Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
TRANEXAMIC ACID
METHAPHARM INC
B02AA02
TRANEXAMIC ACID
100MG
SOLUTION
TRANEXAMIC ACID 100MG
INTRAVENOUS
10ML
Prescription
HEMOSTATICS
Active ingredient group (AIG) number: 0114760002; AHFS:
APPROVED
2016-05-12
_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 Izlasiet visu dokumentu