Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
TRANEXAMIC ACID
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
B02AA02
TRANEXAMIC ACID 100 mg/ml
SOLUTION FOR INJECTION
TRANEXAMIC ACID 100 mg/ml
POM
ANTIHEMORRHAGICS
Withdrawn
2017-01-26
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRANEXAMIC ACID 100 MG/ML SOLUTION FOR INJECTION tranexamic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Tranexamic acid Injection is and what it is used for 2. What you need to know before you are given Tranexamic acid Injection 3. How to take Tranexamic acid Injection 4. Possible side effects 5. How to store Tranexamic acid Injection 6. Contents of the pack and other information 1. WHAT TRANEXAMIC ACID INJECTION AND WHAT IT IS USED FOR Tranexamic acid Injection contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics. Tranexamic acid Injection 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 ARE GIVEN TRANEXAMIC ACID INJECTION DO NOT TAKE TRANEXAMIC ACID INJECTION IF YOU: • are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6) • have (or ever have had) a disease that leads to blood clots • have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot • have kidney problems • have a history of convulsions Due to the risk of cerebral oedema and convul Soma hati kamili
Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT Tranexamic acid 100mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is tranexamic acid. Each 5 ml of the solution contains 500 mg of tranexamic acid. Each 10 ml of the solution contains 1000 mg of tranexamic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection A clear colourless solution, free from visible particulate matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of haemorrhages due to general or local fibrinolysis in adults and children from one year. 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: Page 2 of 8 1. Standard treatment of local fibrinolysis: 0.5 g (1 ampoule of 5 ml) to 1 g (1 ampoule of 10 ml or 2 ampoules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) two to three times daily 2. Standard treatment of general fibrinolysis: 1 g (1 ampoule of 10 ml or 2 ampoules of 5 ml) tranexamic acid by slow intravenous injection (= 1 ml/minute) every 6 to 8 hours, equivalent to 15 mg/kg 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 to moderate renal impairment, the dosage of tran Soma hati kamili