PMS-LOXAPINE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

LOXAPINE (LOXAPINE SUCCINATE)

Tilgængelig fra:

PHARMASCIENCE INC

ATC-kode:

N05AH01

INN (International Name):

LOXAPINE

Dosering:

10MG

Lægemiddelform:

TABLET

Sammensætning:

LOXAPINE (LOXAPINE SUCCINATE) 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTIPSYCHOTICS

Produkt oversigt:

Active ingredient group (AIG) number: 0111557004; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-04-15

Produktets egenskaber

_ _
_pms-LOXAPINE (loxapine) _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-LOXAPINE
Loxapine Succinate Tablets
Tablets 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg
USP
Antipsychotic
Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Initial Authorization:
April 13, 2021
Submission Control Number: 249106
_ _
_ _
_pms-LOXAPINE (loxapine) _
_Page 2 of 36_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.4
Administration
..........................................................................................................
6
4.5
Missed Dose
..............................................................................................................
6
5
OVERDOSAGE
.............................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
........