Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
TRANEXAMIC ACID PH. EUR.
Baxter Holding B.V.
B02AA02
TRANEXAMIC ACID PH. EUR.
100 milligram(s)/millilitre
Solution for injection/infusion
tranexamic acid
Not marketed
2020-06-05
1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER TRANEXAMIC ACID 100MG/ML SOLUTION FOR INJECTION/INFUSION tranexamic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, or pharmacist or nurse. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Tranexamic acid is and what it is used for 2. What you need to know before you use Tranexamic acid 3. How to use Tranexamic acid 4. Possible side effects 5. How to store Tranexamic acid 6. Contents of the pack and other information 1. WHAT TRANEXAMIC ACID IS AND WHAT IT IS USED FOR Tranexamic acid injection/infusion contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics, aminoacids. Tranexamic acid is used in adults and children above one year of age for the prevention and treatment of bleeding due to a process that inhibits blood clotting called fibrinolysis. Specific indications include: - Heavy periods in women - Gastrointestinal bleeding - Haemorrhagic urinary disorders, further to prostate surgery or surgical procedures affecting the urinary tract - Ear, nose or throat surgery - Heart, abdominal or gynaecological surgery - Bleeding after you have been treated with another medicine to break down blood clots. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE TRANEXAMIC ACID DO NOT USE TRANEXAMIC ACID: • If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6) • If you have currently a disease leading to blood clots • If you have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot • If you have kidney problems • If you have a history of convulsions 2/6 Due to the risk of cerebral oedema and convulsions, intrath Citiți documentul complet
Health Products Regulatory Authority 05 June 2020 CRN008TJ2 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tranexamic acid 100 mg/mL solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL vial contains 100 mg of tranexamic Acid. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion Clear, colorless and essentially free from visible particles. pH of the solution is between 6.5 to 8.0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tranexamic acid is indicated in adults and children from one year in prevention and treatment of haemorrhages due to general or local fibrinolysis. Specific indications include: - Haemorrhage caused by general or local fibrinolysis such as: - Menorrhagia and metrorrhagia, - Gastrointestinal bleeding, - Haemorrhagic urinary disorders, further to prostate surgery or surgical procedures affecting the urinary tract, - Ear Nose Throat surgery (adenoidectomy, tonsillectomy, dental extractions), - Gynaecological surgery or disorders of obstetric origin, - Thoracic and abdominal surgery and other major surgical intervention such as cardiovascular surgery, - Management of haemorrhage due to the administration of a fibrinolytic agent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Unless otherwise prescribed, the following doses are recommended: 1. Standard treatment of local fibrinolysis: 0.5 g (1 vial of 5 mL) to 1 g (1 vial of 10 mL or 2 vials of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) two to three times daily. 2. Standard treatment of general fibrinolysis: 1 g (1 vial of 10 mL or 2 vials of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent to 15 mg/kg body weight (BW). _Renal impairment_ 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 Citiți documentul complet