Triomel Peripheral 4g/L nitrogen 700kcal/L with electrolytes emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Patient Information leaflet (PIL)

26-11-2021

Summary of Product characteristics (SPC)

06-10-2020

Active ingredient:

Refined olive oil + refined soybean oil; Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Sodium acetate trihydrate ; Sodium glycerophosphate, hydrated; Potassium chloride; Magnesium chloride hexahydrate; Calcium chloride dihydrate; Glucose monohydrate

Available from:

Baxter Holding B.V.

ATC code:

B05BA; B05BA10

INN (International Name):

Dosage:

4gl/700kcal/L

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2010-04-09

Patient Information leaflet

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 (allergic) to egg

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Summary of Product characteristics

Health Products Regulatory Authority
05 October 2020
CRN009CM8
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triomel Peripheral 4g/L nitrogen 700kcal/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)

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