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KABIVEN PERIPHERAL 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

KabivenTM Peripheral
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 Peripheral and what it is used for
2. Before you receive Kabiven Peripheral
3. How you are given Kabiven Peripheral
4. Possible side effects
5. How Kabiven Peripheral is stored
6. Further information
1. WHAT IS KABIVEN PERIPHERAL AND WHAT IT IS USED FOR
Kabiven Peripheral comes in a three chamber bag in an overpouch. Kabiven
Peripheral 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 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 Peripheral Emulsion for Infusion. It will be
referred to as Kabiven Peripheral throughout this leaflet.
2. BEFORE YOU RECEIVE KABIVEN PERIPHERAL
You should not receive Kabiven Peripheral if you:
• have ever had an allergic reaction to Kabiven Peripheral or any of the ingredients
of Kabiven Peripheral 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 dehydrated with low levels of salts
have heart problems
are in a coma
have severe sepsis (a condition in which your body is fighting a severe infection)

Care should be taken when administering Kabiven Peripheral
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 Peripheral.
Your doctor may want to do regular blood tests to make sure that the treatment with
Kabiven Peripheral 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 Peripheral 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
Peripheral only after careful consideration.
3. HOW YOU ARE GIVEN KABIVEN PERIPHERAL
You will receive your medicine by infusion (IV drip).
The dose of Kabiven Peripheral and which bag size is used depends on your
bodyweight in kilograms and your body’s ability to use fat and sugar. Kabiven
Peripheral 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 Peripheral is not suitable for use in newborns or children under
two years of age.
If you receive too much Kabiven Peripheral
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 Peripheral 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

----------------------------------------------------------------------------------------------------The following information is intended for medical or health care
professionals only:
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.

Like all medicines, Kabiven Peripheral can cause side effects, although not everybody
gets them.

Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or
dyspnoea) should lead to immediate interruption of the infusion.

Very rarely (occurs in the less than 1 in 10000 patients) Kabiven Peripheral
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

Kabiven Peripheral should not be given simultaneously with blood in the same
infusion set due to the risk of pseudoagglutination.

Common side effects (occurs in more than 1 in 100 patients)
• a slightly raised body temperature
• inflammation of the vein where infusion is given
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 Peripheral. 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.

Shelf-life
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.
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 Peripheral
Instructions for use
1.

To remove the cover wrap hold the bag upright and tear from the
notch along the upper edge, then simply tear open the long side,
pull off the plastic covering and discard it along with the oxygen
absorber.

2.

Thrombophlebitis may occur if peripheral veins are used for infusions. The catheter
insertion site should be evaluated daily for local signs of thrombophlebitis.
Method of administration
Intravenous use, infusion into a peripheral or a central vein.
To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes
(taking into account the electrolytes already present in Kabiven Peripheral) should
be added to Kabiven Peripheral 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.

To mix the contents of the bag, place your fingertips on the upper
compartment just on the seal as shown on the picture.

The infusion rate should not exceed 3.7 ml/kg body weight/hour (corresponding to
0.25 g glucose, 0.09 g amino acids, 0.13 g fat per kg body weight). The recommended
infusion period for individual bags of Kabiven Peripheral is 12-24 hours.
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 lipid 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 unused solution remaining after infusion should be discarded.
Compatibility
Only medicinal or nutrition solutions for which compatibility has been documented
may be added to Kabiven Peripheral. Compatibility for different additives and the
storage time of the different admixtures will be available upon request.
Additions should be made aseptically.

Alternative technique (3): Put the bag on a flat surface. Roll
up the bag by using the handle until the seals are opened. Mix
thoroughly by inverting the bag.

5. HOW KABIVEN PERIPHERAL IS STORED

3.

5.

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 Peripheral.
Do not store above 25°C. Do not freeze and always keep the container in the outer
container. 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 remaining emulsion should be disposed of using the
approved hospital procedures.

7.

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

The other ingredients are purified egg phospholipids, glycerol, sodium hydroxide,
glacial acetic acid and water for injections.
What Kabiven Peripheral 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 Peripheral 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 1440 ml, 4 x 1440 ml
1 x 1920 ml, 2 x 1920 ml (Excel), 4 x 1920 ml (Biofine)
1 x 2400 ml, 2 x 2400 ml (Excel), 3 x 2400 ml (Biofine)
Not all pack sizes may be marketed.

