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TRIOMEL 5 G/L NITROGEN 990 KCAL/L WITH ELECTROLYTES EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / ASPARTIC ACID / CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / GLUTAMIC ACID / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / MAGNESIUM CHLORIDE HEXAHYDRATE / METHIONINE / OLIVE OIL REFINED / PHENYLALANINE / POTASSIUM CHLORIDE / PR

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DRAFT

b

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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.

Date:
Date:

Comments:

Sign:
Sign:

BE-30-02-810

Errors: Yes / No PR2:

1

Date: 10 MAY 2017

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.

Version: 01

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).
If you have an abnormally high amount of any of the electrolytes (sodium, potassium, magnesium,
calcium, and/or phosphorus) in your blood.

Artworker: Donovan Fontesse.








ARTWORK DESIGN CENTRE

TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion must
not be used:

Errors: Yes / No PR1:

2. What you need to know before TRIOMEL 5 g/l nitrogen 990 kcal/l with
electrolytes, emulsion for infusion is administered

Draft: 02

TRIOMEL must only be used under medical supervision.

(and pages ___ to ___ for TIL)

FOR SUBMISSION

DRAFT

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.

Applicable for pages ___ to ___

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

Date

1. What TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion is and what it is used for

Signature

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

Name

What is in this leaflet:

Country

• 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.

EMEA ARTWORK DESIGN CENTRE

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

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TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion

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

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.

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

2

BE-30-02-810

Version: 01
Sign:
Sign:

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.

(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

FOR SUBMISSION

DRAFT

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).

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.

Signature

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.

Name

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.

Date:
Date:

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.

Country

However, you may be given TRIOMEL and ceftriaxone sequentially one after another if infusion lines at
different sites are used or if the infusion lines are replaced or were thoroughly flushed with physiological
salt solution between the infusions to avoid precipitation (formation of particles of ceftriaxone-calcium
salt).

EMEA ARTWORK DESIGN CENTRE

The antibiotic named ceftriaxone must not be mixed or given simultaneously with any calcium containing
solutions (including TRIOMEL) given to you by a drip into your vein.
These drugs must not be given to you together even via different infusion lines or different infusion sites.

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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.

Children and adolescents
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.

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.

DRAFT

3. How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion will be used
Dosage

FOR SUBMISSION

TRIOMEL should only be given in adults and children greater than 2 years of age.
It is an emulsion for infusion, to be administered via a tube (catheter) into a vein in your chest.
TRIOMEL should be at room temperature before use.
TRIOMEL is for single use only.
The infusion of 1 bag usually lasts between 12 and 24 hours.

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

Date:
Date:

Dosage – Adults

If you have been administered more TRIOMEL 5 g/l nitrogen 990 kcal/l with
electrolytes, emulsion for infusion than you should
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.
BE-30-02-810
3

Version: 01
Sign:
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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.

Applicable for pages ___ to ___

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

Date

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.

DRAFT

Pregnancy, breast-feeding and fertility

Signature

TRIOMEL contains potassium. Special care should be taken in patients taking diuretics, ACE inhibitors,
angiotensin II receptor antagonists (drugs for high blood pressure), or immunosuppressants. These types
of drugs may increase potassium levels in your blood.

Name

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).

Country

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.

EMEA ARTWORK DESIGN CENTRE

TRIOMEL contains calcium. It should not be given together or through the same tube with the antibiotic
ceftriaxone because particles may form. If the same device is used to give you successively these
medicines, it should be thoroughly rinsed.

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TRIOMEL must not be administered simultaneously with blood through the same infusion tubing.

(and pages ___ to ___ for TIL)

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.

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

4. Possible side effects

DRAFT

Like all medicines, this medicine can cause side effects, although not everybody gets them.

4

BE-30-02-810

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Applicable for pages ___ to ___

FOR SUBMISSION
Date

DRAFT
Signature

Name

Date:
Date:

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).

