Nutrineal PD4 with 1.1% amino acids.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

1. What NUTRINEAL is and what it is used for
2. What you need to know before you use NUTRINEAL
3. How to use NUTRINEAL
4. Possible side effects
5. How to store NUTRINEAL
6. Contents of the pack and other information

You must NOT use NUTRINEAL

• If you are allergic to any amino acids or any of the other ingredients of this medicine (listed in section 6).
• If your blood urea level is above 38 mmol/l.
• If you suffer from a disorder affecting amino acid metabolism.
• If your blood potassium level is too low.
• If you show uraemic symptoms such as loss of appetite, nausea or vomiting.
• If your blood bicarbonate levels are too low.
• If you suffer from liver insufficiency.
• If you already have severe lactic acidosis (too much acid in the blood).
• If you have a surgically uncorrectable problem affecting your abdominal wall or cavity or uncorrectable problem that increases risk of abdominal infections.

Talk to your doctor:

• If you experience loss of appetite, nausea or vomiting. Your doctor may need to reduce the number of NUTRINEAL exchanges or stop NUTRINEAL treatment.
• If you experience abdominal pain or notice cloudiness, haziness or particles in the drained fluid. This may be a sign of peritonitis (inflamed peritoneum) or infection. You should contact your medical team urgently. Note the batch number and bring it along with the drained fluid bag to your medical team. They will decide if the treatment should be stopped or any corrective treatment started. For example if you have an infection your doctor may perform some tests to find out which antibiotic will be best for you. Until your doctor knows which infection you have, he may give you an antibiotic that is effective against a wide number of different bacteria. This is called a broadspectrum antibiotic.
• If you experience a hypersensitivity reaction (an allergic reaction) - see also section 4. Your doctor may need to stop NUTRINEAL treatment
• Since, during peritoneal dialysis your body may lose protein, amino acids, vitamins. Your doctor will know if these need to be replaced.
• If you have problems affecting your abdominal wall or cavity. For example if you have a hernia or a chronic infectious or inflammatory condition affecting your intestines.
• If you had aortic graft placement.
• If you have severe lung disease, e.g. emphysema.
• If you have breathing difficulties.
• If you use insulin or any other treatments for correcting hyperglycaemia. Your doctor may need to adjust their dose.
• If you are undergoing treatment for secondary hyperparathyroidism, your doctor will decide if you can use a dialysis solution with a low calcium content.
• You should also take into account that a disorder called encapsulating peritoneal sclerosis (EPS) is a known, rare complication of peritoneal dialysis therapy. You - possibly together with your doctor - should be aware of this possible complication. EPS causes:
  • inflammation in your abdomen (belly)
  • the growth of sheets of fibrous tissue that cover and bind your organs and affect their normal movement. Rarely this has been fatal.
• Your doctor will check your potassium levels regularly. If they fall too low he may give you some potassium chloride to compensate.
• Your doctor will advise you about particular precautions as it applies to you. He will monitor your blood parameters at regular intervals. He will ensure that they are adequate during your treatment.
• You - possibly together with your doctor - should keep a record of your dietary protein intake, your fluid balance and your body weight.

• Tell your doctor if you are taking, have recently taken or might take any other medicines. If you use other medicines, your doctor may need to increase their dose. This is because peritoneal dialysis treatment increases the elimination of certain medicines.
• Take care if you use heart medicines known as cardiac glycosides (e.g. digoxin). Your heart medicine may not be so effective or its toxicity may be increased. You may:
  • need potassium and calcium supplements
  • develop an irregular heartbeat (an arrhythmia)
  Your doctor will monitor you closely during treatment, especially your potassium, calcium and magnesium levels.

NUTRINEAL is not recommended during pregnancy or while breast-feeding unless your doctor advises differently.

This treatment may cause weakness, malaise or reduction in body fluid volume (hypovolaemia). Do not drive or operate machines if you are affected.

Your doctor will prescribe you the appropriate number of bags you must use. Usually, it varies from one bag of 2.0 litres to one bag of 2.5 litres every day.

If you are below 18 years, your doctor will assess carefully the prescription of NUTRINEAL.

Your doctor will re-evaluate your treatment after 3 months if there is no improvement in your nutritional status.

Before use,

• Warm the bag to 37°C. Use the warming plate specially designed for this purpose. Never immerse in water to warm the bag. Never use a microwave oven to warm the bag.
• Remove the overpouch and administer immediately.
• Use only if the solution is clear and the container undamaged.
• Use each bag only once.
• Discard any unused remaining solution.

Use aseptic technique throughout the administration of the solution as you have been trained.

Your doctor may prescribe you other injectable drugs to be added directly into the NUTRINEAL bag. In that situation, add the drug through the medication site. Use the product immediately after addition of the drug. Check with your doctor if you are not sure.

If you infuse too much NUTRINEAL you may get:

• abdominal distension
• a feeling of fullness

Contact your doctor immediately. He will advise what to do.

Do not stop peritoneal dialysis without the agreement of your doctor. If you stop the treatment it may have life-threatening consequences.

• Peritonitis
• Peritoneal Cloudy effluent
• Abdominal discomfort
• Fever
• Malaise
• Itching
• Hypersensitivity reaction (an allergic reaction)
• Serious allergic reaction which causes swelling of the face or throat (angioedema)

• Infection around the exit site of your catheter
• Catheter related complication
• Decrease in calcium blood level (hypocalcaemia)

If you get any side effects, talk to your doctor or your peritoneal dialysis centre. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Republic of Ireland

Malta

United Kingdom

The formula is

NUTRINEAL PD4 1.1% Amino Acids

Formula in mg/l

Blend of Amino Acids:

Alanine 951

Arginine 1071

Glycine 510

Histidine 714

Isoleucine 850

Leucine 1020

Lysine, HCl 955

Methionine 850

Phenylalanine 570

Proline 595

Serine 510

Threonine 646

NUTRINEAL PD4 1.1% Amino Acids

Formula in mg/l

Tryptophan 270

Tyrosine 300

Valine 1393

Sodium chloride 5380

Calcium chloride dihydrate 184

Magnesium chloride hexahydrate 51

Sodium S-lactate 4480

Composition in mmol/l

Amino Acids 87.16

Sodium 132

Calcium 1.25

Magnesium 0.25

Lactate 40

Chloride 105

The other ingredients are:

• Water for Injections
• Hydrochloric acid, concentrated.

• NUTRINEAL is a clear, colourless to pale yellow, sterile solution for peritoneal dialysis.
• NUTRINEAL is packed in a PVC plastic bag of 1.5 litres, 2.0 litres or 2.5 litres capacity.
• Each bag is over-wrapped in an overpouch and supplied in carton boxes.

Volume Product configuration

1.5 L Single bag

1.5 L Twin bag

2.0 L Single bag

2.0 L Twin bag

2.5 L Single bag

2.5 L Twin bag

Not all configurations may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: