TRIAZOLAM TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

TRIAZOLAM

Dostopno od:

AA PHARMA INC

Koda artikla:

N05CD05

INN (mednarodno ime):

TRIAZOLAM

Odmerek:

0.25MG

Farmacevtska oblika:

TABLET

Sestava:

TRIAZOLAM 0.25MG

Pot uporabe:

ORAL

Enote v paketu:

7

Tip zastaranja:

Targeted (CDSA IV)

Terapevtsko območje:

BENZODIAZEPINES

Povzetek izdelek:

Active ingredient group (AIG) number: 0112970002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2010-06-02

Lastnosti izdelka

_TRIAZOLAM (triazolam) _
_Page 1 of 31_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TRIAZOLAM
Triazolam
Tablets, 0.25 mg and Oral
USP
ATC code: N05CD05
Hypnotic
AA PHARMA INC.
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
DEC 16, 2021
Submission Control Number: 253167
_ _
_TRIAZOLAM (triazolam) _
_Page 2 of 31_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
12/2021
2 Contraindications
12/2021
3 Serious Warnings and Precautions Box
12/2021
4 Dosage and Administration, 4.1 Dosing considerations
12/2021
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
12/2021
7 Warnings and Precautions
12/2021
7 Warnings and Precautions, 7.1.4 Geriatrics
12/2021
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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
.................................................................