Country

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

Version: 01
Sign:
Sign:

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.

EMEA ARTWORK DESIGN CENTRE

The tests your doctor will perform while you are taking the medicine should minimise the risk of side
effects.

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If you notice any changes in the way you feel during or after the treatment, tell your doctor or nurse right
away.

Store in the overpouch.
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.

6. Contents of the pack and other information
What TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion
contains
The active substances for each bag of the reconstituted emulsion are 8.2% (corresponding to
8.2 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) with electrolytes (sodium, potassium, magnesium, phosphate, acetate,
chloride), 20% (corresponding to 20 g/100 mL) lipid emulsion (refined olive oil and refined soybean oil),
and 28.75% (corresponding to 28.75 g/100 mL) glucose solution (as glucose monohydrate) with calcium.
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 with electrolytes and the third compartment
a glucose solution with calcium. 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-30-02-810

Version: 01
Sign:
Sign:

What TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion
looks like and contents of the pack

(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

Do not freeze.

FOR SUBMISSION

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.

Date

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

DRAFT

5. How TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for
infusion is stored

Signature

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

Name

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

DRAFT

Country

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

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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.

EMEA ARTWORK DESIGN CENTRE

Reporting of side effects

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.

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

OLIMEL N5E

In some countries it is registered under a different trade name, as described below:
Austria:
Germany:
Denmark, Iceland, Sweden, Norway, Finland:
The United Kingdom, Ireland, Malta:

ZentroOLIMEL 3,3 % mit Elektrolyten
Olimel 3,3% E
Olimel N5E
Triomel 5g/l nitrogen 990 kcal/l
with electrolytes

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

Version: 01
Sign:
Sign:

Baxter and Triomel are trademarks of Baxter international Inc.

6

BE-30-02-810

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FOR SUBMISSION

Date:
Date:

This leaflet was last revised in 06/2017.

Applicable for pages ___ to ___

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

Date

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

DRAFT

Manufacturer

Signature

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

Name

Marketing Authorisation Holder

Country

Not all pack sizes may be marketed.

EMEA ARTWORK DESIGN CENTRE

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

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Pack sizes

The following information is intended for medical
or healthcare professionals only:
TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion
Pharmacotherapeutic group: Solutions for parenteral nutrition/combinations
ATC code: B05 BA10.

DRAFT

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

300 mL

400 mL

500 mL

Composition of the reconstituted emulsion after mixing the contents of the 3 compartments:
Active substances

1,500 mL

2,000 mL

2,500 mL

Refined olive oil + refined soybean oila

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

172.50 g
(189.75 g)

230.00 g
(253.00 g)

287.50 g
(316.25 g)

Glucose anhydrous
(equivalent to glucose monohydrate)

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%.
BE-30-02-810
7

(and pages ___ to ___ for TIL)

1,000 mL

Applicable for pages ___ to ___

800 mL

FOR SUBMISSION

600 mL

Date

8.2% Amino acid solution
(corresponding to 8.2 g/100 mL)

DRAFT

1,000 mL

Signature

800 mL

Name

2,500 mL

600 mL

Date:
Date:

2,000 mL

28.75% Glucose solution
(corresponding to 28.75 g/100 mL)

Country

Contents per bag
1,500 mL

Version: 01
Sign:
Sign:

Each bag contains a glucose solution with calcium, a lipid emulsion and an amino acid solution with
other electrolytes.

EMEA ARTWORK DESIGN CENTRE

TRIOMEL 5 g/l nitrogen 990 kcal/l with electrolytes, emulsion for infusion is presented in the form of a
3-compartment bag.

