ETOMIDATE INJECTION, USP SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ETOMIDATE

Saatavilla:

FRESENIUS KABI CANADA LTD

ATC-koodi:

N01AX07

INN (Kansainvälinen yleisnimi):

ETOMIDATE

Annos:

2MG

Lääkemuoto:

SOLUTION

Koostumus:

ETOMIDATE 2MG

Antoreitti:

INTRAVENOUS

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0162234001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-04-26

Valmisteyhteenveto

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ETOMIDATE INJECTION, USP
Solution, 2 mg/mL, Intravenous
USP
General Anesthetic
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd Suite 100
Toronto ON M9W 0C8
Date of Revision:
APR 26, 2023
Submission Control Number: 265057
_Etomidate Injection, USP Product Monograph _
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_Page 2 of 28 _
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TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics (< 18 years)
..............................................................................................
4
1.2
Geriatrics (≥ 65 years of age)
...................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
2.1.1
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 5
3
DOSAGE AND ADMINISTRATION
..................................................................................
5
3.1
Dosing Considerations
.............................................................................................
5
3.2
Recommended Dose and Dosage Adjustment
......................................................... 5
3.3
Administration
.........................................................................................................
6
3.4
Reconstitution
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