NUTRINEAL PD Soln for Peritoneal Dialysis

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TYROSINE, TRYPTOPHAN, L-, PHENYLALANINE, THREONINE, SERINE, PROLINE, AMINOACETIC ACID, ALANINE, VALINE, DL-METHIONINE, ISOLEUCINE, LEUCINE, LYSINE, HISTIDINE, ARGININE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM LACTATE, SODIUM CHLORIDE

Available from:

Baxter Healthcare Limited

ATC code:

B05DB

INN (International Name):

TYROSINE, TRYPTOPHAN, L-, PHENYLALANINE, THREONINE, SERINE, PROLINE, AMINOACETIC ACID, ALANINE, VALINE, DL-METHIONINE, ISOLEUCIN

Pharmaceutical form:

Soln for Peritoneal Dialysis

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Hypertonic solutions

Authorization status:

Authorised

Authorization date:

2003-11-04

Patient Information leaflet

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

NUTRINEAL PD4 1.1% AMINO ACIDS
CLEAR-FLEX 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. See section 4. 

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 a

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nutrineal PD4 1.1% Amino Acids Clear-Flex Solution for peritoneal dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Nutrineal is a sterile, clear, colourless solution.
Osmolarity
365 mOsmol/l
pH at 25°C
6.6
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FORMULA IN MG/L
Blend of Amino Acids:
Alanine
951
Arginine
1071
Glycine
510
Histidine
714
Isoleucine
850
Leucine
1020
Lysine, HCl
955
Methionine
850
Phenylalanine
570
Proline
595
Serine
510
Threonine
646
Tryptophan
270
Tyrosine
300
Valine
1393
Sodium chloride
5380
Calcium chloride dihydrate
184
Magnesium chloride hexahydrate
51
Sodium (_S_)-lactate solution equivalent to Sodium (_S_)-lactate
4480
COMPOSITION IN MMOL/L
Amino Acids
87.16
Na
+
132
Ca
++
1.25
Mg
++
0.25
Cl
-
105
C
3
H
5
O
3
-
40
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 18/05/2016_
_CRN 2164592_
_page number: 1_
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
Posology
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.
Treatment should be re-evaluated after 3 months if there is no clinical or biochemical improvement in the status of the
patient.
ADULTS: one peritoneal dialysis exchange per day of 2.0 l or 2.5 l is the recommended dose for a 70 kg body weight
patient. In s