Skip to Content

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SmofKabiven Ntense PIL

Bipacksedel
Tryckspecifikation

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.
Whats 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)
- 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

(replace)

-

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 breast-feeding 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:
HPRA Pharmacovigilance
Earlsfort Terrace
IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Email: medsafety@hpra.ie
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.
6. Contents of the pack and other information
What SmofKabiven extra Nitrogen contains

The active substances are
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

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
0.28
2.3
0.61
2.3
1.6
0.0066
85
8.7
8.7
7.2
4.3

The other ingredients are glycerol, purified egg phospholipids,
all-rac-α-tocopherol, sodium hydroxide (pH-adjustment), sodium
oleate, acetic acid (pH-adjustment), hydrochloric acid (pH-adjustment) and water for injections.
What SmofKabiven extra Nitrogen looks like and contents
of the pack
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

Marketing Authorisation Holder and Manufacturer
Manufacturer:
Fresenius Kabi AB, SE-751 74 Uppsala, Sweden
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 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 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, Addaven, Vitalipid N Adult and Soluvit N (lyophilized)
in defined amounts and generics of electrolytes in defined concentrations.
xxx xxx

Instructions for use SmofKabiven extra Nitrogen

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:

2. Mixing

The bag

Maximal total contents
SmofKabiven extra Nitrogen bag size
1012 ml, 1518 ml, 2025 ml and 2531 ml
Additive Volume
0 - 300 ml
Dipeptiven
Addaven
0 - 20 ml
Soluvit N (lyophilized)
0 - 2 vials
Vitalipid 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 (Glycophos)
0 - 30 mmol/l
Zinc
0 - 0.2 mmol/l
Selenium
0 - 2 µmol/l
Note: This table is intended to indicate compatibility. It is not a dosing guideline.

506 ml

1012 ml, 1518 ml, 2025 ml, 2531 ml

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

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

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:

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 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.

1. Removal of overpouch

• 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

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.

• 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.
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.

Hide