Details for: SEVOFLURANE
Company: BAXTER CORPORATION
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02265974 | SEVOFLURANE | SEVOFLURANE | 99.97 % | LIQUID | INHALATION |
Summary Reports
Summary Safety Review - Sevoflurane - Re-Assessing the potential risk of slow heartbeat (bradycardia) in children with Down syndrome
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
Sevoflurane is an inhalation general anesthetic used during surgery.
What it does
Sevoflurane causes unconsciousness, muscle relaxation, and loss of sensation over the entire body so that surgery can be performed.
When it should not be used
Sevoflurane should not be used in patients who:
- are allergic to sevoflurane or other halogenated agents
- have experienced liver problems, jaundice, unexplained fever, or certain types of inflammation reactions after a previous halogenated anesthetic administration
- are susceptible to malignant hyperthermia
What the medicinal ingredient is
Sevoflurane, USP
What the non-medicinal ingredients are
The finished product is composed solely of the active ingredient, Sevoflurane, USP.
What dosage form it comes in
Sevoflurane is available as a volatile liquid that is 99.97% v/v pure.
Warnings and precautions
Recovery of consciousness following sevoflurane
administration generally occurs within minutes. As
with other anesthetics, small changes in moods may
persist for several days following administration.
Performance of activities requiring mental alertness,
such as operating a motor vehicle or hazardous
machinery, may be impaired for some time after
general anesthesia.
Interactions with this medication
Many drugs may interact with sevoflurane. Tell your doctor if you had a history of drug interactions. Your doctor will manage according to your condition.
Proper use of this medication
Usual Dose
The proper dose is determined by a doctor trained in the administration of general anesthesia.
Side effects and what to do about them
Known side effects when you wake up include:
feeling agitated, increased cough, nausea, and
vomiting.
You should talk to your anesthesia professional prior
to surgery if you are aware of any of the following
conditions:
- you have difficulty with airway intubations
- you are susceptible to malignant hyperthermia
- you are taking medications, non-prescription medications, or herbal medicines
- you have kidney or liver problems
- you have Pompe’s disease or a mitochondrial disorder
- you are pregnant or nursing
| After your surgery, you should tell your doctor if you have any of the following reactions: |
|---|
|
This is not a complete list of side effects. For any unexpected effects while taking sevoflurane, contact your doctor or pharmacist.
How to store
Sevoflurane should be stored between 15°C and 30°C.
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 three 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 ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM 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 the sponsor, Baxter Corporation, at:
1-888-719-9955
This leaflet was prepared by Baxter Corporation,
Mississauga, Ontario L5N 0C2.
Baxter is a registered trademark of Baxter
International Inc.
Last revised: February 21, 2019