Smofkabiven Lov Osmo Peripheral

Leaflet accompanying the packaging: information for the user

SmofKabiven Low Osmo Peripheral,infusion emulsion

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. See section 4.

Table of 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 packaging 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 through a drip (intravenous infusion). The packaging of the medicine consists of a plastic bag containing amino acids (essential components for creating proteins), glucose (carbohydrates), fats (lipids), and salts (electrolytes). The medicine can be used in adults and children over 2 years of age.
Specialized medical personnel administer SmofKabiven Low Osmo Peripheral 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:

• allergy to active substances or any of the other ingredients of this medicine (listed in section 6);
• allergy to fish protein or eggs;
• allergy to peanuts or soy, SmofKabiven Low Osmo Peripheral contains soy oil;
• too high a level of fats in the blood (hyperlipidemia);
• severe liver dysfunction;
• severe blood coagulation disorders (coagulation disorders);
• amino acid metabolism disorder;
• severe kidney disease, without the possibility of dialysis;
• acute shock;
• ineffectively treated increased blood glucose levels (hyperglycemia);
• increased levels of any of the electrolytes contained in SmofKabiven Low Osmo Peripheral in the blood (serum);
• fluid in the lungs (acute pulmonary edema);
• too much fluid in the body (overhydration);
• untreated heart failure;
• blood coagulation disorder (hemophagocytic syndrome);
• unstable general condition, e.g. severe post-traumatic condition, uncontrolled diabetes, acute myocardial infarction, stroke, thrombosis, metabolic acidosis (a disorder characterized by too much acidic substance in the blood), severe infection (severe systemic inflammatory response), coma, fluid deficiency (hypotonic dehydration);

and
should not be used in newborns 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;
• thyroid dysfunction (thyroid disorders);
• sepsis (severe infection).

If during infusion, fever, rash, swelling, breathing difficulties, chills, sweating, nausea, or vomiting occur, immediately inform the doctor or nurse, as these symptoms may be caused by an allergic reaction or administration of too high a dose of the medicine.
The doctor may recommend regular blood tests to determine liver function tests and other values.

Children and adolescents

SmofKabiven Low Osmo Peripheral is not intended for administration to newborns or children under 2 years of age. SmofKabiven Low Osmo Peripheral can be administered to children and adolescents from 2 to 18 years of age.

SmofKabiven Low Osmo Peripheral and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as medicines the patient plans to take, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
There is no data on the use of SmofKabiven Low Osmo Peripheral during pregnancy.
SmofKabiven Low Osmo Peripheral is administered to pregnant women or during breastfeeding only when the doctor considers it necessary. SmofKabiven Low Osmo Peripheral may be administered during pregnancy on the doctor's instructions.
There is no data 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 breast milk. Parenteral nutrition may be necessary during lactation. SmofKabiven Low Osmo Peripheral should be administered to breastfeeding women only after considering the potential risk and benefits.

Driving and using machines

This does not apply, as the medicine is used in a hospital.

3. How to use SmofKabiven Low Osmo Peripheral

This medicine should always be used according to the doctor's instructions. In case of doubts, consult a doctor.
The doctor selects an individual dose depending on the patient's body weight and clinical condition.
SmofKabiven Low Osmo Peripheral is administered only by specialized medical personnel.

Using a higher dose of SmofKabiven Low Osmo Peripheral than recommended

It is unlikely that the patient will receive too high a dose of SmofKabiven Low Osmo Peripheral, as the medicine is administered by specialized medical personnel.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(may occur in up to 1 in 10 patients): slight increase in body temperature, inflammation of the surface veins at the injection site.
Uncommon side effects(may occur in up to 1 in 100 patients): high activity of liver enzymes in the blood, loss of appetite, nausea, vomiting, chills, dizziness, and headaches.
Rare side effects(may occur in up to 1 in 1000 patients): low or high blood pressure, breathing difficulties, rapid heart rate (tachycardia). Allergic reactions (which cause symptoms such as swelling, fever, drop in blood pressure, rash, blisters (raised, red spots), redness, headache). Feeling hot and cold. Paleness. Slight cyanosis of the lips and skin (related to hypoxia). Neck, back, bone, chest, and lumbar pain.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store SmofKabiven Low Osmo Peripheral

The medicine should be stored out of sight and reach of children.
Store in 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 carton. The expiry date refers to the last day of the month.

6. Contents of the packaging and other information

What SmofKabiven Low Osmo Peripheral contains

The active substances of the medicine are:
per 1000 ml
Glucose
(as a monohydrate)
Alanine
3.5
Arginine
3.0
Glycine
2.8
Histidine
0.75
Isoleucine
1.3
Leucine
1.9
Lysine
(as acetate)
1.7
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
(as a dihydrate)
0.14
Sodium glycerophosphate
(as a hydrated)
1.0
Magnesium sulfate
(as a heptahydrate)
0.30
Potassium chloride
1.1
Sodium acetate
(as a trihydrate)
0.85
Zinc sulfate
(as a heptahydrate)
0.0032
Soybean oil, purified
11
Triglycerides of saturated fatty acids with medium chain length
11
Purified olive oil
8.8
Fish oil rich in omega-3 fatty acids
5.3
Other ingredients (excipients) are: glycerol, purified egg phospholipids, all-rac-α-tocopherol, sodium hydroxide (to adjust pH), sodium oleate, glacial acetic acid (to adjust pH), and water for injections.

