Consumer medicine information

INTRALIPID 10%, 20% and 30%

Soya oil; Lecithin; Glycerol

BRAND INFORMATION

Brand name

Intralipid

Active ingredient

Soya oil; Lecithin; Glycerol

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using INTRALIPID 10%, 20% and 30%.

What is in this leaflet

This leaflet answers some common questions about Intralipid. 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 taking Intralipid against any benefits they expect it will have for you.

Please read this leaflet carefully before using Intralipid 10%, 20% and 30%. 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 Intralipid used for and how does it work?

Intralipid is a sterile fat emulsion, which provides your body with energy and fatty acids. The active ingredient in Intralipid is soya oil. Soya oil consists of a mixture of mainly polyunsaturated fatty acids. It also contains egg lecithin as an emulsifier, which is isolated from egg yolk. It is available in 3 strengths namely 10%, 20% and 30%.

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. It is usually given together with carbohydrates, amino acids, salts, trace elements and vitamins to provide a complete intravenous diet.

Before you are given Intralipid

You should not be given Intralipid if

  • You have an allergy to soya oil, eggs, peanuts or any of the ingredients listed at the end of this leaflet.
  • You have an inability to break down fats

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

You should tell your doctor BEFORE using Intralipid 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 soya-, egg- or peanut protein?
  • 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?
  • 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 healthfood shop. These medicines may affect the action of Intralipid or may affect how well Intralipid works.

If you have not told your doctors about any of the above, tell them before you are given Intralipid.

How is Intralipid given?

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

Side Effects

Intralipid, like all other nutrient solutions which are given intravenously, may cause unwanted effects in some people. All the unwanted effects associated with Intralipid may not yet have been detected.

Intralipid may cause a rise in your body temperature (this occurs in less than 3% of people who use it). Shivering, chills and nausea and vomiting occur less often (in less than 1% of people who use it). Reports of other unwanted effects caused by Intralipid are extremely rare.

Unwanted effects which have been reported to occur immediately or soon after Intralipid has been given include: allergic reactions (skin rash and hives); breathing difficulties (rapid breathing, shortness of breath); effects on blood pressure; abdominal pain; tiredness; headaches; flushing; slight pressure over the eyes and dizziness.

If you have these or any other unwanted effects during treatment, tell your doctor.

If you are given too much (overdose)

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

However, if you are given Intralipid too quickly or too much, you may experience the following side effects: fever or convulsions.

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

Storage

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

Intralipid should be stored below 25ºC, but not frozen. Do not use Intralipid if it has been frozen.

The contents of each bottle of Intralipid are for single infusion only. Any unused Intralipid should be discarded. Do not use Intralipid if it is discoloured. Do not use if the product does not look quite right.

List of other ingredients

Intralipid also contains other ingredients such as glycerol, egg lecithin, sodium hydroxide and water for injections.

Intralipid does not contain any preservative.

Product Description

What it looks like

Intralipid is a milky white emulsion which is supplied in glass bottles or plastic bags.

The active ingredient is soya oil. Intralipid comes in three strengths: 10%, 20% and 30%. It also contains egg lecithin, glycerol, sodium hydroxide and water for injections.

1000mL of Intralipid supplies the following calories:

  • 10% 4600 kJ
  • 20% 8400 kJ
  • 30% 12600 kJ.

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

Intralipid comes in different pack sizes and can be identified by AUST R numbers:

Bottle

  • Intralipid 10%, 500 mL AUST R 14471
  • Intralipid 20%, 100 mL AUST R 14472
  • Intralipid 20%, 500 mL AUST R 48245
  • Intralipid 20%, 1000 mL AUST R 48246
  • Intralipid 30%, 250 mL AUST R 53538
  • Intralipid 30%, 333 mL AUST R 53539
  • Intralipid 30%, 500 mL AUST R 53540
  • Intralipid 30%, 1000 mL AUST R 53541

Bags

  • Intralipid 10%, 500 mL AUST R 77744
  • Intralipid 20%, 100 mL AUST R 77745
  • Intralipid 20%, 500 mL AUST R 77746
  • Intralipid 30%, 250 mL AUST R 77747
  • Intralipid 30%, 333 mL AUST R 77748

In New Zealand, the following pack sizes are available:

Bottles

  • Intralipid 10%: 100ml, 250ml, 500 mL
  • Intralipid 20%: 100 mL, 250ml, 500 mL, 1000 mL
  • Intralipid 30%: 250 mL, 333 mL, 500 mL, 1000 mL

Bags

  • Intralipid 10%: 500 mL
  • Intralipid 20%: 100 mL, 500 mL
  • Intralipid 30%: 250 mL, 333 mL

It may be supplied from the pharmacy as a mixture of amino acids, glucose, and vitamins. In this case it would be a milky white mixture in a plastic bag.

