Consumer medicine information

1. Why am I being given FRESOFOL 1% MCT/LCT?

FRESOFOL 1% MCT/LCT contains the active ingredient propofol. FRESOFOL 1% MCT/LCT is a short-acting sleep-inducing medicinal product used to start and sustain a general anaesthesia. It is used to induce sleep or lower your level of consciousness (as a sedative) during intensive care or during diagnostic or surgical procedures.
For more information, see Section 1. Why am I being given FRESOFOL 1% MCT/LCT? in the full CMI.

2. What should I know before I am given FRESOFOL 1% MCT/LCT?

Do not use if you have ever had an allergic reaction to FRESOFOL 1% MCT/LCT 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 am given FRESOFOL 1% MCT/LCT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with FRESOFOL 1% MCT/LCT 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 is FRESOFOL 1% MCT/LCT given?

Your doctor will decide how much FRESOFOL 1% MCT/LCT you should receive and for how long you should receive it.
More instructions can be found in Section 4. How is FRESOFOL 1% MCT/LCT given? in the full CMI.

5. What should I know while receiving FRESOFOL 1% MCT/LCT?

6. Are there any side effects?

• Less serious side effects: Giddiness, vomiting, sleepiness, pain at the injection site, mild to moderate drop in blood pressure, fast breathing or short interruption of breathing, coughing, hiccups, involuntary muscle contractions, abnormally good mood, loss of sexual control, headache, shivering, abnormal colour of urine and fever.
  Speak to your doctor if you have any of these less serious side effects and they worry you.

• Serious side effects: strong drop in blood pressure, allergic reactions including swelling of the face, tongue or throat, wheezing breath, flushing and falling blood pressure, convulsive fits, irregular heartbeat or too slow heartbeat, unconsciousness, swelling of lungs, changes in heartbeat and shock.

1 Name of Medicine

Propofol.

2 Qualitative and Quantitative Composition

Fresofol 1% MCT/LCT is a sterile, milky white, isotonic, oil-in-water emulsion for intravenous infusion or injection. 1 mL of Fresofol 1% MCT/LCT contains 10 mg propofol. It also contains the following excipients: soya oil, medium chain triglycerides, glycerol, egg lecithin, sodium hydroxide, oleic acid and water for injections.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Emulsion for injection.

4 Clinical Particulars

4.9 Overdose

Accidental overdosage is likely to cause cardiorespiratory depression. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression would require lowering the patient's head and, if severe, use of plasma expanders and pressor agents.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Propofol was not genotoxic in a series of assays for gene mutation (Salmonella typhimurium and Saccharomyces cerevisiae), chromosomal damage (dominant lethal, micronucleus and cytogenetics assays) and other genotoxic effects (Saccharomyces cerevisiae gene conversion).
Carcinogenicity. Animal carcinogenicity studies have not been performed with propofol.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPROPOF.gif Chemical name: 2,6-diisopropylphenol.
CAS number. 2078-54-8.

7 Medicine Schedule (Poisons Standard)

Australia: S4 - Prescription Only Medicine.

Summary Table of Changes

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