Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
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; ;
Baxter Healthcare Ltd
Alanine 8 g/L
10 %
Solution for infusion
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
Bottle, glass, 100 mL
General sale
General sale
Evonik Rexim SAS
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.
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
1996-12-05
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 Les hele dokumentet