Leaflet no 338 002 (ersätter 336 362)

Tryckspecifikation
Format: 630 x 210 mm 3:e korr 20-04-16
Färger: PMS svart Johanna Eriksson, 018 64 40 46
Utskrift: anpassat till A3

PERFORERING

Instructions for use

PACKAGE LEAFLET: INFORMATION FOR THE USER - if you have fluid in the lungs (acute pulmonary oedema) If you use more SmofKabiven Central than you should The following information is intended for healthcare Infusion rate:
- if you have too much body fluid (hyperhydration) It is unlikely that you will receive too much medicine as professionals only: The recommended maximum infusion rate is 2.4 ml/kg bw/h
- if you have heart failure that is not treated SmofKabiven Central is given to you by a healthcare professional. (corresponding to 0.12 g amino acids/kg/h, 0.30 g/glucose/kg/h
SmofKabiven Central - if you have a defect in your blood clotting system
Warnings and precautions for use
and 0.09 g lipids/kg/h). At the recommended maximum infusion
Emulsion for infusion (haemophagocytotic syndrome) 4. Possible side effects To avoid risks associated with too rapid infusion rates, it is rate, do not use an infusion period longer than 14 hours
- if you are in an unstable condition, such as after serious trauma, recommended to use a continuous and well-controlled infusion, 30 minutes, except in exceptional cases and with careful monitoring. The bag
uncontrolled diabetes, acute heart attack, stroke, blood clot Like all medicines, this medicine can cause side effects, although if possible by using a volumetric pump. The recommended infusion period is 12-24 hours.
(embolism), metabolic acidosis (a disturbance resulting in too not everybody gets them.
Read all of this leaflet carefully before you start using this Since an increased risk of infection is associated with the use of Maximum daily dose:
medicine because it contains important information for you. much acid in the blood), serious infection (severe sepsis), Common (may affect up to 1 in 10 people): a slightly raised body any central vein, strict aseptic precautions should be taken to The maximum daily dose varies with the clinical condition of the
- Keep this leaflet. You may need to read it again. coma and if you don’t have enough body fluid (hypotonic temperature. avoid any contamination especially during catheter insertion and patient and may even change from day to day. The recommended
- If you have any further questions, ask your doctor, pharmacist dehydration).
Uncommon (may affect up to 1 in 100 people): high blood manipulations. maximum daily dose is 35 ml/kg bw/day.
or nurse. - in children under 2 years of age
(plasma) levels of compounds from the liver, lack of appetite, Serum glucose, electrolytes and osmolarity as well as fluid balance, Adolescents (12-16/18 years)
- If you get any side effects, talk to your doctor, pharmacist Warnings and precautions: nausea, vomiting, chills, dizziness and headache. acid-base status and liver and enzyme tests should be monitored. In adolescents, SmofKabiven can be used as in adults.
or nurse. This includes any possible side effects not listed in this Talk to your doctor before using SmofKabiven Central if you have:
leaflet. See section 4. - kidney problems Rare (may affect up to 1 in 1,000 people): low or high blood Any sign or symptom of anaphylactic reaction (such as fever, Precautions for disposal
- diabetes mellitus pressure, difficulty in breathing, fast heart beat (tachycardia). shivering, rash or dyspnoea) should lead to immediate interruption Do not use if package is damaged.
What is in this leaflet:
- pancreatitis (inflammation of the pancreas) Hypersensitivity reactions (that can give symptoms like swelling, of the infusion.
1. What SmofKabiven Central is and what it is used for Use only if the amino acid and glucose solutions are clear and
- liver problems fever, fall in blood pressure, skin rashes, wheals (raised red areas), SmofKabiven Central should not be given simultaneously with blood
2. What you need to know before you use SmofKabiven Central colourless or slightly yellow and the lipid emulsion is white and
- hypothyrodism (thyroid problems) flushing, headache). Sensations of hot and cold. Paleness. Light in the same infusion set due to the risk of pseudoagglutination.
3. How to use SmofKabiven Central homogenous. The contents of the three separate chambers have
- sepsis (serious infection) blue coloured lips and skin (because of too less oxygen in the
4. Possible side effects Method of administration to be mixed before use, and before any additions are made via
blood). Pain in the neck, back, bones, chest and loins.
5. How to store SmofKabiven Central If during the infusion you get fever, rash, swelling, difficulty in Intravenous use, infusion into a central vein. the additive port.
