Posology : מינונים

4.2. Posology and method of administration

Posology
Adults

Unless otherwise prescribed, the following doses are recommended:

1. Standard treatment of local fibrinolysis:
0.5 g (1 ampoule of 5 ml) to 1 g (2 ampoules of 5 ml or 1 ampoule of 10 ml ) tranexamic acid by slow intravenous injection (= 1 ml/minute) two to three times daily.
2. Standard treatment of general fibrinolysis:

1 g (2 ampoules of 5 ml or 1 ampoule of 10 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6 to 8 hours, equivalent to 15 mg/kg BW.


Renal impairment
In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contra-indicated in patients with severe renal impairment (see section 4.3). For patients with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level:

Serum creatinine                            Dose IV                Administration μmol/l                  mg/10 ml
120 to 249              1.35 to 2.82              10 mg/kg BW               Every 12 hours 250 to 500              2.82 to 5.65              10 mg/kg BW               Every 24 hours
> 500                    > 5.65                 5 mg/kg BW                Every 24 hours 

Hepatic impairment
No dose adjustment is required in patient with hepatic impairment.
Paediatric Population:
In children from 1 year, for current approved indications as described in section 4.1, the dosage is in the region of 20 mg/kg/day. However, data on efficacy, posology and safety for these indications are limited.

The efficacy, posology and safety of tranexamic acid in children undergoing cardiac surgery have not been fully established. Currently, the available data are limited and are described in section 5.1.

Elderly:
No reduction in dosage is necessary unless there is evidence of renal failure.

Method of administration
The administration is strictly limited to slow intravenous injection.