TRIOMEL 7G/L Nitrogen 1140KCAL/L, emulsion for infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

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

Available from:

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

ATC code:

B05BA10

INN (International Name):

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

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

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

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2009-12-11

Patient Information leaflet

Page
1
of
16
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 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 in

Summary of Product characteristics

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIOMEL 7 g/l nitrogen 1140 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
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
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
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
(equivalent to glucose monohydrate)
140.00 g
(154.00 g)
210.00 g
(231.00 g)
280.00 g
(308.00 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%.
Page 2 of 16
For the full list of excipients, see section 6.1.
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
44.3 g
66.4 g
88.6 g
Nitrogen
7.0 g
10.5 g
14.0 g
Glucose
140.0 g
210.0 g
280.0 g
Energy:
Total calories approx.
1,140 kcal
1,710 kcal
2,270 kcal
Non-protein calories
960 kcal
1,440 kcal
1,920 kc