JAMP-QUETIAPINE TABLET (IMMEDIATE RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostępny od:

JAMP PHARMA CORPORATION

Kod ATC:

N05AH04

INN (International Nazwa):

QUETIAPINE

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET (IMMEDIATE RELEASE)

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131858002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2017-07-21

Charakterystyka produktu

JAMP-Quetiapine Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-QUETIAPINE
Quetiapine Tablets
Immediate-Release Tablets, 25, 100, 200 and 300 mg (as quetiapine
fumarate), Oral Use
USP
Antipsychotic Agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
July 21, 2017
Date of Revision:
JAN 4, 2023
Submission Control No.: 270220
JAMP-Quetiapine Page 2 of 58
RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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
4.1
Dosing Considerations
...................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4
Administration
........................................................................................................
7
4.5
Missed
Dose...................................................................................................................
7
5.
OVERDOSAGE
............................................................