Tranexamic Acid 100 Mg Solution

u2022 Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis occurs in the following conditions:

• Prostatectomy and bladder surgery
• Epistaxis
• Conisation of the cervix
• Traumatic hyphaema

u2022 Management of dental extraction in haemophiliacs

u2022 Hereditary angioedema

u2022 Menorrhagia.

Posology

Administration by injection is normally changed to oral administration of an oral dosage form of tranexamic acid after a few days.

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis

Standard treatment of local fibrinolysis

0,5 g (1 ampoule of 5 mL) to 1,0 g (2 ampoules of 5 mL) TRANEXAMIC ACID 100 mg/mL PHARMC by slow intravenous injection (IV) or infusion (= 1 mL/minute) two to three times daily.

Standard treatment of general fibrinolysis

1,0 g (2 ampoules of 5 mL) TRANEXAMIC ACID 100 mg/mL PHARMC by slow intravenous injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent to 15 mg/kg body weight (BW).

Prostatectomy and bladder surgery

0,5 g (1 ampoule of 5 mL) to 1,0 g (2 ampoules of 5 mL) TRANEXAMIC ACID 100 mg/mL PHARMC by slow intravenous injection or infusion (1 mL/min), 2 u2013 3 times daily (the first injection being given during the operation) for the first three days after surgery.

Epistaxis

1,0 g to 1,5 g every 8 u2013 12 hours for 10 days.

Conisation of the cervix

1,0 g to 1,5 g every 8 to 12 hours for 12 days post-operatively.

Traumatic hyphaema

1,0 g to 1,5 g every 8 hours for 6 to 7 days.

Dental operations/extractions in haemophiliacs

25 mg/kg before the operation, together with Factor VIII and Factor IX. After the operation, 25 mg/kg is given 3 to 4 times a day for 6 to 8 days.

Hereditary angioedema

Some patients are aware of the onset of illness; a suitable treatment for these patients is 1,0 g to 1,5 g two to three times daily for some days. Other patients are treated continually at this dosage.

Menorrhagia

1,0 g to 1,5 g three to four times daily, given at the onset of heavy bleeding for the duration of the period.

Special populations

In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contraindicated 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 (micromol/L) Intravenous dose Administration

120 u2013 250 10 mg/kg body weight Every 12 hours

250 u2013 500 10 mg/kg body weight Every 24 hours

> 500 5 mg/kg body weight Every 24 hours

Paediatric population

Data on efficacy and safety in children are limited.

Method of administration

The administration of TRANEXAMIC ACID 100 mg/ml PHARMC is strictly limited to slow intravenous injection over a period of at least five minutes, i.e. maximum 1 mL/minute (see section 4.4), or slow intravenous infusion of maximum 1 mL/minute (see section 6.6).

u2022 Hypersensitivity to tranexamic acid or to any of the excipients (see section 6.1).

u2022 In cases of massive upper urinary tract haemorrhage, TRANEXAMIC ACID 100 mg/mL PHARMC should be avoided to reduce the risk of ureteric obstruction.

u2022 Patients with a pronounced thrombotic tendency or colour vision disorder (see section 4.4).

u2022 Thrombophlebitis.

u2022 Impaired liver function.

u2022 Subarachnoid bleeding.

u2022 Acute venous or arterial thrombosis (see section 4.4).

u2022 Fibrinolytic conditions following consumption coagulopathy except in those with predominant activation of the fibrinolytic system with acute severe bleeding (see section 4.4).

u2022 Severe renal impairment (risk of accumulation).

u2022 History of convulsions.

u2022 Intrathecal and intraventricular injection, intracerebral application (risk of cerebral oedema and convulsions).

The indications and method of administration indicated above should be followed strictly:

u2022 Intravenous injections or infusions should be given very slowly (maximum 1 mL per minute).

u2022 Tranexamic acid should not be administered by the intramuscular route.

u2022 TRANEXAMIC ACID 100 mg/mL PHARMC must not be administered by intrathecal or intraventricular injection, or intracerebral application due to a risk of cerebral oedema and convulsions.

