Skip to Content

TRIOMEL 9 G/L NITROGEN 1070 KCAL/L EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / METHIONINE / OLIVE OIL REFINED / PHENYLALANINE / PROLINE / SERINE / SOYBEAN OIL PURIFIED / THREONINE / TRYPTOPHAN / TYROSINE / VALINE / AL

View full screen / Print PDF » Download PDF ⇩
Transcript
b

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

DRAFT
N/A

N/A

Signature

Date

One chamber contains a glucose solution, the second one contains a lipid emulsion and the third one
contains an amino acid solution.

N/A

TRIOMEL is an emulsion for infusion. It is presented in a bag with 3 chambers.

Name

1. What TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is and what
it is used for

N/A

1. What TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is and what it is used for
2. What you need to know before TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is
administered
3. How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion will be used
4. Possible side effects
5. How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is stored
6. Contents of the pack and other information

DATE

What is in this leaflet:

EMEA ARTWORK DESIGN CENTRE

• 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.

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Read all of this leaflet carefully before you will be administered this medicine because it contains
important information for you.

PLANT APPROVAL
HALLE ONLY

TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion

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.

Errors: Yes / No PR2:

Sign:

Date:

Sign:

Date:

Date: 27 APR 2016
Artworker: Demeulenaere P.

In premature neonates, infants, and children less than 2 years old.
If you are hypersensitive (allergic) to egg, soybean or peanut proteins or to any other ingredient.
If your body has problems using certain amino acids.
If you have an especially high level of fats in your blood.
If you have hyperglycemia (too much sugar in your blood).

Version: 01







ARTWORK DESIGN CENTRE

TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion must not be used:

Errors: Yes / No PR1:

2. What you need to know before TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion
for infusion is administered

Draft: 02

TRIOMEL must only be used under medical supervision.

1

BE-30-02-552

Comments:

In all cases, your doctor will base his/her decision on whether you should receive this medicine on
factors such as your age, weight, and medical condition, together with the results of any test performed.

Warnings and precautions
Talk to your doctor or nurse before TRIOMEL is administered to you.
If you are given total parenteral nutrition (TPN) solutions too fast this may result in injury or death.
The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction
(such as sweating, fever, chills, headache, skin rashes, or difficulty breathing) develop. This medicinal
product contains soybean oil and egg phosphatide. Soybean and egg proteins may cause hypersensitivity
reactions. Cross-allergic reactions between soybean and peanut proteins have been observed.

DRAFT
N/A

N/A

N/A

N/A

Name

Signature

Date

Your doctor should be aware of:
• a severe kidney problem. You also must inform your doctor if you are on dialysis (artificial kidney)
or if you have another form of blood cleaning treatment
• a severe liver problem
• a blood clotting problem
• adrenal glands that are not working properly (adrenal insufficiency). The adrenal glands are
triangle-shaped glands located on top of your kidneys
• heart failure
• lung disease
• a build up of water in your body (hyperhydration)
• not enough water in your body (dehydration)
• high blood sugar (diabetes mellitus) that you are not being treated for
• a heart attack or shock due to a sudden heart failure
• a severe metabolic acidosis (when the blood is too acidic)
• a generalised infection (septicaemia)
• coma.

DATE

The balance of water and salt in your body and metabolic disorders will be corrected before starting
the infusion. Your doctor will monitor your condition while you receive this medicine and may change
the dosage or give you additional nutrients, such as vitamins, electrolytes, and trace elements, if he/she
feels they are appropriate.

EMEA ARTWORK DESIGN CENTRE

If you are severely malnourished such that you need to receive feedings by vein, your doctor should start
the treatment slowly. Also, your doctor should monitor you closely to prevent sudden changes in your
fluid, vitamin, electrolyte and mineral levels.

