TRIOMEL 9G/L Nitrogen 1070KCAL/L, emulsion for infusion

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

PHENYLALANINE, HISTIDINE, ARGININE, ASPARTIC ACID, OLIVE OIL, THREONINE, TYROSINE, VALINE, GLUCOSE MONOHYDRATE, GLUTAMIC ACID, GLYCINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, LYSINE, SERINE, PROLINE, SOYBEAN OIL

Disponível em:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

Código ATC:

B05BA10

DCI (Denominação Comum Internacional):

PHENYLALANINE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL ALANINE THREONINE TYROSINE VALINE GLUCOSE MONOHYDRATE 250 g GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE L-TRYPTOPHAN LYSINE SERINE LEUCINE PROLINE SOYBEAN OIL

Forma farmacêutica:

EMULSION FOR INFUSION

Composição:

PHENYLALANINE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL ALANINE THREONINE TYROSINE VALINE GLUCOSE MONOHYDRATE 250 g GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE L-TRYPTOPHAN LYSINE SERINE LEUCINE PROLINE SOYBEAN OIL

Tipo de prescrição:

POM

Área terapêutica:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Status de autorização:

Authorised

Data de autorização:

2009-12-11

Folheto informativo - Bula

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 9 G/L NITROGEN 1070 KCAL/L, EMULSION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED
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 doctor or nurse.
•
If you get any side effect, talk to your doctor or nurse. This
includes any side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is and
what it is used for
2.
What you need to know before TRIOMEL 9 g/l nitrogen 1070 kcal/l,
emulsion for infusion is
administered
3.
How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion will be
used
4.
Possible side effects
5.
How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is
stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 9 G/L NITROGEN 1070 KCAL/L, EMULSION FOR INFUSION IS AND
WHAT IT IS USED
FOR
TRIOMEL is an emulsion for infusion. It is presented in a bag with 3
chambers.
One chamber contains a glucose solution, the second one contains a
lipid emulsion and the third one
contains an amino acid solution.
TRIOMEL is used to provide nutrition to adults and children greater
than 2 years of age by a tube
into a vein when normal feeding by mouth is not suitable.
TRIOMEL must only be used under medical supervision.
2.
WHAT YOU NEED TO KNOW BEFORE TRIOMEL 9 G/L NITROGEN 1070 KCAL/L,
EMULSION FOR
INFUSION IS ADMINISTERED
TRIOMEL 9 G/L NITROGEN 1070 KCAL/L, EMULSION FOR INFUSION MUST NOT BE
USED:
•
In premature neonates, infants, and children less than 2 years old.
•
If you are hypersensitive (allergic) to egg, soybean, peanut proteins,
or corn/corn products
(see also section “Warnings and precautions” below), or to any
other ingredient of this
medicine (listed in section 6).
•
If your body has problems using certain amino acids.
•
If you have an especially high level of fats i

Características técnicas

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIOMEL is presented in the form of a 3-compartment bag.
Each bag contains a glucose solution, a lipid emulsion and an amino
acid solution.
CONTENTS PER BAG
1,000 ML
1,500 ML
2,000 ML
27.5 % Glucose solution
(corresponding to 27.5 g/100
mL)
400 mL
600 mL
800 mL
14.2 % Amino acid solution
(corresponding to 14.2 g/100
mL)
400 mL
600 mL
800 mL
20 % Lipid emulsion
(corresponding to 20 g/100 mL)
200 mL
300 mL
400 mL
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
ACTIVE SUBSTANCES
1,000 ML
1,500 ML
2,000 ML
Refined olive oil+ refined soya-bean oil
a
40.00 g
60.00 g
80.00 g
Alanine
8.24 g
12.36 g
16.48 g
Arginine
5.58 g
8.37 g
11.16 g
Aspartic acid
1.65 g
2.47 g
3.30 g
Glutamic acid
2.84 g
4.27 g
5.69 g
Glycine
3.95 g
5.92 g
7.90 g
Histidine
3.40 g
5.09 g
6.79 g
Isoleucine
2.84 g
4.27 g
5.69 g
Leucine
3.95 g
5.92 g
7.90 g
Lysine
(equivalent to lysine acetate)
4.48 g
(6.32 g)
6.72 g
(9.48 g)
8.96 g
(12.64 g)
Methionine
2.84 g
4.27 g
5.69 g
Phenylalanine
3.95 g
5.92 g
7.90 g
Proline
3.40 g
5.09 g
6.79 g
Serine
2.25 g
3.37 g
4.50 g
Threonine
2.84 g
4.27 g
5.69 g
Tryptophan
0.95 g
1.42 g
1.90 g
Tyrosine
0.15 g
0.22 g
0.30 g
Valine
3.64 g
5.47 g
7.29 g
Glucose
(equivalent to glucose monohydrate)
110.00 g
(121.00 g)
165.00 g
(181.50 g)
220.00 g
(242.00 g)
a: Mixture of refined olive oil (approximately 80%) and refined
soya-bean oil
(approximately 20%) corresponding to a ratio essential fatty acids /
total fatty acids
of 20%.
For the full list of excipients, see section 6.1.
Page 2 of 16
Nutritional intakes of reconstituted emulsion for each of the bag
sizes:
1,000 ML
1,500 ML
2,000 ML
Lipids
40 g
60 g
80 g
Amino acids
56.9 g
85.4 g
113.9 g
Nitrogen
9.0 g
13.5 g
18.0 g
Glucose
110.0 g
165.0 g
220.0 g
Energy:
Total calories approx.
1,070 kcal
1,600 kcal
2,140 kcal
Non-protein calories
840 kcal
1,260 kcal