Tramix injection solution is indicated for bleeding or risk of bleeding with increased fibrinolysis, both generalized and local, in adults and children over 1 year of age.
Specific indications include bleeding due to increased general or local fibrinolysis, such as:
Menorrhagia and metrorrhagia; Gastrointestinal bleeding; Hemorrhagic disorders of the urinary tract arising in connection with surgery on the prostate gland or as a result of surgical intervention or procedures on the urinary tract; Otolaryngological (adenoid removal, tonsillectomy) and dental (tooth extraction) surgical interventions; Gynecological operations or complications in obstetric practice; Thoracic, abdominal and other major surgical interventions, such as cardiovascular surgery; Control of bleeding in connection with the administration of a fibrinolytic drug.
Composition
Active ingredient: tranexamic acid;
1 ml of solution contains tranexamic acid, calculated as 100% substance - 100.0 mg;
Excipients: water for injections.
Contraindication
Hypersensitivity to the active substance or to any of the components of the drug; acute venous or arterial thrombosis; fibrinolytic conditions with acute severe bleeding due to the administration of coagulopathic agents (anticoagulants), with the exception of those drugs that primarily activate the fibrinolytic system; severe renal failure (there is a risk of drug accumulation); history of seizures; intrathecal and intraventricular injection, intracerebral injection (risk of brain edema with subsequent development of seizures).
Method of application
Tramix should only be administered intravenously (drip, jet).
In case of generalized fibrinolysis, administer in a dose of 1 g (2 ampoules of 5 ml) or 15 mg/kg of body weight every 6-8 hours intravenously slowly (injection rate - 1 ml/min).
For local fibrinolysis, it is recommended to use the drug in a dose of 0.5 g (1 ampoule of 5 ml) to 1 g (2 ampoules of 5 ml) 2-3 times a day intravenously slowly (injection rate - 1 ml/min).
Renal impairment. In case of renal failure there is a risk of accumulation, therefore the use of tranexamic acid in patients with severe renal failure is contraindicated.
For patients with mild to moderate renal insufficiency, the dosage is selected according to the serum creatinine level.
Application features
Pregnant women
Tranexamic acid should only be used during pregnancy if the expected therapeutic benefit outweighs the potential risk.
Children
Children from 1 year of age should be prescribed at a dose of 20 mg/kg/day. Data on efficacy, dosage and safety are limited.
The effectiveness, dosage, and safety of tranexamic acid in children undergoing heart surgery have not been fully established.
Overdose
No cases of overdose were observed.
Symptoms of overdose may include dizziness, headache, hypotension, and convulsions. The incidence of convulsions increases with increasing dose.
Treatment of overdose is symptomatic.
Side effects
Skin and subcutaneous tissue disorders: Uncommon: allergic dermatitis. Gastrointestinal disorders: Common: diarrhoea, vomiting, nausea. Nervous system disorders: Not known: convulsions, particularly in case of misuse. Visual disorders: Not known: visual impairment, including colour vision impairment. Blood and lymphatic system disorders: Not known: malaise due to hypotension, with or without loss of consciousness (usually after too rapid injection, as an exception - after oral administration). Immune system disorders: Not known: hypersensitivity reactions, including anaphylactic-type reactions.
Interaction
Drug interaction studies have not been conducted. Concomitant administration of anticoagulants should be under the strict supervision of a physician experienced in this area of therapy. Drugs that affect hemostasis should be used with caution in patients treated with tranexamic acid. In these cases, there is a risk of thrombosis, for example, when estrogens are used. In addition, the antifibrinolytic effect of the drug may be antagonized by thrombolytics.
Storage conditions
Store in original packaging at a temperature not exceeding 25 °C. Do not freeze!
Keep out of reach of children.
Shelf life - 2 years.