Further Information

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

Sponsor

Australia:

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: (02) 9391 5555

New Zealand:

Fresenius Kabi New Zealand Limited
60 Pavilion Drive
Airport Oaks, Auckland 2022
New Zealand
Freecall: 0800 144 892

® = Registered Trademark

Date of Information

This leaflet was prepared in July 2016.

Published by MIMS February 2017

BRAND INFORMATION

Brand name

Intralipid

Active ingredient

Soya oil; Lecithin; Glycerol

Schedule

Unscheduled

 

1 Name of Medicine

Soya oil.

2 Qualitative and Quantitative Composition

Sterile fat emulsions for intravenous infusion containing (see Table 1):
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Intravenous infusion for injection.
A milky white liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

Part of the intravenous diet in all parenteral nutrition indications including:
1) Preoperative and postoperative nutritional disturbances where an improved nitrogen balance is required;
2) Nutritional disorders or disturbances of nitrogen balance due to inadequate or failing intestinal absorption caused by tumours in the gastrointestinal tract, acute or chronic intestinal diseases (peritonitis, ulcerative colitis, terminal ileitis);
3) Burns, to reduce the frequently excessive nitrogen losses;
4) Prolonged unconsciousness, e.g. following cranial trauma or poisoning in cases where enteral feeding is inappropriate or impossible;
5) Impaired renal function, where a concentrated source of energy may be indicated to reduce protein breakdown;
6) Cachexia; and
7) Patients with essential fatty acid deficiency who cannot maintain or restore a normal essential fatty acid pattern by oral intake.

4.2 Dose and Method of Administration

Intralipid 30% is particularly suitable for patients on fluid restriction due to its more concentrated form. This also provides an advantage in patients with a high energy requirement. A lower phospholipid/ triglyceride ratio provides less phospholipids than the same amount of energy from Intralipid 100 mg/mL and Intralipid 200 mg/mL. About 60% of the fatty acids in Intralipid are essential fatty acids.

Adult dosage and infusion rate.

Intralipid 10% and 20%.

The quantity of Intralipid given intravenously should normally not exceed 2 g triglycerides/kg bodyweight/day. First day: no more than 1 g triglycerides/kg bodyweight/day. Second day: this dose can be doubled provided the patient's ability to eliminate administered fat has been established. (See Section 4.2 Dose and Method of Administration, Important.)
In patients with raised caloric requirements, the supply of Intralipid can be further increased but should not, without special precautions, exceed 3 g triglycerides/kg bodyweight/day.
When starting, the rate of infusion of Intralipid should be about 1 mL/minute during the first 10 minutes. The infusion rate can then be gradually increased so that, after 30 minutes, it can be stabilised at the desired rate of 2 to 3 mL/minute for Intralipid 10% and 1 to 1.5 mL/minute for Intralipid 20%. At this rate, 500 mL can be infused in 3 to 5 and 5 to 8 hours respectively. The infusion times must not be shorter than 3 and 5 hours respectively.

Intralipid 30%.

The ability to eliminate Intralipid 30% should govern the dosage and infusion rate. (See Section 4.2 Dose and Method of Administration, Important.)
The daily supplementation of 330 mL Intralipid 30% (100 g fat) is regarded to be sufficient for a patient (weighing 70 kg) with basal energy requirement and on total parenteral nutrition. The recommended maximum dosage is 3 g triglycerides/kg bodyweight/day. Intralipid 30% can supply up to 70% of the energy requirements in patients with highly increased energy requirements. The infusion rate for Intralipid 30% is approximately 1 mL/minute and should not exceed 330 mL in 5 hours.

Newborns and infant dosage.

Intralipid 10% and 20% only.

The recommended dosage range in neonates and infants is 0.5 to 4 g triglycerides/kg/day. The rate of infusion should not exceed 0.17 g triglycerides/kg/hour (4 g/kg in 24 hours). In premature and low birthweight neonates, Intralipid should preferably be infused continuously over 24 hours. The initial dosage of 0.5 to 1 g/kg/day may be increased by 0.5 to 1 g/kg/day up to 2 g/kg/day. Only with close monitoring of serum triglyceride concentration, liver function tests and oxygen saturation may the dosage be increased to 4 g/kg/day. No attempt should be made to exceed these rates in order to compensate for missed doses.

Intralipid 30%.

Intralipid 30% is not recommended in infants and children because of lack of experience.

