Smofkabiven peripheral

Package leaflet: Information for the user

SmofKabiven Peripheral, emulsion for infusion
Please read all of this leaflet carefully before this medicine is given, 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.

Contents of the leaflet

1. What SmofKabiven Peripheral is and what it is used for
2. Important information before receiving 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

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

SmofKabiven Peripheral is an infusion emulsion administered to the patient via intravenous infusion (IV infusion).
The medicine comes in a plastic bag containing amino acids (components necessary for protein formation), glucose (carbohydrates), fats (lipids) and salts (electrolytes). SmofKabiven Peripheral may be used in adults and children aged 2 years and older.
Healthcare professionals administer SmofKabiven Peripheral when other methods of nutrition are insufficient or not possible.

2. Important information before using SmofKabiven Peripheral

Do not use SmofKabiven Peripheral if the patient has:

• Hypersensitivity to the active substances or to any of the other components of this medicine (listed in section 6);
• Allergy to fish protein or eggs;
• Allergy to peanuts or soy (SmofKabiven Peripheral contains soybean oil);
• High levels of fats in the blood (hyperlipidemia);
• Severe liver function disorders;
• Blood clotting problems (coagulation disorders);
• Amino acid metabolism disorder;
• Severe kidney disease without possibility of dialysis;
• Acute shock;
• Uncontrolled high blood glucose levels (hyperglycemia);
• Increased blood (serum) concentration of any of the electrolytes contained in SmofKabiven Peripheral;
• Fluid in the lungs (acute pulmonary edema);
• Excess fluid in the body (hypervolemia);
• Untreated heart failure;
• Coagulation system disorder (hemophagocytic syndrome);
• Unstable clinical condition, e.g. severe trauma, uncontrolled diabetes, acute myocardial infarction, stroke, thrombosis, metabolic acidosis (a disorder characterized by excessive amounts of acidic substances in the blood), severe infection (severe sepsis), coma, or hypotonic dehydration (fluid deficiency).

SmofKabiven Peripheral should not be used in children under 2 years of age.

Warnings and precautions
Before starting treatment with SmofKabiven Peripheral, discuss with the doctor if the patient has:

• Kidney disease;
• Diabetes;
• Pancreatitis;
• Liver disease;
• Hypothyroidism (thyroid disorders);
• Sepsis (severe infection).

If fever, rash, swelling, breathing difficulties, chills, sweating, nausea or vomiting occur during infusion, medical personnel must be informed immediately, as these symptoms may be due to an allergic reaction or administration of too high a dose of the medicine.
The doctor may recommend regular blood tests to monitor liver function and other parameters.

Children and adolescents
SmofKabiven Peripheral is not intended for use in newborns or children under 2 years of age. SmofKabiven Peripheral may be administered to children aged 2 to 16/18 years.

SmofKabiven Peripheral and other medicines
Inform the doctor about all medicines currently used or recently used by the patient, as well as any medicines the patient intends to use, including those available without prescription.

Pregnancy and breastfeeding
There are no data available on the use of SmofKabiven Peripheral during pregnancy or breastfeeding. SmofKabiven Peripheral should be administered to pregnant or breastfeeding women only if considered necessary by the physician. SmofKabiven Peripheral may be given during pregnancy and breastfeeding under medical supervision.

Driving and operating machinery
Not applicable, as SmofKabiven Peripheral is administered in a hospital setting.

3. How to use SmofKabiven Peripheral

This medicine should always be used exactly as directed by the doctor. If in doubt, consult the doctor.
The doctor will determine the individual dose according to body weight and the patient's clinical condition.
SmofKabiven Peripheral is administered only by trained medical personnel.
Use of a higher than recommended dose of SmofKabiven Peripheral
It is unlikely that a patient would receive an overdose of SmofKabiven Peripheral, since this medicine is administered by trained medical personnel.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in up to 1 in 10 patients):
slight increase in body temperature, inflammation of superficial peripheral veins at the injection site.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
elevated liver enzyme levels in blood, loss of appetite, nausea, vomiting, chills, dizziness, and headache.

Rare adverse reactions (may occur in up to 1 in 1000 patients):
low or high blood pressure, breathing difficulties, increased heart rate (tachycardia). Hypersensitivity reactions (which may present with symptoms such as swelling, fever, drop in blood pressure, skin rash, blisters (raised red spots), redness, headache). Sensation of heat and cold. Pallor. Mild cyanosis of lips and skin (related to blood hypoxia). Pain in the neck, back, bones, chest, and lower back.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to 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.
Do not store above 25°C. Do not freeze. Store in the outer bag.
Do not use this medicine after the expiry date stated on the bag and cardboard box. The expiry date refers to the last day of the indicated month.

