NUTRINEAL PD]4 Peritoneal Dialysis Solution with 1.1% Amino Acids

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

SODIUM LACTATE; L-Isoleucine USP; L-Leucine USP; L-Phenylalanine USP; L-Threonine USP; L-Tryptophan USP; L-Histidine USP; L-Proline USP; L-Serine USP; L-Valine USP; L-Tyrosine USP; L-Methionine USP; L-Alanine USP; L-Arginine USP; L-Lysine HCI USP; Calcium Chloride Dihydrate USP; Sodium Chloride, USP; Glycine, USP; Magnesium Chloride Hexahydrate USP

Fáanlegur frá:

BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.

INN (Alþjóðlegt nafn):

SODIUM LACTATE; L-Isoleucine USP; L-Leucine USP; L-Phenylalanine USP; L-Threonine USP; L-Tryptophan USP; L-Histidine USP; L-Proline USP; L-Serine USP; L-Valine USP; L-Tyrosine USP; L-Methionine USP; L-Alanine USP; L-Arginine USP; L-Lysine HCI USP; Calcium Chloride Dihydrate USP; Sodium Chloride, USP; Glycine, USP; Magnesium Chloride Hexahydrate USP

Einingar í pakka:

2000ml mL

Framleitt af:

BAXTER HEALTHCARE SA, SINGAPORE BRANCH

Upplýsingar fylgiseðill

--
-
_BAXTER_
NUTRINEAL
PD-4PERITONEAL
DIALYSISSOLUTION
WITH1.1%AMINOACIDS
For intraperitoneal
administration
only
PATIENTLEAFLET
COMPOSITION
Each 1000mL contains:
-
Amino Acids
L-Serine
L-Isoleucine
L-Leucine
L-Lysine Hydrochloride
L-Methionine
L-Phenylalanine
L-Threonine
L-Tryptophan
-
L-Valine
L-Alanine
L-Arginine
Glycine
L-Histidine
L-Proline
L-Tyrosine
-
Sodium Chloride
-
Calcium Chloride Dihydrate
-
Magnesium Chloride Hexahydrate
-
Sodium Lactate
-
Hydrochloric Acid
-
Water for injections
Osmolarity:
Ionic formula
Sodium
Calcium
Magnesium
~actate
~hlorides
Amino Acids
0.510 g
0.850 g
1.020 g
0.955
g
0.850 g
0.570 g
0.646 g
0.270 g
1.393 g
0.951 g
1.071 g
0.510 g
0.714 g
0.595 g
0.300 g
5.380 g
0.184 g
0.051 g
4.48 g
q.s.
pH = 6.3
q.s.
_366 mOsm/1_(Calculated excluding HCI)
132 mmol/l
1.25 mmol/l
_0.25 mmol/l_
40 mmolll
105 mmol/l
87 mmolll
PHARMACEUTICAL
FORM
Peritoneal
dialysis solution contained in bags.
CLINICAL
PARTICULARS
1.
TheraDeutic Indications
Nutritional
supplement
for
malnourished
renal
failure
patients
(albumin
concentration lower than 35 g/litre)
being maintained on peritoneal
dialysis.
2.
Posology and Method of
Administration
For intraperitoneal
administration only.
This route requires the use of a specific catheter and an appropriate
administration
set
which connects the solution container to the patient's catheter.
Overpouch must
be removed and solution warmed to body temperature before
use.
Dosage schedule, frequency of treatment and duration of dwell
should be selected
by the prescribing physician according to the patient's clinical
status.
Recommended dietary
allowance of
protein is approximately
1.2-1.3
_g/kg_ for
dialysed adults and 2-3_ g/kg_ for
infants.
Higher
amounts may be necessary in
several
catabolic states.
For information, a 2-litre bag of
NUTRINEALwith 1.1% amino acids provides 22 g
of
amino acids which are equivalent
to 0.30_ g/kg/day_ for a 70 kg adult.
3.
Contraindicatlons
Some clinical
conditions such as recent
abdominal
surgery and gastrointestinal
disturbances have to

Vara einkenni

NUTRINEAL PD‐4 PERITONEAL DIALYSIS SOLUTION
WITH 1.1% AMINO ACIDS
FOR INTRAPERITONEAL ADMINISTRATION ONLY
PATIENT LEAFLET
COMPOSITION
Each 1000mL contains

Amino Acids
L‐Serine
0.510 g
L‐Isoleucine
0.850 g
L‐Leucine
1.020 g
L‐Lysine (as Hydrochloride) 0.955 g
L‐Methionine 0.850 g
L‐Phenylalanine 0.570
g
L‐Threonine 0.646 g
L‐Tryptophan 0.270 g
L‐Valine
1.393 g
L‐Alanine 0.951 g
L‐Arginine
1.071 g
Glycine
0.510 g
L‐Histidine 0.714 g
L‐Proline 0.595 g
L‐Tyrosine 0.300 g

Sodium Chloride 5.380 g

Calcium Chloride Dihydrate
0.184 g

Magnesium Chloride Hexahydrate 0.051 g

Sodium Lactate 4.48 g

Hydrochloric Acid q.s. pH = 6.3

Water for Injections q.s.
Osmolarity: 366 mOsmol/l (Calculated excluding HCI)
Ionic formula
Sodium 132 mmol/l
Calcium 1.25 mmol/l
Magnesium 0.25 mmol/l
Lactate 40 mmol/l
Chlorides
105 mmol/l
Amino Acids 87 mmol/l
PHARMACEUTICAL FORM
Peritoneal dialysis solution contained in bags.
PRODUCT DESCRIPTION
Nutrineal contains 40mM of sodium lactate, 1.25mM of calcium and
0.25mM of magnesium, available in
plasticized PL146‐2 poly (vinyl chloride) VIAFLEX flexible bag.
CLINICAL PARTICULARS
1. THERAPEUTIC INDICATIONS
Nutritional supplement for malnourished renal failure patients
(albumin concentration lower than
35g/litre) being maintained on peritoneal dialysis.
2. DOSAGE AND METHOD OF ADMINISTRATION
Administration:
‐
NUTRINEAL is intended for intraperitoneal administration only. Not for
intravenous administration.
‐
The intraperitoneal administration route requires the use of a
specific peritoneal dialysis catheter
and an appropriate administration set which connects the solution
container to the patient’s
catheter.
‐
NUTRINEAL should be administered at a rate that is comfortable for the
patient. The volume
administered is determined by the prescribing physician.
‐
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.
‐
Treatme