Nutrineal PD4

NUTRINEAL PD4
1.1% amino acids
Peritoneal dialysis solution
Please read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any adverse reactions, inform your doctor. This includes any possible adverse reactions not listed in this leaflet.

Contents of this leaflet:

1. What NUTRINEAL PD4 is and what it is used for
2. What you need to know before using NUTRINEAL PD4
3. How to use NUTRINEAL PD4
4. Possible side effects
5. How to store NUTRINEAL PD4
6. Package contents and other information

1. WHAT NUTRINEAL PD4 IS AND WHAT IT IS USED FOR

Nutrineal PD4 is a glucose-free peritoneal dialysis solution. The medicine removes water and waste products from the blood and corrects abnormal levels of blood components.
Nutrineal PD4 may be prescribed to you:

• If you have renal failure requiring peritoneal dialysis
• If you are in a state of malnutrition

2. WHAT YOU SHOULD KNOW BEFORE USING NUTRINEAL PD4

To assess whether Nutrineal PD4 is an appropriate solution for your peritoneal dialysis treatment, your doctor will take into account any factors in your medical history that might contraindicate the use of peritoneal dialysis solutions.

Do not use NUTRINEAL PD4:

• if you are allergic to any amino acid or to any of the excipients in this medicinal product (listed in section 6)
• if you have serum urea nitrogen levels above 38 mmol/l
• if you have a congenital disorder of amino acid metabolism
• if you have serum potassium levels that are too low
• if you are experiencing uraemic symptoms such as loss of appetite, nausea or vomiting
• if you have serum bicarbonate levels that are too low
• if you have liver failure
• if you have severe lactic acidosis (excess acid in the blood)
• if you have surgically uncorrectable defects affecting your abdominal wall or abdominal cavity, or surgically uncorrectable defects that increase the risk of abdominal infections

Warnings and precautions
Inform your doctor:

• If you experience loss of appetite, nausea or vomiting. Your doctor may decide to reduce the number of exchanges performed with NUTRINEAL PD4 or to discontinue treatment with NUTRINEAL PD4;
• If you develop abdominal pain or notice cloudiness or particles in the drained fluid. These signs could indicate peritonitis (inflammation of the peritoneum) or infection; contact your medical team urgently. Note down the batch number and provide it to your medical team along with the drained fluid bag. They will advise whether to stop treatment and take corrective measures. For example, if you have an infection, your doctor may perform tests to identify the most appropriate antibiotic. Until the type of infection is determined, your doctor may administer an antibiotic effective against a wide range of different bacteria, i.e., a broad-spectrum antibiotic;
• If you experience a hypersensitivity reaction (an allergic reaction) – also refer to section 4. Your doctor may instruct you to stop treatment with Nutrineal PD4;
• During peritoneal dialysis, your body may lose proteins, amino acids and vitamins. Your doctor will advise whether these substances need to be replaced;
• If you have conditions affecting the integrity of the abdominal wall or abdominal cavity, such as a hernia, chronic infection, or an inflammatory condition affecting your intestines;
• If you have undergone aortic graft implantation;
• If you suffer from severe lung disease, such as emphysema;
• If you have respiratory insufficiency;
• If you are using insulin or other medications to correct hyperglycaemia. Your doctor may decide to adjust the dosage;
• If you are being treated for secondary hyperparathyroidism, your doctor will decide whether you can use a dialysis solution with low calcium content. You and possibly your doctor should also be aware that a condition called encapsulating peritoneal sclerosis (EPS) is a known, although rare, complication of peritoneal dialysis therapy. EPS causes:
  • inflammation of the abdomen (belly)
  • growth of fibrous tissue layers that cover and bind organs, preventing their normal movement. This condition rarely leads to fatal outcomes. Your doctor will regularly monitor your potassium levels and, if they are too low, may administer potassium chloride to correct them.
  • Your doctor will advise you on specific precautions to follow. They will monitor your blood parameters at regular intervals and ensure they remain adequate throughout your treatment.
  • You, possibly together with your doctor, should keep a record of your dietary protein intake, fluid balance, and body weight.

Other medicines and NUTRINEAL PD4

• Inform your doctor if you are taking, have recently taken, or might take other medicines. If you are taking other medications, your doctor may need to increase their dosage, as peritoneal dialysis treatment increases the elimination of certain drugs.
• Be cautious if you are taking heart medications known as cardiac glycosides (e.g., digoxin), as their usual effectiveness may be altered or their toxicity may increase. You might:
  • require potassium and calcium supplements
  • develop an irregular heartbeat (arrhythmia). Your doctor will closely monitor you during treatment, particularly checking levels of potassium, calcium, and magnesium.

Pregnancy and breastfeeding
Nutrineal PD4 is not recommended during pregnancy or breastfeeding unless specifically prescribed by your doctor.

Driving and use of machines
This treatment may cause weakness, malaise, or reduced body fluid volume (hypovolaemia). If these effects occur, do not drive or operate machinery.

