What Propofol Injection is used for and how to use it
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Propofol Injection - Consumer Medicine Information

Manufacture: Fresenius Kabi USA, LLC
Country: United States
Condition: Anesthesia, Sedation
Class: General anesthetics
Form: Intravenous (IV), Powder
Ingredients: Propofol, Soybean Oil, Glycerin, Egg Phospholipids, Oleic Acid, Sodium Hydroxide

About This Medication

What the Medication is Used For

Propofol Injection belongs to a group of medicines called general anaesthetics. It is used to induce or maintain anaesthesia.

What it Does

Propofol Injection causes you to become unconscious (asleep) while surgical operations or other procedures are being conducted. In adults only, smaller doses can also be used in certain circumstances to sedate you (make you sleepy or make you go to sleep lightly).

The effect of Propofol Injection starts rapidly, within approximately 30 seconds. The recovery period from anaesthesia or sedation is also usually rapid.

When it Should not be Used

  • In children under the age of 18 years for sedation during surgical/diagnostic procedures or in the intensive care unit.
  • In children under the age of 3 years old for anaesthesia.
  • If you have ever received propofol before and have experienced an allergic reaction to its use or if you know that you are allergic to any of the ingredients listed in this leaflet (see What the nonmedicinal ingredients are:)

What the Medicinal Ingredient Is

Propofol 10 mg/mL.

What the Nonmedicinal Ingredients Are

Propofol Injection contains soybean oil, medium-chain triglycerides, glycerol, purified egg phospholipids, oleic acid, nitrogen, sodium hydroxide, and water for injection.

What Dosage Forms it Comes In

Propofol Injection is available as propofol 1% w/v in 20 mL glass vial, 50 mL and 100 mL glass bottle for single infusion only. Each vial and bottle contains 10 mg/mL of propofol.

Warnings and Precautions

You should talk to your doctor or anesthetist/anaesthesiologist prior to surgery:

  • About all health problems you have now or have had in the past.
  • About other medicines you take, including ones you can buy without a prescription.
  • If you have any other health problems such as problems with your heart, breathing, kidneys or liver or if you have been generally unwell for some time.
  • If you have ever had an epileptic fit or convulsion.
  • If you have ever been told that either you have very high fat levels in your blood or your body has problems in metabolising fat adequately.
  • If you are pregnant, plan to become pregnant or are breastfeeding.
  • If you are planning to drive or operate any tools or machinery on the day of surgery, because Propofol Injection may temporarily interfere with your reactions and muscular coordination.

Interactions with This Medication

Some drugs interact with Propofol Injection. Tell your doctor about all prescription, over the-counter and natural health products that you are using (see Warnings and Precautions above).

Usage of such medicines at the same time as Propofol Injection may increase the risk of serious side effects.

Avoid alcohol before and for at least 8 hours after receiving Propofol Injection.

Proper Use of This Medication

How Propofol Injection is Used

Propofol Injection will be given to you by your anaesthesiologist or intensive care doctor.

Usual Dose

The dose given is decided by the doctor based on the clinical need and your physical condition.

When Receiving Propofol Injection

Propofol Injection will be given to you as an injection into a vein, usually in the back of the hand or in the forearm. Your anaesthesiologist may use a needle, or a fine plastic tube called a cannula. For long operations and for use in intensive care situations, an electric pump may be used to control the rate at which the injection is given.

After Receiving Propofol Injection

You may feel some pain in the arm into which Propofol Injection is given; this is normal. Your anaesthesiologist or intensive care doctor will closely control the amount of Propofol Injection that is given to you. The amount will be adjusted according to how deeply your anaesthesiologist or intensive care doctor wishes you to be sedated or anaesthetised.
He/she will also take account of your age and physical fitness and adjust the amount accordingly.

Several different medicines may be needed in order to keep you asleep or sedated, free from pain, breathing in a healthy way and to keep your blood pressure steady. Your anaesthesiologist or intensive care doctor will decide which medicines to use as the need arises.

During prolonged use of Propofol Injection for intensive care, certain patients may need to be given zinc (a mineral) supplements.

Serious adverse effects resulting from an overdose are extremely rare and need special treatment. The doctor is trained and equipped to handle such situations.

Side Effects and What to do About Them

Like all medicines, Propofol Injection can have side effects. Your anaesthesiologist or intensive care doctor will care for you if any of the following side effects or any other undesirable events occurs.

Medicines affect different people in different ways. Just because side effects have occurred in some patients, does not mean that you will get them.

Serious Side Effects, How Often They Happen and What to do About Them

During use of Propofol Injection

More than 10 of every 100 patients (very common) may experience:

  • A feeling of pain near the injection site before the injectionmakes you unconscious

One to 10 of every 100 patients (common) may experience:

  • A fall in blood pressure/li>
  • A slower heart beat
  • Changes in your breathing pattern

Less than 1 of every 1000 patients (rare) may experience:

  • Some twitching and shaking
  • Feeling of euphoria (sense of happiness)

The majority of the above reactions are mild and transient in nature.

Less than 1of every 10 000 patients (very rare) may experience:

  • Allergic reactions
  • Fluid in the lungs

When Propofol Injection provides sedation in an intensive care unit:

  • Discolouration of the urine has been observed.
  • Breakdown of muscle cells (rhabdomyolysis) has been reported when propofol injectable emulsion has been given in excess of the maximum recommended dose rate.

After use of Propofol Injection:
One to 10 of every 100 patients (common) may experience:

  • Nausea and vomiting
  • Headache

Less than 1 of every 100 patients (uncommon) may experience:

  • Redness or soreness where Propofol Injection was given

Less than 1 of every 1000 patients (rare) may experience:

  • Some twitching and shaking
  • A feeling of euphoria (sense of happiness)

Less than 1 of every 10 000 patients (very rare) may experience:

  • Inflammation of the pancreas
  • Fluid in the lungs
  • Increased body temperature
  • A feeling of sexual arousal
  • Postoperative unconsciousness – recovery without complications has always occurred

Do not be alarmed by this list of possible side effects. You may not experience any of them.

This is not a complete list of side effects. For any unexpected effects while or after taking Propofol Injection, contact your doctor or pharmacist.

How to Store Propofol Injection

Vials:
Store Propofol Injection between 15 °C and 25 °C; do not freeze.

Propofol Injection must be kept out of reach and sight of children and pets.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to:
      Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9
      Postage paid labels and the Consumer Side
      Effect Reporting Form are available at
      MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Ltd., at: 1-877-821-7724