Numeta G16%E Emulsion for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amino acid chamber; Alanine; Arginine; Aspartic acid; Cysteine dab; Glutamic acid; GLYCINE; Histidine; Isoleucine; Leucine; Lysine monohydrate dab; Methionine; Ornithine hydrochloride dab; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyrosine; Valine; Sodium chloride ph.eur.; Potassium acetate; Calcium chloride dihydrate; Magnesium acetate tetrahydrate; Sodium glycerophosphate, hydrated; Glucose chamber; Glucose monohydrate; Lipid chamber; Olive oil, refined; SOYA BEAN OIL, REFINED PH. EU

Available from:

Baxter Healthcare Limited

ATC code:

B05BA; B05BA10

INN (International Name):

Amino acid chamber; Alanine; Arginine; Aspartic acid; Cysteine dab; Glutamic acid; GLYCINE; Histidine; Isoleucine; Leucine; Lysine monohydrate dab; Methionine; Ornithine hydrochloride dab; Phenylalanine; Proline; Serine; Taurine; Threonine; Tryptophan; Tyr

Pharmaceutical form:

Emulsion for infusion

Prescription type:

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

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Authorised

Authorization date:

2011-12-05

Patient Information leaflet

BE-30-02-553
1a
b
Package leaflet: Information for the user
NUMETA G16%E EMULSION FOR INFUSION
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4 for
how to report side effects.
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.
The medicine is called NUMETA G16%E emulsion for infusion but will be
referred to as NUMETA through
the remainder of this leaflet.
What is in this leaflet:
1. What NUMETA is and what it is used for
2. What you need to know before your child is given NUMETA
3. How NUMETA is given
4. Possible side effects
5. How to store NUMETA
6. Contents of the pack and other information
1.
What NUMETA 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 must only be used under medical supervision.
2.
What you need to know before your child is given NUMETA
Your child should not be given NUMETA, 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
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.
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.
CONTAINER
SIZE
50% GLUCOSE
SOLUTION
5.9% AMINO ACIDS
SOLUTION WITH
ELECTROLYTES
12.5% LIPID
EMULSION
500 mL
155 mL
221 mL
124 mL
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
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