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
Tranexamic acid is given by slow intravenous infusion/injection. Administration by injection is usually changed to oral administration after a few days.
1,0 to 1,5 g every 8 hours for six to seven days.
Some patients are aware of the onset of illness; a suitable treatment for these patients is 1,0 – 1,5 g two to three times daily for some days. Other patients are treated continually at this dosage.
For patients in renal failure, tranexamic acid should be given with caution because of the risk of accumulation.
Dosages should be reduced in patients with renal impairment. For patients with moderate to severe impaired renal function, the following dosages are recommended.
| Serum creatinine (μmol/L) | Intravenous Dose |
|---|---|
| 120–250 | 10 mg/kg body weight twice daily |
| 250–500 | 10 mg/kg body weight daily |
| >500 | 5 mg/kg body weight daily |
Tranexamic acid solution for injection is administered intravenously by slow injection over a period of at least five minutes.
Symptoms of overdosage: Dizziness, headache, nausea and vomiting, diarrhoea.
Faintness and hypotension may occur.
Treatment is symptomatic.
Maintain adequate diuresis (with fluids plus diuretics).
3 years.
After first opening: the solution for injection/infusion is for single use only. Unused solution must be discarded.
Store at or below 25°C.
Use immediately after opening. Discard any unused portion.
KEEP OUT OF REACH OF CHILDREN.
5 ml type 1 clear glass ampoules, 5 such ampoules are placed in tray and packed in carton.
TRANMENXIO IV may be mixed with most solutions for infusion such as electrolyte solutions for injection, Dextrose for injection, carbohydrate solutions, aminosol for injection solutions and dextran for injection.
Heparin may be added to TRANMENXIO IV.
TRANMENXIO IV is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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