Convulsions

Cases of convulsions have been reported in association with tranexamic acid as in TRANEXAMIC ACID 100 mg/mL PHARMC treatment. In coronary artery bypass graft (CABG) surgery, most of these cases were reported following intravenous (I.V.) 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. With continuous long-term use of tranexamic acid as in TRANEXAMIC ACID 100 mg/mL PHARMC, regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated. With pathological ophthalmic changes, particularly with diseases of the retina, the medical practitioner must decide after consulting a specialist on the necessity for the long-term use of tranexamic acid in each individual case.

Haematuria

In case of haematuria from the upper urinary tract, there is a risk for urethral obstruction.

Thromboembolic events

Before use of TRANEXAMIC ACID 100 mg/mL PHARMC, risk factors of thromboembolic disease should be considered. In patients with a history of thromboembolic diseases or in those with increased incidence of thromboembolic events in their family history (patients with a high risk of thrombophilia), TRANEXAMIC ACID 100 mg/mL PHARMC is contraindicated (see section 4.3). TRANEXAMIC ACID 100 mg/mL PHARMC should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis (see section 4.5). TRANEXAMIC ACID 100 mg/mL PHARMC should not be administered concomitantly with Factor IX Complex Concentrates or Anti-inhibitor Coagulant Concentrates, as the risk of thrombosis may be increased.

Disseminated intravascular coagulation

Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with TRANEXAMIC ACID 100 mg/mL PHARMC (see section 4.3). If TRANEXAMIC ACID 100 mg/mL PHARMC is given, it must be restricted to those in whom there is predominant activation of the fibrinolytic system with acute severe bleeding. Characteristically, the haematological profile approximates to the following: reduced euglobulin clot lysis time; prolonged prothrombin time; reduced plasma levels of fibrinogen, factors V and VIII, plasminogen fibrinolysin and alpha-2 macroglobulin; normal plasma levels of P and P complex, i.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 100 mg/mL PHARMC is frequently sufficient to control bleeding. Administration of TRANEXAMIC ACID 100 mg/mL PHARMC in DIC should be considered only when appropriate haematological laboratory facilities and expertise are available.

Menorrhagia

Patients with menorrhagia should not use TRANEXAMIC ACID 100 mg/mL PHARMC until the cause of the menorrhagia has been established.

No interaction studies have been performed. Simultaneous treatment with anticoagulants must take place under the strict supervision of a medical practitioner experienced in this field. Medicines that act on haemostasis should be given with caution to patients treated with tranexamic acid. There is a risk of increased thrombus-formation potential, such as with oestrogens. Alternatively, the antifibrinolytic action of the medicine may be antagonised with thrombolytic medicines.

Women of childbearing potential /Contraception in males and females

Women of childbearing potential have to use effective contraception during treatment.

Pregnancy

There are no or limited amount of data from the use of tranexamic acid in pregnant women. As a result, although studies in animals do not indicate teratogenic effects, as precaution for use, TRANEXAMIC ACID 100 mg/mL PHARMC is not recommended during the first trimester of pregnancy. Limited clinical data on the use of tranexamic acid as in TRANEXAMIC ACID 100 mg/mL PHARMC in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus.

Breastfeeding

Tranexamic acid as in TRANEXAMIC ACID 100 mg/mL PHARMC is excreted in human milk. Therefore, breastfeeding is not recommended.

Fertility

There are no clinical data on the effects of tranexamic acid on fertility.

No studies have been performed on the ability to drive and use machines. Since TRANEXAMIC ACID 100 mg/mL PHARMC may cause dizziness and visual disturbances, patients should be cautioned when driving or operating machines.

The ADRs reported from clinical studies and post-marketing experience are listed below according to MedDRA system organ class.

Tabulated summary of adverse reactions

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

Signs and symptoms may include dizziness, headache, nausea, vomiting, diarrhoea, hypotension, and convulsions. It has been shown that convulsions tend to occur at higher frequency with increasing dose. Management of overdose should be supportive. Maintain adequate diuresis (with fluids plus diuretics).