NOZINAN SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

METHOTRIMEPRAZINE (METHOTRIMEPRAZINE HYDROCHLORIDE)

Tilgængelig fra:

NEURAXPHARM ARZNEIMITTEL GMBH

ATC-kode:

N05AA02

INN (International Name):

LEVOMEPROMAZINE

Dosering:

25MG

Lægemiddelform:

SOLUTION

Sammensætning:

METHOTRIMEPRAZINE (METHOTRIMEPRAZINE HYDROCHLORIDE) 25MG

Indgivelsesvej:

INTRAMUSCULAR

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

PHENOTHIAZINES

Produkt oversigt:

Active ingredient group (AIG) number: 0134080002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2000-11-06

Produktets egenskaber

_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
....................