To peel open the lower seal, use the same technique as described
above. Mix thoroughly by gently inverting the bag end-over-end
several times.

Grip the sides of the upper chamber with your fingertips and your
thumbs and gently roll your knuckles together until the seal breaks.

6.

4.

The remaining section of seal may now be gently teased apart.

Support the base of the additive port. Fully insert the needle and
inject the additives (with known compatibility) through the centre of
the injection site. Mix thoroughly between each addition by inverting
the bag several times.

8.

Before injecting additives swab the additive port with disinfectant.

Use a non-vented infusion set or close the air-inlet on a vented set.
Remove the set port cover by pulling the ring upwards. Support the
base of the infusion port. Insert the spike straight into the infusion
port. Twist and push the spike through the diaphragm. The spike
should be fully inserted to secure it in place.

2400 ml
Glucose (Glucose 11%)
1475 ml
Amino acids and electrolytes (Vamin 18 Novum) 500 ml
Fat emulsion (Intralipid 20%)
425 ml

1920 ml
1180 ml
400 ml
340 ml

1440 ml
885 ml
300 ml
255 ml

Active ingredients
Purified soybean oil
Glucose monohydrate
Corresponding to Glucose (anhydrous)
Alanine
Arginine
Aspartic acid
Glutamic acid
Glycine
Histidine
Isoleucine
Leucine
Lysine hydrochloride
Corresponding to Lysine
Methionine
Phenylalanine
Proline
Serine
Threonine
Tryptophan
Tyrosine
Valine
Calcium chloride 2 H2O
Corresponding to Calcium chloride
Sodium glycerophosphate (anhydrous)
Magnesium sulphate 7 H2O
Corresponding to Magnesium sulphate
Potassium chloride
Sodium acetate 3 H2O
Corresponding to Sodium acetate

Marketing Authorisation Holder
Fresenius Kabi Ltd.,
Cestrian Court, Eastgate Way,
Manor Park, Runcorn, Cheshire,
WA7 1NT, U.K.

68 g
143 g
130 g
6.4 g
4.5 g
1.4 g
2.2 g
3.2 g
2.7 g
2.2 g
3.2 g
4.5 g
3.6 g
2.2 g
3.2 g
2.7 g
1.8 g
2.2 g
0.76 g
0.092 g
2.9 g
0.39 g
0.30 g
2.0 g
1.3 g
0.64 g
2.4 g
3.3 g
2.0 g

51 g
107 g
97 g
4.8 g
3.4 g
1.0 g
1.7 g
2.4 g
2.0 g
1.7 g
2.4 g
3.4 g
2.7 g
1.7 g
2.4 g
2.0 g
1.4 g
1.7 g
0.57 g
0.069 g
2.2 g
0.29 g
0.22 g
1.5 g
0.99 g
0.48 g
1.8 g
2.5 g
1.5 g

Manufacturer
Fresenius Kabi AB,
SE-751 74 Uppsala, Sweden.

85 g
178 g
162 g
8.0 g
5.6 g
1.7 g
2.8 g
4.0 g
3.4 g
2.8 g
4.0 g
5.6 g
4.5.g
2.8 g
4.0 g
3.4 g
2.2 g
2.8 g
0.95 g
0.12 g
3.6 g
0.49 g
0.37 g
2.5 g
1.6 g
0.80 g
3.0 g
4.1 g
2.4 g

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
Denmark
Finland
France
Germany
Greece
Iceland
Ireland
Italy
Luxemburg
Netherlands
Norway
Portugal
Spain
Sweden
United Kingdom

Kabiven Peri
Kabiven Perifer
Kabiven Perifer
Perikabiven
Kabiven Peripher
Kabiven Peripheral
Kabiven Perifer
Kabiven Peripheral
Periven
Kabiven Peripheral
Kabiven Perifeer
Kabiven Perifer
Kabiven Peripheral
Kabiven Periférico
Kabiven Perifer
Kabiven Peripheral

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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