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SMOFKABIVEN PERIPHERAL EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / CALCIUM CHLORIDE DIHYDRATE / FISH OIL / GLUCOSE MONOHYDRATE / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / MAGNESIUM SULPHATE HEPTAHYDRATE / MEDIUM-CHAIN TRIGLYCERIDES NEUTRAL / METHIONINE / OLIVE OIL REFINED / PHENYLALANINE / POTAS

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SmofKabiven Peripheral
Emulsion for infusion
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
What is In this leaflet:
1. What SmofKabiven Peripheral is and what it is used for
2. What you need to know before you use SmofKabiven Peripheral
3. How to use SmofKabiven Peripheral
4. Possible side effects
5. How to store SmofKabiven Peripheral
6. Contents of the pack and other information

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if you are in an unstable condition, such as after serious trauma,
uncontrolled diabetes, acute heart attack, stroke, blood clot
(embolism), metabolic acidosis (a disturbance resulting in too
much acid in the blood), serious infection (severe sepsis),
coma and if you don’t have enough body fluid (hypotonic
dehydration).

Warnings and precautions
Talk to your doctor before using SmofKabiven Peripheral if you have:
- kidney problems
- diabetes mellitus
- pancreatitis (inflammation of the pancreas)
- liver problems
- hypothyrodism
- sepsis (serious infection)
If during the infusion you get fever, rash, swelling, difficulty in
breathing, chills, sweating, nausea or vomiting, tell the health care
professional immediately because these symptoms might be caused
by an allergic reaction or that you have been given too much of the
medicine.

1. What SmofKabiven Peripheral is and what it is used for

Your doctor may regularly need to check your blood for liver function
tests and other values.

SmofKabiven Peripheral is an emulsion for infusion given into your
blood by a drip (intravenous infusion). The product contains amino
acids (components used to build proteins),glucose (carbohydrates),
salts (electrolytes), Lipids (fat) and salts (electrolytes) in a plastic bag.

Children and adolescent
SmofKabiven Peripheral is not meant for newborn babies or children
younger than 2 years old. At the moment, there is no experience of the
use of SmofKabiven Peripheral in children from 2 to 11 years of age.

A health care professional will give you SmofKabiven Peripheral
when other forms of feeding are not good enough or have not worked.

Other medicines and SmofKabiven Peripheral
Tell your doctor if you are taking, have recently taken or might take
any other medicines, even without prescription.

2. What you need to know before you use SmofKabiven
Peripheral
Do not use SmofKabiven Peripheral:
if you are allergic (hypersensitive) to active substances or any of the
other ingredients of this medicine (listed in section 6)
- if you are allergic to fish or egg
- if you are allergic to peanuts or soya you should not use this
product. SmofKabiven Peripheral contains soya-bean oil
- if you have too much fat in the blood (hyperlipidaemia)
- if you have a serious liver disease
- if you have blood clotting problems (coagulation disorders)
- if your body has problems using amino acids
- if you have a serious kidney disease without access to dialysis
- if you are in acute shock
- if you have too much sugar in your blood (hyperglycaemia)
which is uncontrolled
- if you have high blood (serum) levels of the salts (electrolytes)
included in SmofKabiven Peripheral
- if you have fluid in the lungs (acute pulmonary oedema)
- if you have too much body fluid (hyperhydration)
- if you have heart failure that is not treated
- if you have a defect in your blood clotting system
(haemophagocytotic syndrome)

