NUTRINEAL PD4 WITH 1.1 % AMINO ACIDS

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ARGININE; CALCIUM CHLORIDE DIHYDRATE; GLYCINE; HISTIDINE; ISOLEUCINE; L- ALANINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; METHIONINE; PHENYLALANINE; PROLINE; SERINE; SODIUM (S) - LACTATE; SODIUM CHLORIDE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE

Inapatikana kutoka:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

ATC kanuni:

B05XA30

Dawa fomu:

SOLUTION FOR PERITONEAL DIALYSIS

Tungo:

TYROSINE 0.3 G/L; TRYPTOPHAN 0.27 G/L; PHENYLALANINE 0.57 G/L; THREONINE 0.646 G/L; SERINE 0.51 G/L; PROLINE 0595 G/L; GLYCINE 0.51 G/L; L- ALANINE 0.951 G/L; VALINE 1.393 G/L; METHIONINE 0.85 G/L; ISOLEUCINE 0.85 G/L; LEUCINE 1.02 G/L; HISTIDINE 0.714 G/L; ARGININE 1.071 G/L; SODIUM CHLORIDE 5.38 G/L; LYSINE HYDROCHLORIDE 0.955 G/L; CALCIUM CHLORIDE DIHYDRATE 0.184 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.051 G/L; SODIUM (S) - LACTATE 4.480 G/L

Njia ya uendeshaji:

PERITONEAL DIALYSIS

Dawa ya aina:

Required

Viwandani na:

BAXTER HEALTHCARE S.A, IRELAND

Kundi la matibabu:

COMBINATIONS OF ELECTROLYTES

Eneo la matibabu:

COMBINATIONS OF ELECTROLYTES

Matibabu dalili:

Nutritional supplement for malnourished renal failure patients (albumin concentration lower then 35 g/liter) being maintained on peritoneal dialysis.

Idhini ya tarehe:

2022-01-31

Taarifa za kipeperushi

Patient leaflet in accordance with the Pharmacists’ Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Nutrineal PD4 with 1.1% amino acids
Solution for peritoneal dialysis
Composition:
Each liter of solution contains:
Tyrosine 300 mg
Tryptophan 270 mg
Phenylalanine 570 mg
Threonine 646 mg
Serine 510 mg
Proline 595 mg
Glycine 510 mg
Alanine 951 mg
Valine 1393 mg
Methionine 850 mg
Isoleucine 850 mg
Leucine 1020 mg
Lysine (hydrochloride)
955 mg
Histidine 714 mg
Arginine 1071 mg
Sodium chloride 5380 mg
Calcium chloride dihydrate 184 mg
Magnesium chloride hexahydrate 51 mg
Sodium (S)-lactate 4480 mg
Solution composition in mmol/l:
87.16
Amino acid
132
Sodium
1.25
Calcium
0.25
Magnesium
40
Lactate
105
Chloride
For information about excipients, see section 6.
Read the entire leaflet carefully before you start using this
medicine. This
leaflet contains concise information about this medicine. If you have
any further
questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them even if it seems to you that their illness is
like yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
Nutrineal PD4 is a solution for peritoneal dialysis, which does not
contain glucose.
•
Nutrineal PD4 solution is intended for nutrition in situations of
malnutrition in patients suffering from chronic kidney failure
(albumin
concentration lower than 35 gr/liter), who are treated with peritoneal
dialysis.
Therapeutic group: Electrolyte solutions
2.
BEFORE USING THIS MEDICINE
Your doctor will evaluate whether the use of Nutrineal PD4 is the
appropriate
treatment for you depending on your medical history.
Do not use this medicine if:
•
You are sensitive (allergic) to any amino acid or any of the other
ingredients in this medicine (see section 6).
•
Your blood urea level is above 38 mmol/l.
•
You suffer from a disorder affecting amino acid metabolism.
•
Your blood potassium level is too low.
•
You experience

Tabia za bidhaa

Physician leaflet in accordance with the Pharmacists’ Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Nutrineal PD4 with 1.1% amino acids
Solution for peritoneal dialysis
1. NAME OF THE MEDICINAL PRODUCT
Nutrineal PD4 with 1.1% Amino Acids
Solution for Peritoneal Dialysis
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
L-Tyrosine
300 mg/l
L-Trytophan
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, HCl
955 mg/l
L-Histidine
714 mg/l
L-Arginine
1071 mg/l
Calcium Chloride, 2H
2
0
184 mg/l
Magnesium Chloride, 6H
2
0
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
Solution for Peritoneal Dialysis.
A clear, colourless to pale yellow, sterile solution.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Nutrineal PD4 is a supplement for malnourished renal failure patients
(albumin
concentration lower than 35 g/liter) being maintained on peritoneal
dialysis.
4.2 Posology and method of administration
Administration
Nutrineal
PD4
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