Consumer medicine information

Kabiven G11% and G19%

Amino acids; Glucose; Triglycerides, long chain

BRAND INFORMATION

Brand name

Kabiven G11%

Active ingredient

Amino acids; Glucose; Triglycerides, long chain

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Kabiven G11% and G19%.

What is in this leaflet

This leaflet answers some common questions about Kabiven. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you being given Kabiven against any benefits they expect it will have for you.

Please read this leaflet carefully. If you have any questions or are unsure about anything, please ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What is Kabiven used for and how does it work

Kabiven is a sterile emulsion which provides your body with nutrition by the intravenous route. When the intake of nutrients or food into the mouth or directly into the gut is not possible, or it is not enough to supply the body’s needs, then intravenous nutrients or foods can be given. This is especially important for people whose bodies are under physical stress from illness or recent surgery. During illness or after surgery the body requires nutrition or food.

Kabiven G19% contains 3.3% amino acids, 3.9% triglycerides (soya oil), 9.7% glucose and 0.7% electrolytes.

Kabiven G11% contains 2.4% amino acids, 3.5% triglycerides, 6.8% glucose and 0.7% electrolytes.

Kabiven is usually given together with trace elements and vitamins to provide a complete intravenous diet.

Before you are given Kabiven

You should NOT be given Kabiven if

  • You have had an allergic reaction to egg-yolk containing foods, peanut or soy products.
  • You have an allergy to any of the ingredients contained in Kabiven as listed at the end of this leaflet.
  • You have an inability to break down fats
  • You have an inability to break down amino acids, for example an inherited condition known as phenylketonuria.
  • You have severe liver failure.
  • You have severe kidney failure (when dialysis facilities are not available).
  • You are suffering from a very serious problem with your blood circulation.
  • You have too much fluid in your body.
  • You have too much acid in your blood, also called metabolic acidosis.
  • You have a build up of fluid in your lungs and
  • You have certain untreated heart problems.
  • You are suffering from a blood disease or an infection of the blood.
  • You are experiencing a sudden decrease in blood pressure.
  • You have too much sugar in your blood.
  • You have too much electrolytes in your blood.
  • There is not enough water content in your body.
  • You are suffering from a severe unstable medical condition.

If you are not sure whether any of these apply to you, check with your doctor.

You should tell your doctor BEFORE given Kabiven if the answer to any of the following questions is YES.

  • Are you pregnant or trying to become pregnant?
  • Are you breastfeeding?
  • Are you allergic to proteins of eggs, peanuts or soy or any other medicines or any other substances, such as foods, preservatives or dyes?
  • Do you have liver or kidney disease?
  • Are you a diabetic?
  • Do you have a disease of the pancreas?
  • Do you have a disorder of the thyroid gland?
  • Do you have a blood infection?
  • Is there not enough oxygen being supplied to your cells?
  • Do you have too much lactic acid in your body?
  • Is your blood very concentrated?
  • Are you taking anticoagulants (medicines for preventing blood clotting)?
  • Are you taking any other medicines including any that you buy without a prescription from your pharmacy, supermarket or health food shop. These medicines may affect the action of Kabiven or may affect how well Kabiven works.

If you have not told your doctor about any of the above, tell your doctor before you are given Kabiven.

How is Kabiven given

Kabiven consists of a three chamber bag containing glucose, amino acids and electrolytes and soya oil. These solutions/emulsions are mixed by pulling apart the seals between the chambers and turning the bag upside down several times.

How much will be given:

The dose of Kabiven which you will require will be determined by your doctor or pharmacist. Your doctor will supervise your treatment with Kabiven.

How is it given:

Kabiven G19% and Kabiven G11% are usually given as a continuous infusion into a peripheral or central vein. An electronic pump may be used to control the speed of the infusion of drip.

If you are given too much (overdose)

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

However, if you are given Kabiven too quickly or too much, you may experience the following side effects: feeling sick (nausea and vomiting) or become flushed and sweaty.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

Otherwise, immediately telephone your doctor or contact the Poisons Information Centre in your country.

Australia: 13 11 26
New Zealand: 0800 764 766.

Side Effects

Like all medicines, Kabiven can cause side effects, although not everybody gets them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • a rise in your body temperature
  • shivering, chills
  • nausea and vomiting
  • tiredness
  • headaches

Tell your doctor as soon as possible if you notice any of the following:

  • abdominal pain
  • persistent painful erection of the penis which occurs without sexual arousal

If any of the following happen, tell your doctor immediately:

  • serious allergic reactions (skin rash and hives);
  • breathing difficulties (rapid breathing)
  • effects on blood pressure

If any of these side effects occurs, or if you notice any side effects not listed in this leaflet, please contact your doctor or a pharmacist.

