SmofKabiven Peripheral emulsion for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SmofKabiven Peripheral 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 questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before using 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 Periférico is and what it is used for

SmofKabiven Periférico is an infusion emulsion administered into your blood through an intravenous drip (intravenous infusion). The product contains amino acids (components used in protein formation), glucose (carbohydrates), lipids (fats), and salts (electrolytes) in a plastic bag, which can be administered to adults or children aged 2 years and older.

A healthcare professional will administer SmofKabiven Periférico to you when other forms of nutrition are insufficient or not possible.

2. What you need to know before using SMOFKABIVEN PERIPHERAL

Do not use SmofKabiven Peripherical:

• if you are allergic (hypersensitive) to the active substances or to any of the other components
  of this medicine (listed in section 6).
• if you are allergic to fish or egg
• if you are allergic to peanuts or soy, you should not use this product. SmofKabiven
  Peripherical contains soybean oil.
• if you have too much fat in your blood (hyperlipidemia)
• if you have severe liver disease
• if you have blood clotting disorders (coagulation disorders)
• if your body has problems utilizing amino acids
• if you have severe kidney disease without possibility of dialysis
• if you are in acute shock
• if you have too much sugar in your blood (hyperglycemia) that is not controlled
• if you have high levels in blood (serum) of the salts (electrolytes) contained in
  SmofKabiven Peripherical
• if you have fluid in the lungs (acute pulmonary edema)
• if you have too much fluid in your body (hyperhydration)
• if you have heart failure that is not being treated
• if you have a defect in your blood clotting system (hemophagocytic syndrome)
• if you are in an unstable condition, such as after severe trauma, uncontrolled diabetes mellitus, acute heart attack, stroke, blood clot, metabolic acidosis (a disorder leading to excess acid in your blood), severe infection (severe sepsis), coma, or if you do not have enough fluid in your body (hypotonic dehydration).
• in children under 2 years of age

Warnings and precautions

Consult your doctor before starting to use SmofKabiven Peripherical if you have:

• kidney problems
• diabetes mellitus
• pancreatitis (inflammation of the pancreas)
• liver problems
• hypothyroidism (thyroid problems)
• sepsis (serious infection)

If during the infusion you develop fever, skin rash, swelling, difficulty breathing, chills, sweating, nausea or vomiting, inform your healthcare professional immediately, as these symptoms could be due to an allergic reaction or because you are receiving too high a dose of the medicine.

Your doctor will need to regularly monitor your blood to check liver function tests and other parameters.

Children and adolescents

SmofKabiven Peripherical is not intended for newborns or children under 2 years of age. SmofKabiven Peripherical may be administered to children aged 2 to 16/18 years.

Use of SmofKabiven Peripherical with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

There is no information available on the use of SmofKabiven Peripherical during pregnancy or breastfeeding. Therefore, SmofKabiven Peripherical should only be administered to pregnant or breastfeeding women if considered necessary by the doctor. The use of SmofKabiven Peripherical may be considered during pregnancy and breastfeeding if advised by your doctor.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Not applicable, as this medicine is administered in hospital.

3. How to use SMOFKABIVEN PERIFERAL

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will individually determine your dose based on your body weight and condition. SmofKabiven Peripheral will be administered to you by a healthcare professional.

If you are given more SmofKabiven Peripheral than you should:

It is very unlikely that you would receive too much medicine, as SmofKabiven Peripheral will be administered by a healthcare professional.

4. Possible adverse effects

Like all medicines, SmofKabiven Periferal can cause adverse effects,
although not everyone will experience them.

Frequent (may affect up to 1 in 10 patients): a slight increase in body temperature. Inflammation of superficial peripheral veins in contact with the injection site.

Uncommon (may affect up to 1 in 100 patients): elevated blood (plasma) levels of liver components, loss of appetite, nausea, vomiting, chills, dizziness, and headache.

Rare (may affect up to 1 in 1,000 patients): low or high blood pressure, difficulty breathing, rapid heart rate (tachycardia). Hypersensitivity reactions (which may cause symptoms such as swelling, fever, drop in blood pressure, skin rash, hives (red, swollen areas), redness, headache). Sensations of cold and heat. Pallor. Bluish discoloration of lips and skin (due to lack of oxygen in the blood). Pain in the neck, back, bones, chest, and lumbar region.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of SMOFKABIVEN PERIFÉRICO

Keep this medicine out of the sight and reach of children.

Store within the overpouch. Do not store above 25°C. Do not freeze.

Do not use this medicine after the expiry date stated on the bag and the carton.

The expiry date refers to the last day of the month indicated.

6. Contents of the pack and other information

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

Appearance of the product 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 homogeneous.

Pack sizes:

1 x 1,206 ml, 4 x 1,206 ml

1 x 1,448 ml, 4 x 1,448 ml

1 x 1,904 ml, 4 x 1,904 ml

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Fresenius Kabi España S.A.U.
C/ Marina 16-18,
08005 Barcelona (Spain)

Manufacturer:

Fresenius Kabi AB, SE-751 74 Uppsala, Sweden
Fresenius Kabi Austria GmbH, AT-8055 Graz, Austria

For any information about this product, please contact the Marketing Authorisation Holder.

Date of the most recent revision of this leaflet: March 2023

This information is intended for healthcare professionals only:

Warnings and special precautions for use

To avoid risks associated with excessively rapid infusion rates, continuous and carefully controlled infusion is recommended, preferably using an infusion pump.

Since the use of a peripheral vein is associated with a high risk of infection, strict aseptic precautions must be taken to prevent contamination, especially during catheter insertion and handling.

Serum glucose, electrolytes and osmolarity, as well as fluid balance, acid-base balance and liver enzyme tests, should be monitored.

