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SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION

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

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SmofKabiven Ntense PIL

Bipacksedel
Tryckspecifikation

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PMS svart
Fontsize: 9 pt

Package leaflet: Information for the user

SmofKabiven extra Nitrogen
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 is and what it is used for
2. What you need to know before you use SmofKabiven
extra Nitrogen
3. How to use SmofKabiven extra Nitrogen
4. Possible side effects
5. How to store SmofKabiven extra Nitrogen
6. Contents of the pack and other information
1. What SmofKabiven extra Nitrogen is and what it is
used for
SmofKabiven extra Nitrogen 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), lipids (fat) and salts
(electrolytes) 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 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
Do not use SmofKabiven extra Nitrogen
- 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 contains soya-bean oil
- if you have too much lipids in the blood (hyperlipidemia)

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5:e korr 2017-07-05
Johanna Eriksson, 018 64 40 46

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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 high blood (serum) levels of the salts (electrolytes)
included in SmofKabiven extra Nitrogen
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
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 is not meant for newborn babies or children younger than 2 years of age. SmofKabiven
extra Nitrogen can be given to children and adolescents
from 2 to 16/18 years old.
Other medicines and SmofKabiven extra Nitrogen
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 during
pregnancy or breast-feeding is lacking. SmofKabiven extra
Nitrogen should therefore be given to pregnant or breastfeeding women only if the doctor find it necessary. The use
of SmofKabiven extra Nitrogen 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 extra Nitrogen
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 will be given to you by a healthcare
professional.
If you use more SmofKabiven extra Nitrogen than you
should
It is unlikely that you will receive too much medicine as
SmofKabiven extra Nitrogen 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

For Ireland – You can report directly via:

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.

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

What SmofKabiven extra Nitrogen looks like and
contents of the pack

By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store SmofKabiven extra Nitrogen
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.

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

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

6. Contents of the pack and other information
What SmofKabiven extra Nitrogen contains
The active substances are
g per 1000 ml

Marketing Authorisation Holder and Manufacturer

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)
Glucose (as monohydrate)
Soya-bean oil, refined
Medium-chyain triglycerides
Olive oil, refined
Fish oil, rich in omega-3-acids

Marketing authorisation holder:
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK

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
0.28
2.3
0.61
2.3
1.6
0.0066
85
8.7
8.7
7.2
4.3

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

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 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 SmofKabiven extra Nitrogen) should be
added to SmofKabiven extra Nitrogen according to the
patients need.
Posology

Adults
Dosage:
The dosage range of 13-31 ml SmofKabiven extra Nitrogen
/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).
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
xxx xxx
careful monitoring.

The recommended infusion period is 12-24 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.

Adolescents (12-16/18 years)
In adolescents, SmofKabiven extra Nitrogen 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.

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

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
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
The bag
506 ml

2. Mixing
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

• 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.

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

• 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 ad
ditive 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.
V001 xxx xxx

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