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KABIVEN EMULSION FOR INFUSION

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLUCOSE MONOHYDRATE / GLYCINE / MAGNESIUM SULPHATE HEPTAHYDRATE / POTASSIUM CHLORIDE / SODIUM ACETATE TRIHYDRATE / SODIUM GLYCEROPHOSPHATE ANHYDROUS / SOYBEAN OIL PURIFIED

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Kabiven

TM

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 if their symptoms are the same as yours
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor, nurse or pharmacist
In this leaflet:
1. What is Kabiven and what it is used for
2. Before you receive Kabiven
3. How you are given Kabiven
4. Possible side effects
5. How Kabiven is stored
6. Further information
1. WHAT IS KABIVEN AND WHAT IT IS USED FOR

Kabiven comes in a three chamber bag in an overpouch. Kabiven
contains the following medicines: amino acids (components used
to build proteins), fat, glucose and electrolyte solutions. It provides
energy (as sugar and fat) and amino acids (proteins) into your
bloodstream when you cannot eat normally.

It is used as part of a balanced intravenous diet, together with salts,
trace elements and vitamins which together provide your complete
nutritional needs.
The full name of this medicine is Kabiven Emulsion for Infusion. It will
be referred to as Kabiven throughout this leaflet.

2. BEFORE YOU RECEIVE KABIVEN

You should not receive Kabiven if you:
• have ever had an allergic reaction to Kabiven or any of the
ingredients of Kabiven mentioned in section 6 (for symptoms
of an allergic reaction please refer to section 4)
• are allergic to products containing egg, soya or peanut
• have too many fatty substances (like cholesterol) in your blood
• have seriously reduced liver function
• suffer from acute shock (resulting from heavy blood loss or
allergic reaction)
• have a bleeding disorder associated with a condition known as
haemophagocytotic syndrome or if your blood is not clotting
properly.
• have a condition where your body has problems using proteins
or amino acids
• have severe problems with your kidneys
• have hyperglycaemia (too much sugar in your blood) where
the administration of more than 6 units of insulin per hour is required
• have raised levels of electrolytes (salts) in your blood
• have metabolic acidosis (the acid levels of your body fluids
and tissues become too high)

• have too much fluid in your body - hyperhydration
• have fluid on your lungs (acute pulmonary oedema)
• are in a coma
• have heart problems
• are dehydrated with low levels of salts
• have severe sepsis (a condition in which your body is fighting a
severe infection)
Care should be taken when administering Kabiven
Inform your doctor if you suffer from:
• reduced liver function
• untreated diabetes
• a condition where your body has problems using fat properly
• kidney problems
• any pancreas problems
• thyroid problems - hypothyroidism
• sepsis (a condition in which your body is fighting an infection)
• your body has problems eliminating electrolytes
• a condition where there is not enough oxygen in your body cells
• dehydration, as not drinking enough water causes the
concentration of chemicals in your blood to increase
(increased serum osmolarity).
This medicine may affect the results of other tests you may have. It is
important to tell any doctor doing tests that you are using Kabiven.
Your doctor may want to do regular blood tests to make sure that the
treatment with Kabiven is working correctly.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Inform your doctor if you are taking
• a drug known as heparin which is used to prevent the formation
and aid in the dispersion of blood clots
• warfarin, because Vitamin K1, which is contained in soybean oil,
could affect the blood clotting ability
• Insulin for the treatment of diabetes
Pregnancy and breast-feeding
The safety of using Kabiven while pregnant or breast-feeding has
not been looked into. If feeding directly into your vein (parenteral
nutrition) becomes necessary during pregnancy or breast-feeding,
your doctor will give you Kabiven only after careful consideration.

3. HOW YOU ARE GIVEN KABIVEN
You will receive your medicine by infusion only into a central vein.
The dose of Kabiven and which bag size is used depends on your
bodyweight in kilograms and your body’s ability to use fat and sugar.
Kabiven will be infused slowly over a period of 12-24 hours. Your
doctor will decide on the correct dose for you or your child to receive.
You may be monitored during your treatment.
Kabiven is not suitable for use in newborns or children under two
years of age.
If you receive too much Kabiven
It is very unlikely that you will receive more infusion than you should
as your doctor or nurse will monitor you during the treatment. The
effects of an overdose may include nausea, vomiting, sweating and
fluid retention.

