Numeta G13%E Preterm infusion 300ml bags

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

L-Ornithine hydrochloride; L-Phenylalanine; L-Proline; L-Serine; Taurine; L-Threonine; L-Tryptophan; L-Tyrosine; L-Valine; Potassium acetate; Calcium chloride dihydrate; Magnesium acetate tetrahydrate; Sodium glycerophosphate hydrate; Glucose monohydrate; Olive oil; Soya oil; L-Alanine; L-Arginine; L-Aspartic acid; L-Cysteine; L-Glutamic acid; Glycine; L-Histidine; L-Isoleucine; L-Leucine; L-Lysine monohydrate; L-Methionine

Mevcut itibaren:

Baxter Healthcare Ltd

ATC kodu:

B05BA10

INN (International Adı):

L-Ornithine hydrochloride; L-Phenylalanine; L-Proline; L-Serine; Taurine; L-Threonine; L-Tryptophan; L-Tyrosine; L-Valine; Potassium acetate; Calcium chloride dihydrate; Magnesium acetate tetrahydrate; Sodium glycerophosphate hydrate; Glucose monohydrate; Olive oil; Soya oil; L-Alanine; L-Arginine; L-Aspartic acid; L-Cysteine; L-Glutamic acid; Glycine; L-Histidine; L-Isoleucine; L-Leucine; L-Lysine monohydrate; L-Methionine

Doz:

1mg/1ml ; 1.3mg/1ml ; 933.33microgram/1ml ; 1.23mg/1ml ; 200microgram/1ml ; 1.17mg/1ml ; 633.33microgram/1ml ; 233.33microgram/1ml ; 2.37mg/1ml ; 2.03mg/1ml ; 1.83mg/1ml ; 333.33microgram/1ml ; 3.27mg/1ml ; 146.67mg/1ml ; 20mg/1ml ; 5mg/1ml ; 2.5mg/1ml ; 2.6mg/1ml ; 1.87mg/1ml ; 600microgram/1ml ; 3.1mg/1ml ; 1.23mg/1ml ; 1.17mg/1ml ; 2.07mg/1ml ; 3.1mg/1ml ; 3.83mg/1ml ; 733.33microgram/1ml

Farmasötik formu:

Infusion

Uygulama yolu:

Intravenous

Sınıf:

No Controlled Drug Status

Reçete türü:

Never Valid To Prescribe As A VMP

Ürün özeti:

BNF: ; GTIN: 5413760404509 05413760404509

Ürün özellikleri

OBJECT 1
NUMETA G13%E PRETERM, EMULSION FOR INFUSION
Summary of Product Characteristics Updated 29-Sep-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Numeta G13%E Preterm, emulsion for infusion.
2. Qualitative and quantitative composition
This medicinal product is presented in the form of a three chamber
bag. Each bag contains a sterile non-
pyrogenic combination of a glucose solution, a paediatric amino acids
solution, with electrolytes, and a
lipid emulsion, as described below.
CONTAINER SIZE
50% GLUCOSE SOLUTION
5.9% AMINO ACIDS
SOLUTION WITH
ELECTROLYTES
12.5% LIPID EMULSION
300 mL
80 mL
160 mL
60 mL
If lipid administration is undesirable, the design of the bag allows
the possibility to activate only the peel
seal between the amino acids/electrolytes and glucose chambers,
leaving the peel seal between the amino
acids and lipid chambers intact. The content of the bag can
subsequently be infused with or without lipids.
The composition of the drug product after mixing of the two (amino
acids and glucose, 2 chamber bag,
240 mL solution) or three (amino acids, glucose and lipid, 3 chamber
bag, 300 mL emulsion) chambers
are provided in the following table.
COMPOSITION
ACTIVE SUBSTANCE
ACTIVATED 2CB
(240 ML)
ACTIVATED 3CB
(300 ML)
AMINO ACID CHAMBER
Alanine
0.75 g
0.75 g
Arginine
0.78 g
0.78 g
Aspartic acid
0.56 g
0.56 g
Cysteine
0.18 g
0.18 g
Glutamic acid
0.93 g
0.93 g
Glycine
0.37 g
0.37 g
Histidine
0.35 g
0.35 g
Isoleucine
0.62 g
0.62 g
Leucine
0.93 g
0.93 g
Lysine monohydrate
(equivalent to Lysine)
1.15 g
(1.03 g)
1.15 g
(1.03 g)
Methionine
0.22 g
0.22 g
Ornithine hydrochloride
(equivalent to Ornithine)
0.30 g
(0.23 g)
0.30 g
(0.23 g)
Phenylalanine
0.39 g
0.39 g
Proline
0.28 g
0.28 g
Serine
0.37 g
0.37 g
Taurine
0.06 g
0.06 g
Threonine
0.35 g
0.35 g
Tryptophan
0.19 g
0.19 g
Tyrosine
0.07 g
0.07 g
Valine
0.71 g
0.71 g
Potassium acetate
0.61 g
0.61 g
Calcium chloride dihydrate
0.55 g
0.55 g
Magnesium acetate tetrahydrate
0.10 g
0.10 g
Sodium glycerophosphate hydrated
0.98 g
0.98 g
GLUCOSE CHAMBER
G