Rubinex 100mg Solution for Injection

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

2. Management of dental extraction in haemophiliacs.

3. Hereditary angioedema

4. Menorrhagia

Posology RUBINEX is given by slow intravenous infusion/injection. Administration by injection is usually changed to oral 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: Factor VIII and Factor IX should be given as well as RUBINEX. After the operation, 25 mg/kg of RUBINEX 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 - 1,5 g two to three times daily for some days. Other patients are treated continually at this dosage.

Menorrhagia: RUBINEX solution for injection is administered intravenously by slow injection over a period of at least five minutes. For intravenous infusion, RUBINEX solution for injection may be mixed with electrolyte solutions, carbohydrate solutions, Aminosol and dextran solutions. Heparin solutions may be added to RUBINEX solution for injection. RUBINEX solution for injection should not be mixed with blood and infusion solutions containing penicillin.

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

Hypersensitivity to tranexamic acid or to any of the excipients of RUBINEX

In cases of massive upper urinary tract haemorrhage, antifibrinolytics should be avoided to reduce the risk of ureteric obstruction.

Patients with a pronounced thrombotic tendency or colour vision disorder should not be given RUBINEX.

Thrombophlebitis, impaired liver function and subarachnoid bleeding.

Intravenous injection or infusions should be given very slowly (maximum 1mL per minute)

Tranexamic acid should not be administered by 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.

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

The safety of RUBINEX has not been established in pregnancy.

RUBINEX passes into breast milk at a concentration of a hundredth of the corresponding serum levels. Caution should be exercised when RUBINEX is given to nursing women.

For patients in renal failure, RUBINEX 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 ( u03bc mol /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

Patients with a previous history of thromboembolic disease should not be given RUBINEX unless simultaneous treatment with anticoagulants can be given.

For patients who are to receive continuous treatment with RUBINEX for longer than several days, an ophthalmological examination is advisable (including visual acuity, colour vision, eye-grounds, field of vision), before commencing treatment, and at regular intervals during treatment.

Medicines with actions on haemostasis should be given with caution to patients on antifibrinolytic therapy. The potential for thrombus formation may be increased by oestrogens as contained in oral contraceptives, for example, or the action of the antifibrinolytic antagonised by compounds such as the thrombolytics.

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. Medicinal products that act on haemostasis should be given with caution to patients treated with RUBINEX. 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 Women of childbearing potential have to use effective contraception during treatment.

Pregnancy There is insufficient clinical data on the use of RUBINEX in pregnant women. As a result, although studies in animals do not indicate teratogenic effects, as precaution for use, RUBINEX is not recommended during pregnancy.

Breast-feeding RUBINEX is excreted in human milk. Therefore, breast-feeding is not recommended.

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

Patients who experience disturbances in vision or dizziness should not drive or operate any machines.

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. 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. Frequency not known (cannot be estimated from the available data).

MedDRA System Organ Class Frequency Undesirable Effects Immune system disorders Frequency not known Hypersensitivity reactions including anaphylaxis Nervous system disorders Frequency not known Convulsions particularly in case of misuse (refer to sections 4.3 and 4.4) Eye disorders Frequency not known Visual disturbances including impaired colour vision Vascular disorders Frequency not known Malaise with hypotension with or without loss of consciousness (generally following a too fast intravenous injection, Arterial or venous embolism 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 medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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

No case of overdose has been reported. Signs and symptoms may include dizziness, headache, hypotension, and convulsions. It has been shown that convulsions tend to occur at higher frequency with increasing dose. Management of overdose should be supportive and symptomatic.