If any sign or symptom of anaphylactic reaction occurs (such as fever, chills, skin rash or dyspnoea), 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.

Thrombophlebitis may occur when peripheral veins are used for infusion. The catheter insertion site should be evaluated daily for local signs of thrombophlebitis.

Method of administration

Intravenous use, infusion via a peripheral or central vein.

To provide complete parenteral nutrition, trace elements, vitamins and possibly electrolytes should be added to SmofKabiven Peripheral (taking into account the electrolytes already present in SmofKabiven Peripheral), according to the patient's needs.

Dosage

Adults

Dosage: A dosage range of 20–40 ml of SmofKabiven Peripheral/kg body weight/day provides 0.6–1.3 g of amino acids/kg body weight/day (corresponding to 0.10–0.20 g nitrogen/kg body weight/day) and 14–28 kcal/kg body weight/day of total energy (11–22 kcal/kg body weight/day of non-protein energy).

Infusion rate

The maximum infusion rate for glucose is 0.25 g/kg body weight/h, for amino acids 0.1 g/kg body weight/h, and for lipids 0.15 g/kg body weight/h.

The infusion rate must not exceed 3.0 ml/kg body weight/hour (equivalent to 0.10 g of amino acids, 0.21 g of glucose and 0.08 g of lipids/kg body weight/h). The recommended infusion period is 14–24 hours.

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

Paediatric population

Children (2–11 years)

Dosage:

A dose of up to 40 ml/kg body weight/day should be regularly adjusted according to the varying requirements of paediatric patients, which differ more than in adult patients.

Infusion rate:

The maximum infusion rate is 3.0 ml/kg body weight/h (equivalent to 0.10 g of amino acids/kg/h, 0.21 g of glucose/kg/h and 0.08 g of lipids/kg/h).

The recommended infusion period is 12–24 hours.

If the recommended maximum daily dose is used, the dose should be infused over a period of at least 13 hours to avoid exceeding the recommended maximum infusion rate, except in special cases.

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

Adolescents (12–16/18 years)

SmofKabiven Peripheral may be used in adolescents in the same way as in adults.

Precautions for use

Do not use the container if it is damaged.

Use only if the amino acid and glucose solutions are clear, colourless or slightly yellow, and if the lipid emulsion is white and homogeneous. The contents of the three separate chambers must be mixed before use, and before any addition is made via the additive port.

After opening the peel seals, the bag should be inverted several times to ensure a homogeneous mixture without evidence of phase separation.

For single use only. Any unused mixture should be discarded after infusion.

Compatibility

Compatibility data are available for defined quantities with the following commercially named products: Dipeptiven 200 mg/ml, Supliven, Glycophos 216 mg/ml, Vitalipid Adult/Infant and Soluvit lyophilised, and generic electrolytes at defined concentrations. When adding electrolytes, the amounts already present in the bag must be taken into account to meet the patient's clinical requirements. Available data support additions to the activated bag as summarised in the table below.

Stable compatibility range for 7 days, i.e., 6 days of storage at 2–8°C followed by 24 hours at 20–25°C.

1 includes the quantities of all products.

Note: This table is intended to indicate compatibility. It is not a dosing guide. For products with brand names, consult the approved summary of product characteristics before prescribing.

Data on compatibility with other additives and shelf life of various mixtures are available upon request.

Additions must be made aseptically.

Stability period after mixing the chambers of the bag

Physical and chemical stability of the mixed three-chamber bag has been demonstrated for 48 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time before use and the conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2–8°C, unless the mixing was carried out under controlled and validated aseptic conditions.

Stability period after mixing with additives

Physical and chemical stability during use of the mixed three-chamber bag with additives has been demonstrated for up to 7 days, i.e., 6 days at 2–8°C followed by 24 hours at 20–25°C, including the duration of administration. From a microbiological standpoint, the product should be used immediately after additives are added. If not used immediately, the storage time before use and the conditions prior to use are the responsibility of the user. Storage time should normally not exceed 24 hours at 2–8°C, unless the mixing was carried out under controlled and validated aseptic conditions.

Instructions for use of SmofKabiven Peripheral

The bag

1. Perforations on the overpouch

2. Hanger

3. Hanging ring for the bag

4. Peel seal

5. Non-functional port (used only during manufacturing)

6. Addition port

7. Infusion port

8. Oxygen absorber

9. Removal of the overpouch

• To remove the overpouch, hold it horizontally and tear at the perforation towards the ports along the upper edge (A).
• Then tear along the package; separate the overpouch and discard it together with the oxygen absorber (B).

1. Mixing

• Place the bag on a flat surface.
• Firmly roll the bag from the hanger end toward the ports, first with the right hand, then applying constant pressure with the left hand until the vertical seal breaks. The peel seal opens due to fluid pressure. Peel seals may also be opened before removing the overpouch.

Note: Liquids mix easily even if the horizontal seal remains closed.

• Mix the contents of the three chambers by inverting the bag three times until components are completely mixed.

1. Completion of preparation:

• Place the bag again on a flat surface. Just before injecting additives, break the white addition port at the arrow mark (A).

Note: The membrane of the addition port is sterile.

• Hold the base of the addition port. Insert the needle and inject the additives (known to be compatible) into the center of the injection site (B).
• Mix thoroughly between each addition by inverting the bag three times. Use syringes with needles of gauge 18–23 and a maximum length of 40 mm.

• Just before inserting the infusion set, break the blue infusion port at the arrow mark (A).

Note: The membrane of the infusion port is sterile.

• Use a non-vented infusion set or close the air inlet of a vented infusion set.
• Hold the base of the infusion port.
• Insert the needle through the infusion port. The spike must be fully inserted to ensure retention.

Note: The inner part of the infusion port is sterile.

1. Hanging the bag

• Hang the bag by the ring located beneath the hanger.