Smofkabiven low osmo peripheral

Package leaflet: Information for the user

SmofKabiven Low Osmo Peripheral, infusion emulsion
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What SmofKabiven Low Osmo Peripheral is and what it is used for
2. Important information before using SmofKabiven Low Osmo Peripheral
3. How to use SmofKabiven Low Osmo Peripheral
4. Possible side effects
5. How to store SmofKabiven Low Osmo Peripheral
6. Contents of the pack and other information

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

SmofKabiven Low Osmo Peripheral is an infusion emulsion administered to the patient via intravenous infusion (intravenous infusion). The medicine comes in a plastic bag containing amino acids (components necessary for protein formation), glucose (carbohydrates), fats (lipids) and salts (electrolytes). The medicine may be used in adults and children aged 2 years and above.
SmofKabiven Low Osmo Peripheral is administered by specialized medical personnel when other methods of nutrition are insufficient, impossible or contraindicated.

2. Important information before using SmofKabiven Low Osmo Peripheral

Do not use SmofKabiven Low Osmo 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 or egg protein;

• allergy to peanuts or soy, SmofKabiven Low Osmo Peripheral contains soybean oil;

• excessively high levels of fats in the blood (hyperlipidemia);

• severe liver function impairment;

• severe coagulation disorders (coagulation disorders);

• amino acid metabolism disorder;

• severe kidney disease without possibility of dialysis;

• acute shock;

• untreated or poorly controlled high blood glucose levels (hyperglycemia);

• elevated blood (serum) levels of any of the electrolytes contained in SmofKabiven Low Osmo Peripheral;

• fluid in the lungs (acute pulmonary edema);

• fluid overload (hypervolemia);

• untreated heart failure;

• coagulation disorders (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 systemic inflammatory response), coma, fluid deficiency (hypotonic dehydration);

• should not be used in neonates and children under 2 years of age.

Warnings and precautions
Before using SmofKabiven Low Osmo Peripheral, inform 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, notify the doctor or nurse 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 tests and other parameters.

Children and adolescents
SmofKabiven Low Osmo Peripheral is not intended for administration to neonates or children under 2 years of age. SmofKabiven Low Osmo Peripheral may be administered to children and adolescents aged 2 to 18 years.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no data available on the use of SmofKabiven Low Osmo Peripheral during pregnancy. SmofKabiven Low Osmo Peripheral may be administered to pregnant women or women who are breastfeeding only if the doctor considers it necessary. SmofKabiven Low Osmo Peripheral may be administered during pregnancy on a doctor's prescription.
There are no data available on the use of SmofKabiven Low Osmo Peripheral during breastfeeding.
Components and metabolites of parenteral nutrition medicines such as SmofKabiven Low Osmo Peripheral pass into human milk. Parenteral nutrition may be necessary during lactation. SmofKabiven Low Osmo Peripheral should be administered to breastfeeding women only after careful consideration of potential risks and benefits.

Driving and operating machinery
Not applicable, as this medicine is administered in a hospital setting.

3. How to use SmofKabiven Low Osmo Peripheral

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
the doctor.
The doctor will determine the individual dose based on the patient's body weight and clinical condition.
SmofKabiven Low Osmo Peripheral is administered only by specialized medical personnel.
Use of a higher than recommended dose of SmofKabiven Low Osmo Peripheral
It is unlikely that a patient would receive an excessive dose of SmofKabiven Low Osmo
Peripheral, as this medicine is administered by specialized medical personnel.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Common adverse reactions (may occur in not more than 1 in 10 patients): slight increase in body temperature, inflammation of superficial peripheral veins at the injection site.
Uncommon adverse reactions (may occur in not more than 1 in 100 patients): elevated liver enzyme activity in blood, loss of appetite, nausea, vomiting, chills, dizziness, and headache.
Rare adverse reactions (may occur in not more than 1 in 1000 patients): low or high blood pressure, breathing difficulties, rapid heart rate (tachycardia). Hypersensitivity reactions (causing symptoms such as swelling, fever, drop in blood pressure, skin rash, blisters (raised, red spots), redness, headache). Feeling hot and cold. Pallor. Mild cyanosis of lips and skin (related to blood hypoxia). Pain in neck, back, bones, chest, and lumbar region.
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 Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: [email protected]
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 the medicinal product SmofKabiven Low Osmo Peripheral

The medicine should be stored in a place out of sight and reach of children.
Store inside the outer bag. Do not store above 25°C.
Do not freeze.
Do not use this medicine after the expiry date stated on the bag and the cardboard box. The expiry date refers to the last day of the stated month.

