Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Alanine, Arginine, Calcium chloride dihydrate, Glycine, Histidine, Isoleucine, Leucine, Lysine, Magnesium chloride hexahydrate, Methionine, Phenylalanine, Proline, Serine, Sodium chloride, Sodium lactate, Threonine, Tryptophan, Tyrosine, Valine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Nutrineal is a solution for peritoneal dialysis which does not contain glucose. It removes water and waste products from the blood and corrects different abnormal components of blood. Nutrineal may be prescribed for you :
2.
e Nutrineal
Your doctor will assess whether Nutrineal is a suitable solution for your peritoneal dialysis treatment. He will have taken into account any factors in your medical history which might exclude the use of peritoneal dialysis solutions. Do not use Nutrineal
You must NOT use Nutrineal
Warnings and precautions Talk to your doctor:
Driving and using machines This treatment may cause weakness, malaise or reduction in body fluid volume (hypovolaemia). Do not drive or operate machines if you are affected.
3.
Nutrineal
Nutrineal is to be administered into your peritoneal cavity. This is the cavity in your abdomen (belly) between your skin and the peritoneum. The peritoneum is the membrane surrounding your internal organs such as your intestines and liver. Nutrineal is not for intravenous use. Always use this medicine exactly as instructed by the medical team specialised in peritoneal dialysis. Check with them if you are not sure. In case of damage, you should discard the bag. How much and how often 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. Use in children and adolescents 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. Method of administration Before use,
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, talk to your doctor. This includes any side effects not listed in this leaflet. If any of the following happen, tell your doctor or your peritoneal dialysis center immediately:
Nausea, vomiting Anorexia (prolonged disorder of eating due to loss of appetite) Gastritis (inflamed stomach) Feeling of weakness increase in body fluid volume (hypervolaemia) High level of acidic substances in the body (acidosis)
Common side effects (occurs in more than 1 in 100 patients treated with Nutrineal):
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 HPRA Pharmacovigilance Website: www.hpra.ie Malta ADR Reporting Website: https://medicinesauthority.gov.mt/adrportal United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
5.
Nutrineal • • • •
Keep this medicine out of the sight and reach of children. Keep the container in the outer carton in order to protect from light. Do not store above 30°C. Do not use this medicine after the expiry date. The date is stated on the carton and on the bag after the abbreviation Exp. and the symbol . The expiry date refers to the last day of that month.
Dispose Nutrineal as you have been trained .
6.
This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor. What Nutrineal PD4 1.1% AMINO ACIDS contains The formula is Nutrineal PD4 1.1% Amino Acids Formula in mg/l
Blend of Amino Acids: Alanine Arginine Glycine Histidine Isoleucine Leucine Lysine, HCl Methionine Phenylalanine Proline Serine Threonine Tryptophan Tyrosine Valine Sodium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium S-lactate
951 1071 510 714 850 1020 955 850 570 595 510 646 270 300 1393 5380 184 51 4480
Composition in mmol/l Amino Acids Sodium Calcium Magnesium Lactate Chloride
87.16 132 1.25 0.25 40 105
The other ingredients are:
What Nutrineal looks like and contents of the pack • • •
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 1.5 L 2.0 L 2.0 L 2.5 L 2.5 L
Single bag Twin bag Single bag Twin bag Single bag Twin bag
Not all configurations may be marketed. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Marketing Authorisation Holder United Kingdom: Vantive Limited, Wavertree Technology Park, 2 Wavertree Boulevard, Liverpool, L7 9PE, United Kingdom Republic of Ireland and Malta: Vantive Belgium SRL, Boulevard d'Angleterre 2, 1420 Braine-l'Alleud, Belgium Manufacturers Vantive Manufacturing Limited Moneen Road Castlebar County Mayo – Ireland This leaflet was last revised 11/2025
For information about NUTRINEAL or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: [email protected] Vantive and NUTRINEAL are trademarks of Vantive Health LLC or its affiliates.
The active substance in Nutrineal PD4 with 1.1% amino acids. is alanine, arginine, calcium chloride dihydrate, glycine, histidine, isoleucine, leucine, lysine, magnesium chloride hexahydrate, methionine, phenylalanine, proline, serine, sodium chloride, sodium lactate, threonine, tryptophan, tyrosine, valine.
