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

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Glucose monohydrate; Olive oil, refined; Soya Bean Oil, Refined Ph.Eur

Dostopno od:

Baxter Holding B.V.

Koda artikla:

B05BA; B05BA10

INN (mednarodno ime):

Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine acetate; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Glucose monohydrate; Olive oil, refined; Soya Bean Oil, Refined Ph.Eur

Odmerek:

12g/l nitrogen 950 kcal/l

Farmacevtska oblika:

Emulsion for infusion

Terapevtsko območje:

Solutions for parenteral nutrition; combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

2019-09-13

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRIOMEL 12 G/L NITROGEN 950 KCAL/L
, 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, 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,
emulsion for infusion is
administered
3.
How TRIOMEL 12 g/l nitrogen 950 kcal/l, emulsion for infusion will be
used
4.
Possible side effects
5.
How TRIOMEL 12 g/l nitrogen 950 kcal/l, emulsion for infusion is
stored
6.
Contents of the pack and other information
1.
WHAT TRIOMEL 12 G/L NITROGEN 950 KCAL/L, EMULSION FOR INFUSION IS AND
WHAT IT IS USED
FOR
TRIOMEL 12 g/l nitrogen 950 kcal/l is an emulsion for infusion. It is
presented in a bag with 3
chambers.
One chamber contains a glucose solution, the second one contains a
lipid emulsion and the third one
contains an amino acid solution.
TRIOMEL 12 g/l nitrogen 950 kcal/l, 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, 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,
EMULSION FOR INFUSION
IS ADMINISTERED
TRIOMEL 12 G/L NITROGEN 950 KCAL/L, EMULSION FOR INFUSION MUST NOT BE
USED:
•
In premature neonates, infants, and children less than 2 years old.
•
If you are allergic to egg, soya-bean, peanut proteins, or corn/corn
products (see also section
“Warnings and precautions” below), or any of the other ingredients
of this medicine (listed in
section 6).
�

Lastnosti izdelka

Health Products Regulatory Authority
08 September 2020
CRN009C66
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TRIOMEL 12 g/l nitrogen 950 kcal/l, emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIOMEL 12 g/l nitrogen 950 kcal/l is presented in the form of a
3-compartment bag.
Each bag contains a glucose solution, a lipid emulsion and an amino
acid solution.
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 soya-bean 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
Glucose
(equivalent to glucose monohydrate)
47.67 g
(52.43 g)
73.33 g
(80.67 g)
110.00 g
(121.00 g)
146.67 g
(161.33 g)
1.
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