What SmofKabiven Low Osmo Peripheral looks like and contents of the packaging

The glucose and amino acid solutions are clear, colorless to slightly yellow, free of 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 authorization holder and manufacturer

Fresenius Kabi AB
SE-751 74 Uppsala
Sweden
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
phone: +48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Warnings and precautions for use

In order to avoid the risks associated with infusion at a rate higher than recommended, it is recommended to administer the infusion continuously and under proper control, if possible using a volumetric pump.
Since the use of a peripheral vein for infusion is associated with an increased risk of infection, when inserting and handling the catheter, it is recommended to strictly follow the principles of aseptic procedure to avoid any infection.
It is also recommended to monitor glucose and electrolyte levels in the serum, osmolality, and fluid balance and acid-base balance, as well as liver enzyme tests.
In case of any signs or symptoms of anaphylactic reaction (such as fever, chills, rash, or shortness of breath), the infusion should be stopped immediately.
SmofKabiven Low Osmo Peripheral should not be administered simultaneously with blood in the same infusion set, due to the risk of pseudoagglutination.
If peripheral veins are used for infusion, thrombophlebitis may occur. The site of catheter insertion should be checked daily to detect local signs of thrombophlebitis.

Method of administration

Intravenous administration, infusion into a peripheral or central vein.
In order to ensure complete parenteral nutrition, it is recommended to add microelements, vitamins, and possibly electrolytes (taking into account the electrolytes already present in the bag) to SmofKabiven Low Osmo Peripheral, according to the patient's needs.

Dosage

Adult patients
Recommended dose
The dose range is 20 to 40 ml of SmofKabiven Low Osmo Peripheral/kg body weight/day, which provides 0.08 to 0.16 g of nitrogen/kg body weight/day (0.5 to 1.0 g of 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 of glucose is 0.25 g/kg body weight/hour, amino acids 0.1 g/kg body weight/hour, and fats 0.15 g/kg body weight/hour.
The infusion rate should not exceed 3.7 ml/kg body weight/hour (which corresponds to 0.25 g of glucose, 0.09 g of amino acids, and 0.13 g of fats/kg body weight/hour). The recommended infusion time is 12 to 24 hours.
Maximum daily dose
The maximum daily dose depends 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.
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 to the needs of the pediatric patient, which change much more than in adults.
Infusion rate
The recommended maximum infusion rate is 4.0 ml/kg body weight/hour (which corresponds to 0.10 g of amino acids/kg body weight/hour, 0.27 g of glucose/kg body weight/hour, and 0.14 g of fats/kg body weight/hour).
Except in special situations that require careful monitoring, when using the recommended maximum infusion rate, the infusion time should not exceed 10 hours.
The recommended infusion time is 12-24 hours.
Maximum daily dose
The maximum daily dose is variable 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 can be dosed as in adults.

Special precautions for disposal and preparation of the medicine for use

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 fat emulsion is white and homogeneous .The contents of the three separate chambers should be mixed before use, and also before adding other substances through the designated port.
After removing the protective covers, turn the bag over several times to mix all the components of the medicine and obtain a homogeneous mixture, in which no signs of phase separation can be seen.
For single use only. The remaining medicine after infusion should be destroyed.
Compatibility
Compatibility data are available for the following medicines: Dipeptiven, Supliven, Vitalipid N Adult, and Soluvit N (lyophilized), Addiphos, and Glycophos in specified amounts, as well as generic products of sodium or potassium with specified concentrations. When adding sodium, potassium, or phosphates, take into account the amounts already present in the bag to meet the patient's clinical needs. The compatibility of the product with individual additives has been confirmed according to the table below:

Note: This table is intended to demonstrate compatibility. It is not a dosing recommendation.
Any additives should be combined with the medicine under aseptic conditions.
Shelf life after mixing
Physical and chemical stability of the mixed contents of the triple-chamber bag has been demonstrated for 36 hours at 25°C. From a microbiological point of view, the medicine should be used immediately. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not exceed 24 hours at 2-8°C.
Shelf life after mixing with additional substances
From a microbiological point of view, the medicine should be used immediately after adding other ingredients. Otherwise, the user is responsible for the storage period during use and the storage conditions before use. This period should not 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. Notch in the outer bag
• 2. Bag handle
• 3. Hole for hanging the bag
• 4. Welds separating the individual chambers of the bag
• 5. Blind port (used only in production)
• 6. Port for administering additional substances
• 7. Infusion port
• 8. Oxygen absorber

1. Removing the outer bag

• To remove the outer bag, place it horizontally and, starting from the notch located near the ports, tear it along the upper edge (A).
• Then tear the outer bag along the long edge, remove it, and discard it along 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 with the right hand and then, applying constant pressure, with the left hand, until the vertical welds break. They open under the pressure of the liquid. The welds can also be opened before removing the outer bag. Note: the liquid mixes easily, even though the horizontal weld remains intact.

• Mix the contents of the three chambers by turning the bag over three times, which should ensure thorough mixing of the ingredients.

3. Final preparation steps

• Place the bag on a flat, even surface. Just before administering additional substances, remove the labeled plug with an arrow from the white port for administering additional substances (A). Note: the membrane of the port for administering additional substances is sterile.
• Hold the base of the port for administering additional substances. Insert the needle and inject the additional substances (with known compatibility) through the center of the injection site (B).
• Mix the contents of the bag thoroughly after adding each ingredient by turning the bag over three times after each addition. Use syringes with needles of 18 to 23 G and a maximum length of 40 mm.

• Just before connecting the infusion set, remove the plug from 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.
• Hold the base of the infusion port.
• Insert the tip of the infusion device into the infusion port. To ensure good fixation of the tip, insert the entire length. Note: the inner surface of the infusion port is sterile.

4. Hanging the bag

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