TRIOMEL PERIPHERAL 4 G/L NITROGEN 700 KCAL/L WITH ELECTROLYTES EMULSION FOR INFUSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes emulsion for infusion
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even iftheir symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
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. Before you take TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion
3. How to take TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion
4. Possible side effects
5. How to store TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion
6. Further information
1.BE-30-01-750
Consistency check with all figures
cited in the product information
Storage Conditions and Shelf-Life
Barcodes, Symbols and Re-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 clinical condition, together with the results of any test performed.
Regulations
• For 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 phosphorous) in your blood.
(API & excipients)
Do not take TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion in the following cases:
RA Proofreading Checklist
2. BEFORE YOU USE TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with
electrolytes emulsion for infusion
Compliance with National
TRIOMEL Peripheral must only be used under medical supervision.
imbursement Information
Product name,strength,composition
TRIOMEL Peripheral is used to provide nutrition to adults and children greater than 2 years of age by atube into a vein when normal feeding by mouth is not suitable.
per RA SOP CE-RAPV-009
TRIOMEL Peripheral is an emulsion for infusion.
Product Information proofread as
1. WHAT TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion IS AND WHAT IT is USED FOR
Take special care with TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with
electrolytes emulsion for infusion
If you are given total parenteral nutrition (TPN) solutions too fast this may result in 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 medicinalproduct contains soybean oil and egg phosphatide. Soybean and egg proteins may cause hypersensitivityreactions. Cross-allergic reactions between soybean and peanut proteins have been observed.
Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in theblood). There is a particular risk of infection or sepsis when a tube (intravenous catheter) is placed inyour vein. Your doctor will carefully watch you for any signs of infection. Patients who require parenteralnutrition (giving nutrition through a tube in your vein) may be more likely to develop infections from theirmedical conditions. Using aseptic (“germ-free”) techniques when placing and maintaining the catheterand when making the nutritional formula can reduce the risk of infection.
If you are severely malnourished such that you need to receive feedings by vein, your doctor should startthe treatment slowly. Also, your doctor should monitor you closely to prevent sudden changes in yourfluid, vitamin, and mineral levels.
The balance of water and salt in your body and metabolic disorders will be corrected before startingthe infusion. Your doctor will monitor your condition while you receive this medicine and may changethe dosage or give you additional nutrients, such as vitamins, electrolytes, and trace elements, if he/shefeels they are appropriate.
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 triangleshaped 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 acid)
• a generalised infection (septicaemia)
• coma.
To check the effectiveness and ongoing safety of the administration, your doctor will perform clinical andlaboratory 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.
Reduced ability of the body to remove the fats contained in TRIOMEL Peripheral may result in a "fat
overload syndrome" (See Section 4 – Possible Side Effects).
If the patient is a child, special care will be taken to give the correct dosage. Increased precautions willalso be taken because of the greater sensitivity of children to the risk of infection. Vitamin and traceelement supplementation is always required. Paediatric formulations must be used for children.
No additions should be made to the bag without first checking the compatibility.
Formation of particles or a breaking down of the lipid emulsion could result. This can lead to blockage ofthe blood vessels.
If your blood sugar gets too high, your doctor should adjust the rate of TRIOMEL Peripheral delivery orgive you insulin.
TRIOMEL Peripheral may be administered via a plastic tube into a vein in your arm or a large vein in yourchest.
Taking other medicines
Simultaneous absorption of other medicinal products is not a contraindication, generally. If you takeother medicinal products, with or without medical prescription, you should inform your doctor in advanceto check compatibility.
TRIOMEL Peripheral must not be administered simultaneously with blood through the same infusion tubing.
TRIOMEL Peripheral contains calcium. It should not be given together with the antibiotic ceftriaxone
because particles may form.
2.BE-30-01-750
Olive and soybean oils present in TRIOMEL Peripheral contain vitamin K. This does not normally affectblood thinning medicines (anticoagulants) like coumarin.
However, if you take anticoagulant medicinesyou should tell your doctor.
The lipids contained in this emulsion may interfere with the results of certain laboratory tests if the bloodsample is taken before the lipids have been eliminated (these are generally eliminated after a period
of 5 to 6 hours without receiving lipids).
TRIOMEL Peripheral contains potassium. Special care should be taken in patientstaking diuretics, ACEinhibitors, angiotensin II receptor antagonists (drugs for high blood pressure), or immunosuppressants.
These types of drugs may increase potassium levels in your blood.
Pregnancy and breast-feeding
Ask your doctor or your pharmacist for advice before taking any medicine.
TRIOMEL Peripheral may be considered during pregnancy and breastfeeding, ifnecessary.
Tell your doctor if you are pregnant or think you are pregnant, or if you are breastfeeding.