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in the
blood). There is a particular risk of infection or sepsis when a tube (intravenous catheter) is placed in
your vein. Your doctor will carefully watch you for any signs of infection. Patients who require parenteral
nutrition (giving nutrition through a tube in your vein) may be more likely to develop infections from their
medical conditions. Using aseptic (“germ-free”) techniques when placing and caring for the catheter and
when making the nutritional formula (TPN) can reduce the risk of infection.

PLANT APPROVAL
HALLE ONLY

Difficulty breathing could also be a sign that small particles have formed, blocking blood vessels in the
lungs (pulmonary vascular precipitates). If you experience any difficulty breathing, tell your doctor or
nurse. They will decide a course of action to be taken.

To check the effectiveness and ongoing safety of the administration, your doctor will perform clinical and
laboratory tests while you are receiving this medicine. If you are given this medicine for several weeks,
your blood will be monitored on a regular basis.

During the infusion if you notice pain, burning or swelling at the infusion site, or leakage of the infusion,
tell your doctor or nurse. The administration will be stopped immediately and restarted in another vein.
If your blood sugar gets too high, your doctor should adjust the rate of TRIOMEL delivery or give you
medication to control your blood sugar (insulin).

Date:
Date:

Reduced ability of the body to remove the fats contained in this medicine may result in a “fat overload
syndrome” (See Section 4 – Possible Side Effects).

TRIOMEL may only be administered via a tube (catheter) into a large vein in your chest (central vein).

If your child is under 18 years old, special care will be taken to give him/her the correct dosage.
Increased precautions will also be taken because of the greater sensitivity of children to the risk of
infection. Vitamin and trace element supplementation is always required. Paediatric formulations must
be used.

2

BE-30-02-552

Version: 01
Sign:
Sign:

Children and adolescents

Other medicines and TRIOMEL
Tell your doctor if you are taking or using, have recently taken or used or might take or use any other
medicines.
Simultaneous absorption of other medicinal products is not a contraindication, generally. If you take
other medicinal products, with or without medical prescription, you should inform your doctor in advance
to check compatibility.
TRIOMEL must not be administered simultaneously with blood through the same infusion tubing.

DRAFT

The lipids contained in this emulsion may interfere with the results of certain laboratory tests if the
blood sample is taken before the lipids have been eliminated from your bloodstream (these are generally
eliminated after a period of 5 to 6 hours without receiving lipids).

Dosage – Adults
Your doctor will specify a flow rate corresponding to your needs and clinical condition.
The prescription may be continued for as long as it is needed, depending upon your clinical condition.

Dosage – Children greater than two years of age and adolescents

N/A

The infusion of 1 bag usually lasts between 12 and 24 hours.

Date

TRIOMEL is for single use only.

N/A

TRIOMEL should be at room temperature before use.

Signature

It is an emulsion for infusion, to be administered via a tube (catheter) into a vein in your chest.

N/A

TRIOMEL should only be given in adults and children greater than 2 years of age.

Name

Dosage

N/A

3. How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion will be used

DATE

TRIOMEL may be considered during pregnancy and breastfeeding, if necessary.

EMEA ARTWORK DESIGN CENTRE

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Pregnancy, breast-feeding and fertility

PLANT APPROVAL
HALLE ONLY

The olive and soybean oils present in TRIOMEL contain vitamin K. This does not normally affect blood
thinning medicines (anticoagulants) like coumarin. However, if you take anticoagulant medicines you
should tell your doctor.

The doctor will decide the dose and for how long the medication will be given. This will depend on age,
weight, height, medical condition and the ability of the body to break down and use the ingredients in
TRIOMEL.

If the dose given is too high or the infusion is too fast, the amino acid content may make your blood
too acidic, and signs of hypervolaemia (increase of circulating blood volume) may occur. The glucose
levels in your blood and urine may increase, hyperosmolar syndrome (excessive blood viscosity) may
develop, and the lipid content may increase the level of triglycerides in your blood. Receiving a volume
of TRIOMEL that is too large may cause nausea, vomiting, chills and electrolyte disturbances. In such
situations, the infusion must be stopped immediately.

