Consumer medicine information

Intralipid 20% Emulsion for infusion

Soya oil

BRAND INFORMATION

Brand name

Intralipid

Active ingredient

Soya oil

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Intralipid 20% Emulsion for infusion.

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?

Things you should do
  • Call you doctor straightaway 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.
Things you should not do
  • Do not stop using this medicine without consulting your health care professional
  • Do not take any other medicines without first telling your health care professional
  • Do not give this medicine to anyone else, even if they have the same condition as you
Driving or using machines
  • 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
  • The effects of alcohol with Intralipid use were not studied. Your doctor will decide what you need to do.
Looking after your medicine
  • Store below 25°C. Do not freeze it. Do not use Intralipid if it has been frozen. Do not use after the expiry date stated on the label.

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.

BRAND INFORMATION

Brand name

Intralipid

Active ingredient

Soya oil

Schedule

Unscheduled

 

1 Name of Medicine

Soya oil.

2 Qualitative and Quantitative Composition

Sterile fat emulsions for intravenous infusion containing (see Table 1):
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/INTRAL01.gif 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

4.9 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

5.3 Preclinical Safety Data

Genotoxicity. No studies have been performed.
Carcinogenicity. No studies have been performed.

6 Pharmaceutical Particulars

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.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSSOYAOI.gif 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

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/INTRALST.gif