Synthamin 17 without electrolytes infusion 3litre bags

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Vara einkenni (SPC)
17-06-2018

Virkt innihaldsefni:

L-Methionine; L-Leucine; L-Isoleucine; L-Lysine; L-Valine; L-Phenylalanine; L-Histidine; L-Threonine; Tryptophan; L-Alanine; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine

Fáanlegur frá:

Baxter Healthcare Ltd

ATC númer:

B05BA01

INN (Alþjóðlegt nafn):

L-Methionine; L-Leucine; L-Isoleucine; L-Lysine; L-Valine; L-Phenylalanine; L-Histidine; L-Threonine; Tryptophan; L-Alanine; L-Arginine; Glycine; L-Proline; L-Serine; L-Tyrosine

Skammtar:

4gram/1litre ; 7.3gram/1litre ; 6gram/1litre ; 5.8gram/1litre ; 5.8gram/1litre ; 5.6gram/1litre ; 4.8gram/1litre ; 4.2gram/1litre ; 1.8gram/1litre ; 20.7gram/1litre ; 11.5gram/1litre ; 10.3gram/1litre ; 6.8gram/1litre ; 5gram/1litre ; 400mg/1litre

Lyfjaform:

Infusion

Stjórnsýsluleið:

Intravenous

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Never Valid To Prescribe As A VMP

Vörulýsing:

BNF: 09030000; GTIN: 05413760303413 55413760303418

Vara einkenni

                                OBJECT 1
SYNTHAMIN 17, 10.0% AMINO ACID INTRAVENOUS
INFUSION WITHOUT ELECTROLYTES
Summary of Product Characteristics Updated 08-Jul-2015 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Synthamin 17, 10.0% Amino Acid Intravenous Infusion without
Electrolytes.
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
L-Proline
L-Serine
L-Tyrosine
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.
Ph. Eur.
0.730 w/v
0.600% w/v
0.580% w/v
0.580% w/v
0.560% w/v
0.480% w/v
0.420% w/v
0.400% w/v
0.180% w/v
2.070% w/v
1.150% w/v
1.030% w/v
0.680% w/v
0.500% w/v
0.040% w/v
3. Pharmaceutical form
The product is a clear, or slightly coloured sterile non-pyrogenic
solution of amino acids for intravenous
infusion to human beings.
4. Clinical particulars
4.1 Therapeutic indications
Synthamin 17, 10.0% Amino Acid Intravenous Infusion without
Electrolytes 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 administration is
governed, especially during the first
few days of t
                                
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