Date:
Date:

If you have been administered more TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion
for infusion than you should

In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys
eliminate the excess product.
To prevent these events occurring, your doctor will regularly monitor your condition and test your blood
parameters.

Version: 01
Sign:
Sign:

If you have any further questions on the use of this product, ask your doctor.

3

BE-30-02-552

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any changes in the way you feel during or after the treatment, tell your doctor or nurse right
away.
The tests your doctor will perform while you are taking the medicine should minimise the risk of side
effects.

DRAFT
N/A

N/A

N/A

N/A

Name

Signature

Date

Date:
Date:
Version: 01
Sign:
Sign:

DATE

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

The following side effects have been reported with similar parenteral nutrition products:
Frequency – Very rare: may affect up to 1 in 10,000 people
• Reduced ability to remove the lipids (fat overload syndrome) associated with sudden and abrupt
worsening of the patient’s medical condition. The following signs of fat overload syndrome are
usually reversible when the lipid emulsion infusion is stopped:
– Fever
– Reduction in red blood cells which can make the skin pale and cause weakness or
breathlessness (anaemia)
– Low white blood cell count, which can increase the risk of infection (leukopenia)
– Low platelet count which can increase the risk of bruising and/or bleeding (thrombocytopenia)
– Coagulation disorders which effect the ability of the blood to clot
– High levels of fats in the blood (hyperlipidaemia)
– Liver fatty infiltration (hepatomegaly)
– Worsening liver function
– Central nervous system manifestations (e.g. Coma).
Frequency – Not known: frequency cannot be estimated from the available data
• Allergic reactions
• Abnormal blood test results for liver function
• Problems with the elimination of bile (cholestasis)
• Increase in the size of the liver (hepatomegaly)
• Icterus (jaundice)
• Decrease in the number of platelets (thrombocytopenia)
• Increased nitrogen levels in the blood (azotemia)
• Elevated liver enzymes
• Formation of small particles which may lead to blockage of blood vessels in the lungs (pulmonary
vascular precipitates) resulting in pulmonary vascular embolism and difficulty breathing
(respiratory distress).

EMEA ARTWORK DESIGN CENTRE

The following side effects have been reported with TRIOMEL:
Frequency – Common: may affect up to 1 in 10 people
• Fast heart rate (tachycardia)
• Loss of appetite (anorexia)
• Increased level of fat in the blood (hypertriglyceridemia)
• Abdominal pain
• Diarrhoea
• Nausea
• Increased blood pressure (hypertension)
Frequency – Not known: frequency cannot be estimated from the available data
• Leakage of the infusion to the surrounding tissue (extravasation) which may result at infusion site
level in pain, irritation, swelling/oedema, redness (erythema)/warmth, death of the tissue cells
(skin necrosis) or blisters

PLANT APPROVAL
HALLE ONLY

If any abnormal signs or symptoms of an allergic reaction develop, such as sweating, fever, chills,
headache, skin rashes, or breathing difficulties, the infusion should be stopped immediately.

4

BE-30-02-552

Reporting of side effects

Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

DRAFT

The active substances for each bag of the reconstituted emulsion are 14.2% (corresponding to
14.2 g/100 mL) L-amino acid solution (alanine, arginine, glycine, histidine, isoleucine, leucine, lysine
(as lysine acetate), methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine,
aspartic acid, glutamic acid), 20% (corresponding to 20 g/100 mL) lipid emulsion (refined olive oil
and refined soybean oil), and 27.5% (corresponding to 27.5 g/100 mL) glucose solution (as glucose
monohydrate).

N/A

What TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion contains

Date

6. Contents of the pack and other information

N/A

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

Signature

Store in the overpouch.

N/A

Do not freeze.

Name

Do not use this medicine after the expiry date that is stated on the container and the outer packaging
(MM/YYYY). The expiry date refers to the last day of that month.

N/A

Keep this medicine out of the sight and reach of children.