Method of administration.

When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see Section 4.4; Section 6.3).

Important.

Following infusion of approximately 1 g Intralipid/kg bodyweight on the first day of parenteral nutrition, the patient's ability to eliminate the infused fat should be tested. Before the infusion begins on the second day, a sample of blood, preferably while the patient is in a fasting state, is taken in the morning. For infusions during a prolonged period, a sample of blood is taken once per week. The sample is taken as for ESR (citrate) and centrifuged at 1,200 to 1,500 RPM. If the plasma is then very opalescent or milky, the planned infusion should be postponed. In most cases, however, the plasma is quite clear 12 hours after the conclusion of an infusion of 2 g triglycerides/kg bodyweight. Hyperlipaemic serum will interfere with blood tests involving photometric determination. If the serum is milky, analysis should be postponed. Hence, the laboratory should always be advised when a patient is receiving Intralipid.

Route of administration.

Intralipid, being isotonic, can be given by a peripheral or central vein, either alone or simultaneously with Vamin and/or glucose 10% to 30%, through a twin infusion set or separate sets connected to a single tap, so that the mixture reaches the vein through the same cannula.

(i) Central vein.

When given simultaneously with Vamin and/or glucose 10% to 30%, a combined infusion rate of between 2 and 4 mL/min is usually most suitable such that 1 L is infused during 4 to 8 hours in adults. Higher or lower infusion rates may be desirable for practical reasons and the individual's tolerance to the total fluid load.
When long-term total parenteral nutrition is considered for a patient, simultaneous infusion of the various nutrients after a period of time can lead to the accumulation of some sediment on the interior wall of the catheter. This complication can be avoided in long-term total parenteral nutrition by first administering the Intralipid. Then glucose solution followed by Vamin N or Vamin Glucose. In this way the catheter can be kept patent without any deposits at all for several months and probably even considerably longer.

(ii) Peripheral vein.

Intralipid can be infused simultaneously with Vamin Glucose into a peripheral vein, thus providing a combined source of fat, glucose, L-amino acids and basal electrolyte requirements. By this method, the risk of thrombophlebitis is reduced to an absolute minimum. This protection results from the dilution effect of the isotonic Intralipid and the transient coating of the blood vessel intima at the infusion site with lipid particles. Peripheral feeding is a means of supplying short-term total parenteral nutrition without the complication of a central venous catheter.
To reduce the risk of thrombophlebitis, it is important that before beginning infusion, future infusion sites are marked and the infusion site is changed every 12 to 24 hours, dependent on the daily infusion period. It is also recommended that a few drops of Intralipid be administered alone at the beginning and end of the simultaneous infusion.

4.3 Contraindications

Intralipid is contraindicated in patients with:
an impaired ability to metabolise fat, such as in severe liver damage and acute shock;
hypersensitivity to egg, soya or peanut protein or to any of the active substances or excipients.

4.4 Special Warnings and Precautions for Use

Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, pancreatitis, certain forms of liver insufficiency, metabolic disorders and sepsis. If intravenous fat is considered to be indicated in patients with the abovementioned disorders, the elimination of fat should be checked daily (see Section 4.2 Dose and Method of Administration).
In cases of verified or suspected liver insufficiency, the condition as well as function of the liver must be closely followed.
Intralipid contains soya oil and egg lecithin which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya bean and peanut.

Use in the elderly.

No data available.

Paediatric use.

Intralipid should be given with caution to neonates and premature infants with hyperbilirubinaemia and in cases with suspected pulmonary hypertension. In low birthweight infants, the risk of lipid infusions may outweigh potential benefits due to further diminution of defences against infection.
In infants, metabolism of lipids in peripheral tissues may be diminished by infection and heparin administration.
In neonates receiving long-term parenteral nutrition, particularly premature neonates, platelet count, liver function tests and serum triglyceride concentration should be monitored.
Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products. When used in neonates and children below 2 years, Intralipid should be protected from ambient light until administration is completed (see Section 4.2; Section 6.3).

Effects on laboratory tests.

