TRANEXAMIC ACID INJECTION BP SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TRANEXAMIC ACID

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

B02AA02

INN (Nama Internasional):

TRANEXAMIC ACID

Dosis:

100MG

Bentuk farmasi:

SOLUTION

Komposisi:

TRANEXAMIC ACID 100MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

5/10/50ML

Jenis Resep:

Prescription

Area terapi:

HEMOSTATICS

Ringkasan produk:

Active ingredient group (AIG) number: 0114760002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2002-10-04

Karakteristik produk

_Tranexamic Acid Injection BP _
_ _
_Page 1 of 26 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION BP
Tranexamic Acid Injection BP
Solution, 100 mg/mL, Intravenous
BP
Antifibrinolytic Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Initial Authorization:
October 4, 2002
Date of Revision:
May 30, 2022
Submission Control Number: 260447
_Tranexamic Acid Injection BP _
_ _
_Page 2 of 26 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
05/2022
7 WARNINGS AND PRECAUTIONS
05/2022
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
......................................................................................
4
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Reconstitution
...........................................................................................