TRANEXAMIC ACID INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TRANEXAMIC ACID

Tersedia dari:

OMEGA LABORATORIES LIMITED

Kode ATC:

B02AA02

INN (Nama Internasional):

TRANEXAMIC ACID

Dosis:

100MG

Bentuk farmasi:

SOLUTION

Komposisi:

TRANEXAMIC ACID 100MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

(10X) 5/10/50ML

Jenis Resep:

Prescription

Area terapi:

HEMOSTATICS

Ringkasan produk:

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

Status otorisasi:

MARKETED

Tanggal Otorisasi:

2013-03-27

Karakteristik produk

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TRANEXAMIC ACID INJECTION (Tranexamic acid) Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRANEXAMIC ACID INJECTION
Tranexamic acid injection
Solution, 100 mg / mL, Intravenous
Omega Standard
Antifibrinolytic agent
Omega Laboratories Limited Date of Initial Authorization:
11 177, Hamon March 27, 2013
Montreal, H3M 3E4 Date of Revision:
Québec, Canada September 14, 2023
Submission Control Number: 274335
Pr
TRANEXAMIC ACID INJECTION (Tranexamic acid) Page 2 of 25
RECENT MAJOR LABEL CHANGES
1
INDICATIONS
, 1.1
Pediatrics
, 1.2
Geriatrics
09/2023
2
CONTRAINDICATIONS
09/2023
4
DOSAGE AND ADMINISTRATION
,
4.4 Administration
09/2023
7
WARNINGS AND PRECAUTIONS
,
7.1 Special Populations
,
7.1.1
Pregnant Women
,
7.1.2 Breast-feeding
09/2023
7
WARNINGS AND PRECAUTIONS
,
Cardiovascular
,
Endocrine
and
Metabolism
Reproductive
Health:
Female
and
Male
Potential
10/2021
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
4
DOSAGE AND ADMINISTRATION
.................................................................