Storage

The expiry date of Kabiven is on the label of the pack. Kabiven should not be used if the expiry date has passed.

Kabiven should be stored below 25°C, but not frozen. Do not use Kabiven if it has been frozen.

The contents of each bag of Kabiven are for single infusion only. Any unused Kabiven should be discarded. Do not use Kabiven if it is discoloured.

Product Description

What it looks like:

Kabiven is supplied in Biofine plastic bags consisting of three chambers. One chamber (glucose 19% for Kabiven G19% or glucose 11% for Kabiven G11%) contain a clear, almost colourless solution, the second chamber (Vamin 18 Novum) contain a clear, colourless to slightly yellow solution while the third chamber (Intralipid 20%) contains a milky white emulsion.

Ingredients

Kabiven contains the active ingredients alanine, arginine, aspartic acid, calcium chloride dihydrate, glucose monohydrate, glutamic acid, glycine, histidine, isoleucine, leucine, lysine hydrochloride, magnesium sulfate heptahydrate, methionine, phenylalanine, potassium chloride, proline, serine, sodium acetate trihydrate, sodium glycerophosphate, soya oil, threonine, tryptophan, tyrosine and valine.

It also contains the inactive ingredients glycerol, egg lecithin, sodium hydroxide, glacial acetic acidand water for injections.

Kabiven does not contain any preservative.

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

Kabiven G19% supplies the following calories:
1026 mL 900 kcal
1540 mL 1400 kcal
2053 mL 1900 kcal
2566 mL 2300 kcal

Osmolality: Approximately 1230 mOsm/kg water

pH: Approximately 5.6.

Kabiven G11% supplies the following calories:
1440 mL 1000 kcal
1920 mL 1400 kcal
2400mL 1700 kcal

Osmolality: Approximately 830 mOsm/kg water

pH: Approximately 5.6.

Kabiven comes in different bag sizes and can be identified by AUST R numbers:

Biofine Bags

Kabiven G19%
1026 mL: AUST R 97889
1540 mL: AUST R 97890
2053 mL: AUST R 97891
2566 mL: AUST R 97892

Kabiven G11%
1440 mL: AUST R 97893
1920 mL: AUST R 97894
2400 mL: AUST R 97895

Further Information

More detailed information is available from your doctor or pharmacist. Therefore, if you have any concerns about the information or about Kabiven ask your doctor or pharmacist.

Sponsor

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

Fresenius Kabi New Zealand Limited
60 Pavilion Drive
Airport OaksMangere
New Zealand
Freecall: 0800 144 892

® = Registered Trademark

Date of information
This leaflet was prepared in July 2019

Published by MIMS September 2019

BRAND INFORMATION

Brand name

Kabiven G11%

Active ingredient

Amino acids; Glucose; Triglycerides, long chain

Schedule

Unscheduled

 

1 Name of Medicine

Glucose monohydrate, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, valine, calcium chloride dihydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate, sodium glycerophosphate, soya oil.

2 Qualitative and Quantitative Composition

Kabiven is a three-chamber bag of amino acid solution with electrolytes, glucose solution and lipid emulsion for intravenous infusion. The glucose and amino acid solutions are clear solutions while the fat emulsion is white.
The active ingredients are:

Amino acids 2.4%.

Alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, isoleucine, leucine, lysine hydrochloride, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine and valine.

Electrolytes 0.7%.

Calcium chloride dihydrate, magnesium sulfate heptahydrate, potassium chloride, sodium acetate trihydrate and sodium glycerophosphate.

Glucose 6.8%.

Glucose monohydrate.

Lipids 3.5%.

Soya oil.
Each bag contains the following different volumes depending on the three pack sizes (see Table 1).
This corresponds to the following compositions (see Table 2).
Excipients with known effect: egg lecithin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection, emulsion.

4 Clinical Particulars

4.1 Therapeutic Indications

Parenteral nutrition for patients when oral or enteral nutrition is impossible or insufficient or contraindicated.

4.2 Dose and Method of Administration

The ability to eliminate fat and metabolise glucose should govern the dosage and infusion rate (see Section 4.4 Special Warnings and Precautions for Use).

Dosage.

