GENTAMICIN INJECTION USP SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

GENTAMICIN (GENTAMICIN SULFATE)

Beschikbaar vanaf:

HIKMA CANADA LIMITED

ATC-code:

J01GB03

INN (Algemene Internationale Benaming):

GENTAMICIN

Dosering:

40MG

farmaceutische vorm:

SOLUTION

Samenstelling:

GENTAMICIN (GENTAMICIN SULFATE) 40MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

AMINOGLYCOSIDES

Product samenvatting:

Active ingredient group (AIG) number: 0105695005; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2022-05-02

Productkenmerken

_Gentamicin Injection USP _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GENTAMICIN INJECTION USP
Solution, 10 mg/mL and 40 mg/mL gentamicin (as gentamicin sulfate),
Intravenous or
Intramuscular
Antibiotic
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, Ontario
L5R 3P9
Submission Control Number: 262818
Date of
Initial Authorization:
May 2, 2022
_ _
_Gentamicin Injection USP _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
None
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
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
5
1.2
Geriatrics
..................................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
.............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
........................................................ 6
4.3
Administration
.........................................................................................................
9
5
OVERDOSAGE
...................