TRANEXAMIC ACID INJECTION SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

TRANEXAMIC ACID

Dostupné s:

METHAPHARM INC

ATC kód:

B02AA02

INN (Mezinárodní Name):

TRANEXAMIC ACID

Dávkování:

100MG

Léková forma:

SOLUTION

Složení:

TRANEXAMIC ACID 100MG

Podání:

INTRAVENOUS

Jednotky v balení:

10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

HEMOSTATICS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2016-05-12

Charakteristika produktu

_Tranexamic Acid Injection _
_ _
_Page 1 of 17 _
PRODUCT MONOGRAPH
PR
TRANEXAMIC ACID INJECTION
100 mg / mL
House Std.
Antifibrinolytic Agent
Methapharm Inc.
Revision Date: September 26, 2019
81 Sinclair Boulevard
Brantford, Ontario
N3S 7X6
Control No. 214311
_Tranexamic Acid Injection _
_ _
_Page 2 of 17 _
PR
TRANEXAMIC ACID INJECTION
100 mg/mL
Antifibrinolytic Agent
ACTION
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.
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 acid is eliminated by glomerular filtration, excretion
being about 30% at one
hour, 55% at three hours and 90% at 24 hours after intravenous
administration of 10 mg
per kg body weight. After oral administration of 10-15 mg per kg body
weight, excretion
was 1% at one hour, 7% at three hours and 39% at 24 hours.
Intravenous administration of 10 mg per kg body weight gave pla