Numeta G19%E emulsion for infusion

国: アルメニア

言語: 英語

ソース: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有効成分:

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

から入手可能:

Baxter SA.

ATCコード:

B05BA10

INN（国際名）:

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

投薬量:

1,83g+ 1,9g+ 1,37g+ 0,43g+ 2,29g+ 0,91g+ 0,87g+ 1,53g+ 2,29g+ 2,82g+ 0,55g+ 0,73g+ 0,96g+ 0,69g+ 0,91g+ 0,14g+ 0,85g+ 0,46g+ 0,18g+ 1,74g+ 1,79g+ 3,14g+ 0,56g+ 0,55g+ 2,21g+ 210,65+ 28,1g

医薬品形態:

emulsion for infusion

パッケージ内のユニット:

(6) bags 1000ml

処方タイプ:

Prescription

認証ステータス:

Registered

承認日:

2020-09-30

情報リーフレット

BLACK
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number:
BE-30-03-318
Date: 13JULY20
Proofread No.: P03
Designer: R.K.
Page: 1 of 16
Colour Reference:
BE-30-03-318
1a
Package leaflet: Information for the user
Numeta G19%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 G19%E is and what it is used for
2. What you need to know before your child is given Numeta G19%E
3. How Numeta G19%E is given
4. Possible side effects
5. How to store Numeta G19%E
6. Contents of the pack and other information
1.
What Numeta G19%E is and what it is used for
Numeta G19%E is a specialised nutrition emulsion designed for children
older than 2 years and
adolescents up to 18 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 G19%E must only be used under medical supervision.
2.
What you need to know before your child is given Numeta G19%E
Your child should not be given Numeta G19%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 pr

製品の特徴

Page
1
of
29
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Numeta G19%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
1000 mL
383 mL
392 mL
225 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, 775 mL solution) or three (amino acids, glucose and lipid
3 chamber
bag, 1000 mL emulsion) chambers are provided in the following table.
Page
2
of
29
COMPOSITION
ACTIVE SUBSTANCE
ACTIVATED 2CB
(775 ML)
ACTIVATED 3CB
(1000 ML)
AMINO ACID CHAMBER
Alanine
1.83 g
1.83 g
Arginine
1.92 g
1.92 g
Aspartic acid
1.37 g
1.37 g
Cysteine
0.43 g
0.43 g
Glutamic acid
2.29 g
2.29 g
Glycine
0.91 g
0.91 g
Histidine
0.87 g
0.87 g
Isoleucine
1.53 g
1.53 g
Leucine
2.29 g
2.29 g
Lysine monohydrate
(equivalent to Lysine)
2.82 g
(2.51 g)
2.82 g
(2.51 g)
Methionine
0.55 g
0.55 g
Ornithine hydrochloride
(equivalent to Ornithine)
0.73 g
(0.57 g)
0.73 g
(0.57 g)
Phenylalanine
0.96 g
0.96 g
Proline
0.69 g
0.69 g
Serine
0.91 g
0.91 g
Taurine
0.14 g
0.14 g
Threonine
0.85 g
0.85 g
Tryptophan
0.46 g
0.46 g
Tyrosine
0.18 g
0.18 g
Valine
1.74 g
1.74 g
Sodium chloride
1.79 g
1.79 g
Potassium acetate
3.14 g
3.14 g
Calcium chloride dihydrate
0.56 g
0.56 g
Magnesium acetate tetrahydrate
0.55 g
0.55 g
Sodium glycerophosphate hydrated
2.21 g
2.21 g
GLUCOSE CHAMBER
Glucose monohydrate
(equivalent to glucose anhydro