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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM CHLORIDE, DIHYDRATE, PHENYLALANINE, POTASSIUM CHLORIDE, HISTIDINE, ARGININE, ASPARTIC ACID, OLIVE OIL, THREONINE, TYROSINE, VALINE, GLUCOSE MONOHYDRATE, GLUTAMIC ACID, GLYCINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, LYSINE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SERINE, PROLINE, SODIUM ACETATE, TRIHYDRATE, SODIUM GLYCEROPHOSPHATE, SOYBEAN OIL

Available from:

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

ATC code:

B05BA10

INN (International Name):

CALCIUM CHLORIDE DIHYDRATE PHENYLALANINE POTASSIUM CHLORIDE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL THREONINE TYROSINE VALINE GLUCOSE MONOHYDRATE GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE L-TRYPTOPHAN LYSINE MAGNESIUM CHLORIDE HEXAHYDRATE SERINE PROLINE SODIUM ACETATE TRIHYDRATE SODIUM GLYCEROPHOSPHATE SOYBEAN OIL

Pharmaceutical form:

EMULSION FOR INFUSION

Composition:

CALCIUM CHLORIDE DIHYDRATE PHENYLALANINE POTASSIUM CHLORIDE HISTIDINE ARGININE ASPARTIC ACID OLIVE OIL THREONINE TYROSINE VALINE GLUCOSE MONOHYDRATE GLUTAMIC ACID GLYCINE METHIONINE ISOLEUCINE L-TRYPTOPHAN LYSINE MAGNESIUM CHLORIDE HEXAHYDRATE SERINE PROLINE SODIUM ACETATE TRIHYDRATE SODIUM GLYCEROPHOSPHATE 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
17
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 7 G/L NITROGEN 1140 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 7 g/l nitrogen 1140 kcal/l with electrolytes, 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 with
electrolytes,
emulsion for infusion is administered
3.
How TRIOMEL 7 g/l nitrogen 1140 kcal/l with electrolytes, emulsion for
infusion will be
used
4.
Possible side effects
5.
How TRIOMEL 7 g/l nitrogen 1140 kcal/l with electrolytes, emulsion for
infusion is stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 7 G/L NITROGEN 1140 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 7 G/L NITROGEN 1140 KCAL/L WITH
ELECTROLYTES,
EMULSION FOR INFUSION IS ADMINISTERED
TRIOMEL 7 G/L NITROGEN 1140 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” b

Summary of Product characteristics

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIOMEL 7 g/l nitrogen 1140 kcal/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
1,000 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
Sodium acetate, trihydrate
1.50 g
2.24 g
2.99 g
Sodium glycerophosphate, hydrated
3.67 g
5.51 g
7.34 g
Potassium chloride
2.24 g
3.35 g
4.47 g
Magnesium chloride, hexahydrate
0.81 g
1.22 g
1.62 g
Calcium chloride, dihydrate
0.52 g
0.77 g
1.03 g
Glucose
(equivalent to glucose monohydrate)
140.00 g
(154.00 g)
210.00 g
(231.00 g)
280.00 g
(308.00 g)
Page 2 of 17
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.
Nutritional intakes of reconstit