DATE

5. How TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion is stored

EMEA ARTWORK DESIGN CENTRE

United Kingdom:
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Republic of Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRE – Dublin 2.
Tel: +353 1 6764971,
Fax: +353 1 6762517,
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

PLANT APPROVAL
HALLE ONLY

If you get any side effect, talk to your doctor or nurse. This includes any possible side effect not listed in
this leaflet. You can also report side effects directly (see details below). By reporting side effects you can
help provide more information on the safety of this medicine.

Lipid emulsion
compartment

Amino acid solution
compartment

Glucose solution
compartment

Purified egg phosphatide,
glycerol, sodium oleate, sodium
hydroxide (for pH adjustment),
water for injection

Glacial acetic acid
(for pH adjustment), water for
injection

Hydrochloric acid
(for pH adjustment), water for
injection

Date:
Date:

The other ingredients are:

TRIOMEL is an emulsion for infusion packaged in a 3-compartment bag. One compartment contains
a lipid emulsion, another compartment an amino acid solution and the third compartment a glucose
solution. These compartments are separated by nonpermanent seals. Before administration, the content
of the compartments need to be mixed by rolling the bag onto itself, starting at the top of the bag until
the peal seal is open.

5

BE-30-02-552

Version: 01
Sign:
Sign:

What TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion looks like and
contents of the pack

Appearance prior to reconstitution:
• The amino acid and glucose solutions are clear, colourless, or slightly yellow.
• The lipid emulsion is homogenous with a milky appearance.

Appearance after reconstitution: homogeneous milk-like emulsion.
The 3-compartment bag is a multilayer plastic bag. The inner (contact) layer of the bag material is
designed to be compatible with the constituents and authorised additives.

DRAFT

To prevent contact with oxygen contained in the air, the bag is packaged in an oxygen barrier overpouch
with an oxygen absorber sachet that may include an oxygen indicator (OXYDETECT).

1,000 mL bag: 1 carton with 6 bags
1,500 mL bag: 1 carton with 4 bags
2,000 mL bag: 1 carton with 4 bags
1 bag of 1,000 mL, 1,500 mL and 2,000 mL

N/A

ZentroOLIMEL 5,7 %
Olimel 5,7%
Olimel N9
Triomel 9g/l nitrogen 1070 kcal/l
Olimel 9g/l nitrogén emulziós infúzió

Date

Austria:
Germany:
Denmark, Iceland, Sweden, Norway, Finland:
The United Kingdom, Ireland, Malta:
Hungary:

N/A

OLIMEL N9

In some countries it is registered under a different trade name, as described below:

Signature

France, Portugal, Estonia, Poland, Lithuania, Bulgaria, Romania,
Latvia, Czech Republic, Belgium, Spain, Slovak Republic,
The Netherlands, Luxemburg, Slovenia, Italy, Greece, Cyprus:

N/A

This medicinal product is authorised in the Member States of the EEA under the following names:

Name

BAXTER S.A.
BOULEVARD RENE BRANQUART, 80
7860 LESSINES
BELGIUM

N/A

Manufacturer

DATE

Baxter Healthcare Limited
Caxton Way, Thetford,
Norfolk, IP24 3SE
United Kingdom

EMEA ARTWORK DESIGN CENTRE

Marketing Authorisation Holder

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Not all pack sizes may be marketed.

PLANT APPROVAL
HALLE ONLY

Pack sizes

For information about TRIOMEL or to request this
leaflet in formats such as audio or large print
please contact the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345

Date:
Date:

This leaflet was last revised in 04/2016.

Version: 01
Sign:
Sign:

Baxter, Triomel and Oxydetect are trademarks of Baxter international Inc.

6

BE-30-02-552

The following information is intended for medical
or healthcare professionals only:
TRIOMEL 9 g/l nitrogen 1070 kcal/l, emulsion for infusion
Pharmacotherapeutic group: Solutions for parenteral nutrition/combinations
ATC code: B05 BA10.

