TRANEXAMIC ACID TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TRANEXAMIC ACID

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

B02AA02

INN (Nama Internasional):

TRANEXAMIC ACID

Dosis:

500MG

Bentuk farmasi:

TABLET

Komposisi:

TRANEXAMIC ACID 500MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

HEMOSTATICS

Ringkasan produk:

Active ingredient group (AIG) number: 0114760001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-08-18

Karakteristik produk

Page 1 of 22
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Tranexamic Acid
Tranexamic acid Tablets, BP
Tablet, 500 mg, Oral
BP
Anti-fibrinolytic agent
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 266700
Date of Initial Authorization:
AUG 18, 2021
Date of Revision:
SEPT 07, 2022
Page 2 of 22
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
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
4
DOSAGE AND ADMINISTRATION
.....................................................................................5
4.1
Dosing Considerations
...............................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
..........................................................................
5
4.5
Missed Dose
..............................................................................................................................
5
5
OVERDOSAGE
............