Primene

Pajjiż: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Alanine 8 g/L;  ;  ;  ; Arginine 8.4 g/L;  ;  ;  ; Aspartic acid 6 g/L;  ;  ; Cysteine 1.89 g/L;  ; Glutamic acid 10 g/L;  ; Glycine 4 g/L;  ;  ; Histidine 3.8 g/L;  ;  ; Isoleucine 6.7 g/L;  ;  ;  ;  ;  ; Leucine 10 g/L;  ;  ;  ;  ; Lysine 11 g/L; Methionine 2.4 g/L;  ;  ; Ornithine hydrochloride 3.18 g/L;  ; Phenylalanine 4.2 g/L;  ;  ;  ;  ; Proline 3 g/L;  ;  ; Serine 4 g/L;  ;  ; Taurine 0.6 g/L;  ; Threonine 3.7 g/L;  ;  ;  ; Tryptophan 2 g/L;  ;  ;  ; Tyrosine 0.45 g/L;  ;  ; Valine 7.6 g/L;  ;  

Disponibbli minn:

Baxter Healthcare Ltd

INN (Isem Internazzjonali):

Alanine 8 g/L

Dożaġġ:

10 %

Għamla farmaċewtika:

Solution for infusion

Kompożizzjoni:

Active: Alanine 8 g/L       Arginine 8.4 g/L       Aspartic acid 6 g/L     Cysteine 1.89 g/L   Glutamic acid 10 g/L   Glycine 4 g/L     Histidine 3.8 g/L     Isoleucine 6.7 g/L           Leucine 10 g/L         Lysine 11 g/L Methionine 2.4 g/L     Ornithine hydrochloride 3.18 g/L   Phenylalanine 4.2 g/L         Proline 3 g/L     Serine 4 g/L     Taurine 0.6 g/L   Threonine 3.7 g/L       Tryptophan 2 g/L       Tyrosine 0.45 g/L     Valine 7.6 g/L     Excipient: Malic acid Water for injection

Unitajiet fil-pakkett:

Bottle, glass, 100 mL

Klassi:

General sale

Tip ta 'preskrizzjoni:

General sale

Manifatturat minn:

Evonik Rexim SAS

Indikazzjonijiet terapewtiċi:

Primene 10% amino acids IV infusion solution is indicated in infants and neonates at term or premature for short-term use, of normal or low birth-weight when oral or enteral nutrition is impossible, insufficient or contraindicated. It is used as an amino acid component in a composite admixture of total parenteral solution.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 24 months from date of manufacture stored at or below 25°C protect from light - Bottle, glass, - 250 mL - 24 months from date of manufacture stored at or below 25°C protect from light

Data ta 'l-awtorizzazzjoni:

1996-12-05

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
Primene Data Sheet 19 November 2019
Page 1 of 18
Baxter Healthcare Ltd
1 PRIMENE (10% solution for infusion)
Primene 10% solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Primene 10% amino acids intravenous (IV) solution for infusion
contains essential and non‐essential
L‐amino acids. The composition and quantity of the L‐amino acids
in Primene 10% are shown in the
following table:
EACH 1000ML OF PRIMENE 10% (W/V) SOLUTION FOR INFUSION CONTAINS
ACTIVE CONSTITUENTS:
(G)
LYSINE
11.00
GLUTAMIC ACID
10.00
LEUCINE
10.00
ARGININE
8.40
ALANINE
8.00
VALINE
7.60
ISOLEUCINE
6.70
ASPARTIC ACID
6.00
PHENYLALANINE
4.20
GLYCINE
4.00
SERINE
4.00
HISTIDINE
3.80
THREONINE
3.70
ORNITHINE MONOHYDROCHLORIDE
3.18 (2.49)*
PROLINE
3.00
METHIONINE
2.40
TRYPTOPHAN
2.00
CYSTEINE
1.89
TAURINE
0.60
TYROSINE
0.45
Note: Those amino acids are L‐isomer form
* equivalent to ornithine base 2.49g.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
_Appearance _
Primene 10% amino acids IV solution for infusion is a sterile,
nonpyrogenic, hypertonic, clear,
colourless solution of amino acids.
It is intended for nutritional support in infants administered as an
intravenous infusion.
Primene 10% contains 100.24g/litre of amino acids, which supplies
15.15g/litre of nitrogen. It does
not contain electrolytes.
NEW ZEALAND DATA SHEET
Primene Data Sheet 19 November 2019
Page 2 of 18
Baxter Healthcare Ltd
_Osmolality/Osmolarity _
Primene 10% is a hypertonic solution having osmolality of 840mOsmol/kg
(10% solution) and
Osmolarity of 780mOsmol/L. Under dilute conditions, osmolarity
(mOsmol/L) is similar to osmolality
(mOsmol/kg).
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
Primene 10% amino acids IV solution for infusion is indicated in
infants and neonates at term or
premature for short‐term use, of normal or low birth‐weight, when
oral or enteral nutrition is
impossible, insufficient or contraindicated. It is used as an amino
acid component in a composite
a