This leaflet reproduces the patient information leaflet approved for Nutrineal PD4 with 1.1% amino acids., as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Nutrineal is recommended as a non-glucose based peritoneal dialysis solution as part of a peritoneal dialysis regimen for the treatment of chronic renal failure patients. In particular, it is recommended for the malnourished peritoneal dialysis patients.
Administration
Nutrineal is intended for intraperitoneal administration only. Not for intravenous administration.
Peritoneal dialysis solutions may be warmed in the overpouch to 37°C to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water due to an increased risk of contamination. Solutions should not be heated in a microwave oven due to the potential for damage to the solutions container and patient injury or discomfort.
Aseptic technique should be employed throughout the peritoneal dialysis procedure.
Do not administer if the solution is discoloured, cloudy, contains particulate matter or shows evidence of leakage, or if seals are not intact.
The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.
For single use only.
Posology
The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the prescribing physician
Treatment should be re-evaluated after 3 months if there is no clinical or biochemical improvement in the status of the patient.
Adults: one peritoneal dialysis exchange per day of one 2.0 l or one 2.5 l bag is the recommended dose for a 70 kg body weight patient. In smaller patients the fill volume may need to be reduced depending on body size. In exceptional cases, a different posology may be indicated but the dose should not exceed two exchanges per day. Note that the recommended daily total intake of proteins is over or equal to 1.2 g/kg body weight for adult dialysis patients. A 2.0 l bag of Nutrineal contains 22 g of amino acids which corresponds to 0.30 g/kg body weight/24 h (approximately 25% of the daily protein requirements) for an adult dialysis patient of 70 kg body weight.
Elderly: as for adults.
Children and adolescents:
Safety and effectiveness in paediatric patients has not been established. If Nutrineal is used, the recommended posology is one peritoneal dialysis exchange per day.
The clinical benefits of Nutrineal have to be balanced versus the risk of side effects in this patient category. For paediatric patients > 2 years old, a fill volume of 800 to 1400 ml/m2 to a maximum amount of 2000 ml, as tolerated, has been recommended. Fill volumes of 200 to 1000 ml/m2 are recommended in children less than 2 years of age.
Nutrineal is contraindicated in patients with:
- known hypersensitivity to any amino acids in the product or to any of the excipients listed in section 6.1,
- serum urea level above 38 mmol/L,
- uraemic symptoms,
- metabolic acidosis,
- inborn errors of amino acid metabolism,
- liver insufficiency,
- severe hypokalaemia,
- uncorrectable mechanical defects that prevent effective PD or increase the risk of infection
- Documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.
- Encapsulating peritoneal sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including Nutrineal.
- If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.
- If any signs or symptoms of a suspected hypersensitivity reaction develop, intraperitoneal administration of Nutrineal should be stopped immediately. Appropriate therapeutic measures should be instituted as clinically indicated.
- Metabolic acidosis should be corrected before and during Nutrineal treatment.
- Safety and effectiveness in paediatric patients has not been established.
- Significant losses of medicinal products (including water soluble vitamins) may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.
- Dietary protein intake should be monitored
- Peritoneal dialysis should be done with caution in patients with: 1) abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, from congenital anomalies or trauma until healing is complete, abdominal tumours, abdominal wall infection, hernias, faecal fistula, colostomy or iliostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity; and 2) other conditions including aortic graft placement and severe pulmonary disease.
- Overinfusion of a peritoneal dialysis solution into the peritoneal cavity may be characterised by abdominal distension/abdominal pain and/or shortness of breath.
- Treatment of peritoneal dialysis solution overinfusion is to drain the solution from the peritoneal cavity.
- Patients should be carefully monitored to avoid over- and underhydration. An accurate fluid balance record should be kept and the patient's body weight monitored.
- Potassium is omitted from Nutrineal solutions due to the risk of hyperkalaemia.
In situations in which there is a normal serum potassium level or hypokalaemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalaemia and should be made after careful evaluation of serum and total body potassium, only under the direction of a physician.
- Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone) and haematological parameters should be monitored periodically.
- In diabetic patients, blood glucose levels should be regularly monitored and the dosage of insulin or other treatment for hyperglycaemia should be adjusted.
