Synthamin 14 infusion 500ml bags

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

L-Leucine; L-Methionine; L-Isoleucine; L-Lysine; L-Valine; L-Phenylalanine; L-Histidine; L-Threonine; Tryptophan; L-Alanine; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine; Sodium acetate; Dipotassium hydrogen phosphate; Sodium chloride; Magnesium chloride

Available from:

Baxter Healthcare Ltd

ATC code:

B05BA01

INN (International Name):

L-Leucine; L-Methionine; L-Isoleucine; L-Lysine; L-Valine; L-Phenylalanine; L-Histidine; L-Threonine; Tryptophan; L-Alanine; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine; Sodium acetate; Dipotassium hydrogen phosphate; Sodium chloride; Magnesium chloride

Dosage:

6.2gram/1litre ; 3.4gram/1litre ; 5.1gram/1litre ; 4.93gram/1litre ; 4.93gram/1litre ; 4.76gram/1litre ; 4.08gram/1litre ; 3.57gram/1litre ; 1.53gram/1litre ; 17.6gram/1litre ; 9.78gram/1litre ; 8.76gram/1litre ; 5.78gram/1litre ; 4.25gram/1litre ; 340mg/1litre ; 5.94gram/1litre ; 5.22gram/1litre ; 1.54gram/1litre ; 1.02gram/1litre

Pharmaceutical form:

Infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 09030000; GTIN: 55413760019401 05413760019406

Summary of Product characteristics

OBJECT 1
SYNTHAMIN 14, 8.5% AMINO ACID INTRAVENOUS
INFUSION
Summary of Product Characteristics Updated 08-Jul-2015 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Synthamin 14, 8.5% Amino Acid Intravenous Infusion
2. Qualitative and quantitative composition
L-Leucine
L-Isoleucine
L-Lysine (as hydrochloride
salt)
L-Valine
L-Phenylalanine
L-Histidine
L-Threonine
L-Methionine
L-Tryptophan
L-Alanine
L-Arginine
Amino acetic acid (glycine)
L-Proline
L-Serine
L-Tyrosine
Sodium acetate
Dibasic potassium phosphate
Sodium chloride
Magnesium chloride
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
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Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur
Ph. Eur.
Ph. Eur.
Ph. Eur.
Ph. Eur.
0.620% w/v
0.510% w/v
0.493% w/v
0.493% w/v
0.476% w/v
0.408% w/v
0.357% w/v
0.340% w/v
0.153% w/v
1.760% w/v
0.978% w/v
0.876% w/v
0.578% w/v
0.425% w/v
0.034% w/v
0.594% w/v
0.522% w/v
0.154% w/v
0.102% w/v
3. Pharmaceutical form
The product is a sterile aqueous solution of amino acids and
electrolytes for intravenous infusion to
human beings.
4. Clinical particulars
4.1 Therapeutic indications
Synthamin 14, 8.5% Amino Acid Intravenous Infusion provides a
biologically available source of
nitrogen (L-amino acids) for amino acids synthesis. When administered
with an adequate source of
energy such as concentrated carbohydrate solutions, minerals and
vitamins, the mixture provides (with the
exception of essential fatty acids) sufficient parenteral nutrition
for patients unable to absorb adequate
oral nutrition.
4.2 Posology and method of administration
The solution is for administration by intravenous infusion through a
central venous catheter with the tip
located in the central vena cava. The total daily dose of the solution
depends upon the patient's metabolic
requirement and clinical response. The determination of nitrogen
balance and accurate daily body
weights, corrected for fluid balance, are probably the best means of
assessing individual nitrogen
requirements.
In addition to meeting nitrogen needs, the rate of