TRANEXAMIC ACID

Posology Adults Unless otherwise prescribed, the following doses are recommended: 1. 5 g (1 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection (= 1 mL/minute) two to three times daily 2.

3). 65 5 mg/kg BW Every 24 hours Hepatic impairment No dose adjustment is required in patients with hepatic impairment. 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. 1. Elderly No reduction in dosage is necessary unless there is evidence of renal failure. 6) of maximum 1 ml per minute.

4). 6).

The ADRs reported from clinical studies and post-marketing experience are listed below according to system organ class. Tabulated list of adverse reactions Adverse reactions reported are presented in table below. Adverse reactions are listed according to MedDRA primary system organ class.

Adverse reactions are presented in the order of decreasing seriousness and their frequency is defined as follows: very common (≥1/10); common (≥ 1/100 to <1/10); uncommon: (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000) and very rare (<1/10,000) and frequency not known (cannot be estimated from the available data).

4) Eye disorders - Visual disturbances including impaired colour vision Vascular disorders - Malaise with hypotension, with or without loss of consciousness (generally following a too fast intravenous injection, exceptionally after oral administration) - Arterial or venous thrombosis at any sites Gastrointestinal disorders - Diarrhoea - Vomiting - Nausea Skin and subcutaneous tissue disorders - Dermatitis allergic - Fixed drug eruption Renal and urinary disorders - Acute renal cortical necrosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The indications and method of administration indicated above should be followed strictly: • Intravenous injections should be given very slowly (maximum 1 ml per minute). • Tranexamic acid should not be administered by the intramuscular route.

Risk of medication errors due to incorrect route of administration Tranexamic acid is for intravenous use only. 3). Serious adverse reactions including fatal events have been reported when tranexamic acid was inadvertently administered intrathecally.

These events have included severe back, gluteal and lower limb pain, myoclonus and generalised seizures, and cardiac arrhythmias. Care should be exercised to ensure the correct route of administration of tranexamic acid. Healthcare professionals should be aware of the potential for confusion of tranexamic acid with other injectables which could result in inadvertent intrathecal administration of tranexamic acid.

This includes in particular intrathecally administered injectables that may be used during the same procedure as tranexamic acid. Syringes containing tranexamic acid should be clearly labelled with the intravenous route of administration.

Convulsions Cases of convulsions have been reported in association with tranexamic acid treatment. In coronary artery bypass graft (CABG) surgery, most of these cases were reported following intravenous (IV) injection of tranexamic acid in high doses.

With the use of the recommended lower doses of tranexamic acid, the incidence of post- operative seizures was the same as that in untreated patients. Visual disturbances Attention should be paid to possible visual disturbances including visual impairment, vision blurred, impaired colour vision and if necessary, the treatment should be discontinued.

) are indicated. With pathological ophthalmic changes, particularly with diseases of the retina, the physician must decide after consulting a specialist on the necessity for the long-term use of tranexamic acid solution for injection in each individual case.

Haematuria In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction at the lower levels of the tract. If left untreated, urinary obstruction may lead to serious consequences such as renal insufficiency, urinary tract infection, hydronephrosis, and anuria.

Therefore, close monitoring is recommended for those patients with haematuria or risk of haematuria from the upper urinary tract. Thromboembolic events Before use of tranexamic acid, risk factors of thromboembolic disease should be considered.

3). 5). 3). If tranexamic acid is given it must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding. e. factors II (prothrombin), VIII and X; increased plasma levels of fibrinogen degradation products; a normal platelet count.

The foregoing presumes that the underlying disease state does not of itself modify the various elements in this profile. In such acute cases a single dose of 1 g tranexamic acid is frequently sufficient to control bleeding. Administration of tranexamic acid in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available.

1. 4). 4). Severe renal impairment (risk of accumulation). History of convulsions. Intrathecal, epidural, intraventricular injection and intracerebral application (risk of cerebral oedema and convulsions and death).