Land: Kanada
Sprache: Englisch
Quelle: Health Canada
METHOTRIMEPRAZINE (METHOTRIMEPRAZINE HYDROCHLORIDE)
NEURAXPHARM ARZNEIMITTEL GMBH
N05AA02
LEVOMEPROMAZINE
25MG
SOLUTION
METHOTRIMEPRAZINE (METHOTRIMEPRAZINE HYDROCHLORIDE) 25MG
INTRAMUSCULAR
15G/50G
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0134080002; AHFS:
APPROVED
2000-11-06
_Page 1 of 31_ _NOZINAN (Methotrimeprazine Hydrochloride Injection, USP)_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr NOZINAN® Methotrimeprazine Hydrochloride Injection, USP Solution, 25 mg/mL methotrimeprazine as methotrimeprazine hydrochloride, intravenous and intramuscular USP Neuroleptic Neuraxpharm Arzneimittel GmbH Elisabeth-Selbert-Str. 23, 40764 Langenfeld Germany Imported and distributed by Xediton Pharmaceuticals Inc, 2020 Winston Park Drive, Suite 402 Oakville, Ontario L6H 6X7 Submission Control Number: 279974 Date of Initial Authorization: NOV 15, 2023 _ _ _NOZINAN (Methotrimeprazine Hydrochloride Injection, USP) _ _Page 2 of 31_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1 Pediatrics 09/2022 1 INDICATIONS, 1.2 Geriatrics 09/2022 2 CONTRAINDICATIONS 09/2022 3 SERIOUS WARNNGS AND PRECAUTIONS BOX 09/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 09/2022 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 09/2022 7 WARNINGS AND PRECAUTIONS 09/2022 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 ...................................................................................................................... 4 1.2 Geriatrics ...................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .................... Lesen Sie das vollständige Dokument