TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for infusion

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Magnesium chloride hexahydrate; Potassium chloride; Sodium acetate trihydrate ; Sodium glycerophophate hydrate; Glucose monohydrate; Calcium chloride dihydrate; Olive oil, refined; Soya Bean Oil, Refined Ph.Eur

Verfügbar ab:

Baxter Holding B.V.

ATC-Code:

B05BA; B05BA10

INN (Internationale Bezeichnung):

Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Magnesium chloride hexahydrate; Potassium chloride; Sodium acetate trihydrate ; Sodium glycerophophate hydrate; Glucose monohydrate; Calcium chloride dihydrate; Olive oil, refined; Soya Bean Oil, Refined Ph.Eur

Dosierung:

12g/l nitrogen 950 kcal/l wtih electrolytes

Darreichungsform:

Emulsion for infusion

Therapiebereich:

Solutions for parenteral nutrition; combinations

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2019-09-13

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 12 G/L NITROGEN 950 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 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion
for infusion is and what
it is used for
2.
What you need to know before TRIOMEL 12 g/l nitrogen 950 kcal/l with
electrolytes, emulsion
for infusion is administered
3.
How TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for
infusion will be used
4.
Possible side effects
5.
How TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for
infusion is stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 12 G/L NITROGEN 950 KCAL/L WITH ELECTROLYTES, EMULSION
FOR INFUSION
IS AND WHAT IT IS USED FOR
TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes 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 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for
infusion 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 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for
infusion must only be used under
medical supervision.
2.
WHAT YOU NEED TO KNOW BEFORE TRIOMEL 12 G/L NITROGEN 950 KCAL/L WITH
ELECTROLYTES,
EMULSION FOR INFUSION IS ADMINISTERED
TRIOMEL 12 G/L NITROGEN 950 KCAL/L WITH ELECTROLYTES, EMULSION FOR
INFUSION MUST NOT BE USED:

In premature neonates, infants, and children le

Fachinformation

Health Products Regulatory Authority
08 September 2020
CRN009C38
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIOMEL 12 g/l nitrogen 950 kcal/l with electrolytes, emulsion for
infusion 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
​
​
​
650 ML
1,000 ML
1,500 ML
2,000 ML
27.5% Glucose solution
(corresponding to 27.5 g/100 mL)
173 mL
267 mL
400 mL
533 mL
14.2% Amino acid solution
(corresponding to 14.2 g/100 mL)
347 mL
533 mL
800 mL
1,067 mL
17.5% Lipid emulsion
(corresponding to 17.5 g/100 mL)
130 mL
200 mL
300 mL
400 mL
Composition of the reconstituted emulsion after mixing the contents of
the 3 compartments:
ACTIVE SUBSTANCES
650 ML
1,000 ML
1,500 ML
2,000 ML
Refined olive oil+ refined soyabean oil
a
22.75 g
35.00 g
52.50 g
70.00 g
Alanine
7.14 g
10.99 g
16.48 g
21.97 g
Arginine
4.84 g
7.44 g
11.16 g
14.88 g
Aspartic acid
1.43 g
2.20 g
3.30 g
4.39 g
Glutamic acid
2.46 g
3.79 g
5.69 g
7.58 g
Glycine
3.42 g
5.26 g
7.90 g
10.53 g
Histidine
2.94 g
4.53 g
6.79 g
9.06 g
Isoleucine
2.46 g
3.79 g
5.69 g
7.58 g
Leucine
3.42 g
5.26 g
7.90 g
10.53 g
Lysine
(equivalent to lysine acetate)
3.88 g
(5.48 g)
5.97 g
(8.43 g)
8.96 g
(12.64 g)
11.95 g
(16.85 g)
Methionine
2.46 g
3.79 g
5.69 g
7.58 g
Phenylalanine
3.42 g
5.26 g
7.90 g
10.53 g
Proline
2.94 g
4.53 g
6.79 g
9.06 g
Serine
1.95 g
3.00 g
4.50 g
5.99 g
Threonine
2.46 g
3.79 g
5.69 g
7.58 g
Tryptophan
0.82 g
1.26 g
1.90 g
2.53 g
Tyrosine
0.13 g
0.20 g
0.30 g
0.39 g
Valine
3.16 g
4.86 g
7.29 g
9.72 g
Sodium acetate, trihydrate
0.97 g
1.5 g
2.24 g
2.99 g
Sodium glycerophosphate, hydrated
2.39 g
3.67 g
5.51 g
7.34 g
Potassium chloride
1.45 g
2.24 g
3.35 g
4.47 g
Magnesium chloride, hexahydrate
0.53 g
0.81 g
1.22 g
1.62 g
Calcium chloride, dihydrate
0.34 g
0.52 g
0.77 g
1.03 g
Gluco