GD-TRANEXAMIC ACID SOLUTION

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

TRANEXAMIC ACID

Pieejams no:

GENMED A DIVISION OF PFIZER CANADA ULC

ATĶ kods:

B02AA02

SNN (starptautisko nepatentēto nosaukumu):

TRANEXAMIC ACID

Deva:

100MG

Zāļu forma:

SOLUTION

Kompozīcija:

TRANEXAMIC ACID 100MG

Ievadīšanas:

INTRAVENOUS

Vienības iepakojumā:

5ML/10ML

Receptes veids:

Prescription

Ārstniecības joma:

HEMOSTATICS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED PRE MARKET

Autorizācija datums:

2021-01-15

Produkta apraksts

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