Intralipid may interfere with certain laboratory measurements (bilirubin, lactate dehydrogenase, oxysaturation, haemoglobin), if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat free interval of 5 to 6 hours in most patients.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Heparin in clinical doses causes a transient increase in lipolysis in plasma, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase.
Soya oil has a natural content of vitamin K1. This is considered important only for patients treated with coumarin derivatives, which interfere with vitamin K1. The dose of coumarin derivatives may need to be increased when soy bean oil containing fat emulsions are administered.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No studies have been performed.
It is not known whether Intralipid can cause foetal harm when administered to pregnant women or can affect reproductive capacity. This matter should be taken into consideration when this therapy is indicated in pregnant women.
 It is not known whether Intralipid can enter maternal milk. This matter should be taken into consideration when this therapy is indicated in lactating 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)

Intralipid infusion may cause a rise in body temperature (incidence < 3%) and, less frequently, shivering, chills and nausea/ vomiting (incidence < 1%). Reports of other adverse events in conjunction with Intralipid infusion are extremely rare, less than one report of certain events per one million infusions.

Immediate adverse reactions.

Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (tachypnoea) and circulatory effects (hypertension, hypotension) have been described.
Thrombosis, haemolysis, reticulocytosis, abdominal pain, tiredness, priapism and neurological adverse reactions including headaches, flushing, dyspnoea, slight pressure over the eyes and dizziness have been reported.

Delayed adverse reactions.

Thrombocytopenia has been reported in association with prolonged Intralipid treatment in infants.
Transient increase in liver function tests after prolonged intravenous nutrition with or without Intralipid have also been noted.

Fat overload syndrome.

An impaired capacity to eliminate Intralipid may lead to 'fat overload syndrome' as a result of overdosage. It may also occur at recommended rates of infusion in association with a sudden change in the clinical condition such as renal function impairment or infection. Fat overload syndrome is characterised by bone marrow depression, anaemia, thrombocytopenia, hepatosplenomegaly, splenomegaly, hyperlipaemia, fever, fat infiltration, focal seizures and shock. All symptoms are usually reversible if the infusion of Intralipid is discontinued.
Pigmentation of tissues after prolonged therapy with lipid emulsion infusions has also been reported.

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 https://www.tga.gov.au/reporting-problems.

4.9 Overdose

Please see Section 4.8 Adverse Effects (Undesirable Effects), Fat overload syndrome.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The particle size is less than 1 micron which gives a stable emulsion and excludes the risk of fat embolism. Intralipid enters the bloodstream in a similar manner to natural chylomicron rich lymph in both size and form, and is eliminated from the circulation according to the same kinetic principles as dietary chylomicron rich lymph. It is formulated as a concentrated source of energy to be used together with carbohydrates and amino acids in parenteral nutrition, is isotonic, and provides a source of basal phosphate requirements (15 mmol/L) and a source of vitamin E. The vitamin E content in Intralipid 10%, 20% and 30% is 6.5, 13 and 19.5 microgram/mL, respectively.
Intralipid prevents essential fatty acid deficiency (EFAD) and corrects the clinical manifestations of EFAD. However, for patients requiring complete parenteral nutrition, complementary vitamin supplements are required.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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 taken up by the LDL receptors and primarily hydrolysed in the peripheral circulation which removes the triglycerides. Thus a transient triglyceride level may be elevated after Intralipid infusion. The triglycerides are hydrolysed by lipoprotein lipase to fatty acids and glycerol. The free fatty acids are used by the muscle as an immediate source of energy or reconverted into triglycerides and stored as a fat in the subcutaneous tissue for energy reserve. The free fatty acids also undergo entero-hepatic recycling and re-enter the systemic circulation in the form of very low-density lipoproteins (VLDL).
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.
There is no information available on the elimination half-life.

5.3 Preclinical Safety Data

Genotoxicity.

No studies have been performed.

Carcinogenicity.

No studies have been performed.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Table 2.

6.2 Incompatibilities

Additions may only be made to Intralipid where compatibility is documented. Additions made for which compatibility has not been documented may cause the mixture to crack.
The following additions have been shown to be compatible with Intralipid:
1. Vitalipid N Adult or Vitalipid N Infant.
2. Soluvit N (see Soluvit N Product Information for details on reconstitution).
Additions should be made aseptically.
Intralipid can also be delivered from a phthalate-free plastic bag (ethylene vinyl acetate (EVA), for example) as one part of an All-in-One admixture containing also carbohydrates, amino acids, electrolytes, vitamins and trace elements. (See Section 6.3 Shelf Life.)
Admixtures prepared with these amino acids must be used within 24 hours of admixing. (See Section 6.3 Shelf Life.)
Apart from the components of approved admixtures, nutrient solutions, electrolytes, water soluble vitamins (other than Soluvit N) or other drugs should not be added to Intralipid. However, nutrient solutions such as Vamin with electrolytes and glucose can be infused simultaneously using a short Y-connector or 3-way tap, where the common segment in which the solutions are in contact should be no longer than 10 to 15 cm. Fat soluble vitamins may be added directly to Intralipid.