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A. QUALITATIVE AND QUANTITATIVE COMPOSITION

The excipients are:
Lipid emulsion compartment

Amino acid solution with
electrolytes compartment

Glucose solution with calcium
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:

10.4 g

13.0 g

172.5 g

230.0 g

287.5 g

1,490 kcal

1,980 kcal

2,480 kcal

Energy:
Total calories approx.
Non-protein calories

1,290 kcal

1,720 kcal

2,150 kcal

Glucose calories

690 kcal

920 kcal

1,150 kcal

Lipid caloriesa

600 kcal

800 kcal

1,000 kcal

Non-protein calories/nitrogen ratio

165 kcal/g

165 kcal/g

165 kcal/g

Glucose/lipid calories ratio

53/47

53/47

53/47

Lipid/total calories

40%

40%

40%

Sodium

52.5 mmol

70.0 mmol

87.5 mmol

Potassium

45.0 mmol

60.0 mmol

75.0 mmol

Magnesium

6.0 mmol

8.0 mmol

10.0 mmol

Calcium

5.3 mmol

7.0 mmol

8.8 mmol

Phosphateb

22.5 mmol

30.0 mmol

37.5 mmol

Acetate

55 mmol

73 mmol

91 mmol

Chloride

68 mmol

90 mmol

113 mmol

Electrolytes:

pH
Osmolarity

6.4

6.4

6.4

1,120 mosm/L

1,120 mosm/L

1,120 mosm/L

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

B. POSOLOGY AND METHOD OF ADMINISTRATION

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).

Version: 01
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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:

Posology

8

BE-30-02-810

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7.8 g

Glucose

Applicable for pages ___ to ___

Nitrogen

Date

82.3 g

DRAFT

65.8 g

Signature

100 g

49.4 g

FOR SUBMISSION

2,500 mL

Name

80 g

Country

2,000 mL

60 g

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Amino acids

1,500 mL

EMEA ARTWORK DESIGN CENTRE

Lipids

2 to 11 years
Constituent

Recommendeda

12 to 18 years

TRIOMEL
Max Vol

Recommendeda

TRIOMEL
Max Vol

Maximum Daily Dose
Fluids (mL/kg/d)
Amino acids (g/kg/d)
Glucose (g/kg/d)

60 – 120

13

50 – 80

13

1 – 2 (up to 3)

0.4

1–2

0.4

12 – 14 (up to 18)

1.5

3 – 10 (up to 14)

1.5

Lipids (g/kg/d)

0.5 – 3

0.5

0.5 – 2 (up to 3)

0.5

Total energy (kcal/kg/d)

60 – 90

13

30 – 75

13

Amino acids (g/kg/h)

0.20

0.11

0.12

0.11

Glucose (g/kg/h)

1.2

0.38

1.2

0.38

Lipids (g/kg/h)

0.13

0.13

0.13

0.13

FOR SUBMISSION

Maximum Hourly Rate
TRIOMEL (mL/kg/h)

3.3

3.3

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.

Date:
Date:

a: Recommended values from 2005 ESPGHAN/ESPEN Guidelines

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).

Method and duration of administration
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.
For instructions for preparation and handling of the emulsion for infusion, see section 6.6 of the SmPC.
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.
Treatment with parenteral nutrition may be continued for as long as required by the patient’s clinical
conditions.
BE-30-02-810
9

Version: 01
Sign:
Sign:

For single use only.

Date

For TRIOMEL, the limiting factors for the above-mentioned paediatric age groups are phosphate
concentration for daily dose (0.2 mmol/kg/day)a and lipid concentration for hourly rate, resulting in the
following intakes:

DRAFT

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.

Signature

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.

Name

In children greater than 2 years of age
There have been no studies performed in the paediatric population.

Country

For TRIOMEL, the maximal infusion rate is 2.1 mL/kg/hour, corresponding to 0.07 g/kg/hour amino acids,
0.24 g/kg/hour glucose, and 0.08 g/kg/hour lipids.

EMEA ARTWORK DESIGN CENTRE

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.

