Numeta G16%E emulsion for infusion

Ülke: Ermenistan

Dil: İngilizce

Kaynak: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktif bileşen:

alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, Isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, calcium chloride dehydrate, magnesium acetate tetrahydrate, sodium glycerophosphate hydrated, glucose monohydrate, refined olive oil + refined soya bean oil

Mevcut itibaren:

Baxter SA.

ATC kodu:

B05BA10 օրիգինալ դեղի հաջորդ դեղաչափ

INN (International Adı):

alanine, arginine, aspartic acid, cysteine, glutamic acid, glycine, histidine, Isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, calcium chloride dehydrate, magnesium acetate tetrahydrate, sodium glycerophosphate hydrated, glucose monohydrate, refined olive oil + refined soya bean oil

Doz:

1,03g+ 1,08g+ 0,77g+ 0,24g+ 1,29g+ 0,51g+ 0,49g+ 0,86g+ 1,29g+ 1,59g+ 0,31g+ 0,41g+ 0,54g+ 0,39g+ 0,51g+ 0,08g+ 0,48g+ 0,26g+ 0,10g+ 0,98g+ 0,30g+ 1,12g+ 0,46g+ 0,33g+ 0,98g+ 85,25+ 15,5g (6) bags 500ml

Farmasötik formu:

emulsion for infusion

Paketteki üniteler:

1,03g+1,08g+0,77g+0,24g+1,29g+0,51g+0,49g+0,86g+1,29g+1,59g+0,31g+0,41g+0,54g+0,39g+0,51g+0,08g+0,48g+0,26g+0,10g+0,98g+0,30g+1,12g+0,46g+0,33g+0,98g+85,25+15,5g (6) bags 500ml

Reçete türü:

Prescription

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

2020-09-30

Bilgilendirme broşürü

BLACK
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number:
BE-30-03-317
Date: 13JULY20
Proofread No.: P03
Designer: R.K.
Page: 1 of 6
Colour Reference:
BE-30-03-317
1a
Package leaflet: Information for the user
Numeta G16%E emulsion for infusion
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your child’s doctor,
pharmacist or nurse.
• If your child gets any side effects, talk to your child’s doctor
or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Numeta G16%E is and what it is used for
2. What you need to know before your child is given Numeta G16%E
3. How Numeta G16%E is given
4. Possible side effects
5. How to store Numeta G16%E
6. Contents of the pack and other information
1.
What Numeta G16%E is and what it is used for
Numeta G16%E is a specialised nutrition emulsion designed for full
term newborns and children up to
2 years. It is given through a tube which is placed in your child’s
vein, when your child is not able to eat
all of his or her nutrition by mouth.
Numeta is presented in the form of a three chamber bag in which the
separate chambers contain:
a 50 % glucose solution
a 5.9% paediatric amino acid solution, with electrolytes
a 12.5% lipid (fat) emulsion
Depending on your child’s needs, two or three of these solutions are
mixed together in the bag before it
is given to your child.
Numeta G16%E must only be used under medical supervision.
2.
What you need to know before your child is given Numeta G16%E
Your child should not be given Numeta G16%E, in the following cases:
With 2 solutions mixed together in the bag (“2 in 1”):
• If your child is allergic to egg proteins, soya, peanuts or to any
ingredient in the glucose or amino
acids chamber (listed in section 6).
• If your child’s body has problems using building blocks of
protein.
• If

Ürün özellikleri

Page
1
of
28
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Numeta G16%E 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
500 mL
155 mL
221 mL
124 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, 376 mL solution) or three (amino acids, glucose and
lipid, 3 chamber
bag, 500 mL emulsion) chambers are provided in the following table.
COMPOSITION
ACTIVE SUBSTANCE
ACTIVATED 2CB
(376 ML)
ACTIVATED 3CB
(500 ML)
AMINO ACID CHAMBER
Alanine
1.03 g
1.03 g
Arginine
1.08 g
1.08 g
Aspartic acid
0.77 g
0.77 g
Cysteine
0.24 g
0.24 g
Glutamic acid
1.29 g
1.29 g
Glycine
0.51 g
0.51 g
Histidine
0.49 g
0.49 g
Isoleucine
0.86 g
0.86 g
Leucine
1.29 g
1.29 g
Lysine monohydrate
(equivalent to Lysine)
1.59 g
(1.42 g)
1.59 g
(1.42 g)
Page
2
of
28
COMPOSITION
ACTIVE SUBSTANCE
ACTIVATED 2CB
(376 ML)
ACTIVATED 3CB
(500 ML)
Methionine
0.31 g
0.31 g
Ornithine hydrochloride
(equivalent to Ornithine)
0.41 g
(0.32 g)
0.41 g
(0.32 g)
Phenylalanine
0.54 g
0.54 g
Proline
0.39 g
0.39 g
Serine
0.51 g
0.51 g
Taurine
0.08 g
0.08 g
Threonine
0.48 g
0.48 g
Tryptophan
0.26 g
0.26 g
Tyrosine
0.10 g
0.10 g
Valine
0.98 g
0.98 g
Sodium chloride
0.30 g
0.30 g
Potassium acetate
1.12 g
1.12 g
Calcium chloride dihydrate
0.46 g
0.46 g
Magnesium acetate tetrahydrate
0.33 g
0.33 g
Sodium glycerophosphate hydrated
0.98 g