The dose should be individualised and the choice of bag size should be made with regard to the patient's clinical condition, body weight and nutritional requirements.
The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 nitrogen/kg body weight (b.w.)/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30 g nitrogen/kg b.w./day (1.0-2.0 g amino acid/kg b.w./day). The corresponding commonly accepted requirements are 2.0-6.0 g for glucose and 1.0-2.0 g for fat.
The total energy requirement depends on the patient's clinical condition and is most often between 20-30 kcal/kg b.w./day. In obese patients the dose should be based on the estimated ideal weight.
Kabiven G11% is produced in three sizes intended for patients with moderately increased, basal or low nutritional requirements. To provide total parenteral nutrition, the addition of trace elements, vitamins and supplemental electrolytes may be required.
The dose range of 0.10-0.15 g nitrogen/kg b.w./day (0.7-1.0 g amino acid/kg b.w./day) and a total energy of 20-30 kcal/kg b.w./day corresponds to approximately 27-40 mL Kabiven G11%/kg b.w./day.

Infusion rate.

The maximum infusion rate for glucose is 0.25 g/kg/h.
Amino acid dosage should not exceed 0.1 g/kg/h.
Fat dosage should not provide more than 0.15 g/kg/h.
The infusion rate should not exceed 3.7 mL/kg b.w./hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.13 g fat/kg b.w.). The recommended infusion period for individual bags of Kabiven G11% is 12-24 hours.

Maximum daily dose.

40 mL/kg b.w./day. This is equal to one bag (largest size) to a 64 kg-patient and will provide 0.96 g amino acids/kg b.w./day (0.16 g N/kg b.w./day), 25 kcal/kg b.w./day non-protein energy (2.7 g glucose/kg b.w./day and 1.4 g fat/kg b.w./day).
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day.

Method and duration of administration.

Intravenous infusion into a central or peripheral vein (see Section 4.8 Adverse Effects (Undesirable Effects); Section 5.1 Pharmacodynamic Properties, Clinical trials). Infusion may be continued for as long as required by the patient's clinical condition. Kabiven G11% should be used within 24 hours of preparation.
In order to minimise the risk of thrombophlebitis, daily rotation of infusion site is recommended.

Instructions for use.

Use in one person on one occasion only. Contains no antimicrobial preservative. Discard any unused mixture.
Do not use if package is damaged. Kabiven G11% should only be mixed and used if the solutions are clear and colourless or slightly yellow and if the emulsion is white and homogenous.
The contents of the three separate chambers have to be mixed before use. Mixing of the solutions by opening the seals between the chambers results in the ready-to-use solution. For that purpose pressure must be exerted on one solution chamber by rolling up the bag from one of the side edges until the middle seal opens. After separation of the seals the bag should be inverted on a number of occasions to ensure a homogenous mixture.
After breaking the seals, chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 24 hours at 25°C.
Aseptic technique must be used to inject additives and the product must be used within 24 hours.

Compatibility.

Additives.

Only medicinal or nutritional solutions for which compatibility has been documented may be added to Kabiven G11%.
Additions should be made aseptically (see Table 3).
 Any mixture remaining after infusion must be discarded.

Special handling instructions.

1. Removal of overpouch.

To remove overpouch, hold the bag horizontally and tear from the notch close to the ports along the upper edge.
Then simply tear the long side, pull off the overpouch and discard it along with the oxygen absorber.

2. Mixing.

Place the bag on a flat surface.
Roll up the bag tightly from the handle side towards the ports, firstly with the right hand and then applying a constant pressure with the left hand until the vertical seals are broken. The vertical peel seals open due to the pressure of the fluid. The peel seals can also be opened before removing the overpouch.
Please note: The liquids mix easily although the horizontal seal remains closed.
Mix the contents of the three chambers by inverting the bag three times until the components are thoroughly mixed.

3. Finalising the preparation.

Place the bag on a flat surface again. Shortly before injecting the additives, break off the tamper-evident arrow flag from the white additive port.
Please note: The membrane in the additive port is sterile.
Hold the base of the additive port. Insert the needle, inject the additives (with known compatibility) through the centre of the injection site.
Mix thoroughly between each addition by inverting the bag three times. Use syringes with needles of 18-23 gauge and a length of max. 40 mm.
Shortly before inserting the infusion set, break off the tamper evident arrow flag from the blue infusion port.
Please note: The membrane in the infusion port is sterile.
Use a nonvented infusion set or close the air-inlet on a vented set.
Hold the base of the infusion port.
Push the spike through the infusion port. The spike should be fully inserted to secure it in place.
Please note: The inner part of the infusion port is sterile.

4. Hanging up the bag.

Hang the bag up by the hole below the handle.

