Numeta G13%E Preterm Emulsion for Infusion

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Alanine; Arginine; Aspartic acid; Cysteine; Glutamic acid; GLYCINE; Histidine; Isoleucine; Leucine; Lysine monohydrate; Methionine; Ornithine hydrochloride; Phenylalanine; Proline; Serine; Taurine; Tryptophan; Tyrosine; Valine; Potassium acetate; Calcium chloride dihydrate; Magnesium acetate tetrahydrate; Sodium glycerophosphate, hydrated; Glucose monohydrate; Refined olive oil + refined soybean oil; Threonine

Dostupné z:

Baxter Healthcare Limited

ATC kód:

B05BA; B05BA10

INN (Medzinárodný Name):

Alanine; Arginine; Aspartic acid; Cysteine; Glutamic acid; GLYCINE; Histidine; Isoleucine; Leucine; Lysine monohydrate; Methionine; Ornithine hydrochloride; Phenylalanine; Proline; Serine; Taurine; Tryptophan; Tyrosine; Valine; Potassium acetate; Calcium c

Forma lieku:

Emulsion for infusion

Typ predpisu:

Product subject to prescription which may not be renewed (A)

Terapeutické oblasti:

Solutions for parenteral nutrition; combinations

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2016-05-06

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
NUMETA G13E 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 G13E is and what it is used for
2.
What you need to know before your child is given Numeta G13E
3.
How Numeta G13E is given
4.
Possible side effects
5.
How to store Numeta G13E
6.
Contents of the pack and other information
1.
WHAT NUMETA G13E IS AND WHAT IT IS USED FOR
Numeta G13E is a specialised nutrition emulsion designed for preterm
newborns. 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 G13E must only be used under medical supervision.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD IS GIVEN NUMETA G13E
YOUR CHILD SHOULD NOT BE GIVEN NUMETA G13E, IN THE FOLLOWING CASES:
WITH THE GLUCOSE AND AMINO ACID/ELECTROLYTE SOLUTIONS MIXED TOGETHER
IN THE BAG (“2 IN 1”):
-
If your child is allergic to egg, soya, peanuts or to any ingredient
of this medicine or
component of the container (listed in section 6).
-
If your child’s body has problems using building blocks of protein.
-
If your child has high concentrations of any of the electrolytes
included in Numeta G13E
in their blood.
-
Numeta G13E (or other calcium containing solutions) must not be given
at the

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
CONTAINER
SIZE
50% GLUCOSE
SOLUTION
5.9% AMINO ACIDS
SOLUTION WITH
ELECTROLYTES
12.5% LIPID
EMULSION
300 mL
80 mL
160 mL
60 mL
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
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