6. Contents of the pack and other information breathing, chills, sweating, nausea or vomiting, tell the healthcare Reporting of side effects After separation of the peelable seals the bag should be inverted  Notches in the overpouch
If you get any side effects, talk to your doctor, pharmacist or To provide total parenteral nutrition, trace elements, vitamins and  Handle
1. What SmofKabiven Central is and what it is used for professional immediately because these symptoms might be on a number of occasions to ensure a homogenous mixture,
nurse. This includes any possible side effects not listed in this leaflet. possibly electrolytes (taking into account the electrolytes already  Hole for hanging the bag
caused by an allergic reaction or that you have been given too which does not show any evidence of phase separation.
SmofKabiven Central is an emulsion for infusion given into your present in SmofKabiven Central) should be added to SmofKabiven  Peelable seals
much of the medicine. For UK - You can also report side effects directly via the Yellow
blood by a drip (intravenous infusion). The product contains Central according to the patients need. For single use only. Any unused solution remaining after infusion  Blind port (only used during manufacturing)
Your doctor may regularly need to check your blood for liver Card Scheme at: www.mhra.gov.uk/yellowcard should be discarded.
amino acids (components used to build proteins), glucose Posology  Additive port
(carbohydrates), fat (lipids) and salts (electrolytes) in a plastic bag function tests and other values. For Ireland - You can report directly via;  Infusion port
Compatibility
and can be given to adults and children aged 2 years and above. HPRA Pharmacovigilance Adults  Oxygen absorber
Children and adolescents Only medicinal or nutrition solutions for which compatibility
Earlsfort Terrace Dosage: has been documented may be added to SmofKabiven Central.
A healthcare professional will give you SmofKabiven Central when SmofKabiven Central is not meant for newborn babies or children 1. Removal of overpouch
IRL - Dublin 2 The dosage range of 13-31 ml SmofKabiven/kg bw/day will Compatibility for different additives and the storage time of the
other forms of feeding are not good enough or have not worked. younger than 2 years old. SmofKabiven can be given to children Tel: +353 1 6764971 provide 0.6-1.6 g amino acids/kg bw/day (corresponds to 0.10- different admixtures will be available upon request.
from 2 to 16/18 years old. Fax: +353 1 6762517
2. What you need to know before you use SmofKabiven 0.25 g nitrogen/kg bw/day) and 14-35 kcal/kg bw/day of total Additions should be made aseptically.
Other medicines and SmofKabiven Central Website: www.hpra.ie energy (12-27 kcal/kg bw/day of non-protein energy).
Central Shelf-life after mixing
Tell your doctor if you are taking, have recently taken or might take e-mail: medsafety@hpra.ie
Do not use SmofKabiven Central: Infusion rate: Chemical and physical in-use stability of the mixed three
any other medicines, even without prescription. By reporting side effects you can help provide more information
if you are allergic (hypersensitive) to active substances or any of The maximum infusion rate for glucose is 0.25 g/kg bw/h, for chamber bag has been demonstrated for 36 hours at 25°C.
Pregnancy and breast-feeding on the safety of this medicine. amino acids 0.1 g/kg bw/h, and for lipids 0.15 g/kg bw/h. From a microbiological point of view the product should be used
the other ingredients of this medicine (listed in section 6)
- if you are allergic to fish or egg Data from using SmofKabiven Central during pregnancy or breast- immediately. If not used immediately, in-use storage times and
5. How to store SmofKabiven Central The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding
- if you are allergic to peanuts or soya you should not use this feeding is lacking. SmofKabiven Central should therefore be given conditions prior to use are the responsibility of the user and
to 0.25 g glucose, 0.10 g amino acids, and 0.08 g lipids/kg bw/h).
product. SmofKabiven Central contains soybean oil to pregnant or breast-feeding women only if the doctor finds it Keep this medicine out of the sight and reach of children. would normally not be longer than 24 hours at 2-8°C.
The recommended infusion period is 14-24 hours.
- if you have too much lipids in the blood (hyperlipidaemia) necessary. The use of SmofKabiven Central may be considered Store in overpouch. Do not store above 25°C. Do not freeze.
- if you have serious liver disorder during pregnancy and breastfeeding, as advised by your doctor Maximum daily dose: Shelf-life after mixing with additives
Do not use this medicine after the expiry date which is stated on
- if you have blood clotting problems (coagulation disorders) The maximum daily dose varies with the clinical condition of the From a microbiological point of view, the product should be
Driving and using machines the label on the bag and box. The expiry date refers to the last
- if your body has problems using amino acids patient and may even change from day to day. The recommended used immediately when additions have been made. If not used
Not relevant as the medicine is given at the hospital. day of that month.
