Nutrineal Solution for Peritoneal Dialysis 4 with 1.1% Amino Acids
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
30-12-2017
Summary of Product characteristics
(SPC)
24-07-2018
Active ingredient:
Sodium chloride; L-histidine; L-tryptophan; L-arginine; L-valine; L-tyrosine; Sodium (s)-lactate solution; L-lysine hydrochloride; L-leucine; L-isoleucine; L-proline; Glycine; L-phenylalanine; L-threonine; L-serine; L-methionine; L-alanine; Magnesium chloride; Calcium chloride
Available from:
Baxter Healthcare Limited
ATC code:
B05DB
INN (International Name):
Sodium chloride; L-histidine; L-tryptophan; L-arginine; L-valine; L-tyrosine; Sodium (s)-lactate solution; L-lysine hydrochloride; L-leucine; L-isoleucine; L-proline; Glycine; L-phenylalanine; L-threonine; L-serine; L-methionine; L-alanine; Magnesium chlor
Dosage:
1.1 percent
Pharmaceutical form:
Solution for peritoneal dialysis
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Hypertonic solutions
Authorization status:
Marketed
Authorization date:
1994-08-08
Patient Information leaflet
1
CB-30-02-317
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRINEAL PD4 1.1% Amino Acids, Solution for Peritoneal Dialysis
Read all of this leaflet carefully before you start using this
medicine because
it contains important information for you.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor.
–
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this leaflet.
What is in this leaflet
1.
What NUTRINEAL is and what it is used for
2.
What you need to know before you use NUTRINEAL
3.
How to use NUTRINEAL
4.
Possible side effects
5.
How to store NUTRINEAL
6.
Contents of the pack and other information
1.
WHAT NUTRINEAL IS AND WHAT IT IS USED 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:
•
if you have kidney failure which needs peritoneal dialysis
•
in particular if you are malnourished.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE 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
•
If you are allergic to any amino acids or any of the other ingredients
of
this medicine (listed in section 6).
•
If your blood urea level is above 38 mmol/l.
•
If you suffer from a disorder affecting amino acid metabolism.
•
If your blood potassium level is too low.
•
If you show uraemic symptoms such as loss of appetite, nausea or
vomiting.
•
If your blood bicarbonate levels are too low.
•
If you suffer from liver insufficiency.
•
If you already have severe lactic acidosis (too much acid in the
blood).
•
If you have a surgically uncorrectable problem affecting your
abdominal wall or cavity or uncor
Read the complete document
Summary of Product characteristics
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.
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Read the complete document