Pregnancy and breast-feeding
Data from using SmofKabiven Peripheral during pregnancy or breastfeeding is lacking. SmofKabiven Peripheral should therefore be
given to pregnant or breast-feeding women only if the doctor finds it
necessary. The use of SmofKabiven Peripheral may be considered
during pregnancy and breastfeeding, as advised by your doctor
Driving and using machines
Not relevant as the medicine is given at the hospital.
3. How to use SmofKabiven Peripheral
Always use this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
Your doctor will decide on the dose for you individually depending on
your body weight and function. SmofKabiven Peripheral will be given
to you by a health care professional.
If you use more SmofKabiven Peripheral than you should
It is unlikely that you will receive too much medicine as SmofKabiven
Peripheral is given to you by a health care professional.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Common (may affect up to 1 in 10 people):
• a slightly raised body temperature.
• Inflammation in superficial peripheral veins in connection to the
injection site.
Uncommon (may affect up to 1 in 100 people):
• high blood (plasma) levels of compounds from the liver
• lack of appetite
• nausea
• vomiting
• chills
• dizziness
• headache
Rare (may affect up to 1 in 1,000 people):
• low or high blood pressure
• difficulty in breathing
• fast heart beat (tachycardia)
• Hypersensitivity reactions (that can give symtoms like swelling,
fever, fall in blood pressure, skin rashes, wheals (raised red
areas), flushing, headache)
• Sensations of hot and cold
• Pain in the neck, back, bones and breast
• Paleness
• Light blue coloured lips and skin (because of too little oxygen in
the blood).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
For UK - You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
For Ireland - You can report directly via;
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store SmofKabiven Peripheral
Keep this medicine out of the sight and reach of children.
Store in overpouch. Do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the
label on the bag and box. The expiry date refers to the last day of
that month.

The following information is intended for healthcare 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
peripheral 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.
SmofKabiven Peripheral should not be given simultaneously with
blood in the same infusion set due to the risk of pseudoagglutination.
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 SmofKabiven Peripheral) should be added to SmofKabiven
Peripheral according to the patients need.

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 SmofKabiven Peripheral. Compatibility
for different additives and the storage time of the different admixtures
will be available upon request.

Instructions for use
The bag

Additions should be made aseptically.
Shelf-life after mixing
Chemical and physical in-use stability of the mixed three chamber bag
has been demonstrated for 36 hours at 25°C. From a microbiological
point of view the product should be used immediately. If not used
immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24
hours at 2-8°C.
Shelf-life after mixing with additives
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. The storage time should normally not
be longer than 24 hours at 2-8°C.

 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

Infusion rate
The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino
acid 0.1 g/kg bw/h, and for fat 0.15 g/kg bw/h.
The infusion rate should not exceed 3.0 ml/kg bw/h (corresponding
to 0.21 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h). The
recommended infusion period is 14-24 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 on
a number of occasions to ensure a homogenous mixture, which does
not show any evidence of phase separation.








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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PACKAGE LEAFLET: INFORMATION FOR THE USER

xxx xxx

Manufacturer:
Fresenius Kabi Austria, GmbH, Graz, Austria

6. Further information

2. Mixing

What SmofKabiven Peripheral contains
The active substances are

• 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

g per 1000 ml

Glucose (as monohydrate)
Alanine
Arginine
Glycine
Histidine
Isoleucine
Leucine
Lysine (as acetate)
Methionine
Phenylalanine
Proline
Serine
Taurine
Threonine
Tryptophan
Tyrosine
Valine
Calcium chloride (as dihydrate)
Sodium glycerophosphate (as hydrate)
Magnesium sulphate (as heptahydrate)
Potassium chloride
Sodium acetate (as trihydrate)
Zinc sulphate (as heptahydrate)
Soya-bean oil, refined
Medium-chain triglycerides
Olive oil, refined
Fish oil, rich in omega-3-fatty acids

This leaflet was last revised in 01/2015

71
4.4
3.8
3.5
0.93
1.6
2.3
2.1
1.3
1.6
3.5
2.1
0.32
1.4
0.63
0.12
2.0
0.18
1.3
0.38
1.4
1.1
0.004
8.5
8.5
7.0
4.2

The other ingredients are: glycerol, purified egg phospholipids,
all-rac-α-tocopherol, sodium hydroxide (pH adjustment), sodium
oleate, glacial acetic acid (pH adjustment) and water for injections.
What SmofKabiven Peripheral looks like and contents of the pack
Glucose and amino acid solutions are clear and colourless or slightly
yellow and free from particles. The lipid emulsion is white and
homogenous.

• 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.

Pack sizes:
1 x 1206 ml, 4 x 1206 ml
1 x 1448 ml, 4 x 1448 ml
1 x 1904 ml, 4 x 1904 ml
Marketing Authorisation Holder and Manufacturer

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

Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court, Eastgate Way
Manor Park, Runcorn
Cheshire, WA7 1NT
UK

V003/UP

• 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.

xxx xxx

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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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