GD-TRANEXAMIC ACID SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

TRANEXAMIC ACID

Доступна з:

GENMED A DIVISION OF PFIZER CANADA ULC

Код атс:

B02AA02

ІПН (Міжнародна Ім'я):

TRANEXAMIC ACID

Дозування:

100MG

Фармацевтична форма:

SOLUTION

Склад:

TRANEXAMIC ACID 100MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

5ML/10ML

Тип рецепту:

Prescription

Терапевтична области:

HEMOSTATICS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2021-01-15

Характеристики продукта

PRODUCT MONOGRAPH
PR
GD
*
-TRANEXAMIC ACID
500 mg Tranexamic acid tablets House Std. and
100 mg/ml Tranexamic acid injection House Std.
Antifibrinolytic agent
GenMed, a division of Pfizer Canada Inc.
Date of Preparation:
17,300 Trans-Canada Highway
October 22, 2018
Kirkland, Quebec
H9J 2M5
Control No. 220955
* GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee

Pfizer Canada Inc. 2018
_GD-TRANEXAMIC ACID (tranexamic acid) _
_Page 2 of 22 _
PRODUCT MONOGRAPH_ _
PR
GD
*
-TRANEXAMIC ACID
TRANEXAMIC ACID TABLETS HOUSE STD. AND
TRANEXAMIC ACID INJECTION B HOUSE STD.
THERAPEUTIC CLASSIFICATION
Antifibrinolytic agent
_ _
_ _
ACTION
GD-Tranexamic Acid (tranexamic acid) produces an antifibrinolytic
effect by competitively
inhibiting the activation of plasminogen to plasmin. It is also a weak
non-competitive inhibitor of
plasmin. These properties make possible its clinical use as an
antifibrinolytic in the treatment of
both general and local fibrinolytic hemorrhages. It has an action
mechanism similar to, but about
10 times more potent
_in vitro_
, than that of E amino caproic acid (EACA).
Absorption from the human gastrointestinal tract is not complete
(40%).
Tranexamic acid binds considerably more strongly than EACA to both the
strong and weak sites
in the plasminogen molecule in a ratio corresponding to the difference
in potency between the
compounds. The pharmacological significance of the binding to these
different sites has not yet
been evaluated.
Tranexamic acid does not bind to serum albumin. The plasma protein
binding seems to be fully
accounted for by its binding to plasminogen and appears to be
negligible at therapeutic plasma
levels of 5-10 mg/L.
_GD-TRANEXAMIC ACID (tranexamic acid) _
_Page 3 of 22 _
Possible routes of biotransformation are acetylation or deamination
followed by oxidation or
reduction. After oral administration approximately 50% of the parent
compound, 2% of the
deaminated dicarboxylic acid, and 0.5% of the acetylated product are
excreted.
Tranexamic