Nutrineal PD4 with 1.1% amino acids solution for peritoneal dialysis 2litre twin bags with spike connector

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

L-Tyrosine; L-Tryptophan; L-Serine; L-Proline; Glycine; L-Alanine; L-Valine; L-Isoleucine; L-Leucine; L-Lysine monohydrochloride; L-Histidine; L-Arginine; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate; Sodium chloride; L-Threonine; L-Phenylalanine; L-Methionine

Available from:

Baxter Healthcare Ltd

ATC code:

n/a

INN (International Name):

L-Tyrosine; L-Tryptophan; L-Serine; L-Proline; Glycine; L-Alanine; L-Valine; L-Isoleucine; L-Leucine; L-Lysine monohydrochloride; L-Histidine; L-Arginine; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium lactate; Sodium chloride; L-Threonine; L-Phenylalanine; L-Methionine

Dosage:

300mg/1litre ; 270mg/1litre ; 510mg/1litre ; 595mg/1litre ; 510mg/1litre ; 951mg/1litre ; 1.393gram/1litre ; 850mg/1litre ; 1.02gram/1litre ; 955mg/1litre ; 714mg/1litre ; 1.071gram/1litre ; 184mg/1litre ; 51mg/1litre ; 4.48gram/1litre ; 5.38gram/1litre ; 646mg/1litre ; 570mg/1litre ; 850mg/1litre

Pharmaceutical form:

Solution for peritoneal dialysis

Administration route:

Intraperitoneal

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF:

Summary of Product characteristics

OBJECT 1
NUTRINEAL PD4 WITH 1.1% AMINO ACIDS.
Summary of Product Characteristics Updated 06-Dec-2017 | Baxter
Healthcare Ltd
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 onl