He/she willdetermine whether or not you should continue with treatment.
3. HOW TO USE TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion
Dosage
TRIOMEL Peripheral 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 plastic tube into a vein in your arm or in a largevein in your chest.
TRIOMEL Peripheral should be at room temperature before use.
TRIOMEL Peripheral is for single use only.
Before taking TRIOMEL Peripheral, the bag will be prepared as shown below.
• Before opening the overpouch and if present, check the colour of the oxygen indicator. Compare it tothe reference colour printed next to the OK symbol and depicted in the printed area of the indicatorlabel.
Do not use the product if the colour of the oxygen indicator does not correspond to thereference colour printed next to OK symbol.
Check the integrity of the packaging and seals and the appearance of the mixed emulsion prior to use.
Use only if the solutions are clear, colourless or slightly yellow, practically free of visible particles and ifthe emulsion is homogeneous and with a milky appearance.
1.
2.
3.
Tear from the top to openthe overpouch.
Peel the front of theoverpouch to reveal the
TRIOMEL Peripheral bag.
Discard the overpouch andoxygen absorber sachet.
Place the bag flat on ahorizontal and clean surfacewith the handle in front ofyou.
3
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4.
5.
6.
Lift the hanger area toremove solution from the
upper bag.
Roll the upperpart of the bag firmly untilpeal seals are fully open(approximately half way).
Mix by turning the bag
upside-down at least 3
times.
Hang the bag.
Twist offthe protector from the
administration outlet.
Firmly plug the spikeconnector.
Dosage – Adults
Your doctor will specify a flow rate corresponding to your needs and clinical condition.
Always take TRIOMEL Peripheral exactly as your doctor has told you. You should check with your doctorif you are not sure.
The prescription may be continued for as long as it is needed, depending upon your clinical condition.
The infusion of 1 bag usually lasts between 12 and 24 hours. Usually the flow rate is increased graduallyduring the first hour without exceeding 3.2 ml/kg of bodyweight/hour. Due to the fluid volume, themaximal daily dose is usually 40 ml/kg of body weight.
Dosage – Children greater than 2 years of age and adolescents
Your doctor will decide the dose the child will need and for how long it will be given. This will depend onage, weight, height, clinical condition, daily fluid volume, and energy and nitrogen requirements.
Always take TRIOMEL Peripheral exactly as your doctor has told you. You should check with your doctorif you are not sure.
Pediatrics (2 – 11 years)
If you have any further questions on the use of this product, ask your doctor.
BE-30-01-750
4.Consistency check with all figures
cited in the product information
Storage Conditions and Shelf-Life
Regulations
Barcodes, Symbols and Re-
To prevent these events occurring, your doctor will regularly monitor your condition and test your bloodparameters.
(API & excipients)In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneyseliminate the excess product.
Compliance with National
If the dose given is too high or the infusion is too fast, the amino acid content may make your blood tooacidic, and signs of hypervolaemia (increase of circulating blood volume) may occur. The glucose levelsin 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. Giving a volume of TRIOMEL
Peripheral that is too large may cause nausea, vomiting, chills and electrolyte disturbances.
In suchsituations, the infusion must be stopped immediately.
RA Proofreading Checklist
If you use more TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes
emulsion for infusion than you shouldimbursement Information
Product name,strength,composition
Usually the flow rate is increased gradually during the first hour without exceeding 4.3 ml/kg ofbodyweight/hour. Due to the phosphate content, the maximal daily dose is usually 24 ml/kg of bodyweight.
per RA SOP CE-RAPV-009
Pediatrics (12 – 18 years)
Product Information proofread as
Usually the flow rate is increased gradually during the first hour without exceeding 5.7 ml/kg ofbodyweight/hour. Due to the phosphate content, the maximal daily dose is usually 24 ml/kg of bodyweight.
4. POSSIBLE SIDE EFFECTS
Like all medicines, TRIOMEL Peripheral emulsion for infusion can cause side effects, although noteverybody gets them.
If you notice any changes in the way you feel during or after the treatment, tell your doctor or nurse rightaway.
The tests your doctor will perform while you are taking the medicine should minimise the risk of sideeffects.
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.
The following side effects have been reported with TRIOMEL Peripheral:
Common: (≥ 1/100 to < 1/10):
• Fast heart rate (tachycardia)
• Loss of appetite (anorexia)
• Increased level of fat in the blood (hypertriglyceridemia)
• Abdominal pain
• Diarrhoea
• Nausea
• Increased blood pressure (hypertension)
The following side effects have been reported with similar parenteral nutrition products:
Frequency: not known
• Allergic reactions
• Abnormal blood test results for liver function
• Increase in the size of the liver (hepatomegaly)
• Icterus (jaundice)
• Decrease in the number of platelets (thrombocytopenia)
• Increased nitrogen levels in the blood (azotemia)
Very rare: (< 1/10,000)
• Reduced ability to remove the lipids contained in TRIOMEL Peripheral may result in a "fat overload syndrome".
