Triomel 5g/L nitrogen 990kcal/L with electrolytes, emulsion for infusion

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

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

Disponible des:

Baxter Holding B.V.

Codi ATC:

B05BA; B05BA10

Designació comuna internacional (DCI):

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

Dosis:

5g/L/ 990kcal/L

formulario farmacéutico:

Emulsion for infusion

Área terapéutica:

Solutions for parenteral nutrition; combinations

Estat d'Autorització:

Marketed

Data d'autorització:

2010-04-09

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 5 G/L NITROGEN 990 KCAL/L WITH ELECTROLYTES, 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 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion is and what it
is used for
2.
What you need to know before TRIOMEL 5 g/l nitrogen 990 kcal/l with
electrolytes, emulsion
for infusion is administered
3.
How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion will be used
4.
Possible side effects
5.
How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion is stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 5 G/L NITROGEN 990 KCAL/L WITH ELECTROLYTES, 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 with calcium, the second one
contains a lipid emulsion and
the third one contains an amino acid solution with other electrolytes.
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 5 G/L NITROGEN 990 KCAL/L WITH
ELECTROLYTES,
EMULSION FOR INFUSION IS ADMINISTERED
TRIOMEL 5 G/L NITROGEN 990 KCAL/L WITH ELECTROLYTES, 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 othe

Fitxa tècnica

Health Products Regulatory Authority
14 October 2020
CRN009ZK9
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triomel 5g/L nitrogen 990kcal/L with electrolytes, 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 with calcium, a lipid emulsion
and an amino acid solution with other electrolytes.
CONTENTS PER BAG
​
​
1,500 ML
2,000 ML
2,500 ML
28.75 % Glucose solution
(corresponding to 28.75 g/100 mL)
600 mL
800 mL
1000 mL
8.2 % Amino acid solution (corresponding to 8.2 g/100 mL)
600 mL
800 mL
1000 mL
20 % Lipid emulsion
(corresponding to 20 g/100 mL)
300 mL
400 mL
500 mL
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
ACTIVE SUBSTANCES
1,500 ML
2,000 ML
2,500 ML
Refined olive oil+ refined soya-bean oil
a
60.00 g
80.00 g
100.00 g
Alanine
7.14 g
9.52 g
11.90 g
Arginine
4.84 g
6.45 g
8.06 g
Aspartic acid
1.43 g
1.90 g
2.38 g
Glutamic acid
2.47 g
3.29 g
4.11 g
Glycine
3.42 g
4.56 g
5.70 g
Histidine
2.95 g
3.93 g
4.91 g
Isoleucine
2.47 g
3.29 g
4.11 g
Leucine
3.42 g
4.56 g
5.70 g
Lysine
(equivalent to lysine acetate)
3.88 g
(5.48 g)
5.18 g
(7.30 g)
6.47 g
(9.13 g)
Methionine
2.47 g
3.29 g
4.11 g
Phenylalanine
3.42 g
4.56 g
5.70 g
Proline
2.95 g
3.93 g
4.91 g
Serine
1.95 g
2.60 g
3.25 g
Threonine
2.47 g
3.29 g
4.11 g
Tryptophan
0.82 g
1.10 g
1.37 g
Tyrosine
0.13 g
0.17 g
0.21 g
Valine
3.16 g
4.21 g
5.26 g
Sodium acetate, trihydrate
2.24 g
2.99 g
3.74 g
Sodium glycerophosphate, hydrated
5.51 g
7.34 g
9.18 g
Potassium chloride
3.35 g
4.47 g
5.59 g
Magnesium chloride, hexahydrate
1.22 g
1.62 g
2.03 g
Calcium chloride, dihydrate
0.77 g
1.03 g
1.29 g
Glucose
(equivalent to glucose monohydrate)
172.50 g
(189.75 g)
230.00 g
(253.00 g)
287.50 g
(316.25 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 o