Details for: PROPOFOL
Company: BAXTER CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02468336 | PROPOFOL | PROPOFOL | 10 MG / ML | EMULSION | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
PROPOFOL (propofol) belongs to a group of medicines called general anesthetics. It is used to induce or maintain anesthesia.
What it does
PROPOFOL 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 starts rapidly, within approximately 30
seconds. The recovery period from anesthesia 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.
- 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 NON-MEDICINAL INGREDIENTS ARE)
What the medicinal ingredient is
Propofol
What the non-medicinal ingredients are
Egg lecithin, glycerol, sodium hydroxide, sodium oleate, soybean oil and water for injection.
What dosage form it comes in
Injection 1% w/v: 10 mg/mL
Warnings and precautions
You should talk to your doctor or anesthetist 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 may temporarily interfere with your reactions and muscular coordination.
Interactions with this medication
Some drugs interact with PROPOFOL. 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 may
increase the risk of serious side effects.
Proper use of this medication
HOW PROPOFOL IS USED:
PROPOFOL will be given to you by your anesthetist 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
PROPOFOL will be given to you as an injection into a vein,
usually in the back of the hand or in the forearm. Your anaesthetist
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
You may feel some pain in the arm into which PROPOFOL is
given; this is normal.
Your anesthetist or intensive care doctor will closely control the
amount of PROPOFOL that is given to you. The amount will be
adjusted according to how deeply your anesthetist or intensive care
doctor wishes you to be sedated or anaesthetized.
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 anesthetist or intensive care
doctor will decide which medicines to use as the need arises.
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 can have side effects. Your anesthetist 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 ANESTHESIA
More than 10 of every 100 patients (very common) may experience:
- A feeling of pain near the injection site before the injection makes you unconscious
1 to 10 of every 100 patients (common) may experience:
- A fall in blood pressure
- A slower heart beat
- Changes in your breathing pattern
Less than 1 of every 1000 patients (rare) may experience:
- Some twitching and shaking
The majority of the above reactions are mild and transient in nature.
Less than 1 of every 10 000 patients (very rare) may experience:
- Allergic reactions
- Fluid in the lungs
AFTER ANESTHESIA
1 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 the anaesthetic was given
Less than 1 of every 1000 patients (rare) may experience:
- Some twitching and shaking
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
DURING INTENSIVE CARE SEDATION (ADULTS ONLY)
1 to 10 of every 100 patients (common) may experience:
- A fall in blood pressure
- A slower heart beat
Less than 1 of every 100 patients (uncommon) may experience:
- Redness or soreness where the anesthetic was given
Less than 1 of every 1000 patients (rare) may experience:
- Some twitching and shaking
Less than 1 of every 10 000 patients (very rare) may experience:
- Allergic reactions
- Increased body temperature
- Breakdown of muscle cells (rhabdomyolysis) when propofol has been given in excess of the maximum recommended dose rate. A causal relationship with propofol has not been established.
- Inflammation of the pancreas
- Discolouration of the urine
This is not a complete list of side effects. For any unexpected effects while or after taking PROPOFOL contact your doctor or pharmacist.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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 Baxter
Corporation at 1-888-719-9955.
This leaflet was prepared by
Baxter Corporation
Mississauga, Ontario
L5N 0C2
Last revised: September 29, 2017