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

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

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

Tilgjengelig fra:

Baxter Healthcare Limited

ATC-kode:

B05BA10

INN (International Name):

CALCIUM CHLORIDE DIHYDRATE; PHENYLALANINE; POTASSIUM CHLORIDE; HISTIDINE; ARGININE; ASPARTIC ACID; OLIVE OIL; THREONINE; TYROSIN

Legemiddelform:

EMULSION FOR INFUSION

Sammensetning:

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

Resept typen:

POM

Terapeutisk område:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Autorisasjon status:

Authorised

Autorisasjon dato:

2009-12-11

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 9 G/L NITROGEN 1070 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 9 g/l nitrogen 1070 kcal/l with electrolytes, 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 with
electrolytes, emulsion
for infusion is administered
3.
How TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for
infusion will be used
4.
Possible side effects
5.
How TRIOMEL 9 g/l nitrogen 1070 kcal/l with electrolytes, emulsion for
infusion is stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 9 G/L NITROGEN 1070 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 9 G/L NITROGEN 1070 KCAL/L WITH
ELECTROLYTES,
EMULSION FOR INFUSION IS ADMINISTERED
TRIOMEL 9 G/L NITROGEN 1070 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 or peanut
proteins or to any other ingredient.

If your body has problems using certain amino acids.

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIOMEL
9 g/l nitrogen 1070 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
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 soybean 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
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 anhydrous
(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
soybean 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 reconstituted emul