- A portion of the amino acids in Nutrineal is converted to metabolic nitrogenous waste, such as urea. If dialysis is insufficient, the additional metabolic waste generated by the use of Nutrineal may lead to the appearance of uraemic symptoms such as anorexia or vomiting. Symptoms can be managed by reduction of the number of Nutrineal exchanges, or discontinuation of Nutrineal or an increased dialysis dose with a non amino acid based solution.
- In patients with secondary hyperparathyroidism, the benefits and risks of the use of dialysis solution with a low calcium content should be carefully considered as it might worsen hyperparathyroidism.
- No interaction studies have been conducted with Nutrineal. Blood concentration of other dialysable medicinal products may be reduced during dialysis.
- Plasma levels of potassium, calcium and magnesium in patients using cardiac glucosides must be carefully monitored, as there is a risk of digitalis intoxication. Potassium supplements may be necessary.
There are no clinical data on exposed pregnancies and lactation, and no animal studies are available. Nutrineal should not be used during pregnancy or lactation unless clearly necessary. See section 4.4.
End stage renal disease (ESRD) patients undergoing peritoneal dialysis may experience undesirable effects, which could affect the ability to drive or use machines (e.g. Malaise, Hypovolaemia).
The adverse reactions within this section represent those that are thought to have an association with Nutrineal or in conjunction with performing the peritoneal dialysis procedure.
Undesirables effects which occurred in patients treated with Nutrineal from clinical trials and post marketing are listed below.
Frequency is based upon the following scale: Very Common (≥1/10); Common (≥1/100 - <1/10), Uncommon (≥1/1,000 - <1/100), Rare (≥1/10,000 - <1/1,000), Very Rare (<1/10,000)
System Organ Class (SOC)
Preferred MedDRA Term
Frequency
INFECTIONS AND INFESTATIONS
Infection
Common
IMMUNE SYSTEM DISORDERS
Hypersensitivity
Not known
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anaemia
Common
METABOLISM AND NUTRITION DISORDERS
Acidosis
Hypervolaemia
Hypokalaemia
Hypovolaemia
Anorexia
Very Common
Very Common
Common
Common
Very common
PSYCHIATRIC DISORDERS
Depression
Common
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Dyspnoea
Common
GASTROINTESTINAL DISORDERS
Vomiting*
Nausea
Gastritis
Abdominal pain
Sclerosing encapsulating peritonitis
Abdominal discomfort
Peritonitis
Peritoneal Cloudy effluent
Very Common
Very Common
Very Common
Common
Not known
Not known
Not known
Not known
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Asthenia
Pyrexia
Malaise
Very Common
Not known
Not known
INVESTIGATIONS
Blood urea increased
Peritoneal fluid analysis abnormal
Very Common
Not known
SKIN AND SUBCUTANEOUS DISORDERS
Pruritis
Angioedema
Not known
Not known
*The term nausea and vomiting is not available in MedDRA 11.0. The term has been retained to reflect the available source data.
Other undesirable effects of peritoneal dialysis related to the procedure: catheter site infection, catheter related complication, hypocalcaemia and peritonitis bacterial.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
There is potential for overdose resulting in hypervolaemia and electrolyte disturbances.
Management of Overdose:
- Hypervolaemia may be managed by using hypertonic peritoneal dialysis solutions and fluid restriction.
- Electrolyte disturbances may be managed according to the specific electrolyte disturbance verified by blood testing. The most probable disturbance, hypokalaemia, may be managed by the oral ingestion of potassium or by the addition of potassium chloride in the peritoneal dialysis solution prescribed by the treating physician (see section 6.2).
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Alanine, Arginine, Calcium chloride dihydrate, Glycine, Histidine, Isoleucine, Leucine, Lysine, Magnesium chloride hexahydrate, Methionine, Phenylalanine, Proline, Serine, Sodium chloride, Sodium lactate, Threonine, Tryptophan, Tyrosine, Valine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Alanine, Arginine, Calcium chloride dihydrate, Glycine, Histidine, Isoleucine, Leucine, Lysine, Magnesium chloride hexahydrate, Methionine, Phenylalanine, Proline, Serine, Sodium chloride, Sodium lactate, Threonine, Tryptophan, Tyrosine, Valine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Nutrineal PD4 with 1.1% amino acids.. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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