Numeta G13%E Preterm emulsion for infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

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

Dostopno od:

Baxter Holding B.V.

Koda artikla:

B05BA; B05BA10

INN (mednarodno ime):

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

Odmerek:

-

Farmacevtska oblika:

Emulsion for infusion

Terapevtsko območje:

Solutions for parenteral nutrition; combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

2016-05-06

Navodilo za uporabo

BLACK
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number:
BE-30-04-035
Date: 07SEP23
Proofread No.: P01
Designer: M.T
Page: 1 of 16
Colour Reference:
BE-30-04-035
1a
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 G13%E Preterm is and what it is used for
2.
What you need to know before your child is given Numeta G13%E Preterm
3.
How Numeta G13%E Preterm is given
4.
Possible side effects
5.
How to store Numeta G13%E Preterm
6.
Contents of the pack and other information
1.
What Numeta G13%E Preterm is and what it is used for
Numeta G13%E Preterm 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 G13%E Preterm must only be used under medical supervision.
2.
What you need to know before your child is given Numeta G13%E Preterm
Your child should not be given Numeta G13%E Preterm, 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.
• I

Lastnosti izdelka

Health Products Regulatory Authority
26 February 2021
CRN009NTR
Page 1 of 19
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.
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
​
​
Gl