6. Contents of the packaging and other information

What SmofKabiven Low Osmo Peripheral contains
The active substances are:
g per 1000 ml
Glucose
(in monohydrate form)
Alanine 3.5
Arginine 3.0
Glycine 2.8
Histidine 0.75
Isoleucine 1.3
Leucine 1.9
Lysine 1.7
(as acetate)
Methionine 1.1
Phenylalanine 1.3
Proline 2.8
Serine 1.6
Taurine 0.25
Threonine 1.1
Tryptophan 0.50
Tyrosine 0.10
Valine 1.6
Calcium chloride 0.14
(as dihydrate)
Sodium glycerophosphate 1.0
(as hydrated form)
Magnesium sulfate 0.30
(as heptahydrate)
Potassium chloride 1.1
Sodium acetate 0.85
(as trihydrate)
Zinc sulfate 0.0032
(as heptahydrate)
Soybean oil, purified 11
Medium-chain triglycerides 11
Purified olive oil 8.8
Fish oil rich in omega-3 fatty acids 5.3

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 Low Osmo Peripheral looks like and contents of the packaging
Solutions of glucose and amino acids are clear, colourless to slightly yellow, and free from
particulate matter. The fat emulsion is white and homogeneous.

Pack sizes:
1 x 850 ml, 5 x 850 ml
1 x 1400 ml, 4 x 1400 ml
1 x 1950 ml, 4 x 1950 ml
1 x 2500 ml, 3 x 2500 ml

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

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria SmofKabiven Low Osmo peripher
Emulsion zur Infusion
Belgium SmofKabiven Low Osmo Perifeer
Smofkabiven Low Osmo Périphérique
SmofKabiven Low Osmo Peripher
Bulgaria СмофКабивен Лоу Осмо Периферал
инфузионна емулсия
Croatia SmofKabiven Low Osmo Peripheral
Cyprus SmofKabiven Low Osmo Peripheral
Czech Republic SmofKabiven Low Osmo Peripheral
Denmark SmofKabiven Low Osmo Peripheral
Estonia SmofKabiven Low Osmo Peripheral
Finland SmofKabiven Low Osmo Peripheral
Greece SmofKabiven Low Osmo Peripheral
Spain SmofKabiven Low Osmo Periférico
Netherlands SmofKabiven Low Osmo Perifeer
Ireland SmofKabiven Low Osmo Peripheral
Iceland SmofKabiven Low Osmo Peripheral
Lithuania SmofKabiven Low Osmo Peripheral
Latvia SmofKabiven Low Osmo Peripheral
Luxembourg SmofKabiven Low Osmo peripher
Emulsion zur Infusion
Germany SmofKabiven Low Osmo peripher
Emulsion zur Infusion
Norway SmofKabiven Low Osmo Peripheral
Poland SmofKabiven Low Osmo Peripheral
Portugal SmofKabiven Low Osmo Peripheral
Romania SmofKabiven Low Osmo Peripheral
emulsie perfuzabilă
Slovakia SmofKabiven Low Osmo Peripheral
Slovenia SmofKabiven Peripheral Low Osmo
emulzija za infundiranje
Sweden SmofKabiven Low Osmo Peripheral
Hungary SmofKabiven Low Osmo Peripheral
United Kingdom SmofKabiven Low Osmo Peripheral

Information intended exclusively for medical professionals:

Warnings and precautions for use
To avoid risks associated with infusion rates exceeding the recommended rate, it is advised to administer the infusion continuously and appropriately controlled, 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 techniques during catheter insertion and handling is recommended to prevent any infection.
It is also recommended to monitor serum glucose and electrolyte concentrations, osmolarity, fluid balance and acid-base equilibrium, as well as liver enzymes.
If any signs or symptoms of anaphylactic reaction occur (such as fever, chills, rash, or dyspnea), the infusion must be stopped immediately.
SmofKabiven Low Osmo Peripheral must not be administered simultaneously with blood through the same infusion set due to the risk of pseudoagglutination.
When peripheral veins are used for infusion, thrombophlebitis may occur. The catheter insertion site should be examined daily for local signs of thrombophlebitis.