4.3 Contraindications

Hypersensitivity to egg-, soya- or peanut protein or to any of the ingredients.
Severe hyperlipidaemia.
Severe liver insufficiency.
Severe blood coagulation disorders.
Inborn errors of amino acid metabolism.
Severe renal insufficiency without access to haemofiltration or dialysis.
Acute shock.
Hyperglycaemia, which requires more than 6 units insulin/h.
Pathologically elevated serum levels of any of the included electrolytes.
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency and hypotonic dehydration.
Haemophagocytotic syndrome.
Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma).
Due to composition, Kabiven G11% is not suitable for use in new-borns or infants under 2 years of age.

4.4 Special Warnings and Precautions for Use

The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/L during infusion.
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.
Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. 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.
Kabiven G11% should be given with caution in conditions of impaired lipid metabolism, such as in renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridaemia) and sepsis. If Kabiven G11% is given to patients with these conditions, close monitoring of serum triglycerides is mandatory.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests (alkaline phosphatase, ALT, AST) should be monitored.
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 metabolic acidosis, lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.
Kabiven G11% should be given with caution to patients with a tendency towards electrolyte retention.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and in particular, 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. Careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
Kabiven G11% 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.
Kabiven G11% contains soya oil and egg lecithin which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.

Peripheral infusion.

As with all hypertonic solutions, thrombophlebitis may occur if peripheral veins are used for infusions. Several factors contribute to the incidence of thrombophlebitis. These include the type of cannula used and its diameter and length, the duration of infusion, pH and osmolality of infusates, infection and the number of manipulations. It is recommended that venous access sites for TPN should not be used for other intravenous additives or solutions (see Section 5.1 Pharmacodynamic Properties, Clinical trials).

Use in the elderly.

No data available.

Paediatric use.

Kabiven G11% is not recommended to neonates and infants under 2 years of age.

Effects on laboratory tests.

The fat content of Kabiven G11% may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, and haemoglobin) 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.

4.5 Interactions with Other Medicines and Other Forms of Interactions

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.
Other drugs, like insulin, may influence lipase activity but there is no evidence to suggest that this adversely affects therapeutic value.
Soya oil has a natural content of vitamin K1. This may interfere with the therapeutic effect of coumarin derivatives, which should be closely monitored in patients treated with such drugs.
There are no clinical data to show that any of the above listed interactions are of definite clinical relevance.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category Exempt)
Reproduction studies in animals have not been conducted with Kabiven G11%. No clinical data are currently available to assess the safety of Kabiven G11% in pregnancy. The prescriber should consider the benefit/risk relationship before administering Kabiven G11% to pregnant women.
 No clinical data are currently available on the use of Kabiven G11% in breast-feeding women. Following intravenous infusion, most of the active ingredients contained in Kabiven G11% are expected to be excreted into human milk, and the safety to the breast-feeding infant has not been adequately established. The prescriber should consider the benefit/risk relationship before administering Kabiven G11% to breast-feeding women.

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)

The infusion may cause a rise in body temperature (incidence < 3%) and, less frequently, shivering, chills and nausea/vomiting (incidence < 1%). Transient increases in liver enzymes during intravenous nutrition have also been reported.
Thrombophlebitis is probably the most common adverse event in patients in general surgical wards. The cause is in most cases due to infusions of saline, glucose or similar fluids and drugs. The development of thrombophlebitis is dependent on many factors, which are: osmolarity of the injected substance; pH of the injected substance; chemical structure of the injected substance; amount of blood flow; size of the blood vessel; presence of protective drugs or substances; duration of injection/infusion; speed of injection/infusion; material of the catheter; size of the catheter; movement of the catheter; microbiological agents.
The rate of thrombophlebitis with Kabiven G11% from post-marketing surveillance is estimated to be common (> 1/100). The risks of thrombophlebitis should be weighed against the benefits when peripheral administration is intended.
Reports of other undesirable effects in conjunction with the included components are extremely rare. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haemolysis, reticulocytosis, abdominal pain, headache, tiredness and priapism have been reported.

Fat overload syndrome.

An impaired capacity to eliminate fat may lead to the fat overload syndrome. This may occur as a result of overdosage, but also at recommended rates of infusion, in association with a sudden change in the patient's clinical condition resulting in severe renal or hepatic impairment.
The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. These changes are invariably reversible on discontinuation of the fat infusion.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

See Section 4.8 Adverse Effects (Undesirable Effects), Fat overload syndrome.
Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate.
If symptoms of overdose occur, the infusion should be slowed down or discontinued.
Additionally, overdose might cause fluid overload, electrolyte imbalances, hyperglycaemia and hyperosmolality.
In some rare serious cases, haemodialysis, haemofiltration or haemodiafiltration may be necessary.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Fat emulsion.

