Neotranex injection solution is used for bleeding or risk of bleeding with increased fibrinolysis, both generalized and local, in adults and children over one year of age.
Composition
5 ml of solution contain (active ingredient) tranexamic acid 500 mg.
Excipients: concentrated hydrochloric acid (to adjust pH to 6.5-7.5), water for injection.
Contraindication
hypersensitivity to tranexamic acid and the components that make up 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 drugs that mainly 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
Neotranex should be administered intravenously (drip, jet).
In case of generalized fibrinolysis, tranexamic acid should be administered intravenously slowly at a dose of 1 g (two 5 ml ampoules) or 15 mg/kg of body weight every 6-8 hours, the rate of administration is 1 ml/minute.
For local fibrinolysis, it is recommended to use the drug starting from a dose of 500 mg (one 5 ml ampoule) to one g (two 5 ml ampoules) intravenously slowly (approximately 1 ml/minute) 2-3 times a day.
Application features
Pregnant women
Women of childbearing potential should use effective contraception during treatment. There are insufficient clinical data on the use of tranexamic acid in pregnant women. During the first trimester of pregnancy, the use of tranexamic acid as a precautionary measure is not recommended. There are only limited clinical data on the use of tranexamic acid in various clinical hemorrhagic conditions during the second and third trimesters of pregnancy, from which it is impossible to identify a harmful effect on the fetus. Tranexamic acid should be used during pregnancy only if the expected therapeutic benefit outweighs the potential risk.
Tranexamic acid passes into breast milk. Therefore, breastfeeding is not recommended.
There are no clinical data on the effect of tranexamic acid on fertility.
Children
The maximum single dose for children aged one year and over is 10 mg/kg body weight. The maximum daily dose is 20 mg/kg body weight.
Drivers
There are no studies assessing the effect on the ability to drive vehicles or other mechanisms.
Overdose
No cases of overdose were observed.
Symptoms of overdose may include dizziness, headache, hypotension, and convulsions. Convulsions have also been shown to occur more frequently with higher doses and are more common with increasing doses.
Treatment of overdose is symptomatic.
Side effects
Adverse reactions are listed below, classified according to MedDRA system organ class (main organ system classes). Within each system organ class, adverse reactions are ranked by frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing incidence. The frequency has been defined as follows: very common (> 1/10); common (> 1/100, <1/10); uncommon (> 1/1000, <1/100); frequency unknown (cannot be estimated from the available data).
Skin and subcutaneous tissue disorders: uncommon - allergic dermatitis.
From the gastrointestinal tract: often - diarrhea, vomiting, nausea.
Nervous system: frequency unknown - convulsions, particularly in case of improper use.
On the part of the organs of vision: frequency unknown - visual impairment, including color vision impairment.
From the blood and lymphatic system: frequency unknown - malaise caused by hypotension, with or without loss of consciousness (usually after too rapid injection, as an exception - after ingestion); arterial or venous thromboembolism at any site.
On the part of the immune system: frequency unknown - hypersensitivity reactions, including anaphylactic-type reactions.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 3 years.
