Very common side effects (occurring in more than 1 in 10 patients using Nutrineal):

• nausea, vomiting
• anorexia (long-term eating disorder due to loss of appetite)
• gastritis
• feeling of weakness
• increased fluid volume in the body (hyperolemia)
• high levels of acidic substances in the body (acidosis)

Common side effects (occurring in more than 1 in 100 patients using Nutrineal):

• anemia
• depression
• shallow breathing
• abdominal pain
• decreased fluid volume in the body (hypovolemia)
• low potassium levels in the blood (hypokalemia)
• infection

Other reported side effects (occurring in an unknown number of patients using Nutrineal):

• peritonitis
• cloudiness of the dialysate
• discomfort in the abdominal cavity
• fever
• malaise
• itching
• allergic reaction (hypersensitivity reaction)
• severe allergic reactions causing facial and throat swelling (angioedema)

Other reported side effects related to the peritoneal dialysis procedure:

• infection around the catheter exit site
• complications related to the presence of the catheter
• low calcium levels in the blood (hypocalcemia)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Nutrineal

The medicine should be stored out of sight and reach of children.
Store in the original packaging.
Store at a temperature below 30°C. Protect from light.
Do not use this medicine after the expiry date. The expiry date is stated on the carton and on the bag after the words "Expiry date" and the symbol . The expiry date refers to the last day of the month stated.
Nutrineal 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 further questions or doubts, you should consult a doctor.
What does Nutrineal PD4 (with 1.1% amino acid solution) contain
The composition of the medicine is as follows:

Other ingredients are:

• water for injections;
• hydrochloric acid (concentrated).

What Nutrineal looks like and what the packaging contains

Nutrineal is packaged in a plastic bag with PCW, containing 1.5 liters, 2.0 liters, or 2.5 liters of solution.
Each bag is packaged in an outer protective bag and supplied in cardboard boxes.
1.5 l - 6 single bags in a cardboard box
1.5 l - 6 double bags in a cardboard box
2.0 l - 5 single bags in a cardboard box
2.0 l - 5 double bags in a cardboard box
2.0 l - 6 single bags in a cardboard box
2.0 l - 6 double bags in a cardboard box
2.0 l - 8 single bags in a cardboard box
2.0 l - 8 double bags in a cardboard box
2.5 l - 4 single bags in a cardboard box
2.5 l - 4 double bags in a cardboard box
Not all packaging sizes may be marketed.
To obtain more detailed information, you should contact the marketing authorization holder:

Marketing authorization holder

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

Manufacturer

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