DRAFT

A. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bag contains a glucose solution, a lipid emulsion and an amino acid solution.

300 mL

400 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

Refined olive oil + refined soybean oila

40.00 g

60.00 g

80.00 g

Alanine

8.24 g

12.36 g

16.48 g

Arginine

5.58 g

8.37 g

11.16 g

Aspartic acid

1.65 g

2.47 g

3.30 g

Glutamic acid

2.84 g

4.27 g

5.69 g

Glycine

3.95 g

5.92 g

7.90 g

Histidine

3.40 g

5.09 g

6.79 g

Isoleucine

2.84 g

4.27 g

5.69 g

Leucine

3.95 g

5.92 g

7.90 g

Lysine
(equivalent to lysine acetate)

4.48 g
(6.32 g)

6.72 g
(9.48 g)

8.96 g
(12.64 g)

Methionine

2.84 g

4.27 g

5.69 g

Phenylalanine

3.95 g

5.92 g

7.90 g

Proline

3.40 g

5.09 g

6.79 g

Serine

2.25 g

3.37 g

4.50 g

Threonine

2.84 g

4.27 g

5.69 g

Tryptophan

0.95 g

1.42 g

1.90 g

Tyrosine

0.15 g

0.22 g

0.30 g

Valine

3.64 g

5.47 g

7.29 g

110.00 g
(121.00 g)

165.00 g
(181.50 g)

220.00 g
(242.00 g)

Glucose anhydrous
(equivalent to glucose monohydrate)

N/A

200 mL

Date

20% Lipid emulsion
(corresponding to 20 g/100 mL)

N/A

800 mL

Signature

600 mL

N/A

400 mL

Name

14.2% Amino acid solution
(corresponding to 14.2 g/100 mL)

N/A

800 mL

Date:
Date:

600 mL

DATE

2,000 mL

400 mL

EMEA ARTWORK DESIGN CENTRE

1,500 mL

27.5% Glucose solution
(corresponding to 27.5 g/100 mL)

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Contents per bag
1,000 mL

PLANT APPROVAL
HALLE ONLY

TRIOMEL is presented in the form of a 3-compartment bag.

Version: 01
Sign:
Sign:

a: Mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%)
corresponding to a ratio essential fatty acids/total fatty acids of 20%.

7

BE-30-02-552

The excipients are:
Lipid emulsion compartment

Amino acid solution
compartment

Glucose solution compartment

Purified egg phosphatide,
glycerol, sodium oleate, sodium
hydroxide (for pH adjustment),
water for injection

Glacial acetic acid
(for pH adjustment), water for
injection

Hydrochloric acid
(for pH adjustment), water for
injection

DRAFT

Nutritional intakes of reconstituted emulsion for each of the bag sizes:

Amino acids

1,000 mL

1,500 mL

40 g

60 g

2,000 mL
80 g

56.9 g

85.4 g

113.9 g

Nitrogen

9.0 g

13.5 g

18.0 g

Glucose

110.0 g

165.0 g

220.0 g

1,070 kcal

1,600 kcal

2,140 kcal

Non-protein calories

840 kcal

1,260 kcal

1,680 kcal

Glucose calories

440 kcal

660 kcal

880 kcal

Lipid caloriesa

400 kcal

600 kcal

800 kcal

Non-protein calories/nitrogen ratio

Phosphateb

3.0 mmol

4.5 mmol

6.0 mmol

Acetate

40 mmol

60 mmol

80 mmol

pH
Osmolarity

6.4

6.4

6.4

1,170 mosm/L

1,170 mosm/L

1,170 mosm/L

a: Includes calories from purified egg phosphatide
b: Includes phosphate provided by the lipid emulsion

B. POSOLOGY AND METHOD OF ADMINISTRATION

DATE

N/A

37%

Electrolytes:

Date

37%

N/A

37%

Signature

52/48

Lipid/total calories

N/A

93 kcal/g

52/48

Name

93 kcal/g

52/48

N/A

93 kcal/g

Glucose/lipid calories ratio

EMEA ARTWORK DESIGN CENTRE

Total calories approx.