3. HOW TO USE NUTRINEAL PD4

NUTRINEAL PD4 must be administered into the peritoneal cavity, which is the space within the abdomen (belly) between the skin and the peritoneum. The peritoneum is the membrane that surrounds internal organs such as the intestines and liver.
Do not use intravenously.
Always use NUTRINEAL PD4 exactly as instructed by your medical team specialized in peritoneal dialysis. Consult with them if you have any doubts.
The medicine should be used immediately after removal of the outer packaging.
If the bag is damaged, discard it.
Your doctor will determine the number of bags you need to use. Usually, the daily volume ranges from one 2.0-litre bag to one 2.5-litre bag.

Use in children and adolescents:
If you are under 18 years of age, your doctor will carefully evaluate the need for prescribing NUTRINEAL PD4.
Your doctor will reassess your treatment after 3 months if there is no improvement in your nutritional status.

Method of administration
Before use:

• Warm the bag to 37°C. Use a heating plate specifically designed for this purpose. Never immerse the bag in water to warm it. Never use microwave ovens to heat the bag.
• Use immediately after removal of the outer packaging.
• Use the product only if the solution is clear and the container is undamaged.
• For single use only.
• Discard any unused portion of the solution. During administration of the solution, an aseptic technique must be used, according to the instructions provided.

Compatibility with other medicines
Your doctor may prescribe adding other injectable medicines directly into the NUTRINEAL PD4 bag. In such cases, the medicine must be added through the injection site.
Use NUTRINEAL PD4 immediately after adding any such medicines. Consult your doctor if you have any doubts.

If you use more than 1 bag of NUTRINEAL PD4 in 24 hours
If an excessive amount of NUTRINEAL PD4 is infused, the following may occur:

• abdominal distension
• sensation of fullness

Contact your doctor immediately. They will advise you on what to do.

If you stop treatment with NUTRINEAL PD4
Do not stop peritoneal dialysis without your doctor's approval. Stopping treatment may have life-threatening consequences.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Nutrineal PD4 can cause adverse reactions, although not everyone experiences
them. If you experience any of the adverse reactions listed below, inform your doctor. This
includes any adverse reaction not listed in this leaflet.
If you experience any of the following events, inform your doctor or your peritoneal dialysis center
immediately:

• Abdominal pain

Very common adverse reactions (observed in more than 1 in 10 patients treated with NUTRINEAL PD4):

• Nausea and vomiting
• Anorexia (prolonged eating disorder due to loss of appetite)
• Gastritis (inflammation of the stomach)
• Feeling of weakness
• Increased blood volume (hypervolemia)
• Elevated levels of acidic substances in the body (acidosis)

Common adverse reactions (observed in more than 1 in 100 patients treated with NUTRINEAL PD4):

• Anaemia
• Depression
• Shortness of breath
• Abdominal pain
• Reduction in blood volume (hypovolemia)
• Decreased level of potassium salts in the blood (hypokalaemia)
• Infection

Adverse reactions reported (frequency not known in patients treated with NUTRINEAL PD4):

• Peritonitis
• Cloudy peritoneal effluent
• Abdominal discomfort
• Fever
• Malaise
• Pruritus
• Hypersensitivity reaction (an allergic reaction)
• Severe allergic reaction causing swelling of the face or throat (angioedema)

Other adverse reactions related to the peritoneal procedure:

• Infection around the catheter exit site
• Catheter-related complications
• Decreased plasma calcium concentration (hypocalcaemia)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or
pharmacist. You may also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse By reporting adverse reactions, you can
help provide more information on the safety of this medicine.

5. HOW TO STORE NUTRINEAL PD4

• Keep NUTRINEAL PD4 out of the reach and sight of children.
• Store the medicine in its original packaging.
• Store below 30°C and protect from light.
• Do not use NUTRINEAL PD4 after the expiry date. The expiry date is stated on the packaging and on the bag after the abbreviation Exp. and the symbol . The expiry date refers to the last day of the month.
• Dispose of NUTRINEAL PD4 as instructed to you.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

This leaflet does not contain all the information about this medicine. If you have any further
questions or if you are in doubt, please consult your doctor.
What NUTRINEAL PD4 contains

Excipients
Concentrated hydrochloric acid
Water for injections

Description of the appearance of Nutrineal PD4 and contents of the pack
Nutrineal PD4 is supplied in flexible PVC bags of 1.0 litre, 2.0 litres and 2.5 litres.
The 2.0-litre flexible bag is also available in the following pack: 5 flexible bags of 2.0 litres in a cardboard box.
The 2.5-litre flexible bag is also available in the following pack: 4 flexible bags of 2.5 litres in a cardboard box.
Each bag is contained in an outer wrapper and supplied with a cardboard box.
Not all pack sizes may be marketed.

For any further information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Marketing Authorization Holder
Vantive S.r.l. - 00142 Rome, Italy

Manufacturer
Vantive Manufacturing Limited - Moneen Road - Castlebar - County Mayo - Ireland