Pharma-Q Tranexamic 1000 mg Injection

u2022 Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery.

u2022 Management of dental extraction in haemophiliacs.

u2022 Hereditary angio-oedema.

Posology

TRANEXAMIC INJECTION PHARMA-Q is given by slow intravenous infusion/injection. Administration by injection is usually changed to oral tranexamic acid administration after a few days.

Traumatic hyphaema 1,0 to 1,5 g every 8 hours for six to seven days.

Patients with established coagulopathies undergoing minor surgery Conization of the cervix: 1,0 to 1,5 g every 8 to 12 hours for 12 days post-operatively.

Dental operations/extractions 25 mg/kg two hours before the operation. Factor VIII and Factor IX should be given as well as tranexamic acid. After the operation, 25 mg/kg of tranexamic acid is given 3 to 4 times a day for 6 to 8 days.

Hereditary angio-oedema 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.

Method of administration

TRANEXAMIC INJECTION PHARMA-Q is administered intravenously by slow injection over a period of at least five minutes. For intravenous infusion, TRANEXAMIC INJECTION PHARMA-Q may be mixed with electrolyte solutions, carbohydrate solutions, amino acid solutions, and dextran solutions. Heparin solutions may be added to TRANEXAMIC INJECTION PHARMA-Q solution for injection. For incompatibilities, see section 6.2.

u2022 Hypersensitivity to tranexamic acid or to any of the excipients of TRANEXAMIC INJECTION PHARMA-Q (see section 6.1).

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 Impaired liver function and subarachnoid bleeding

u2022 Patients with colour vision disturbances

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.

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. With continuous long-term use of tranexamic acid, 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, 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 should only be administered if there is a strong medical indication after consulting a medical practitioner experienced in haemostaseology and under strict medical supervision (see section 4.3).

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis (see section 4.5).

Disseminated intravascular coagulation Patients with disseminated intravascular coagulation (DIC) should in most cases not be treated with tranexamic acid (see section 4.3). 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. 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 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.

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 theoretical 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 INJECTION PHARMA-Q is not recommended during the first trimester of pregnancy. Limited clinical data on the use of tranexamic acid in different clinical haemorrhagic settings during the second and third trimesters did not identify deleterious effect for the foetus.

Breastfeeding TRANEXAMIC INJECTION PHARMA-Q 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 INJECTION PHARMA-Q may cause dizziness or 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 system organ class.

Tabulated summary of adverse reactions Adverse reactions reported are presented in table below. Adverse reactions are listed according to MedDRA primary system organ class. Within each system organ class, adverse reactions are ranked by frequency. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

MedDRA System Organ Class Frequency Adverse reactions Immune system disorders Frequency unknown Hypersensitivity reactions including anaphylaxis Nervous system disorders Frequency unknown Convulsions particularly in case of misuse (see sections 4.3 and 4.4), dizziness Eye disorders Frequency unknown Visual disturbances including impaired colour vision Vascular disorders Frequency unknown 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 Frequent Diarrhoea, vomiting, nausea Skin and subcutaneous tissue disorders Less frequent Dermatitis allergic 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. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions & Quality Problem Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

Symptoms of overdosage: Dizziness, headache, nausea and vomiting, diarrhoea. Faintness and hypotension may occur. Treatment is symptomatic and supportive. Maintain adequate diuresis (with fluids plus diuretics).