TRIOMEL PERIPHERAL 4G/L Nitrogen 700KCAL/L with electrolytes, emulsion for infusion

País: Malta

Idioma: anglès

Font: Medicines Authority

ingredients actius:

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

Disponible des:

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

Codi ATC:

B05BA10

Designació comuna internacional (DCI):

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

formulario farmacéutico:

EMULSION FOR INFUSION

Composición:

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

tipo de receta:

POM

Área terapéutica:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Estat d'Autorització:

Authorised

Data d'autorització:

2009-12-11

Informació per a l'usuari

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 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 Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes,
emulsion for infusion is
and what it is used for
2.
What you need to know before TRIOMEL Peripheral 4 g/l nitrogen 700
kcal/l with electrolytes,
emulsion for infusion is administered
3.
How TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes,
emulsion for infusion will
be used
4.
Possible side effects
5.
How TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes,
emulsion for infusion is
stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 KCAL/L WITH ELECTROLYTES,
EMULSION FOR
INFUSION IS AND WHAT IT IS USED FOR
TRIOMEL Peripheral 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 Peripheral 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 Peripheral must only be used under medical supervision.
2.
WHAT YOU NEED TO KNOW BEFORE TRIOMEL PERIPHERAL 4 G/L NITROGEN 700
KCAL/L WITH
ELECTROLYTES, EMULSION FOR INFUSION IS ADMINISTERED
TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 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 (all

Fitxa tècnica

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
TRIOMEL PERIPHERAL 4 g/l nitrogen 700 kcal/l with electrolytes,
emulsion for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIOMEL PERIPHERAL 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
2,500 ML
18.75 % Glucose solution
(corresponding to 18.75 g/100
mL)
400 mL
600 mL
800 mL
1000 mL
6.3 % Amino acid solution
(corresponding to 6.3 g/100 mL)
400 mL
600 mL
800 mL
1000 mL
15 % Lipid emulsion
(corresponding to 15 g/100 mL)
200 mL
300 mL
400 mL
500 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
2,500 ML
Refined olive oil + refined soya-bean
oil
a
30.00 g
45.00 g
60.00 g
75.00 g
Alanine
3.66 g
5.50 g
7.33 g
9.16 g
Arginine
2.48 g
3.72 g
4.96 g
6.20 g
Aspartic acid
0.73 g
1.10 g
1.46 g
1.83 g
Glutamic acid
1.26 g
1.90 g
2.53 g
3.16 g
Glycine
1.76 g
2.63 g
3.51 g
4.39 g
Histidine
1.51 g
2.26 g
3.02 g
3.77 g
Isoleucine
1.26 g
1.90 g
2.53 g
3.16 g
Leucine
1.76 g
2.63 g
3.51 g
4.39 g
Lysine
(equivalent to lysine acetate)
1.99 g
(2.81 g)
2.99 g
(4.21 g)
3.98 g
(5.62 g)
4.98 g
(7.02 g)
Methionine
1.26 g
1.90 g
2.53 g
3.16 g
Phenylalanine
1.76 g
2.63 g
3.51 g
4.39 g
Proline
1.51 g
2.26 g
3.02 g
3.77 g
Serine
1.00 g
1.50 g
2.00 g
2.50 g
Threonine
1.26 g
1.90 g
2.53 g
3.16 g
Tryptophan
0.42 g
0.64 g
0.85 g
1.06 g
Tyrosine
0.06 g
0.10 g
0.13 g
0.16 g
Valine
1.62 g
2.43 g
3.24 g
4.05 g
Sodium acetate, trihydrate
1.16 g
1.73 g
2.31 g
2.89 g
Sodium glycerophosphate, hydrated
1.91 g
2.87 g
3.82 g
4.78 g
Potassium chloride
1.19 g
1.79 g
2.38 g
2.98 g
Magnesium chloride, hexahydrate
0.45 g
0.67 g
0.90 g
1.12 g
Calcium chloride, dihydrate
0.30 g
0.44 g
0.59 g
0.74 g
Glucose
(equivalent to glucose monohydrate)
75.00 g
(82.50 g)
112.50 g
(123.75 g)
150.00 g
(165.00 g)
187.50 g
(206.25 g)
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