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SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE EMULSION FOR INFUSION

Active substance(s): ALANINE / ARGININE / FISH OIL / GLUCOSE MONOHYDRATE / GLYCINE / HISTIDINE / ISOLEUCINE / LEUCINE / LYSINE ACETATE / MEDIUM CHAIN TRIGLYCERIDES / METHIONINE / OLIVE OIL REFINED / PHENYLALANINE / PROLINE / SERINE / SOYA-BEAN OIL REFINED / TAURINE / THREONINE / TRYPTOPHAN / TY

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SmofKabiven Ntense EF PIL

Bipacksedel
Tryckspecifikation

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Fontsize: 9 pt

Package leaflet: Information for the user

SmofKabiven extra Nitrogen
Electrolyte free
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,
pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What SmofKabiven extra Nitrogen Electrolyte Free is and
what it is used for
2. What you need to know before you use SmofKabiven extra
Nitrogen Electrolyte free
3. How to use SmofKabiven extra Nitrogen Electrolyte free
4. Possible side effects
5. How to store SmofKabiven extra Nitrogen Electrolyte free
6. Contents of the pack and other information
1. What SmofKabiven extra Nitrogen Electrolyte free
is and what it is used for

SmofKabiven extra Nitrogen Electrolyte free 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) and lipids
(fat) in a plastic bag and can be given to adults and children
aged 2 years and above.
A healthcare professional will give you SmofKabiven extra
Nitrogen Electrolyte free when other forms of feeding are
not good enough or have not worked.
2. What you need to know before you use SmofKabiven
extra Nitrogen Electrolyte free
Do not use SmofKabiven extra Nitrogen Electrolyte free
- 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 extra Nitrogen Electrolyte free
contains soya-bean oil

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4: korr 2017-04-05
Johanna Eriksson, 018 64 40 46

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if you have too much lipids in the blood (hyperlipidemia)
if you have serious liver disorder
if you have blood clotting problems (coagulation disorder)
if your body has problems using amino acids
if you have 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 fluid in the lungs (acute pulmonary oedema)
if you have too much body fluid (hyperhydrated)
if you have heart failure that is not treated
if you have a defect in your blood clotting system (hemophagocytotic syndrome)
if you are in an unstable condition, such as after serious
trauma, uncontrolled diabetes, acute heart attack, stroke,
blood clot, 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)
in newborn babies or children under 2 years of age

Warnings and precautions
Talk to your doctor before using SmofKabiven extra Nitrogen
Electrolyte free if you have:
- kidney problems
- diabetes mellitus
- pancreatitis (inflammation of the pancreas)
- liver problems
- hypothyrodism (thyroid problems)
- sepsis (serious infection)
If you during the infusion get fever, rash, swelling, difficulty
in breathing, chills, sweating, nausea or vomiting, tell the
healthcare professional immediately because these symptoms
might be caused by an allergic reaction or that you have
been given too much of the medicine.
Your doctor may regularly need to check your blood for
liver function tests and other values.
Children and adolescents
SmofKabiven extra Nitrogen Electrolyte free is not meant
for newborn babies or children younger than 2 years of age.
SmofKabiven extra Nitrogen Electrolyte free can be given to
children and adolescents from 2 to 16/18 years old.
Other medicines and SmofKabiven extra Nitrogen
Electrolyte free
Tell your doctor if you are taking, have recently taken or
might take any other medicines, even without prescription.

Pregnancy and breast-feeding
Data from using SmofKabiven extra Nitrogen Electrolyte free
during pregnancy or breast-feeding is lacking. SmofKabiven
extra Nitrogen Electrolyte free should therefore be given
to pregnant or breast-feeding women only if the doctor
find it necessary. The use of SmofKabiven extra Nitrogen
Electrolyte free may be considered during pregnancy and
breastfeeding, as advised by your doctor.

For Ireland – You can report directly via:

What SmofKabiven extra Nitrogen Electrolyte free
looks like and contents of the pack

HPRA Pharmacovigilance
Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Email: medsafety@hpra.ie

Glucose- and amino acid solutions are clear, colourless or
slightly yellow and free from particles. The lipid emulsion is
white and homogenous.

Driving and using machines
Not relevant as the medicine is given at the hospital.

5. How to store SmofKabiven extra Nitrogen Electrolyte free

3. How to use SmofKabiven extra Nitrogen Electrolyte free

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

Pack sizes:
1 x 506 ml, 6 x 506 ml
1 x 1012 ml, 4 x 1012 ml
1 x 1518 ml, 4 x 1518 ml
1 x 2025 ml, 4 x 2025 ml
1 x 2531 ml, 3 x 2531 ml

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 extra Nitrogen Electrolyte free will be given to you by
a healthcare professional.

Store in overpouch. Do not store above 25°C. Do not freeze.

Marketing Authorisation Holder and Manufacturer

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.

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

If you use more SmofKabiven extra Nitrogen Electrolyte
free than you should
It is unlikely that you will receive too much medicine as SmofKabiven extra Nitrogen Electrolyte free is given to you by a
healthcare 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.
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 and 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 symptoms like swelling, fever, fall in blood pressure, skin rashes, wheals (raised
red areas), flushing, headache). Sensations of hot and cold.
Paleness. Light blue coloured lips and skin (because of too
less oxygen in the blood). Pain in the neck, back, bones,
chest and loins.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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

By reporting side effects you can help provide more information on the safety of this medicine.