This may be caused by overdose but may also occur at the start of an infusion, evenwhen the product is administered according to instructions.
It is associated with a sudden deterioration in the patient's clinical condition and characterised by excessive lipids in blood (hyperlipidaemia), fever, liver fatty infiltration and/or an increase of liver size (hepatomegaly).
Anaemia, a decrease in white blood cells and/or platelets, problem with your blood clotting, and/ or coma may also occur. These symptoms are usually reversible when the lipid emulsion infusion is
stopped.
If any side effect get serious, or if you notice any side effect not listed in this leaflet, please tell yourdoctor or pharmacist.
5. HOW TO STORE TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with
electrolytes emulsion for infusionKeep out of the reach and sight of children.
Do not use TRIOMEL Peripheral 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.
Do not freeze.
Store in the overpouch.

After reconstitution:
It is recommended that the product is used immediately after the nonpermanent seals between the
3 compartments have been opened; however, once reconstituted, the stability of the emulsion hasbeen demonstrated for a maximum of 7 days (between 2°C and 8°C) followed by a maximum of 48 h attemperature, not exceeding 25°C.
5.BE-30-01-750
After addition of supplements (electrolytes, trace elements and vitamins)
For specific admixtures, in-use stability has been demonstrated for 7 days (between 2°C and 8°C)followed by 48 hours at temperature not exceeding 25°C.
From a microbiological point of view, any admixture should be used immediately. If not usedimmediately, storage times and conditions after mixing and prior to use are the responsibility of the userand would normally not be longer than 24 hours at 2°C to 8°C, unless addition of supplements has takenplace in controlled and validated aseptic conditions.
This medicine needs to be at room temperature to be administered.
Medicines should not be disposed of via wastewater or household Ask your pharmacist how todispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes emulsion for
infusion containsThe active substances for each bag of the reconstituted emulsion are 6.3%(corresponding to6.3 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), 15% (corresponding to 15 g/100 ml) lipid emulsion (refined olive oil and refined soybean oil),and 18.75% (corresponding to 18.75 g/100 ml) glucose solution (as glucose monohydrate) with calcium.
The other ingredients are:
Lipid emulsion compartmentAmino acid solutioncompartmentGlucose solutioncompartment
Purified egg phosphatide,glycerol, sodium oleate, sodiumhydroxide (for pHadjustment),
water for injection
Glacial acetic acid (for pHadjustment), water for injectionHydrochloric acid (for pHadjustment), water for injectionThe active substances for each bag of the reconstituted emulsion are:
Active substances
Refined olive oil + refined soybean oil (a)
Alanine
Arginine
Aspartic acid
Glutamic acid
Glycine
Histidine
Isoleucine
Leucine
Lysine
(equivalent to lysine acetate)
Methionine
Phenylalanine
Proline
Serine
Threonine
Tryptophan
Tyrosine
Valine
Sodium acetate trihydrate
Sodium glycerophosphate, hydrated
Potassium chloride
Magnesium chloride hexahydrate
Calcium chloride dihydrate
Glucose anhydrous
(equivalent to glucose monohydrate)
a Mixture
1000 ml
30.00 g
3.66 g
2.48 g
0.73 g
1.26 g
1.76 g
1.51 g
1.26 g
1.76 g
1.99 g
(2.81 g)
1.26 g
1.76 g
1.51 g
1.00 g
1.26 g
0.42 g
0.06 g
1.62 g
1.16 g
1.91 g
1.19 g
0.45 g
0.30 g
75.00 g
(82.50 g)
1500 ml
45.00 g
5.50 g
3.72 g
1.10 g
1.90 g
2.63 g
2.26 g
1.90 g
2.63 g
2.99 g
(4.21 g)
1.90 g
2.63 g
2.26 g
1.50 g
1.90 g
0.64 g
0.10 g
2.43 g
1.73 g
2.87 g
1.79 g
0.67 g
0.44 g
112.50 g
(123.75 g)
2000 ml
60.00 g
7.33 g
4.96 g
1.46 g
2.53 g
3.51 g
3.02 g
2.53 g
3.51 g
3.98 g
(5.62 g)
2.53 g
3.51 g
3.02 g
2.00 g
2.53 g
0.85 g
0.13 g
3.24 g
2.31 g
3.82 g
2.38 g
0.90 g
0.59 g
150.00 g
(165.00 g)
2500 ml
75.00 g
9.16 g
6.20 g
1.83 g
3.16 g
4.39 g
3.77 g
3.16 g
4.39 g
4.98 g
(7.02 g)
3.16 g
4.39 g
3.77 g
2.50 g
3.16 g
1.06 g
0.16 g
4.05 g
2.89 g
4.78 g
2.98 g
1.12 g
0.74 g
187.50 g
(206.25 g)
of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%)
corresponding to a ratio essential fatty acids / total fatty acids of 20%.
