SmofKabiven®

The SmofKabiven® range is the latest generation of Fresenius Kabi’s 3CBs

It sets new handling and safety standards and provides clinical advantages from its composition and components (since 2018 in Indian market)

Available in different sizes with electrolytes, peripheral and central version

SMOFlipid®: benefits of the unique 4-oil combination

The lipid emulsion SMOFlipid® 20% with

                    30% Soybean oil
                    30% Medium-chain triglycerides (MCT)
                    25% Olive oil
                    15% Fish oil
Provides a well-balanced fatty acid profile with the
recommended w-6/w-3 fatty acid ratio of 2.5/1

High amino acid content and providing taurine

Glucose: for the provision of energy in the recommended ratio

SmofKabiven® container:

Sterile port membranes – enable first use without disinfection

Self-sealing and stable ports – simplify handling

Easily opening peel seals – facilitate handling

Amino Acids : Meeting high demands with a content aminoacids

High amino acid (& nitrogen) content with Aminoven 10% and supplementation of taurine

50 g/L in the central version

32 g/L in the peripheral version

Including taurine:

May alleviate cholestasis in post-operative patients

Has immunomodulatory effects

Is a conditionally essential nutrient for

critically ill patients

postoperative patients

patients with trauma or sepsis

patients undergoing radiation or chemotherapy

1.Cooper A at al. J Pediatr Surg. 1984 Aug; 19(4): 462-6

2. Stapleton PP et al. JPEN 1998; 42-48

3. Redmond HP et al. Nutrition 1998; 14: 499-604

4. Vermeulen M et al. Clin. Nutr. Suppl. 2009; 4(2)

5. Wang WY. JPEN 1991; 15: 294- 297

6. Paauw JD. Am J Clin Nutr. 1990 Oct; 52(4): 657- 60

7. Chiarla C et al. J Nutr. 2000 Sep; 130(9): 2222-7

8. Desai TK et al. Am J Clin Nutr. 1992 Mar; 55(3): 708-11.

Lipid: SMOFlipid 20% with soybean oil, MTC, olive oil and fish oil which provides a well-balanced fatty acid profile (optimal ω-6/≥ω-3 fatty acid ratio of 2.5/1)

Electrolyte: Supplementation of Zinc

Range & bag: 6 different formulations are available in FMCB

Central  - 986 ml, 1477 ml, 1970 ml

Peripheral - 1206 ml, 1448 ml, 1904 ml

The innovative 3-in-1 mix with fish oil:

Well-tolerated mixture of macronutrients and electrolytes based
on SMOFlipid® and Aminoven® – just in one package system

SMOFlipid®

Positive impact on liver cell function and integrity

Favourable immune and inflammatory response

Study results indicate a reduced length of hospital stay
in a subgroup analysis

Controlled triglyceride levels

Favourable clinical outcome

Pediatric indication*

Approval for unlimited duration of use*
SmofKabiven® – What your patients need
Amino acids : Aminoven®

Provides high amounts of amino acids, suitable for
increased requirements

Meets the requirements for essential  AA (41.4 %) and BCAA  (18.6 %)

Covers increased nitrogen demands without the risk of caloric overload for patients with moderate to severe illness

Prevent taurine deficiency in patients with sepsis, trauma, post-operative surgery, and long-term TPN without cysteine

Glucose - the carbohydrate component

Completes SmofKabiven® to a unique mix of macronutrients

A moderate dose of glucose for the provision of energy in the recommended glucose-lipid ratio1 of 30-50% energy from lipids

Ratio g nitrogen to energy is
1:108 in SmofKabiven® central and
1:110 in SmofKabiven® peripheral
and thus within the recommendation2 of 1:100-150

Carpentier Y in: Sobotka L (Editor-in-Chief). Basics in Clinical Nutrition, Third edition. Galen 2004

2 Roth E: Stoffwechsel der Nährsubstrate. In: Handbuch der Infusionstherapie
  und klinischen Ernährung (Reissigl H, ed), II, Karger 1985, 55-113
 
Electrolytes : Supplementation of zinc prevents disturbances in wound healing and impairments in immune function & glucose tolerance
Range and Bag :

Offers a wide range of bag sizes to meet the patient‘s individual needs

The convenient and safe handling of FMCB
  
The innovative 3-in-1 mix with fish oil:
The container – Big steps ahead with a bag

Sterile port membranes – enable first use without disinfection

Self-sealing and stable ports – simplify handling

Easily opening peel seals – facilitate handling
è Easy handling, mixing and administration
Safe, convenient and time-saving use
Long shelf life at room temperature
(24 months at 20 – 25°C); no refrigerator needed
Environment-friendly, lightweight material

SmofKabiven ® is indicated in adult patients …

… when oral or enteral nutrition is impossible,
insufficient or contraindicated.

SmofKabiven® central

Patients undergoing major surgery,critically ill, oncology, BMT,liver transplant on PN

Patients in need of immunomodulating and anti-inflammatory nutritional treatment

Patients in need of rapidly available energy

Patients with high nitrogen requirements

Patients at risk of and with already increased liver parameters

Patients on long-term PN (perspectively)

Due to the beneficial impact on the liver parameters
SmofKabiven® peripheral

All patients on complete PN with basic to moderate nitrogen and energy requirements at ward level or patients without central line

Patients on partial PN

Patients in need of immunomodulating and anti-inflammatory nutritional treatment

Patients in need of rapidly available energy

Patients at risk of and with already increased liver parameters

Posology and Method of Administration

The appearance of the product after mixing the 3 chambers is a white emulsion.

The patient’s ability to eliminate fat and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section 4.4.

The dose should be individualised with regard to the patient’s clinical condition and body weight (bw).

The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism).

The requirements are 0.10-0.15 g nitrogen/kg bw/day (0.6-0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the

SmPC 11-385, 2011-12-14 and 12-397, 2012-06-04 MRP approved 2012-07-03 2(11)

- Hypersensitivity to fish-, egg-, soya- or peanut protein or to any of the active substances or excipients

- Severe hyperlipidemia

- Severe liver insufficiency

- Severe blood coagulation disorders

- Congenital errors of amino acid metabolism

- Severe renal insufficiency without access to hemofiltration or dialysis

- Acute shock

- Uncontrolled hyperglycaemia

- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated   cardiac insufficiency

- Hemophagocytotic syndrome

range of 0.15-0.25 g nitrogen/kg bw/day (0.9-1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.

Dosage

The dosage range of 13 ml – 31 ml SmofKabiven Electrolyte Free/kg bw/day corresponds to 0.10-0.25 g nitrogen/kg bw/day (0.6-1.6 g amino acids/kg bw/day) and 14-35 kcal/kg bw/day of total energy (12-27 kcal/kg bw/day of non-protein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight.

Infusion rate

The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for fat 0.15 g/kg bw/h.

The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.25 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h). The recommended infusion period is 14-24 hours.

Maximum daily dose

The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 35 ml/kg bw/day.

The recommended maximum daily dose of 35 ml/kg bw/day will provide 0.28 g nitrogen/kg bw/day (corresponding to 1.8 g amino acids/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g fat/kg bw/day and a total energy of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).

Method of administration

Intravenous use, infusion into a central vein.

The five different package sizes of SmofKabiven Electrolyte Free are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, electrolytes and vitamins should be added to SmofKabiven Electrolyte Free according to the patients need.

Pediatric patients

SmofKabiven Electrolyte Free is not recommended for use in children, see section 4.4.

4.3 Contraindications

- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma)

4.4 Special warnings and precautions for use

The capacity to eliminate fat is individual and should therefore be monitored according to the routines of the clinician. This is in general done by checking the triglyceride levels. The concentration of triglycerides in serum should not exceed 4 mmol/l during infusion. An overdose may lead to fat overload syndrome, see section 4.8.

SmofKabiven Electrolyte Free should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.

This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut

To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and well-controlled infusion, if possible by using a volumetric pump.

Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.

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

Blood cell count and coagulation should be monitored when fat is given for a longer period.

SmofKabiven Electrolyte Free is produced almost electrolyte free for patients with special and/or limited electrolyte requirements. Sodium, potassium, calcium, magnesium and additional amounts of phosphate should be added governed by the clinical condition of the patient and by frequent monitoring of serum levels.

In patients with renal insufficiency, the phosphate intake should be carefully controlled to prevent hyperphosphatemia.

The amount of individual electrolytes to be added is governed by the clinical condition of the patient and by frequent monitoring of serum levels.

Parenteral nutrition should be given with caution in lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.

Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.

The fat content of SmofKabiven Electrolyte Free may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hours in most patients.

SmPC 11-385, 2011-12-14 and 12-397, 2012-06-04 MRP approved 2012-07-03 4(11)

Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, in particular copper and zinc. This should be considered in the dosing of trace elements, especially during long-term intravenous nutrition.

In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water soluble vitamins. These changes can occur within 24 to 48 hours, therefore careful and slow initiation of parenteral nutrition is recommended in this patient group, together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.

SmofKabiven Electrolyte Free should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

In patients with hyperglycaemia, administration of exogenous insulin might be necessary.

Due to composition of the amino acid solution in SmofKabiven Electrolyte Free it is not suitable for the use in new-borns or infants below 2 years of age. There is at present no clinical experience of the use of SmofKabiven Electrolyte Free in children (age 2 years to 11 years).

4.5 Interaction with other medicinal products and other forms of interaction

Some medicinal products, like insulin, may interfere with the body’s lipase system. This kind of interaction seems, however, to be of limited clinical importance.

Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.

Soya-bean oil has a natural content of vitamin K1. However, the concentration in SmofKabiven Electrolyte Free is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.

4.6 Pregnancy and lactation

There are no data available on exposure of SmofKabiven Electrolyte Free in pregnant or breast-feeding women. There are no studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during pregnancy and lactation. SmofKabiven Electrolyte Free should only be given to pregnant and breast-feeding women after careful consideration.

4.7 Effects on ability to drive and use machines

Not relevant.

SmPC