Synthamin 17 (without electrolytes)

Држава: Нови Зеланд

Језик: Енглески

Извор: Medsafe (Medicines Safety Authority)

Активни састојак:

Alanine 20.7 g/L;  ; Arginine 11.5 g/L;  ; Glycine 10.3 g/L;  ; Histidine 4.8 g/L;  ; Isoleucine 6 g/L;  ; Leucine 7.3 g/L;  ; Lysine 5.8 g/L;  ; Methionine 4 g/L;  ; Phenylalanine 5.6 g/L;  ; Proline 6.8 g/L;  ; Serine 5 g/L; Threonine 4.2 g/L;  ; Tryptophan 1.8 g/L;  ; Tyrosine 0.4 g/L;  ; Valine 5.8 g/L;  

Доступно од:

Baxter Healthcare Ltd

INN (Међународно име):

Alanine 20.7 g/L

Дозирање:

10 %

Фармацеутски облик:

Solution for infusion

Састав:

Active: Alanine 20.7 g/L   Arginine 11.5 g/L   Glycine 10.3 g/L   Histidine 4.8 g/L   Isoleucine 6 g/L   Leucine 7.3 g/L   Lysine 5.8 g/L   Methionine 4 g/L   Phenylalanine 5.6 g/L   Proline 6.8 g/L   Serine 5 g/L Threonine 4.2 g/L   Tryptophan 1.8 g/L   Tyrosine 0.4 g/L   Valine 5.8 g/L  

Јединице у пакету:

Bottle, glass, 500ml, 12 dose units

Класа:

General sale

Тип рецептора:

General sale

Произведен од:

Tanabe Seiyaku & Co Ltd

Терапеутске индикације:

Synthamin infusion solutions are indicated as an adjunct in the prevention of net nitrogen loss or in the treatment of negative nitrogen balance in patients where: 1. the alimentary tract, by the oral, gastrostomy or jejunostomy route, cannot or should not be used. 2. gastrointestinal absorption of protein is impaired, or 3. metabolic requirements for protein are substantially increased, as with extensive burns.

Резиме производа:

Package - Contents - Shelf Life: Bottle, glass, 12 x 500ml - 12 dose units - 24 months from date of manufacture stored at or below 30°C

Датум одобрења:

1979-10-18

Карактеристике производа

NEW ZEALAND DATA SHEET
Synthamin Data Sheet 30 March 2020
Page 1 of 11
Baxter Healthcare Ltd
1
SYNTHAMIN (infusion, solution)
Synthamin 9 (amino acid) with electrolytes, 5.5% Infusion, solution
Synthamin 13 (amino acid) with electrolytes, 8% Infusion, solution
Synthamin 17 (amino acid) with electrolytes, 10% Infusion solution
Synthamin 9 (amino acid) (without electrolytes), 5.5% Infusion,
solution
Synthamin 13 (amino acid) (without electrolytes), 8% Infusion,
solution
Synthamin 17 (amino acid) (without electrolytes),
10% Infusion, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Synthamin intravenous infusion solutions are solutions of essential
and non‐essential L‐amino acids
provided with or without electrolytes, available in 5.5%, 8% and 10%
strengths.. Each strength has a
pH of approximately 6.0 and each 500mL unit contains amino acids and
nitrogen the following
quantities:
_Amino acids and nitrogen: _
5.5%
8%
10%
Amino Acids
27.5g
40g
50g
Nitrogen
4.5g
6.6g
8.3g
_Each 1000mL of Synthamin infusion solutions without electrolytes
contains: _
5.5%
8%
10%
L‐Amino Acids
55g
80g
100g
Total Nitrogen
9.09g
13.2g
16.5g
Approximate pH
6.0
6.0
6.0
Protein Equivalents
56.8g
82.7g
103.0g
_Essential amino acids _
5.5%
8%
10%
Leucine
4.02g
5.84g
7.30g
Phenylalanine
3.08g
4.48g
5.60g
Methionine
2.20g
3.20g
4.00g
Lysine (as the
hydrochloride salt)
3.19g
4.64g
5.80g
Isoleucine
3.30g
4.80g
6.00g
Valine
3.19g
4.64g
5.80g
Histidine
2.64g
3.84g
4.80g
Threonine
2.31g
3.36g
4.20g
Tryptophan
999mg
1.44g
1.80g
_Nonessential amino acids _
5.5%
8%
10%
Alanine
11.4g
16.6g
20.7g
Glycine
5.66g
8.24g
10.3g
Arginine
6.32g
9.20g
11.5g
Proline
3.74g
5.44g
6.80g
Tyrosine
220mg
320mg
400mg
Serine
2.75g
4.00g
5.00g
Approximately 1.5mmol/L sodium metabisulfite B.P. is added as
stabiliser.
NEW ZEALAND DATA SHEET
Synthamin Data Sheet 30 March 2020
Page 2 of 11
Baxter Healthcare Ltd
_In addition to the above, Synthamin infusion solutions with
electrolytes contain in each 1000mL: _
_Electrolytes _
5.5%
8%
10%
Sodium Acetate, B.P.
4.31g
6.8g
6