LEVETIRACETAM INJECTION USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

LEVETIRACETAM

Disponibil de la:

STERIMAX INC

Codul ATC:

N03AX14

INN (nume internaţional):

LEVETIRACETAM

Dozare:

100MG

Forma farmaceutică:

SOLUTION

Compoziție:

LEVETIRACETAM 100MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Rezumat produs:

Active ingredient group (AIG) number: 0148843005; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2022-05-16

Caracteristicilor produsului

_Product Monograph - Levetiracetam Injection USP _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
L
EVETIRACETAM INJECTION USP
Levetiracetam for Injection
Solution, 100 mg/mL, Intravenous
Concentrate – must be diluted before use
Antiepileptic Agent
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario
L6H 6R4
Date of Initial Authorization:
May 13, 2022
Submission Control No: 255674
_Product Monograph - Levetiracetam Injection USP _
_Page 2 of 47 _
RECENT MAJOR LABEL CHANGES
None at the time of authorization.
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 INFORM ATION
........................................................4
1.
INDICATIONS
............................................................................................................4
1.1
Pediatrics
...........................................................................................................4
1.2
Geriatrics
...........................................................................................................4
2.
CONTRAINDICATIONS
............................................................................................4
4.
DOSAGE AND ADMINISTRATION
..........................................................................5
4.1
Dosing Considerations
......................................................................................5
4.2
Recommended Dose and Dosage Adjustment
................................................5
4.3
Reconstitution
....................................................................................................9
4.4
Administration
....................................................................................................9
5.
OVERDOSAGE
....