Hyperglycaemia (too much sugar in your blood) and electrolyte
disturbances have also been reported.
In case of overdose there is a risk of taking in too much fat. This is
called ‘fat overload syndrome’. See section 4 “Possible side effects” for
more information. If you experience any of the symptoms described
above or believe that you have received too much Kabiven inform
your doctor or nurse immediately. The infusion may either be stopped
immediately or continued with a reduced dosage. These symptoms
will usually disappear on reducing the rate or stopping the infusion.
If you have any further questions on the use of this product, ask your
doctor, nurse or pharmacist

4. POSSIBLE SIDE EFFECTS

Like all medicines, Kabiven can cause side effects, although not
everybody gets them.
Very rarely (occurs in the less than 1 in 10000 patients) Kabiven
may cause an allergic reaction. Tell your doctor immediately if:
• a bumpy and itchy rash appears on your body
• you have very high temperature
• you have difficulties breathing
• you get a fever
• you experience shivering
Common side effects (occurs in more than 1 in 100 patients)
• a slightly raised body temperature
The following uncommon side effects (occurs in less than 1
in 100 patients but in more than 1 in 1000 patients) have been
observed
• chills and shivers
• tiredness
• stomach pain
• headache
• feeling sick or being sick
• increase of liver enzymes. Your doctor will tell you if this happens.
Other side effects are very rare (occurs in less than 1 in 10000
patients)
• high or low blood pressure
• difficulty in breathing
• prolonged, painful erections in men

problems with your blood

Fat overload syndrome
This might happen when your body has problems using fat, because
of having too much Kabiven. It may also happen because of a sudden
change in your condition (such as kidney problems or infection).
Possible symptoms are fever, increased levels of fat in your blood,
your cells and your tissues, disorders in various organs and coma. All
these symptoms will usually disappear if the infusion is discontinued.

If any of the side effects becomes serious or if you notice a side
effect not listed in this leaflet, please tell your doctor, nurse or
pharmacist.

5. HOW KABIVEN IS STORED

Keep out of the reach and sight of children.
Your doctor and hospital pharmacist are responsible for the correct
storage, use and disposal of Kabiven. Do not store above 25° C. Do not
freeze and always keep the container in the outer container.

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Shelf-life

The following information is intended for medical or healthcare
professionals only:

Shelf-life after mixing
After breaking the seals, chemical and physical in-use stability of the
mixed three chamber bag has been demonstrated for 24 hours at
25°C.

Warnings and precautions for use
To avoid risks associated with too rapid infusion rates, it is
recommended to use a continuous and well-controlled infusion, if
possible by using a volumetric pump.
Since an increased risk of infection is associated with the use of any
central vein, strict aseptic precautions should be taken to avoid any
contamination especially during catheter insertion.
Serum glucose, electrolytes and osmolarity as well as fluid balance,
acid-base status and liver and enzyme tests should be monitored.
Any sign or symptom of anaphylactic reaction (such as fever, shivering,
rash or dyspnoea) should lead to immediate interruption of the
infusion.

Shelf-life after mixing with additives
After opening the peelable seals and mixing of the three solutions,
additions can be made via additive port.
From a microbiological point of view the product should be
used immediately when additions have been made. If not used
immediately, the in-use storage time and conditions prior to use are
the responsibility of the user and should normally not be longer than
24 hours at 2-8°C. If storage can not be avoided and provided that
additions are made under controlled and validated aseptic conditions
the mixed emulsion may be stored up to 6 days at 2-8°C before being
used. After removal from storage at 2-8°C, the admixture should be
infused within 24 hours.