- if you have serious kidney disease without access to dialysis maximum daily dose is 35 ml/kg bw/day. immediately, the in-use storage time and conditions prior to
- if you are in acute shock 3. How to use SmofKabiven Central use are the responsibility of the user. The storage time should
6. Contents of the pack and other information Paediatric population • To remove overpouch, hold the bag
- if you have too much sugar in your blood (hyperglycaemia) normally not be longer than 24 hours at 2-8°C.
which is uncontrolled Always use this medicine exactly as your doctor has told you. What SmofKabiven Central contains Children (2-11 years) horizontally and tear from the notch close to
- if you have high blood (serum) levels of the salts (electrolytes) Check with your doctor if you are not sure. the ports along the upper edge (A).
The active substances are g per 1000 ml Dosage: • Then simply tear the long side, pull off the
included in SmofKabiven Central Your doctor will decide on the dose for you individually depending
Alanine 7.1 The dose up to 35 ml/kg bw/day should be regularly adjusted to overpouch and discard it along with the
on your body weight and function. SmofKabiven Central will be V004
Arginine 6.1 the requirements of the paediatric patient that varies more than oxygen absorber (B).
given to you by a healthcare professional. 338 002
in adult patients.
 Glycine 5.6 MAH for IRL:
Histidine 1.5 Fresenius Kabi Deutschland GmbH
Else-Kröner-Straße 1,
2. Mixing Isoleucine 2.5
61352 Bad Homburg
Leucine 3.8
Lysine (as acetate) 3.4 v.d.Höhe
Methionine 2.2 Germany
Phenylalanine 2.6
Proline 5.7 Manufacturer:
Serine 3.3 Fresenius Kabi AB, SE-751 74 Uppsala, Sweden
Taurine 0.5
Threonine 2.2 This leaflet was last revised in October 2019.
Tryptophan 1.0
Tyrosine 0.20
Valine 3.1
Calcium chloride (as dihydrate) 0.28
Sodium glycerophosphate (as hydrate) 2.1
Magnesium sulphate (as heptahydrate) 0.61
• Mix the contents of the three chambers by inverting Potassium chloride 2.3
the bag three times until the components are Sodium acetate (as trihydrate) 1.7
thoroughly mixed. Zinc sulphate (as heptahydrate) 0.0066
Glucose (as monohydrate) 127
• Shortly before inserting the infusion set, break off Soybean oil, refined 11.4
the tamper evident arrow flag from the blue
3. Finalising the preparation: infusion port (A).
Medium-chain triglycerides 11.4
Olive oil, refined 9.5
Please note: The membrane in the infusion port is sterile. Fish oil, rich in omega-3-fatty acids 5.7
• Use a non-vented infusion set or close the air-inlet
on a vented set. The other ingredients are: glycerol, purified egg phospholipids,
• Hold the base of the infusion port. all-rac-a-tocopherol, sodium hydroxide (pH adjustment), sodium
• Push the spike through the infusion port. oleate, glacial acetic acid (pH adjustment), hydrochloric acid (pH
The spike should be fully inserted to secure it in place. adjustment) and water for injections.
Please note: The inner part of the infusion port is sterile.
What SmofKabiven Central looks like and contents of the pack
4. Hanging up the bag Glucose and amino acid solutions are clear and colourless or
slightly yellow and free from particles. The lipid emulsion is white
and homogenous.
Pack sizes:
1 x 493 ml, 6 x 493 ml
1 x 986 ml, 4 x 986 ml
1 x 1477 ml, 4 x 1477 ml
1 x 1970 ml, 4 x 1970 ml
1 x 2463 ml, 3 x 2463 ml
• Place the bag on a flat surface. • Place the bag on a flat surface again. Shortly before
• Roll up the bag tightly from the handle side injecting the additives, break off the tamper-evident Marketing Authorisation Holder and Manufacturer
towards the ports, firstly with the right hand and arrow flag from the white additive port (A). MAH for UK:
then applying a constant pressure with the left Please note: The membrane in the additive port is sterile. Fresenius Kabi Ltd
hand until the vertical seals are broken. The vertical • Hold the base of the additive port. Insert the needle, Cestrian Court
peel seals open due to the pressure of the fluid. inject the additives (with known compatibility) Eastgate Way
The peel seals can also be opened before removing through the centre of the injection site (B). Manor Park
the overpouch. • Mix thoroughly between each addition by inverting Runcorn
Please note: The liquids mix easily although the the bag three times. Use syringes with needles of • Hang the bag up by the hole below the handle.
Cheshire
­horizontal seal remains closed. 18-23 gauge and a length of max. 40 mm. WA7 1NT
United Kingdom V004
338 002