TRIOMEL 7G/L NITROGEN 1140KCAL/L

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Baxter Healthcare Limited

ATC code:

B05BA10

INN (International Name):

REFINED OLIVE OIL + REFINED SOYBEAN OIL ; ALANINE ; ARGININE ; ASPARTIC ACID ; GLUTAMIC ACID ; GLYCINE; HISTIDINE ; ISOLEUCINE ; LEUCINE ; LYSINE ; METHIONINE; PHENYLALANINE ; PROLINE ; SERINE ; THREONINE ; TRYPTOPHAN, L- ; TYROSINE ; VALINE ; GLUCOSE MONO

Dosage:

Unknown

Pharmaceutical form:

Emulsion for Infusion

Prescription type:

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

Therapeutic area:

combinations

Authorization status:

Marketed

Authorization date:

2010-04-09

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 7 G/L NITROGEN 1140 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 7 g/l nitrogen 1140 kcal/l, emulsion for infusion is and
what it is used for
2.
What you need to know before TRIOMEL 7 g/l nitrogen 1140 kcal/l,
emulsion for infusion is
administered
3.
How TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion will be
used
4.
Possible side effects
5.
How TRIOMEL 7 g/l nitrogen 1140 kcal/l, emulsion for infusion is
stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 7 G/L NITROGEN 1140 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 7 G/L NITROGEN 1140 KCAL/L,
EMULSION FOR INFUSION
IS ADMINISTERED
TRIOMEL 7 G/L NITROGEN 1140 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.

If your body has problems using certain amino acids.

If you have an especially high level of fats in your blood.

If you have hyperglycemia (too much

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triomel 7g/L nitrogen 1140kcal/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.
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
a: Mixture of refined olive oil (approximately 80%) and refined
soybean oil (approximately 20%)
corresponding to a ratio essential fatty acids / total fatty acids of
20%.
CONTENTS PER BAG
1,000 ML
1,500 ML
2,000 ML
35 % Glucose solution
(corresponding to 35 g/100 mL)
400 mL
600 mL
800 mL
11.1 % Amino acid solution
(corresponding to 11.1 g/100 mL)
400 mL
600 mL
800 mL
20 % Lipid emulsion
(corresponding to 20 g/100 mL)
200 mL
300 mL
400 mL
ACTIVE SUBSTANCES
1,000 ML
1,500 ML
2,000 ML
Refined olive oil+ refined soybean oil
a
40.00 g
60.00 g
80.00 g
Alanine
6.41 g
9.61 g
12.82 g
Arginine
4.34 g
6.51 g
8.68 g
Aspartic acid
1.28 g
1.92 g
2.56 g
Glutamic acid
2.21 g
3.32 g
4.42 g
Glycine
3.07 g
4.60 g
6.14 g
Histidine
2.64 g
3.97 g
5.29 g
Isoleucine
2.21 g
3.32 g
4.42 g
Leucine
3.07 g
4.60 g
6.14 g
Lysine
(equivalent to lysine acetate)
3.48 g
(4.88 g)
5.23 g
(7.31 g)
6.97 g
(9.75 g)
Methionine
2.21 g
3.32 g
4.42 g
Phenylalanine
3.07 g
4.60 g
6.14 g
Proline
2.64 g
3.97 g
5.29 g
Serine
1.75 g
2.62 g
3.50 g
Threonine
2.21 g
3.32 g
4.42 g
Tryptophan
0.74 g
1.10 g
1.47 g
Tyrosine
0.11 g
0.17 g
0.22 g
Valine
2.83 g
4.25 g
5.66 g
Glucose anhydrous
(equivalent to glucose monohydrate)
140.00 g
(154.00 g)
210.00 g
(231.00 g)
280.00 g
(308.00 g)
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