TRIOMEL 5G/L NITROGEN 990KCAL/L WITH ELECTROLYTES

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

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 ; SODIUM ACETATE TRIHYDRATE; SODIUM GLYCEROPHOSPHATE, HYDRATED ; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE ; CALCIUM CHLORIDE DIHYDRATE ; GLUCOSE MONOHYDRATE

Inapatikana kutoka:

Baxter Healthcare Limited

ATC kanuni:

B05BA10

INN (Jina la Kimataifa):

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 ; SODIUM ACETA

Kipimo:

Unknown

Dawa fomu:

Emulsion for Infusion

Dawa ya aina:

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

Eneo la matibabu:

combinations

Idhini hali ya:

Marketed

Idhini ya tarehe:

2010-04-09

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 5 G/L NITROGEN 990 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 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion is and what it
is used for
2.
What you need to know before TRIOMEL 5 g/l nitrogen 990 kcal/l with
electrolytes, emulsion
for infusion is administered
3.
How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion will be used
4.
Possible side effects
5.
How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion is stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 5 G/L NITROGEN 990 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 5 G/L NITROGEN 990 KCAL/L WITH
ELECTROLYTES,
EMULSION FOR INFUSION IS ADMINISTERED
TRIOMEL 5 G/L NITROGEN 990 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” below), or to any other

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triomel 5g/L nitrogen 990kcal/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.
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
CONTENTS PER BAG
1,500 ML
2,000 ML
2,500 ML
28.75 % Glucose solution
(corresponding to 28.75 g/100
mL)
600 mL
800 mL
1000 mL
8.2 % Amino acid solution
(corresponding to 8.2 g/100
mL)
600 mL
800 mL
1000 mL
20 % Lipid emulsion
(corresponding to 20 g/100
mL)
300 mL
400 mL
500 mL
ACTIVE SUBSTANCES
1,500 ML
2,000 ML
2,500 ML
Refined olive oil+ refined soybean oil
a
60.00 g
80.00 g
100.00 g
Alanine
7.14 g
9.52 g
11.90 g
Arginine
4.84 g
6.45 g
8.06 g
Aspartic acid
1.43 g
1.90 g
2.38 g
Glutamic acid
2.47 g
3.29 g
4.11 g
Glycine
3.42 g
4.56 g
5.70 g
Histidine
2.95 g
3.93 g
4.91 g
Isoleucine
2.47 g
3.29 g
4.11 g
Leucine
3.42 g
4.56 g
5.70 g
Lysine
(equivalent to lysine acetate)
3.88 g
(5.48 g)
5.18 g
(7.30 g)
6.47 g
(9.13 g)
Methionine
2.47 g
3.29 g
4.11 g
Phenylalanine
3.42 g
4.56 g
5.70 g
Proline
2.95 g
3.93 g
4.91 g
Serine
1.95 g
2.60 g
3.25 g
Threonine
2.47 g
3.29 g
4.11 g
Tryptophan
0.82 g
1.10 g
1.37 g
Tyrosine
0.13 g
0.17 g
0.21 g
Valine
3.16 g
4.21 g
5.26 g
Sodium acetate, trihydrate
2.24 g
2.99 g
3.74 g
Sodium glycerophosphate, hydrated
5.51 g
7.34 g
9.18 g
Potassium chloride
3.35 g
4.47 g
5.59 g
Magnesium chloride, hexahydrate
1.22 g
1.62 g
2.03 g
Calcium chloride, dihydrate
0.77 g
1.03 g
1.29 g
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