Kabiven
Instructions for use
The bag

Kabiven should not be given simultaneously with blood in the same
infusion set due to the risk of pseudoagglutination.
Method of administration
Intravenous use, infusion into a central vein.
To provide total parenteral nutrition, trace elements, vitamins and
possibly electrolytes (taking into account the electrolytes already
present in Kabiven) should be added to Kabiven according to the
patients need.
Infusion rate
The maximum infusion rate for glucose is 0.25 g/kg/h.
Amino acid dosage should not exceed 0.1 g/kg/h.
Fat dosage should not provide more than 0.15 g/kg/h.
The infusion rate should not exceed 2.6 ml/kg body weight/hour
(corresponding to 0.25 g glucose, 0.09 g amino acid and 0.1 g fat/
kg body weight). The recommended infusion period is 12-24 hours.

 Notches in the overpouch
 Handle
 Hole for hanging the bag
 Peelable seals
 Blind port (only used during Manufacturing)
 Additive port
 Infusion port
 Oxygen absorber
1. Removal of overpouch

Precautions for disposal
Do not use if package is damaged. Use only if the amino acid and
glucose solutions are clear and colourless or slightly yellow and the
fat emulsion is white and homogenous. The contents of the three
separate chambers have to be mixed before use and before any
additions are made via the additive port.
After separation of the peelable seals the bag should be inverted three
times to ensure a homogenous mixture which does not show any
evidence of phase separation.
For single use only. Any mixture remaining after infusion must be
discarded.
Compatibility
Only medicinal or nutrition solutions for which compatibility has been
documented may be added to Kabiven. Compatibility for different
additives and the storage time of the different admixtures will be
available upon request.
Additions should be made aseptically.

• To remove overpouch, hold the bag horizontally
and tear from the notch close to the ports along
the upper edge (A).
• Then simply tear the long side, pull off the overpouch
and discard it along with the oxygen absorber (B).

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The emulsion must not be used after the expiry date shown on the
label. The expiry date refers to the last day of that month. Do not use
if the bag is leaking
For single use only. Any mixture remaining after infusion must be
disposed of using the approved hospital procedures.

2. Mixing

6. FURTHER
INFORMATION

What Kabiven contains
Kabiven is available in a three chamber bag system. Each bag contains
the following different volumes depending on the four pack sizes:

2566 ml 2053 ml 1540 ml 1026 ml
Glucose (Glucose 19%)
1316 ml 1053 ml 790 ml 526 ml
Amino acids and electrolytes
(Vamin 18 Novum)
750 ml 600 ml 450 ml 300 ml
Fat emulsion (Intralipid 20%)
500 ml 400 ml 300 ml 200 ml

• Mix the contents of the three chambers by inverting
the bag three times until the components are
thoroughly mixed.
3. Finalising the preparation:

• Shortly before inserting the infusion set, break off the
tamper evident arrow flag from the blue infusion port (A).
Please note: The membrane in the infusion port is sterile.
• Use a non-vented infusion set or close the air-inlet
on a vented set.
• Hold the base of the infusion port.
• Push the spike through the infusion port.

The spike should be fully inserted to secure it in place.
Please note: The inner part of the infusion port is sterile.

4. Hooking up the bag

• Place the bag on a flat surface.
• Roll up the bag tightly from the handle side towards the
ports, firstly with the right hand and then applying a
constant pressure with the left hand until the vertical
seals are broken. The vertical peel seals open due to the
pressure of the fluid. The peel seals can also be opened
before removing the overpouch.
Please note: The liquids mix easily although the horizontal
seal remains closed.

• Place the bag on a flat surface again. Shortly before
injecting the additives, break off the tamper-evident
arrow flag from the white additive port (A).
Please note: The membrane in the additive port is sterile.
• Hold the base of the additive port. Insert the needle,
inject the additives (with known compatibility) through
the centre of the injection site (B).
• Mix thoroughly between each addition by inverting the
bag three times. Use syringes with needles of 18-23
gauge and a length of max. 40 mm.

• Hook the bag up by the hole below the handle.