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6.Nutritional intakes of reconstituted emulsion:
Lipid
Amino acids
Nitrogen
Glucose
Energy:
Total calories approx.
Non-protein calories
Glucose calories
Lipid calories (a)
Non-protein calories / nitrogen ratio
Glucose / lipid calories ratio
Lipid / total calories
Electrolytes:
Sodium
Potassium
Magnesium
Calcium
Phosphate (b)
Acetate
Chloride
pH
Osmolarity
a
b
1000 ml
30 g
25.3 g
4.0 g
75.0 g
1500 ml
45 g
38.0 g
6.0 g
112.5 g
2000 ml
60 g
50.6 g
8.0 g
150.0 g
2500 ml
75 g
63.3 g
10.0 g
187.5 g
700 kcal
600 kcal
300 kcal
300 kcal
1050 kcal
900 kcal
450 kcal
450 kcal
1400 kcal
1200 kcal
600 kcal
600 kcal
1750 kcal
1500 kcal
750 kcal
750 kcal
150 kcal/g
50/50
43%
150 kcal/g
50/50
43%
150 kcal/g
50/50
43%
150 kcal/g
50/50
43%
21.0 mmol
16.0 mmol
2.2 mmol
2.0 mmol
8.5 mmol
27 mmol
24 mmol
6.4
760 mosm/l
31.5 mmol
24.0 mmol
3.3 mmol
3.0 mmol
12.7 mmol
41 mmol
37 mmol
6.4
760 mosm/l
42.0 mmol
32.0 mmol
4.4 mmol
4.0 mmol
17.0 mmol
55 mmol
49 mmol
6.4
760 mosm/l
52.5 mmol
40.0 mmol
5.5 mmol
5.0 mmol
21.2 mmol
69 mmol
61 mmol
6.4
760 mosm/l
Includes calories from purified egg phosphatide
Includes phosphate provided by the lipid emulsion
What TRIOMEL Peripheral 4 g/l nitrogen 700 kcal/l with electrolytes emulsion for
infusion looks like and contents of the pack
TRIOMEL Peripheral 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 peal seal is open.
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.
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).
Pack sizes
1000 ml bag: 1 carton with 6 bags
1500 ml bag: 1 carton with 4 bags
2000 ml bag: 1 carton with 4 bags
2500 ml bag: 1 carton with 2 bags
Not all pack sizes may be marketed.
7.BE-30-01-750
Marketing Authorisation Holder
Baxter Healthcare Limited
Caxton Way, Thetford,
Norfolk, IP24 3SE
United Kingdom
Manufacturer
Baxter S.A.
Boulevard Rene Branquart, 80
7860 Lessines
Belgium
This medicinal product is authorised in the Member States of the EEA under the following names:
France, Portugal, Bulgaria, Romania,
Czech Republic, Belgium, Spain,
Slovak Republic, Luxemburg, Slovenia:
PERIOLIMEL N4E
In some countries it is registered under a different trade name, as described below:
Estonia, Poland, Lithuania, Latvia, Greece:
The Netherlands:
Italy:
Austria:
Germany:
Denmark, Iceland, Sweden,
Norway, Finland:
The United Kingdom, Ireland, Malta:
OLIMEL PERI N4E
Olimel Perifeer N4E
OLIMEL Periferico N4E
PeriOLIMEL 2,5 % mit Elektrolyten
Olimel Peri 2,5% E
Olimel Perifer N4E
Triomel Peripheral 4 g/l nitrogen 700 kcal/l with
electrolytes
This leaflet was revised in 07/2011
For information about TRIOMEL Peripheral orto request this leaflet in formats such as audioor large print please contact the MarketingAuthorisation Holder:
Tel: +44 (0)1635 206345.
Baxter, Triomel and Oxydetect are trademarks of Baxter International Inc.
8.BE-30-01-750
 http://www.baxterhealthcare.co.uk/downloads/prescribing_information/hospital_products/nutrition/triomel_pi.pdf

http://www.mhra.gov.uk/home/groups/comms-ic/documents/drugsafetymessage/con428390.pdf


http://www.drugs.com/uk/pdf/leaflet/257012.pdf


http://www.old.health.gov.il/units/pharmacy/trufot/alonim/TRIOMEL_PERIPHERAL_4_dr_1367743393596.pdf