6. Contents of the pack and other information
What SmofKabiven extra Nitrogen Electrolyte free
contains

The active substances are
Alanine
Arginine
Glycine
Histidine
Isoleucine
Leucine
Lysine (as acetate)
Methionine
Phenylalanine
Proline
Serine
Taurine
Threonine
Tryptophan
Tyrosine
Valine
Glucose (as monohydrate)
Soya-bean oil, refined
Medium-chain triglycerides
Olive oil, refined
Fish oil, rich in omega-3 fatty acids

g per 1000 ml
9.2
7.9
7.2
2.0
3.3
4.8
4.3
2.8
3.3
7.3
4.3
0.65
2.9
1.3
0.26
4.1
85
8.7
8.7
7.2
4.3

The other ingredients are glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (pHadjustment), sodium oleate, acetic acid (pH-adjustment),
hydrochloric acid (pH-adjustment) and water for injections.

Marketing authorisation holder:
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
This leaflet was last revised in
May 2017
------------------------------------------------------------------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 central vein, strict aseptic precautions should be
taken to avoid any contamination especially during catheter
insertion and manipulations.
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 extra Nitrogen Electrolyte free 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, electrolytes and vitamins should be added to SmofKabiven extra
Nitrogen Electrolyte free according to the patients need.

Dosage:
The dosage range of 13-31 ml SmofKabiven extra Nitrogen
Electrolyte free /kg bw/day corresponds to 0.14-0.32 g
nitrogen/kg bw/day (0.85-2.0 g amino acids/kg bw/day) and
12-28 kcal/kg bw/day of total energy (8-19 kcal/kg bw/day
of non-protein energy).

Posology

Adults

Infusion rate:
The maximum infusion rate for glucose is 0.25 g/kg bw/h,
for amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h.
The infusion rate should not exceed 1.5 ml/kg bw/h (corresponding to 0.13 g glucose, 0.10 g amino acids, and 0.04 g
lipids/kg bw/h). The recommended infusion period is 14-24
hours.
Maximum daily dose:
The maximum daily dose varies with the clinical condition
of the patient and may even change from day to day. The
recommended maximum daily dose is 31 ml/kg bw/day.

Paediatric population
Children (2-11 years)
Dosage:
The dose up to 31 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that
varies more than in adult patients.
Infusion rate:
The recommended maximum infusion rate is 1.8 ml/kg
bw/h (corresponding to 0.12 g amino acids/kg/h, 0.15 g/
glucose/kg/h and 0.05 g lipids/kg/h). At the recommended
maximum infusion rate, do not use an infusion period
longer than 17 hours, except in exceptional cases and with
careful monitoring.
The recommended infusion period is 12-24 hours.
xxx xxx

Maximum daily dose:
The maximum daily dose varies with the clinical condition
of the patient and may even change from day to day. The
recommended maximum daily dose is 31 ml/kg bw/day.

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.

Adolescents (12-16/18 years)

For single use only. Any unused solution remaining after
infusion should be discarded.

In adolescents, SmofKabiven extra Nitrogen Electrolyte free
can be used as in adults.
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.

Compatibility
Compatibility data are available with the named branded
products Dipeptiven, Additrace N (Ireland only), Vitlipid
N Adult, Solivito N (lyophilized) in defined amounts and
generics of electrolytes in defined concentrations. When
making electrolyte additions, the amounts already present
in the bag should be taken into account to meet the clinical
needs of the patient. Generated data supports additions to
the activated bag according to the summary table below:


Maximal total contents
SmofKabiven extra Nitrogen bag size
1012 ml, 1518 ml, 2025 ml and 2531 ml
Electrolyte free bag size
Additive Volume
Dipeptiven
0 - 300 ml
Additrace N (Ireland only)
0 - 20 ml
Solivito N (lyophilized)
0 - 2 vials
Vitlipid N Adult
0 - 20 ml

Concentration
Sodium
0 - 150 mmol/l
Potassium
0 - 150 mmol/l
Calcium
0 - 5 mmol/l
Magnesium
0 - 5 mmol/l
Phosphate (Addiphos) OR
0 - 15 mmol/l
Phosphate (sodium glycerophosphate)
0 - 30 mmol/l
Zinc
0 - 0.2 mmol/l
Selenium
0 - 2 µmol/l

506 ml

0 - 150 ml
0 - 10 ml
0 - 1 vial
0 - 10 ml

Instructions for use SmofKabiven extra Nitrogen Electrolyte free
The bag
506 ml

1012 ml, 1518 ml, 2025 ml, 2531 ml

1. Notches in the overpouch
2. Handle
3. Hole for hanging the bag
4. Peelable seals
5. Blind port (only used during manufacturing)
6. Additive port
7. Infusion port
8. Oxygen absorber

Shelf-life after mixing
Chemical and physical in-use stability of the mixed three
chamber bag has been demonstrated for 36 hours at 25ºC.
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 2-8ºC.

506 ml, 1012 ml, 1518 ml, 2025 ml, 2531 ml

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

3. Finalising the preparation:

1. Removal of overpouch

0 - 150 mmol/l
0 - 150 mmol/l
0 - 5 mmol/l
0 - 5 mmol/l
0 - 15 mmol/l
0 - 30 mmol/l
0 - 0.2 mmol/l
0 - 2 µmol/l

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 2-8ºC.

• 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. Hanging up the bag

Note: This table is intended to indicate compatibility. It is not a dosing guideline.
Additions should be made aseptically.

2. Mixing

• 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 over
pouch and discard it along with the oxygen
absorber (B).

• 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 1823 gauge and a length of max. 40 mm.

• Hook the bag up by the hole below the handle.
V001 xxx xxx

+ 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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