Active ingredients
Purified soybean oil
100 g
80 g
60 g 40 g
Glucose monohydrate
275 g 220 g 165 g 110 g
Corresponding to Glucose (anhydrous) 250 g 200 g 150 g 100 g
Alanine
12.0 g
9.6 g 7.2 g 4.8 g
Arginine
8.5 g
6.8 g 5.1 g 3.4 g
Aspartic acid
2.6 g
2.0 g 1.5 g 1.0 g
Glutamic acid
4.2 g
3.4 g 2.5 g 1.7 g
Glycine
5.9 g
4.7 g 3.6 g 2.4 g
Histidine
5.1 g
4.1 g 3.1 g 2.0 g
Isoleucine
4.2 g
3.4 g 2.5 g 1.7 g
Leucine
5.9 g
4.7 g 3.6 g 2.4 g
Lysine hydrochloride
8.5 g
6.8 g 5.1 g 3.4 g
Corresponding to Lysine
6.8 g
5.4 g 4.1 g 2.7 g
3.4 g 2.5 g 1.7 g
Methionine
4.2 g
Phenylalanine
5.9 g
4.7 g 3.6 g 2.4 g
Proline
5.1 g
4.1 g 3.1 g 2.0 g
Serine
3.4 g
2.7 g 2.0 g 1.4 g
Threonine
4.2 g
3.4 g 2.5 g 1.7 g
Tryptophan
1.4 g
1.1 g 0.86 g 0.57 g
Tyrosine
0.17 g 0.14 g 0.10 g 0.07 g
Valine
5.5 g
4.4 g 3.3 g 2.2 g
Calcium chloride 2 H2O
0.74 g 0.59 g 0.44 g 0.29 g
Corresponding to Calcium chloride 0.56 g 0.44 g 0.33 g 0.22 g
Sodium glycerophosphate (anhydrous) 3.8 g
3.0 g 2.3 g 1.5 g
2.5 g
2.0 g 1.5 g 0.99 g
Magnesium sulphate 7 H2O
Corresponding to Magnesium sulphate 1.2 g 0.96 g 0.72 g 0.48 g
Potassium chloride
4.5 g
3.6 g 2.7 g 1.8 g
Sodium acetate 3 H2O
6.1 g
4.9 g 3.7 g 2.5 g
Corresponding to Sodium acetate
3.7 g
2.9 g 2.2 g 1.5 g

The other ingredients are purified egg phospholipids, glycerol,
sodium hydroxide, glacial acetic acid and water for injections.
What Kabiven looks like and contents of the pack
Glucose and amino acid solutions are clear and colourless or slightly
yellow and the fat emulsion is white.

Kabiven consists of a three chamber bag and an overpouch. An oxygen
absorber is placed between the inner bag and the overpouch, which
should be discarded before use. The inner bag is separated into three
chambers by peelable seals.The contents of the three chambers have
to be mixed before use, by opening the peelable seals.
Pack sizes:
1 x 1026 ml, 4 x 1026 ml
1 x 1540 ml, 4 x 1540 ml
1 x 2053 ml, 2 x 2053 ml (Excel), 4 x 2053 ml (Biofine)
1 x 2566 ml, 2 x 2566 ml (Excel), 3 x 2566 (Biofine)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Fresenius Kabi Ltd.,
Cestrian Court, Eastgate Way,
Manor Park, Runcorn, Cheshire,
WA7 1NT, U.K.
Manufacturer
Fresenius Kabi AB,
SE-751 74 Uppsala, Sweden.
Fresenius Kabi Austria GmbH,
Hafnerstrasse 36,
AT-8055 Graz, Austria.
This medicinal product is authorised in the Member States of
the EEA under the following names:
Belgium
Kabiven
Denmark
Kabiven
Finland
Kabiven
France
Kabiven
Germany
Kabiven
Greece
Kabiven
Iceland
Kabiven
Ireland
Kabiven
Italy

Kabiven
Luxemburg

Kabiven
Netherlands

Kabiven
Portugal
Kabiven
Spain

Kabiven
Sweden
Kabiven
Kabiven
United Kingdom

This leaflet was last approved in December 2009









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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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