All-in-one mixing guidelines and limitations.

Using aseptic techniques, Intralipid 10%, 20% or 30% may be combined with other nutrients by adding the emulsion to a mixture of amino acids and glucose in the proportions listed in Table 3. Do not add electrolytes or trace elements directly to Intralipid. Total quantities of electrolytes, trace minerals and vitamins in the admixture must not exceed those listed in Table 4. Amino acids with a low pH such as Aminosyn and Tropamine must not be used for All-in-One admixing.

6.3 Shelf Life

Approved shelf life as packaged for sale.

24 months.

Shelf life after first opening the container.

The emulsion should be used directly due to the risk of microbiological contamination. Any unused emulsion should be discarded.

Shelf life after addition or mixing according to directions.

Although physical and chemical stability of the nominated admixtures of Intralipid has been demonstrated for 6 days when packed in EVA bags stored at 2-8°C followed by one day at 25°C, it is recommended that in order to reduce microbiological contamination hazards, infusion should be commenced as soon as practicable after preparation of the mixture. The resulting solution should be used within 24 hours and any residue discarded.
When used in neonates and children below 2 years, the solution (in bags and administration sets) should be protected from light exposure until administration is completed (see Section 4.2; Section 4.4).

6.4 Special Precautions for Storage

Store below 25°C. Do not freeze.
Emulsions which have been frozen should be discarded.
Any remaining emulsion from an opened bottle must be discarded.
Do not use if emulsion is discoloured.
When stored correctly, Intralipid can be used until the expiry date printed on the labels.
Intralipid 10%, 20% and 30% contain no preservatives.

Gravity dispersion.

Separation of the product (gravity dispersion) occurs after a period of time, hence, inverting or gently shaking the solution before usage is needed. Do not use if inversion or gentle shaking does not result in an even mixture.

6.5 Nature and Contents of Container

Glass bottles.

Type II clear glass bottle with butyl rubber stopper and aluminium cap.

Infusion bags.

The container consists of an inner bag and an overpouch. An oxygen absorber and integrity indicator are placed between the inner bag and the overpouch. The inner bag is the primary container for Intralipid. The overpouch provides protection during storage by contributing with barrier properties towards water and oxygen to the Intralipid container system. The oxygen absorber will absorb and bind oxygen remaining between the inner bag and the overpouch. The integrity indicator will react with free oxygen and change from clear to black in case of a damaged overpouch.
The inner bag is made of a multilayer polymer film called 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.
The oxygen barrier overpouch consists of polyolefin and polyethylene terephtalate or polyolefin, polyethylene terephthalate and poly(ethyl vinyl) alcohol (EVOH).
The oxygen absorber consists of iron powder in a polymer sachet.
The integrity indicator (Oxalert) consists of an oxygen sensitive solution in a polymer sachet.
All packaging components for the bottle and the bag are latex- and PVC-free.

Pack sizes in Australia.

Glass bottles.

Intralipid 20% 100 mL (AUST R 14472).
Intralipid 20% 500 mL (AUST R 48245).
Intralipid 20% 1000 mL (AUST R 48246).

Biofine bags.

Intralipid 10% 500 mL (AUST R 77744).
Intralipid 20% 100 mL (AUST R 77745).
Intralipid 20%, 500 mL (AUST R 77746).
Intralipid 30% 250 mL (AUST R 77747).
Intralipid 30%, 333 mL (AUST R 77748).

In New Zealand.

Glass bottles.

Intralipid 20%: 100 mL, 250 mL, 500 mL, 1000 mL.

Biofine bags.

Intralipid 10%: 500 mL.
Intralipid 20%: 100 mL, 500 mL.
Intralipid 30%: 250 mL, 333 mL.

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.

Soya oil is a mixture of triglycerides, i.e. triacylglycerols. The triglycerides, triacylglycerols, are fatty acid triesters of glycerol (propane-1, 2, 3-triol). The main fatty acids are linoleic acid (C18:2), oleic acid (C18:1) and palmitic acid (C16:0). The number of double bonds in the different fatty acids can vary from zero (saturated) to three (unsaturated). As with most vegetable oils, the saturated acids are preferably esterified in sn-1 and sn-3 position. The molecular structure is well known from general literature on lipid chemistry.
Molecular weight: 871 g/mol (typical mean value, the molecular weight depends on the fatty acid pattern of the triglyceride).

CAS number.

Active Substance: Soya oil.
CAS number: 8001-22-7.

7 Medicine Schedule (Poisons Standard)

Australia: Not Scheduled.
New Zealand: General Sale Medicine.

Summary Table of Changes