ARTWORK APPROVAL
2nd DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

For TRIOMEL, the maximal daily dose is defined by fluid intake, 40 mL/kg, corresponding to 1.3 g/kg
amino acids, 4.6 g/kg glucose, 1.6 g/kg lipids, 1.4 mmol/kg sodium, and 1.2 mmol/kg potassium.
For a 70 kg patient, this would be equivalent to 2,800 mL TRIOMEL per day, resulting in an intake of 92 g
amino acids, 322 g glucose, and 112 g lipids (i.e., 2,408 non-protein kcal and 2,772 total kcal).

(and pages ___ to ___ for TIL)

DRAFT

Applicable for pages ___ to ___

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.

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

To open
Remove the protective overpouch.
Discard the oxygen absorber sachet.
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.

FOR SUBMISSION

Mixing the solutions and the emulsion
Ensure that the product is at room temperature when breaking the nonpermanent seals.
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.
Mix by inverting the bag at least 3 times.

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

Date:
Date:

After reconstitution, the mixture is a homogeneous emulsion with a milky appearance.

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).

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

10

BE-30-02-810

Version: 01
Sign:
Sign:

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

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

DRAFT

D. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

Signature

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

Name

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

Country

Ceftriaxone and calcium-containing solutions may be administered sequentially one after another
if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed
between infusions with physiological salt-solution to avoid precipitation.

EMEA ARTWORK DESIGN CENTRE

Ceftriaxone must not be mixed or administered simultaneously with intravenous calcium-containing
solutions, including TRIOMEL, through the same infusion line (e.g., via Y-connector) because of the risk of
precipitation of ceftriaxone-calcium salt (see section 4.4 and 4.5 of the SmPC).

ARTWORK APPROVAL
2nd DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

TRIOMEL contains calcium ions which pose additional risk of coagulation precipitated in citrate
anticoagulated/preserved blood or components.

(and pages ___ to ___ for TIL)

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).

Applicable for pages ___ to ___

C. INCOMPATIBILITIES

150 mmol

1.6 mmol

5.6 mmol

Calcium

3.5 mmol

1.5 (0.0a) mmol

5.0 (3.5a) mmol

0 mmol

3.0 mmol

3.0 mmol

15 mmolb

10 mmol

25 mmolb

Organic Phosphate

a: Value corresponding to the addition of inorganic phosphate.
b: Including phosphate provided by the lipid emulsion.
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.
When making additions, the final osmolarity of the mixture must be measured before administration via
a peripheral vein.
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.

Preparation of the infusion
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.
Figure 1: Preparation steps for the administration of TRIOMEL
1.

2.

Tear from the top to open the
overpouch.

4.

3.

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

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-30-02-810

Version: 01
Sign:
Sign:

Inorganic Phosphate

(and pages ___ to ___ for TIL)

120 mmol

4.0 mmol

Applicable for pages ___ to ___

30 mmol

Magnesium

FOR SUBMISSION

Potassium

DRAFT

Date

150 mmol

DRAFT

115 mmol

Signature

35 mmol

Sodium

Name

Maximal total level

Date:
Date:

Maximal further
addition

Country

Per 1,000 mL
Included level

ARTWORK APPROVAL
2nd DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

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

EMEA ARTWORK DESIGN CENTRE

Additions must be performed by qualified personnel under aseptic conditions.

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.

Version: 01
Sign:
Sign:

Date:
Date:

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

12

BE-30-02-810

(and pages ___ to ___ for TIL)
Applicable for pages ___ to ___

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

FOR SUBMISSION

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.

Date

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.

DRAFT

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

Signature

Extravasation

Name

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

Country

Do not connect bags in series in order to avoid the possibility of air embolism due to gas contained in
the primary bag.

EMEA ARTWORK DESIGN CENTRE

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.

ARTWORK APPROVAL
2nd DRAFT
LAYOUT AND FORMAT
PLANT APPROVAL
APPROVAL
HALLE ONLY

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

Expand Transcript

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.

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