Nutrineal Solution for Peritoneal Dialysis 4 with 1.1% Amino Acids

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

L-tyrosine; L-tryptophan; L-phenylalanine; L-threonine; L-serine; L-proline; Glycine; L-alanine; L-valine; L-methionine; L-isoleucine; L-leucine; L-lysine hydrochloride; L-histidine; L-arginine; Calcium chloride; Magnesium chloride; Sodium (S) - lactate ; Sodium chloride

Available from:

Baxter Holding B.V.

ATC code:

B05DB

INN (International Name):

L-tyrosine; L-tryptophan; L-phenylalanine; L-threonine; L-serine; L-proline; Glycine; L-alanine; L-valine; L-methionine; L-isoleucine; L-leucine; L-lysine hydrochloride; L-histidine; L-arginine; Calcium chloride; Magnesium chloride; Sodium (S) - lactate ; Sodium chloride

Dosage:

1.1 percent

Pharmaceutical form:

Solution for peritoneal dialysis

Therapeutic area:

Hypertonic solutions

Authorization status:

Marketed

Authorization date:

1994-08-08

Summary of Product characteristics

Health Products Regulatory Authority
22 March 2019
CRN008KFM
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrineal Solution for Peritoneal Dialysis 4 with 1.1% Amino Acids
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tyrosine 300 mg/l
Tryptophan 270 mg/l
Phenylalanine 570 mg/l
Threonine 646 mg/l
Serine 510 mg/l
Proline 595 mg/l
Glycine 510 mg/l
Alanine 951 mg/l
Valine 1393 mg/l
Methionine 850 mg/l
Isoleucine 850 mg/l
Leucine 1020 mg/l
Lysine hydrochloride 955 mg/l
Histidine 714 mg/l
Arginine 1071 mg/l
Calcium chloride dihydrate 184 mg/l
Magnesium chloride hexahydrate 51 mg/l
Sodium Lactate 4480 mg/l
Sodium Chloride 5380 mg/l
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
A clear, colourless to pale yellow, sterile solution.
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 discolored, 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.