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Energy:

PLANT APPROVAL
HALLE ONLY

Lipids

Posology

In adults
The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the
ability to metabolise the constituents of TRIOMEL, as well as additional energy or proteins provided
orally/enterally; therefore, the bag size should be chosen accordingly.
The average daily requirements are:
– 0.16 to 0.35 g nitrogen/kg body weight (1 to 2 g of amino acids/kg), depending on the patient’s
nutritional status and degree of catabolic stress,
– 20 to 40 kcal/kg,
– 20 to 40 mL fluid/kg, or 1 to 1.5 mL per expended kcal.
For TRIOMEL, the maximal daily dose is defined by amino acids intake, 35 mL/kg corresponding to
2.0 g/kg amino acids, 3.9 g/kg glucose, and 1.4 g/kg lipids. For a 70 kg patient, this would be equivalent
to 2,450 mL TRIOMEL per day, resulting in an intake of 140 g amino acids, 270 g glucose, and 98 g lipids
(i.e., 2,058 non-protein kcal and 2,622 total kcal).
BE-30-02-552
8

Version: 01
Sign:
Sign:

The maximum daily dose mentioned below should not be exceeded. Due to the static composition of
the multi-chamber bag, the ability to simultaneously meet all nutrient needs of the patient may not
be possible. Clinical situations may exist where patients require amounts of nutrients varying from
the composition of the static bag. In this situation any volume (dose) adjustments must take into
consideration the resultant effect this will have on the dosing of all other nutrient components of
TRIOMEL. For example, paediatric patients may require greater than 0.2 mmol/kg/day of phosphate. In
those situations, health care professionals may consider adjusting the volume (dose) of TRIOMEL in order
to meet these increased requirements.

Date:
Date:

TRIOMEL is not recommended for use in children less than 2 years of age due to inadequate composition
and volume (see sections 4.4; 5.1 and 5.2 of the SmPC).

Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take
into account the dose being administered, the daily volume intake, and the duration of the infusion.
For TRIOMEL, the maximal infusion rate is 1.8 mL/kg/hour, corresponding to 0.10 g/kg/hour amino acids,
0.19 g/kg/hour glucose, and 0.07 g/kg/hour lipids.
In children greater than 2 years of age
There have been no studies performed in the paediatric population.
The dosage depends on the patient’s energy expenditure, clinical status, body weight, and the ability
to metabolise constituents of TRIOMEL, as well as additional energy or proteins given orally/enterally;
therefore, the bag size should be chosen accordingly.

DRAFT

For TRIOMEL in the 2 to 11 year age group, the limiting factors are amino acid concentration for daily
dose and lipid concentration for hourly rate. In the 12 to 18 year age group, the limiting factors are amino
acid concentration for both daily dose and hourly rate. The resulting intakes are displayed below:

Amino acids (g/kg/d)

1 – 2 (up to 3)

3

1–2

2

12 – 14 (up to 18)

5.8

3 – 10 (up to 14)

3.9

Lipids (g/kg/d)

0.5 – 3

2.1

0.5 – 2 (up to 3)

1.4

Total energy (kcal/kg/d)

60 – 90

56

30 – 75

37

Amino acids (g/kg/h)

0.20

0.19

0.12

0.12

Glucose (g/kg/h)

1.2

0.36

1.2

0.23

Lipids (g/kg/h)

0.13

0.13

0.13

0.08

Glucose (g/kg/d)

Maximum Hourly Rate
TRIOMEL (mL/kg/h)

3.3

2.1

a: Recommended values from 2005 ESPGHAN/ESPEN Guidelines
Normally, the flow rate must be increased gradually during the first hour and then be adjusted to take
into account the dose being administered, the daily volume intake, and the duration of the infusion.
In general, it is recommended to start the infusion for small children with low daily dose and gradually
increase it up to the maximal dosage (see above).

N/A

35

Date

50 – 80

N/A

53

Signature

Fluids (mL/kg/d)

N/A

60 – 120

Maximum Daily Dose

Name

TRIOMEL
Max Vol

N/A

Recommendeda

DATE

TRIOMEL
Max Vol

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

12 to 18 years

Recommendeda

EMEA ARTWORK DESIGN CENTRE

2 to 11 years
Constituent

PLANT APPROVAL
HALLE ONLY

In addition, daily fluid, nitrogen, and energy requirements continuously decrease with age. Two groups,
ages 2 to 11 years and 12 to 18 years, are considered.

Method and duration of administration
For single use only.
It is recommended that, after opening the bag, the contents are used immediately and not stored for
subsequent infusion.
After reconstitution, the mixture is homogenous with a milky appearance.
Due to its high osmolarity, TRIOMEL can only be administered through a central vein.
The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours.

Version: 01
Sign:
Sign:

Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical
conditions.

Date:
Date:

For instructions for preparation and handling of the emulsion for infusion, see section 6.6 of the SmPC.

9

BE-30-02-552

C. INCOMPATIBILITIES
Do not add other medicinal products or substances to any components of the bag or to the reconstituted
emulsion without first confirming their compatibility and the stability of the resulting preparation (in
particular, the stability of the lipid emulsion).
Incompatibilities may be produced, for example, by excessive acidity (low pH) or inappropriate content of
divalent cations (Ca2+ and Mg2+), which may destabilize the lipid emulsion.
As with any parenteral nutrition admixture, calcium and phosphate ratios must be considered. Excess
addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of
calcium phosphate precipitates.

DRAFT

Do not administer before, simultaneously with, or after blood through the same equipment because of
the risk of pseudoagglutination.

Manually roll the bag onto itself, starting at the top of the bag (hanger end). The nonpermanent seals
will disappear from the side near the inlets. Continue to roll the bag until the seals are open along
approximately half of their length.

DATE

N/A

Ensure that the product is at room temperature when breaking the nonpermanent seals.

Date

Mixing the solutions and the emulsion

N/A

Confirm the integrity of the bag and of the nonpermanent seals. Use only if the bag is not damaged; if
the nonpermanent seals are intact (i.e., no mixture of the contents of the 3 compartments); if the amino
acid solution and the glucose solution are clear, colourless, or slightly yellow, and practically free of
visible particles; and if the lipid emulsion is a homogeneous liquid with a milky appearance.

Signature

Discard the oxygen absorber/oxygen indicator sachet.

N/A

Remove the protective overpouch.

Name

To open

N/A

An overview of the preparation steps for the administration of TRIOMEL are provided in Figure 1.

EMEA ARTWORK DESIGN CENTRE

Check the colour of the oxygen indicator, if present, before opening the overpouch. Compare it to the
reference colour printed next to the OK symbol and depicted in the printed area of the indicator label.
Do not use the product if the colour of the oxygen indicator does not correspond to the reference colour
printed next to OK symbol.

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

D. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

PLANT APPROVAL
HALLE ONLY

Check compatibility with solutions administered simultaneously through the same administration set,
catheter, or cannula.

Mix by inverting the bag at least 3 times.
After reconstitution, the mixture is a homogeneous emulsion with a milky appearance.

Additions

Any additions (including vitamins) may be made into the reconstituted mixture (after the nonpermanent
seals have been opened and after the contents of the 3 compartments have been mixed).
Vitamins may also be added into the glucose compartment before the mixture is reconstituted (before
opening the nonpermanent seals and before mixing the 3 compartments).

Date:
Date:

The capacity of the bag is sufficient to enable additions such as vitamins, electrolytes, and trace
elements.

Version: 01
Sign:
Sign:

When making additions to formulations containing electrolytes, the amount of electrolytes already
present in the bag should be taken into account.

10

BE-30-02-552

Additions must be performed by qualified personnel under aseptic conditions.