Administration method
Intravenous administration, infusion into peripheral or central vein.
To ensure complete parenteral nutrition, trace elements, vitamins, and if necessary electrolytes (taking into account electrolytes already present in SmofKabiven Low Osmo Peripheral) should be added to SmofKabiven Low Osmo Peripheral according to the patient's individual requirements.

Dosage
Adult patients
Recommended dose
The dosage range is 20 to 40 ml of SmofKabiven Low Osmo Peripheral/kg body weight/day, providing 0.08 to 0.16 g nitrogen/kg body weight/day (0.5 to 1.0 g amino acids/kg body weight/day) and 14 to 29 kcal/kg body weight/day of total energy (12 to 25 kcal/kg body weight/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 fat/kg body weight/hour.
The infusion rate should not exceed 3.7 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acids, and 0.13 g fat/kg body weight/hour). The recommended duration of infusion is 12 to 24 hours.

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

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

Infusion rate
The recommended maximum infusion rate is 4.0 ml/kg body weight/hour (corresponding to 0.10 g amino acids/kg body weight/hour, 0.27 g glucose/kg body weight/hour, and 0.14 g fat/kg body weight/hour).
Except in special circumstances requiring careful monitoring, when the recommended maximum infusion rate is used, the infusion duration should not exceed 10 hours.
The recommended duration of infusion is 12–24 hours.

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

Adolescents aged 12–18 years
In adolescents, SmofKabiven Low Osmo Peripheral may be dosed as in adults.

Special precautions for disposal and preparation of the medicinal product for administration
Do not use if the packaging is damaged.
Use only when amino acid and glucose solutions are clear, colorless to slightly yellow, and the fat emulsion is white and homogeneous. The contents of the three separate compartments must be mixed before use, as well as before adding any other substances via the designated port.
After removing the protective seals, the bag should be inverted several times to thoroughly mix all components and achieve a homogeneous mixture with no visible signs of phase separation.
For single use only. Any remaining medicinal product after infusion must be discarded.

Compatibility
Compatibility data are available for the following products from the manufacturer: Dipeptiven, Supliven, Vitalipid N Adult and Soluvit N (lyophilized), Addiphos and Glycophos at specified quantities, as well as generic sodium or potassium products at specified concentrations. When adding sodium, potassium, or phosphates, their already present amounts in the bag must be taken into account to meet the patient's clinical needs. Product compatibility with individual additives has been confirmed according to the table below:

Warning: This table is intended to demonstrate compatibility only. It is not a dosage recommendation.
All additives must be combined with the medicinal product under aseptic conditions.
Stability after mixing
Physical and chemical stability of the contents of the three-chamber bag has been demonstrated for 36 hours at 25°C. From a microbiological point of view, the product should be used immediately. Otherwise, the user is responsible for the in-use storage duration and storage conditions prior to use. This period should not generally exceed 24 hours at 2–8°C.
Stability after mixing with additional substances
From a microbiological point of view, the product should be used immediately after addition of other components. Otherwise, the user is responsible for the in-use storage duration and storage conditions prior to use. This period should not generally exceed 24 hours at 2–8°C.

Instructions for use of SmofKabiven Low Osmo Peripheral
Bag
850 ml, 1400 ml, 1950 ml, 2500 ml

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

1. Removing the outer bag

• To remove the outer bag, lay it flat and starting from the perforation near the ports, tear along the upper edge (A).
• Then tear the outer bag along the long edge, remove and discard it together with the oxygen absorber (B).

2. Mixing

• Place the bag on a flat surface.
• Starting from the handle side, firmly roll the bag towards the ports, first using 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 liquid mixes easily even though the horizontal seal remains intact.

• Mix the contents of the three chambers 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 closure cap marked with an arrow, which protects 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 additional substances (with known compatibility) 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 closure 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 infusion spike fully 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.