TRANMENXIO Solution for injection/infusion Ref.[115289] Active ingredients: Tranexamic acid

Source: Health Products Regulatory Authority (ZA)  Publisher: Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16<sup>th</sup> Street, Randjespark, Midrand 1685, South Africa, Tel. nr: 011 848 3050

Product name and form

TRANMENXIO IV.

Pharmaceutical Form

Solution for injection/infusion.

Clear, colourless solution with pH of 6,5-8,0.

Qualitative and quantitative composition

Each 5 ml ampoule contains 500 mg Tranexamic acid.

Sugar free.

For a full list of excipients, see section 6.1.

Active Ingredient

Tranexamic acid is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin. Tranexamic acid is a competitive inhibitor of plasminogen activation, and at much higher concentrations, a noncompetitive inhibitor of plasmin, i.e., actions similar to aminocaproic acid. Tranexamic acid is about 10 times more potent in vitro than aminocaproic acid. Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds.

List of Excipients

Water for injection

Pack sizes and marketing

5 ml type 1 clear glass ampoules, 5 such ampoules are placed in tray and packed in carton.

Marketing authorization holder

Biotech Laboratories (Pty) Ltd, Ground Floor, Block K West, Central Park, 400 16th Street, Randjespark, Midrand 1685, South Africa, Tel. nr: 011 848 3050

Marketing authorization dates and numbers

56/8.1/0497

29 March 2022

Drugs

Drug Countries
TRANMENXIO South Africa

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.