Maximal total level

0 mmol

150 mmol

150 mmol
150 mmol

Sodium
Potassium

0 mmol

150 mmol

Magnesium

0 mmol

5.6 mmol

5.6 mmol

Calcium

0 mmol

5.0 (3.5a) mmol

5.0 (3.5a) mmol

Inorganic Phosphate

0 mmol

8.0 mmol

8.0 mmol

Organic Phosphate

3 mmolb

22 mmol

25 mmolb

DRAFT

Tear from the top to open the
overpouch.

Peel the front of the overpouch
to reveal the TRIOMEL bag.
Discard the overpouch and
oxygen absorber sachet.
5.

4.

Lift the hanger area to remove
solution from the upper bag. Roll
the upper part of the bag firmly
until peal seals are fully open
(approximately half way).

Place the bag flat on a
horizontal and clean surface
with the handle in front of you.
6.

Mix by turning the bag
upside-down at least 3 times.

11

Hang the bag. Twist off
the protector from the
administration outlet. Firmly
plug the spike connector.
BE-30-02-552

N/A

3.

Date

2.

N/A

1.

Signature

Figure 1: Preparation steps for the administration of TRIOMEL

N/A

Aseptic conditions must be observed.
Suspend the bag.
Remove the plastic protector from the administration outlet.
Firmly insert the spike of the infusion set into the administration outlet.

Name

Preparation of the infusion

N/A

To perform an addition:
– Aseptic conditions must be observed.
– Prepare the injection site of the bag.
– Puncture the injection site and inject the additives using an injection needle or a reconstitution
device.
– Mix content of the bag and the additives.

DATE

When making additions, the final osmolarity of the mixture must be measured before administration via
a peripheral vein.

EMEA ARTWORK DESIGN CENTRE

Trace elements and vitamins:
Stability has been demonstrated with commercially-available preparations of vitamins and trace
elements (containing up to 1 mg of iron).
Compatibility for other additives is available upon request.

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

a: Value corresponding to the addition of inorganic phosphate.
b: Including phosphate provided by the lipid emulsion.

Date:
Date:

Maximal further
addition

PLANT APPROVAL
HALLE ONLY

Per 1,000 mL
Included level

Version: 01
Sign:
Sign:

TRIOMEL may be supplemented with electrolytes according to the table below:

DRAFT

Administration
For single use only.
Only administer the product after the nonpermanent seals between the 3 compartments have been
broken and the contents of the 3 compartments have been mixed.
After opening the bag, the contents must be used immediately. The opened bag must never be stored for
a subsequent infusion. Do not reconnect any partially used-bag.
Do not connect bags in series in order to avoid the possibility of air embolism due to gas contained in
the primary bag.

N/A

N/A

Signature

Date

Version: 01
Sign:
Sign:

Date:
Date:

The infusion should not be restarted in the same central vein.

N/A

The extravasation site should be monitored at least every 4 hours during the 24 first hours, then once
daily.

Name

Depending on the extravasated product (including the product(s) being mixed with TRIOMEL, if
applicable) and the stage/extend of any injury, appropriate specific measures should be taken. Options
for management may include non-pharmacologic, pharmacologic and/or surgical intervention. In case of
large extravasation, plastic surgeon advice should be sought within the first 72 hours.

N/A

If extravasation occurs, the administration should be stopped immediately, keeping the inserted catheter
or cannula in place for immediate management of the patient. If possible, aspiration should be performed
through the inserted catheter/cannula, in order to reduce the amount of fluid present in the tissues
before removing the catheter/cannula.

DATE

Catheter site should be monitored regularly to identify signs of extravasation.

EMEA ARTWORK DESIGN CENTRE

Extravasation

ARTWORK APPROVAL
2nd DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

Any unused product or waste material and all necessary devices must be discarded.

PLANT APPROVAL
HALLE ONLY

Ensure that the final emulsion for infusion does not show any evidence of phase separation.

12

BE-30-02-552

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide