NOZINAN SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

METHOTRIMEPRAZINE (METHOTRIMEPRAZINE HYDROCHLORIDE)

Verfügbar ab:

NEURAXPHARM ARZNEIMITTEL GMBH

ATC-Code:

N05AA02

INN (Internationale Bezeichnung):

LEVOMEPROMAZINE

Dosierung:

25MG

Darreichungsform:

SOLUTION

Zusammensetzung:

METHOTRIMEPRAZINE (METHOTRIMEPRAZINE HYDROCHLORIDE) 25MG

Verabreichungsweg:

INTRAMUSCULAR

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

PHENOTHIAZINES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2000-11-06

Fachinformation

_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
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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
......................................................................................................................
4
1.2 Geriatrics
......................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
....................