TRANEXAMIC ACID TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRANEXAMIC ACID

Διαθέσιμο από:

JAMP PHARMA CORPORATION

Φαρμακολογική κατηγορία (ATC):

B02AA02

INN (Διεθνής Όνομα):

TRANEXAMIC ACID

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TRANEXAMIC ACID 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

HEMOSTATICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2021-08-18

Αρχείο Π.Χ.Π.

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
............