Numeta G16%E 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; Sodium chloride ph.eur.; 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; Sodium chloride ph.eur.; 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:

2011-12-05

Navodilo za uporabo

BLACK
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number:
BE-30-04-036
Date: 07SEP23
Proofread No.: P01
Designer: M.T
Page: 1 of 6
Colour Reference:
BE-30-04-036
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 yo

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 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
1.03g
1.03g
Arginine
1.08g
1.08g
Aspartic acid
0.77g
0.77g
Cysteine
0.24g
0.24g
Glutamic acid
1.29g
1.29g
Glycine
0.51g
0.51g
Histidine
0.49g
0.49g
Isoleucine
0.86g
0.86g
Leucine
1.29g
1.29g
Lysine monohydrate
(equivalent to Lysine)
1.59g
(1.42g)
1.59g
(1.42g)
Methionine
0.31g
0.31g
Ornithine hydrochloride
(equivalent to Ornithine)
0.41g
(0.32g)
0.41g
(0.32g)
Phenylalanine
0.54g
0.54g
Proline
0.39g
0.39g
Serine
0.51g
0.51g
Taurine
0.08g
0.08g
Threonine
0.48g
0.48g
Tryptophan
0.26g
0.26g
Tyrosine
0.10g
0.10g
Valine
0.98g
0.98g
Sodium chloride
0.30g
0.30g
Potassium acetate
1.12g
1.12g
Calcium chloride dihydrate
0.46g
0.46g
Magnesium acetate tetrahydrate
0.33g
0.33g
Sodium glycerophosphate hydrated
0.98g
0.98g
GLUCOSE CHAMBER
Glucose monohydrate
(equivalent to glucose anhydrous)
85