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SEVOFLURANE is a brand name for Sevoflurane, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SEVOFLURANE (sevoflurane) is indicated for: • induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. 1.1 Pediatrics Pediatrics (< 18 years of age): For a brief discussion, see 7.1.3 Pediatrics. 1.2 Geriatrics Geriatrics (> 65 years of age): For a brief…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Fresh gas flow rates of less than 2 L/min in a circle absorber system are not recommended, as safety at lower rates has not yet been established: Sevoflurane Product Monograph Page 5 of 33 The concentration of sevoflurane being delivered from a vaporizer during anesthesia should be known.
This may be accomplished by using a vaporizer calibrated specifically for sevoflurane. The administration of general anesthesia must be individualized based on the patient's response.
Pre-Anesthetic Medication:
No specific premedication is either indicated or contraindicated with SEVOFLURANE. The decision as to whether or not to premedicate and the choice of premedication is left to the discretion of the anesthesiologist.
Induction:
Sevoflurane has a non-pungent odour and does not cause respiratory irritability; therefore, it is suitable for mask induction in pediatrics and adults. 5 to 3% sevoflurane with or without the concomitant use of nitrous oxide. 4 Drug-Drug Interactions.
Table 6. Sevoflurane can be administered with any type of anesthesia circuit. 2 Recommended Dose and Dosage Adjustment Minimum alveolar concentration (MAC) values according to age are presented in Table 1. 3%.
Note 2:
In 1 to < 3 years old pediatric patients, 60% N2O / 40% O2 was used. 4 Administration SEVOFLURANE should be administered only by persons trained in the administration of general anesthesia. See 7 WARNINGS AND PRECAUTIONS, General.
1 Adverse Reaction Overview Adverse events are derived from controlled clinical trials conducted in the United States, Canada and Europe. The reference drugs were isoflurane, enflurane, and propofol in adults and halothane in pediatric patients.
The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered.
Nausea, vomiting, and delirium have been observed in the post-operative period, common sequelae of surgery and general anesthesia, which may be due to inhalational anesthetic, other agents administered intra-operatively or post-operatively, and to the patient's response to the surgical procedure.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. Of the 5182 patients enrolled in the clinical trials, 2906 were exposed to sevoflurane, including 118 adults and 507 pediatric patients who underwent mask induction.
Each patient was counted once for each type of adverse event. Adverse events reported in patients in clinical trials are presented within each body system in Table 3, Table 4 and Table 5. One case of malignant hyperthermia was reported in pre-registration clinical trials.
Table 3 - Adverse Events During Induction Period (From Onset of Anesthesia by Mask Induction to Surgical Incision) Possibly or Probably Related with Incidence > 1% Body System Adult Patients N = 118 (%) Pediatric Patients N = 507 (%) Cardiovascular Bradycardia 5 - Hypotension 4 4 Tachycardia 2 6 Nervous System Agitation 7 15 Increased salivation - 2 Sevoflurane Product Monograph Page 12 of 33 Body System Adult Patients N = 118 (%) Pediatric Patients N = 507 (%) Respiratory System Airway obstruction 8 - Apnea - 2 Breath-holding 5 5 Cough increased 5 5 Laryngospasm 8 3 NOTE: Similar incidence of adverse events was noted when all adverse reactions were recorded, not only possibly or probably related.
3 Pediatrics 03/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics ..........................................................................................................
2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .......................................................................................
2 Recommended Dose and Dosage Adjustment..................................................... 4 Administration................................................................................................... 5 5 OVERDOSAGE .............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations ............................................................................................
• SEVOFLURANE is contraindicated in patients with known sensitivity to sevoflurane or to other halogenated inhalation anesthetics. • SEVOFLURANE is contraindicated in patients in whom liver dysfunction, jaundice or unexplained fever, leucocytosis, or eosinophilia has occurred after a previous halogenated anesthetic administration.
See 7 WARNINGS AND PRECAUTION, Hepatic/Biliary/Pancreatic. • SEVOFLURANE is contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia, or in patients with a known or suspected history of malignant hyperthermia.
• SEVOFLURANE should not be used when general anesthesia is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sevoflurane in Canada.
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4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Transient elevations in glucose, liver function tests, and white blood cell count may occur as with use of other anesthetic agents. 5 Post-Market Adverse Reactions Adverse events have been spontaneously reported during post-approval use of sevoflurane.
These events are reported voluntarily from a population of an unknown rate of exposure. Therefore, it is not possible to estimate reliably the true incidence of adverse events or establish a causal relationship to sevoflurane exposure.
QT Prolongation:
There are literature and post-market reports that link sevoflurane with QT prolongation. Very rare cases of torsade de pointes, some resulting in deaths, have been reported. See 7 WARNINGS AND PRECAUTIONS, Cardiovascular.
Cardiac Arrest:
There have been very rare post-marketing reports of cardiac arrest in the setting of sevoflurane use.
Malignant Hyperthermia:
There have been post-marketing reports of rare events of malignant hyperthermia. See 2 CONTRAINDICATIONS and 7 WARNINGS AND […]
1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................ 3 Pediatrics ...................................................................................................
4 Geriatrics ................................................................................................... 10 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview.............................................................................. 2 Clinical Trial Adverse Reactions ........................................................................ 3 Less Common Clinical Trial Adverse Reactions ..................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...................................................................................................... 5 Post-Market Adverse Reactions........................................................................
15 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview .............................................................................. 3 Drug-Behavioural Interactions ..........................................................................
4 Drug-Drug Interactions ..................................................................................... 5 Drug-Food Interactions..................................................................................... 6 Drug-Herb Interactions .....................................................................................
7 Drug-Laboratory Test Interactions.................................................................... 18 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action..................................................................................
2 Pharmacodynamics .................................................................................... 3 Pharmacokinetics ....................................................................................... 19 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
21 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 21 PART II: SCIENTIFIC INFORMATION ......................................................................................
22 13 PHARMACEUTICAL INFORMATION............................................................................ 22 14 CLINICAL TRIALS........................................................................................................
1 Trial Design and Study Demographics ......................................................... 2 Study Results ............................................................................................. 23 15 MICROBIOLOGY ........................................................................................................
26 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 26 17 SUPPORTING PRODUCT MONOGRAPHS.................................................................... 28 PATIENT MEDICATION INFORMATION .................................................................................
29 Sevoflurane Product Monograph Page 4 of 33 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS SEVOFLURANE (sevoflurane) is indicated for: • induction and maintenance of general anesthesia in adult and pediatric patients for inpatient […]