Intralipid, the fat emulsion used in Kabiven G11%, provides essential and non-essential long chain fatty acids for energy metabolism and the structural integrity of cell membranes.
Intralipid in the recommended dosage does not cause haemodynamic changes. No clinically significant changes in pulmonary function have been described when Intralipid is used properly. The transient increase in liver enzymes seen in some patients on parenteral nutrition is reversible and disappears when parenteral nutrition is discontinued. Similar changes are also seen in parenteral nutrition without fat emulsions.

Amino acids and electrolytes.

The amino acids, constituents of protein in ordinary food, are utilised for tissue protein synthesis and any surplus is channelled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.

Glucose.

Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal nutritional status.

Clinical trials.

There was an open, randomised, comparative clinical study comparing the safety/tolerance of Kabiven G11% with a compounded intravenous TPN preparation. A total of 46 subjects requiring total parenteral nutrition and appropriate for infusion in a peripheral vein were evaluated. One bag of Kabiven G11% 2400 mL or trial medication was administered over 12-24 hours daily at an infusion rate not exceeding 4.2 mL/kg bw/hour. Moderate or worse venous reactions (pain, swelling, redness, palpable vein cord) were seen in fifteen patients who received Kabiven G11% versus nine who received the compounded preparation. The evaluation of clinical and laboratory safety parameters, adverse events and local tolerance demonstrated that the two trial products were equally safe and well tolerated.

5.2 Pharmacokinetic Properties

Fat emulsion.

Intralipid has biological properties similar to those of endogenous chylomicrons. Unlike chylomicrons, Intralipid does not contain cholesterol esters or apolipoproteins, while its phospholipid content is significantly higher.
Intralipid is eliminated from the circulation via a pathway similar to that of endogenous chylomicrons, at least early on in the catabolism. The exogenous fat particle is primarily hydrolysed in the circulation and taken up by the LDL receptors peripherally and by the liver. The elimination rate is determined by the composition of the fat particles, the nutritional status, the disease and the rate of infusion. In healthy volunteers, the maximum clearance rate of Intralipid after fasting overnight is equivalent to 3.8 ± 1.5 g of triglyceride per kg body weight per 24 hours.
Both the elimination and the oxidation rates are dependent on the patient's clinical condition; elimination is faster and utilisation is increased in postoperative patients and in trauma, while patients with renal failure and hypertriglyceridaemia show lower utilisation of exogenous fat emulsions.

Amino acids and electrolytes.

The pharmacokinetic properties of the infused amino acids and electrolytes are essentially the same as for amino acids and electrolytes supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the systemic circulation directly. This difference results only in a marginal change of kinetics and does not change the bioavailability of the amino acids.

Glucose.

The pharmacokinetic properties of infused glucose are essentially the same as those of glucose supplied by ordinary food.

5.3 Preclinical Safety Data

Genotoxicity.

No study has been conducted to examine the mutagenic potential of Kabiven G11%. The effects of Kabiven G11% have not been investigated in animal studies.

Carcinogenicity.

No study has been conducted to examine the carcinogenic potential of Kabiven G11%. The effects of Kabiven G11% have not been investigated in animal studies.

6 Pharmaceutical Particulars

6.1 List of Excipients

Egg lecithin, glycerol, sodium hydroxide, glacial acetic acid, water for injections.

6.2 Incompatibilities

Kabiven G11% may only be mixed with other medicinal products for which compatibility has been documented (see Section 4.2 Dose and Method of Administration, Compatibility, Additives).

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

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

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, consisting 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 poly [styrene-block-(butylene-co-ethylene)] (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.

1 x 1440 mL, 4 x 1440 mL (AUST R 97893).
1 x 1920 mL, 4 x 1920 mL (AUST R 97894).
1 x 2400 mL, 3 x 2400 mL (AUST R 97895).

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

CAS number.

Amino acids.

Alanine (56-41-7), arginine (74-79-3), aspartic acid (6899-03-2), glutamic acid (56-86-0), glycine (56-40-6), histidine (71-00-1), isoleucine (73-32-5), leucine (61-90-5), lysine hydrochloride (657-27-2), methionine (63-68-3), phenylalanine (63-91-2), proline (147-85-3), serine (56-45-1), threonine (72-19-5), tryptophan (73-22-3), tyrosine (60-18-4), valine (72-18-4).

Electrolytes.

Calcium chloride dihydrate (10035-04-8), magnesium sulfate heptahydrate (10034-99-8), potassium chloride (7447-40-7), sodium acetate trihydrate (6131-90-4) and sodium glycerophosphate (1334-74-3).

Glucose.

Glucose monohydrate (5996-10-1).

Lipids.

Soya oil (8001-22-7).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes