SUMMARY CMI

SmofKabiven^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using SmofKabiven?

SmofKabiven contains the active ingredients alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride dihydrate, sodium glycerophosphate hydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, zinc sulfate heptahydrate, glucose monohydrate, soya oil, medium chain triglycerides, olive oil and fish oil-rich in omega-3 acids.

SmofKabiven is used as parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

For more information, see Section 1. Why am I using SmofKabiven? in the full CMI.

2. What should I know before I use SmofKabiven?

Do not use if you have ever had an allergic reaction to SmofKabiven or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use SmofKabiven? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SmofKabiven and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use SmofKabiven?

• Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven will be given to you by a health care professional.
• Follow the instructions provided and use SmofKabiven until your doctor tells you to stop.

More instructions can be found in Section 4. How do I use SmofKabiven? in the full CMI.

5. What should I know while using SmofKabiven?

For more information, see Section 5. What should I know while using SmofKabiven? in the full CMI.

6. Are there any side effects?

Less serious side effects have been reported during post-market monitoring. If you get any adverse effects, talk to your doctor or nurse. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

SmofKabiven^®

Active ingredient(s): Amino acids 5.1%, lipids 3.8%, glucose 12.7% & electrolytes 0.7%

Consumer Medicine Information (CMI)

This leaflet provides important information about using SmofKabiven. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using SmofKabiven.

Where to find information in this leaflet:

1. Why am I using SmofKabiven?
2. What should I know before I use SmofKabiven?
3. What if I am taking other medicines?
4. How do I use SmofKabiven?
5. What should I know while using SmofKabiven?
6. Are there any side effects?
7. Product details

1. Why am I using SmofKabiven?

SmofKabiven contains the active ingredients alanine, arginine, glycine, histidine, isoleucine, leucine, lysine acetate, methionine, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, calcium chloride dihydrate, sodium glycerophosphate hydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, zinc sulfate heptahydrate, glucose monohydrate, soya oil, medium chain triglycerides, olive oil and fish oil-rich in omega-3 acids.

SmofKabiven is a solution for parenteral nutrition comprising of amino acids (components used to build proteins), glucose (carbohydrates), lipids (fat) and salts (electrolytes). It is an emulsion for infusion given into your blood by a drip (intravenous infusion).

SmofKabiven is used as parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated. A health care professional will give you SmofKabiven when other forms of feeding are not good enough or have not worked.

2. What should I know before I use SmofKabiven?

Warnings

Do not use SmofKabiven if:

• you are allergic to the active ingredients, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
• if you are allergic to fish or egg
• if you are allergic to peanuts, soya or corn (maize) as SmofKabiven contains soya oil
• if you have too much fat in the blood (hyperlipidaemia)
• if you have serious liver disease
• if you have blood clotting problems (coagulation disorders)
• if your body has problems using amino acids
• if you have serious kidney disease without access to dialysis
• if you are in acute shock
• if you have too much sugar in your blood (hyperglycaemia) which is uncontrolled
• if you have high blood (serum) levels of the salts (electrolytes)
• if you have fluid in the lungs (acute pulmonary oedema)
• if you have too much body fluid (hyperhydrated)
• if you have heart failure that is not treated
• if you have a defect in your blood clotting system (haemophagocytotic syndrome)
• if you are in an unstable condition, such as after serious trauma, uncontrolled diabetes, acute heart attack, stroke, blood clot, metabolic acidosis (a disturbance resulting in too much acid in the blood), serious infection (severe sepsis), coma and if you don't have enough body fluid (hypotonic dehydration).

Check with your doctor if you:

• kidney problems
• diabetes mellitus
• pancreatitis (inflammation of the pancreas)
• liver problems
• hypothyrodism (toxic goiter)
• sepsis (serious infection)
• take any medicines for any other condition

If during the infusion you get fever, rash, swelling, difficulty in breathing, chills, sweating, nausea or vomiting, tell the health care professional immediately because these symptoms might be caused by an allergic reaction or that you have been given too much of the medicine.

Your doctor may regularly need to check your blood for liver function tests and other values.

SmofKabiven is not suitable for use in neonates and infants below 2 years of age. There is at present no clinical trial conducted on the use of SmofKabiven in children age 2 years to 11 years.

Please tell your doctor if you have or recently have taken some medicines, even without prescription.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

SmofKabiven should only be given to pregnant or breastfeeding women if the doctor finds it necessary.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with SmofKabiven and affect how it works.

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect SmofKabiven.

4. How do I use SmofKabiven?

How much to take / use

• Your doctor will decide on the dose for you individually depending on your body weight and function. SmofKabiven will be given to you by a health care professional.
• Follow the instructions provided and use SmofKabiven until your doctor tells you to stop.

When to take / use SmofKabiven

• SmofKabiven should be administered by continuous flow into a large main vein using a sterile tubing and a catheter needle. It should only be administered to you by qualified medical staff.

If you forget to use SmofKabiven

This rarely happens as SmofKabiven is usually administered under the care of a trained health care professional in a hospital or clinic setting.

If you use too much SmofKabiven

This rarely happens as SmofKabiven is usually administered under the care of a trained health care professional in a hospital or clinic setting.

If you think that you have been given too much SmofKabiven, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using SmofKabiven?

Things you should do

Follow the instructions provided and use SmofKabiven until your doctor tells you to stop.

Call your doctor straight away if you:

• have signs and symptoms of allergic reactions. In case of an allergic reaction, the infusion should be stopped immediately, and appropriate measures need to be taken.

Remind any doctor, nurse, dentist or pharmacist you visit that you are using SmofKabiven.

Things you should not do

• Do not stop using this medicine until your doctor tells you to stop.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how SmofKabiven affects you.

The effects of SmofKabiven on a person's ability to drive and use machines were not studied.

Drinking alcohol

Tell your doctor if you drink alcohol.

The effects of alcohol with SmofKabiven use were not studied. Your doctor will decide what you need to do.

Looking after your medicine

SmofKabiven should be stored in its overpouch below 25°C and not be frozen. Do not use infusion bags that have been used, have expired or the container is damaged.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

The below less serious side effects were reported during post-market monitoring.

Less serious side effects

Tell your doctor if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What SmofKabiven contains

Do not take this medicine if you are allergic to any of these ingredients.

SmofKabiven does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

SmofKabiven does not contain any preservative.

What SmofKabiven looks like

SmofKabiven comes in a 3-chamber plastic bag called Biofine bag in 4 pack sizes. Each chamber contains glucose, amino acids with electrolytes and a lipid emulsion separately. The glucose and amino acid solutions are clear, colourless or slightly yellow and free from particles. The lipid emulsion is white and homogeneous.

They can be identified by the following AUST R numbers:

AUST R 173890: 986 mL

AUST R 180543: 1477 mL

AUST R 180546: 1970 mL

AUST R 180547: 2463 mL

Who distributes SmofKabiven

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way,
Mount Kuring-gai, NSW 2080,
Australia.
Telephone: 1300 361 004

This leaflet was prepared in November 2021.

Published by MIMS April 2024

1 Name of Medicine

Amino acids 5.1%.

Lipids 3.8%.

Glucose 12.7%.

Electrolytes 0.7%.

2 Qualitative and Quantitative Composition

SmofKabiven is a three chamber bag system of amino acid solution with electrolytes, glucose solution and lipid emulsion for intravenous infusion.
Each bag contains the following partial volumes depending on the four pack sizes (see Table 1).
This corresponds to the following total compositions (see Table 2):
Corresponding to (see Table 3):

Excipients with known effect.

3 Pharmaceutical Form

Emulsion for intravenous infusion.
Glucose and amino acid solutions are clear and colourless to slightly yellow solution and free from particles.
The lipid emulsion is white and homogeneous.

Osmolality.

Osmolarity.

pH (after mixing).

4 Clinical Particulars

4.1 Therapeutic Indications

Parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

4.2 Dose and Method of Administration

Dosage (dose and interval).

Additives.

Adults.

Dosage.

Infusion rate.

Maximum daily dose.

Paediatric population.

Dosage.

Infusion rate.

Maximum daily dose.

Method of administration.

Compatibility.

Compatibility data are available with the named branded products Addaven, Vamin 18EF, Glycophos, Vitalipid N Adult/Infant and Soluvit N in defined amounts and generics of electrolytes in defined concentrations. When making electrolyte additions, the amounts already present in the bag should be taken into account to meet the clinical needs of the patient. Generated data supports additions to the activated bag according to the summary in Table 4:
Note: This table is intended to present compatibility. It is not a dosing guideline.

Special handling instructions.

1. Removal of overpouch.

2. Mixing.

Please note.

3. Finalising the preparation.

Please note.

Please note.

Please note.

4. Hanging up the bag.

4.3 Contraindications

Hypersensitivity to fish, egg, soya or peanut protein or corn (maize) and corn products or to any of the active substances or excipients.
Severe hyperlipidaemia.
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.
Pathologically elevated serum levels of any of the included electrolytes.
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency.
Haemophagocytotic syndrome.
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).
Infants and children under 2 years of age.

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 3 mmol/L during infusion. An overdose may lead to fat overload syndrome. (Please also see "Fat overload syndrome".)
SmofKabiven 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 oil, fish oil, and egg phospholipids which may rarely cause allergic reactions. This applies also to corn (maize) and corn that may be contained in the medicine as small amounts of impurities. Cross allergic reaction has been observed between soybean, 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 an appropriate infusion pump as per each hospital setting needs, e.g. 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.
Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
SmofKabiven should be given with caution to patients with a tendency towards electrolyte retention. Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be discontinued.
The monitoring of serum glucose, electrolytes, and osmolarity as well as fluid balance, acid-base status, and liver enzyme tests is recommended.
Blood cell count and coagulation should be monitored when fat is given for a longer period.
In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphataemia and hyperkalaemia.
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.
The infusion should be stopped immediately at any sign or symptom of anaphylactic reaction (such as fever, shivering, rash, or dyspnoea).
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. Amounts of zinc administered with SmofKabiven should be taken into account.
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 should not be given simultaneously with blood in the same infusion set due to the risk of pseudo-agglutination.
In patients with hyperglycaemia, administration of exogenous insulin might be necessary.
Amino acid solutions may cause acute folate deficiency; folic acid should therefore be given daily.
Vitamin B complex deficiency may occur with glucose administration.
Review of current available literature associated with Parenteral Nutrition Associated Liver Dysfunction (PNALD) shows emerging evidence indicating that fish oil-based lipid emulsions improve liver function within the scope of PN in general and may have the potential to reverse PNALD in children with short bowel syndrome.
Excessive exposure to light and UV light should be avoided as peroxide formation may occur.

Fat overload syndrome.

Excess of amino acid infusion.

Excess of glucose infusion.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse events with at least possible relationship to the study drug observed in the study 03-3CB7-001 with SmofKabiven are presented in Table 5.
Drug-related adverse events have been reported from 7 clinical studies with the separate components of SmofKabiven, SMOFlipid 20% and Aminoven 10%.
Table 6 lists the common drug-related Treatment-Emergent Adverse Events (TEAEs) occurring in more than 2 patients in SMOFlipid 20% group versus comparator pooled groups.
Table 7 lists the drug-related adverse events reported in the clinical study AS CS 01 FR with Aminoven 10%.
Adverse events in Table 8 are based on general assessment of trials and clinical experience of the product SmofKabiven.
Should these side-effects occur, the risk-benefits assessment of continuing infusion of SmofKabiven should be performed.

Reporting suspected adverse effects.

4.9 Overdose

Please also see Section 4.4 Special Warnings and Precautions for Use, Fat overload syndrome, Excess of amino acid infusion, Excess of glucose infusion.
If symptoms of overdose of fat or amino acids occur, the infusion should be slowed down or discontinued. There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems.
Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
If hyperglycaemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate.
Additionally, overdose might cause fluid overload, electrolyte imbalances, and hyperosmolality.
In some rare serious cases, haemodialysis, haemofiltration or haemodiafiltration may be considered.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Lipid emulsion.

Amino acids and electrolytes.

Glucose.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Amino acids and electrolytes.

Glucose.

Distribution.

Metabolism.

Amino acids and electrolytes.

Excretion.

Lipid emulsion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Glycerol; egg lecithin; dl-alpha-tocopherol; sodium hydroxide (for pH adjustment); sodium oleate; glacial acetic acid (for pH adjustment); hydrochloric acid (for pH adjustment); water for injections.

6.2 Incompatibilities

Only medicinal or nutrition solutions for which compatibility has been documented may be added to SmofKabiven. See Section 4.2 Dose and Method of Administration, Compatibility.

6.3 Shelf Life

Shelf life before mixing.

Shelf life after mixing the contents of the three chambers.

Shelf life after mixing with additives.

6.4 Special Precautions for Storage

Store below 25°C. Do not freeze. Store in overpouch.

Instructions for use.

6.5 Nature and Contents of Container

The container consists of a multi-chamber inner bag and an overpouch. The inner bag is separated into three chambers by peelable seals. An oxygen absorber is placed between the inner bag and the overpouch. The inner bag is made of a multilayer polymer film - Biofine. The Biofine inner bag film consists of poly(propylene-co-ethylene), synthetic rubber poly[styrene-block-(butylene-co-ethylene)] (SEBS) and synthetic rubber poly(styrene-block-isoprene) (SIS). The infusion and additive ports are made of polypropylene and synthetic rubber SEBS equipped with synthetic polyisoprene (latex-free) stoppers. The blind port, which is only used during manufacturing, is made of polypropylene equipped with a synthetic polyisoprene (latex-free) stopper.

Pack sizes*.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Glucose monohydrate.

Calcium chloride dihydrate.

Magnesium sulfate heptahydrate.

Potassium chloride.

Sodium acetate trihydrate.

Sodium glycerophosphate.

Zinc sulfate heptahydrate.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not Scheduled.

Summary Table of Changes