6. Contents of the pack and other information

What SmofKabiven Peripheral contains
The active substances are:
g per 1000 ml
glucose (monohydrate) 71
alanine 4.4
arginine 3.8
glycine 3.5
histidine 0.93
isoleucine 1.6
leucine 2.3
lysine (as acetate) 2.1
methionine 1.3
phenylalanine 1.6
proline 3.5
serine 2.1
taurine 0.32
threonine 1.4
tryptophan 0.63
tyrosine 0.12
valine 2.0
calcium chloride (as dihydrate) 0.18
sodium glycerophosphate (as monohydrate) 1.3
magnesium sulfate (as heptahydrate) 0.38
potassium chloride 1.4
sodium acetate (as trihydrate) 1.1
zinc sulfate (as heptahydrate) 0.004
refined soybean oil 8.5
medium-chain triglycerides 8.5
refined olive oil 7.0
fish oil rich in omega-3 fatty acids 4.2

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

What SmofKabiven Peripheral looks like and contents of the pack
Glucose and amino acid solutions are clear, colourless to slightly yellow, and free from particulate matter. The fat emulsion is white and homogeneous.

Pack sizes:
1 × 1206 ml, 4 × 1206 ml
1 × 1448 ml, 4 × 1448 ml
1 × 1904 ml, 4 × 1904 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fresenius Kabi AB
SE-751 74 Uppsala
Sweden

Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
Fresenius Kabi AB
SE-751 74 Uppsala
Sweden

For further information, contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Tel.: +48 22 345 67 89

Information intended exclusively for medical professionals:

Warnings and precautions for use
To avoid risks associated with infusion rates exceeding the recommended rate, continuous and appropriately controlled administration is recommended, preferably using a volumetric pump.
Since the use of peripheral veins for infusion is associated with an increased risk of infection, strict adherence to aseptic procedures during catheter insertion and handling is recommended to prevent any infection.
Monitoring of serum glucose and electrolyte concentrations, osmolality, fluid balance and acid-base equilibrium, as well as performance of liver enzyme tests, is also recommended.
If any signs or symptoms of an anaphylactic reaction (such as fever, chills, rash or dyspnea) occur, the infusion must be stopped immediately.
SmofKabiven Peripheral should not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
When infusions are administered into peripheral veins, there is a risk of thrombophlebitis. Local signs of thrombophlebitis at the catheter insertion site should be checked daily.

Method of administration
Intravenous administration, infusion into peripheral or central veins.
To ensure complete parenteral nutrition, microelements, vitamins and, if necessary, electrolytes (taking into account electrolytes already present in SmofKabiven Peripheral) should be added to SmofKabiven Peripheral according to the patient's individual needs.

Dosage

Adult patients
Recommended dosage
The recommended dose range is 20 to 40 ml of SmofKabiven Peripheral per kg body weight per day, providing 0.6 to 1.3 g of amino acids per kg body weight per day (corresponding to 0.10 to 0.20 g nitrogen per kg body weight per day) and 14 to 28 kcal per kg body weight per day of total energy (11 to 22 kcal per kg body weight per day of non-protein energy).

Infusion rate
The maximum infusion rate is 0.25 g glucose/kg body weight/hour, 0.1 g amino acids/kg body weight/hour, and 0.15 g lipids/kg body weight/hour.
The infusion rate should not exceed 3.0 ml/kg body weight/hour (corresponding to 0.10 g amino acids, 0.21 g glucose and 0.08 g lipids per kg body weight per hour). The recommended duration of infusion is 14 to 24 hours.

Maximum daily dose
The maximum daily dose depends on the patient's clinical condition and may vary from day to day. The recommended maximum daily dose is 40 ml/kg body weight per day.

Children and adolescents

Children aged 2–11 years
Recommended dosage
A dose of up to 40 ml/kg body weight per day should be regularly adjusted according to the individual requirements of pediatric patients, which vary more significantly than in adults.

Infusion rate
The recommended maximum infusion rate is 3.0 ml/kg body weight/hour (corresponding to 0.10 g amino acids, 0.21 g glucose and 0.08 g lipids per kg body weight per hour). The recommended duration of infusion is 12 to 24 hours.
Except in special circumstances, when administering the maximum recommended daily dose, the infusion duration should not be shorter than 13 hours to avoid exceeding the maximum infusion rate.

Maximum daily dose
The maximum daily dose varies depending on the patient's clinical condition and may change from day to day. The maximum recommended daily dose is 40 ml/kg body weight per day.

Adolescents aged 12–16/18 years
SmofKabiven Peripheral may be dosed in adolescents as in adult patients.

Special precautions for removal and preparation of the medicinal product for administration
Do not use if the packaging is damaged.
Use only if the amino acid and glucose solutions are clear, colorless to slightly yellow, and the lipid emulsion is white and homogeneous. The contents of the three separate compartments should be mixed before use, as well as before adding any other substances through the designated port.
After removing the protective seals, invert the bag several times to thoroughly mix all components and obtain a homogeneous mixture without visible signs of phase separation.
For single use only. Any unused portions of the medicinal product remaining after infusion must be discarded.

Compatibility
Compatibility data are available for the following medicinal products: Dipeptiven, Addamel N/Supliven, Glycophos, Addiphos, Vitalipid N Adult/Infant and Soluvit N, in specified quantities and with electrolytes at specified concentrations. When adding electrolytes, their quantities already present in the bag must be taken into account to meet the patient's clinical requirements. Available data confirm the compatibility of the above-mentioned medicinal products when added to the activated bag according to the table below:
Compatibility range: stable for 7 days, i.e. 6 days stored at 2–8 °C, followed by 24 hours at 20–25 °C.

Warning: This table is intended to demonstrate compatibility. It does not constitute dosing guidelines. The approved package leaflets must be consulted before prescribing the aforementioned medicinal products.
Information on compatibility with other additives and storage times for various mixtures is available on request.
All additives must be combined with the medicinal product under aseptic conditions.

Shelf life after mixing the contents of the bag compartments
Physical and chemical stability of the mixed contents of the three-compartment bag has been demonstrated for 48 hours at 20–25 °C. From a microbiological standpoint, the product should be used immediately. Otherwise, the user is responsible for the in-use storage period and storage conditions prior to use. This period should not generally exceed 24 hours at 2–8 °C, unless mixing was carried out under controlled and validated aseptic conditions.

Shelf life after mixing with additional substances
Physico-chemical stability of the mixed contents of the three-compartment bag with additional substances has been demonstrated for up to 7 days: 6 days at 2–8 °C, followed by 24 hours at 20–25 °C, including infusion duration. From a microbiological standpoint, the product should be used immediately after addition of other components. Otherwise, the user is responsible for the in-use storage period and storage conditions prior to use. This period should not generally exceed 24 hours at 2–8 °C, unless mixing was carried out under controlled and validated aseptic conditions.

SmofKabiven Peripheral Instructions for preparing the bag for use

1. Cut in the outer bag
2. Bag handle
3. Hanger hole
4. Seals separating the individual bag compartments
5. Blind port (used only during manufacturing)
6. Port for administration of additional substances
7. Infusion port
8. Oxygen absorber

1. Removal of the outer bag

To remove the outer pouch, lay it flat and starting from the slit
located near the ports, tear along the top edge (A).
Then tear the outer pouch along the long edge, remove it and discard together
with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Starting from the handle side, tightly roll the bag towards the ports, first with the right hand, then applying steady pressure with the left hand until the vertical seals rupture. These seals open under fluid pressure. The seals may also be opened before removing the outer bag. Note: The solution mixes easily even if the horizontal seal remains intact.

• Mix the contents of the three compartments thoroughly by inverting the bag three times, which should ensure adequate mixing of the components.

3. Final preparation steps

• Place the bag again on a flat, level surface. Just before adding additional substances, remove the single-use cap marked with an arrow protecting the white port for administration of additional substances (A). Note: The membrane of the port for additional substances is sterile.
• Hold the base of the port for administration of additional substances. Insert the needle and inject the additional substances (known to be compatible) through the center of the injection site (B).
• After each addition, mix the bag contents thoroughly by inverting the bag three times. Use syringes with needles sized 18 to 23 G and with a maximum length of 40 mm.

• Just before connecting the infusion set, remove the single-use cap protecting the blue infusion port (A). Note: The membrane of the infusion port is sterile.
• Use infusion sets without an air vent, or close the air vent if present.
• Hold the base of the infusion port.
• Insert the spike of the infusion set into the infusion port. To ensure proper fixation, insert the entire length of the spike. Note: The inner surface of the infusion port is sterile.

4. Hanging the bag

• Hang the bag using the hole located below the handle.