SUMMARY CMI

Intralipid^® 10%, 20% & 30%

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 Intralipid?

Intralipid contains the active ingredient soya oil. Intralipid is a supplement to parenteral nutrition, which provides your body with energy and fatty acids. It is usually given together with carbohydrates, amino acids, salts, trace elements and vitamins to provide a complete intravenous diet.

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

2. What should I know before I use Intralipid?

• Do not use if you have ever had an allergic reaction to soy, eggs, peanuts or any of the ingredients listed at the end of the CMI. Tell your doctor if you have an inability to break down fats.

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 Intralipid? in the full CMI.

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 Intralipid 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 Intralipid?

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

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

5. What should I know while using Intralipid?

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

6. Are there any side effects?

Less serious side effects have been reported during post-marketing, including rise in body temperature, nausea, vomiting, shivering, chills, skin rash, hives, rapid breathing, shortness of breath, headache, effects on blood pressure, slight pressure over the eyes, abdominal pain, flushing and dizziness. 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

Intralipid^® 10%, 20% & 30%

Active ingredient: soya oil

Consumer Medicine Information (CMI)

This leaflet provides important information about using Intralipid. 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 Intralipid.

Where to find information in this leaflet:

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

1. Why am I using Intralipid?

Intralipid contains the active ingredient soya oil. Intralipid is a supplement to parenteral nutrition.

Soya oil consists of a mixture of mainly polyunsaturated fatty acids. Intralipid is a sterile fat emulsion, which provides your body with energy and fatty acids.

When the intake of nutrients or food into the mouth or directly into the gut is not possible or not enough to supply the needs, then intravenous nutrients or foods can be given. This is especially important for people under physical stress from illness or recent surgery.

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

Intralipid is part of the intravenous diet in many situations where parenteral nutrition is required

2. What should I know before I use Intralipid?

Warnings

Do not use Intralipid if:

• you are allergic to soy, eggs, peanuts, 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 have an inability to break down fats

Check with your doctor if you:

• are pregnant or trying to become pregnant
• are breastfeeding
• have any other medical conditions such as liver or kidney disease
• are diabetic
• have a disease of the pancreas
• have a disorder of the thyroid gland
• are taking anticoagulants (medicines for preventing bold clotting)
• are 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 Intralipid or may affect how well Intralipid works.

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

It is not known whether Intralipid can cause harm to the baby when administered to pregnant women or can affect reproductive capacity.

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.

Use in liver impairment

Intralipid is contraindicated in patients with an impaired ability to metabolise fat, such as severe liver damage. In cases of verified or suspected liver insufficiency the condition, as well as function, of the liver must be closely monitored.

Use in renal impairment

Intralipid should be used with caution in patients with impaired renal function as fat metabolism may be disturbed. The elimination of fat should be checked daily.

Use in elderly

No data is available for use of Intralipid in elderly patients. Your doctor will decide what to do.

Use in Paediatrics

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 defenses 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.

When used in neonates and children below 2 years, Intralipid should be protected from ambient light until administration is completed.

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 Intralipid and affect how it works.

Tell your doctor or pharmacist if you are taking anticoagulants (medicines for preventing blood clotting) or any other medicines. 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 soya oil containing fat emulsions are administered.

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

4. How do I use Intralipid?

How much is given

• The dose of Intralipid which you will require will be determined by your doctor or pharmacist.

How to take Intralipid

• Intralipid will be given to you by a health care professional. Your doctor will supervise your treatment with Intralipid.

If you forget to use Intralipid

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

If you use too much Intralipid

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.

If you think that you have used too much Intralipid, 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 Intralipid?

Things you should do

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, dentist, pharmacist or nurse you visit that you are using Intralipid.

Things you should not do

• Do not stop using this medicine without consulting your health care professional.

Driving or using machines

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

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

Drinking alcohol

Tell your doctor if you drink alcohol.

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

Looking after your medicine

Intralipid is usually administered under the care of a trained health care professional in a hospital or clinic setting.

Intralipid is recommended to be stored below 25°C in a cool dry place, protected from light, moisture or heat. Do not freeze. Do not use Intralipid if it has been frozen.

Keep it where young children cannot reach it.

Do not use this medicine after the expiry date which is stated on the carton label and the bottle or bag. The expiry date refers to the last day of that month.

Your doctor and hospital pharmacist are responsible for the correct storage, use and disposal of Intralipid.

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 nurse 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 or nurse 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 Intralipid contains

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

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

1000mL of Intralipid supplies the following calories:
10% 4600 kJ
20% 8400 kJ
30% 12600kJ

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

Bottles

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 mLAUST 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

What Intralipid looks like

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

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.

Who distributes Intralipid

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 March 2023.

Published by MIMS April 2024

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%.

Intralipid 30%.

Newborns and infant dosage.

Intralipid 10% and 20% only.

Intralipid 30%.

Method of administration.

Important.

Route of administration.

(i) Central vein.

(ii) Peripheral vein.

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.

Paediatric use.

Effects on laboratory tests.

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.

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.

Delayed adverse reactions.

Fat overload syndrome.

Reporting suspected adverse effects.

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.

Clinical trials.

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.

Carcinogenicity.

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.

6.3 Shelf Life

Approved shelf life as packaged for sale.

Shelf life after first opening the container.

Shelf life after addition or mixing according to directions.

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.

6.5 Nature and Contents of Container

Glass bottles.

Infusion bags.

Pack sizes in Australia.

Glass bottles.

Biofine bags.

In New Zealand.

Glass bottles.

Biofine bags.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

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

Summary Table of Changes