Nutrineal PD4 with 1.1% amino acids

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

CALCIUM CHLORIDE DIHYDRATE; PHENYLALANINE; HISTIDINE; ARGININE; ALANINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE; GLYCINE; METHIONINE; ISOLEUCINE; LYSINE; MAGNESIUM CHLORIDE HEXAHYDRATE; SERINE; LEUCINE; PROLINE; SODIUM CHLORIDE; SODIUM LACTATE

Dostępny od:

Baxter Healthcare Limited

Kod ATC:

B05DB

INN (International Nazwa):

CALCIUM CHLORIDE DIHYDRATE; PHENYLALANINE; HISTIDINE; ARGININE; ALANINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE; GLYCINE; METHI

Forma farmaceutyczna:

SOLUTION FOR PERITONEAL DIALYSIS

Skład:

CALCIUM CHLORIDE DIHYDRATE 184 mg/l; PHENYLALANINE 570 mg/l; HISTIDINE 714 mg/l; ARGININE 1071 mg/l; ALANINE 951 mg/l; THREONINE 646 mg/l; TRYPTOPHAN 270 mg/l; TYROSINE 300 mg/l; VALINE 1393 mg/l; GLYCINE 510 mg/l; METHIONINE 850 mg/l; ISOLEUCINE 850 mg/l; LYSINE 955 mg/l; MAGNESIUM CHLORIDE HEXAHYDRATE 51 mg/l; SERINE 510 mg/l; LEUCINE 1020 mg/l; PROLINE 595 mg/l; SODIUM CHLORIDE 5380 mg/l; SODIUM LACTATE 4480 mg/l

Typ recepty:

POM

Dziedzina terapeutyczna:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status autoryzacji:

Authorised

Data autoryzacji:

2005-12-29

Ulotka dla pacjenta

1
TR200929 E
CB-30-01-935
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).
�

Charakterystyka produktu

Page 1 of 8 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Nutrineal PD4 with 1.1% amino acids. 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

L-Tyrosine 

0.300 g/l 

L-Tryptophan   

0.270 g/l 

L-Phenylalanine 

0.570 g/l 

L-Threonine   

0.646 g/l 

L-Serine 

0.510 g/l 

L-Proline 

0.595 g/l 

Glycine 

0.510 g/l 

L-Alanine 

0.951 g/l 

L-Valine 

1.393 g/l 

L-Methionine   

0.850 g/l 

L-Isoleucine   

0.850 g/l 

L-Leucine 

1.020 g/l 

L-Lysine (chlorhydrate) 

0.955 g/l 

L-Histidine 

0.714 g/l 

L-Arginine 

1.071 g/l 

Calcium chloride dihydrate   

0.184 g/l 

Magnesium chloride hexahydrate 

0.051 g/l 

Sodium Lactate 

4.48 g/l 

Sodium Chloride 

5.38 g/l 
For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for Peritoneal Dialysis 

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 
Page 2 of 8 

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