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Nutrineal PD4 with 1.1% amino acids.

Last Updated on eMC 06-Dec-2017 View changes  | Baxter Healthcare Ltd Contact details

1. Name of the medicinal product

Nutrineal PD4 with 1.1% amino acids.

2. Qualitative and quantitative composition

L-Tyrosine

300 mg/l

L-Tryptophan

270 mg/l

L-Phenylalanine

570 mg/l

L-Threonine

646 mg/l

L-Serine

510 mg/l

L-Proline

595 mg/l

Glycine

510 mg/l

L-Alanine

951 mg/l

L-Valine

1393 mg/l

L-Methionine

850 mg/l

L-Isoleucine

850 mg/l

L-Leucine

1020 mg/l

L-Lysine hydrochloride

955 mg/l

L-Histidine

714 mg/l

L-Arginine

1071 mg/l

Calcium chloride dihydrate

184 mg/l

Magnesium chloride hexahydrate

51 mg/l

Sodium S-Lactate

4480 mg/l

Sodium Chloride

5380 mg/l

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Peritoneal dialysis solution contained in bags.

4. Clinical particulars
4.1 Therapeutic indications

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.

4.2 Posology and method of administration

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.

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

- 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.

4.5 Interaction with other medicinal products and other forms of interaction

- 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.

4.6 Pregnancy and lactation

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.

4.7 Effects on ability to drive and use machines

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).

4.8 Undesirable effects

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

4.9 Overdose

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).

5. Pharmacological properties
5.1 Pharmacodynamic properties

Sterile and nonpyrogenic solution for extrarenal waste removal in continuous ambulatory peritoneal dialysis.

The concentration of electrolytes in the fluid is similar to the electrolyte composition of normal extracellular fluid (except for lactate).

Osmolarity of the Nutrineal PD4 solution with 1.1% amino acids: 365 mOsm/litre.

5.2 Pharmacokinetic properties

The solution is administered into the peritoneal cavity, and then drained.

The solution takes effect across the peritoneal membrane according to the principles of osmosis and diffusion; the exchange (dialysis) is made between the solution (dialysate) and the patient's plasma.

Electrolytes follow the standard metabolism of each ion.

Lactate is a biological precursor of bicarbonate.

Seventy to eighty percent of the amino acids infused are absorbed after 6 hours of dwell in the peritoneal cavity.

5.3 Preclinical safety data

Toxicity data on 1.1% amino acids solutions show predicted margins of safety in rats and dogs. There is no evidence of adverse effects in studies of foetal toxicity or fertility, mutagenic potential, carcinogenic potential, irritancy or sensitization potential, or risk of addiction or dependency.

6. Pharmaceutical particulars
6.1 List of excipients

Concentrated hydrochloric acid

Water for Injections

6.2 Incompatibilities

When additives are used, pH and compatibility with salts should be taken into account.

There is no incompatibility between Nutrineal and the addition of Heparin or Insulin.

Currently, no information is available on the stability of Nutrineal with aminoglycosides.

Check compatibilities before mixing additives.

Check clarity and colour before use.

6.3 Shelf life

Two years.

12 months (for medicinal product manufactured at Alliston, Canada only)

6.4 Special precautions for storage

Do not store above 30°C. Keep the container in the outer carton in order to protect from light.

6.5 Nature and contents of container

The fluid is hermetically sealed inside a bag manufactured from medical grade plasticised PVC, designated PL-146.

In the Single Bag System, the solution bag is fitted with a port for connection to a suitable administration set.

In the Twin Bag System, the solution bag and a drainage bag are connected to an integral administration set via a Y-transfer line.

The bag is also fitted with a resealable injection port for the addition of medication to the solution prior to administration, if appropriate.

The bag is then sealed inside an overpouch.

Container sizes: 500ml, 1000ml, 1500ml, 2000ml, 2500ml, 3000ml,

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Follow directions of attending physician and information gained from training program.

7. Marketing authorisation holder

Baxter Healthcare Ltd.,

Caxton Way,

Thetford,

Norfolk,

IP24 3SE

United Kingdom

8. Marketing authorisation number(s)

PL 00116/0253

9. Date of first authorisation/renewal of the authorisation

Date of First Authorisation: 13 April 1994

Date of Renewal of Authorisation: 11 April 2007

10. Date of revision of the text

30 November 2017

Company contact details

Baxter Healthcare Ltd

Company image
Address

Caxton Way, Thetford, Norfolk, IP24 3SE, UK

Medical Information Direct Line

+44 (0)1635 206345

Medical Information Fax

+44 (0)1635 206071

Fax

+44 (0)1635 206071

Medical Information e-mail

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Active ingredients

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

Legal categories

POM - Prescription Only Medicine

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