Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Tranexamic acid
Pfizer Healthcare Ireland
B02AA; B02AA02
Tranexamic acid
100 milligram(s)/millilitre
Solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Amino acids; tranexamic acid
Marketed
1983-04-01
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. See section 4. WHAT IS IN THIS LEAFLET 1. What Cyklokapron is and what it is used for 2. What you need to know before you are given Cyklokapron 3. How to take Cyklokapron 4. Possible side effects 5. How to store Cyklokapron 6. Contents of the pack and other information 1. WHAT CYKLOKAPRON IS AND WHAT IT IS USED FOR Cyklokapron contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolitics, aminoacids. Cyklokapron 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 gynecological 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 CYKLOKAPRON DO NOT TAKE CYKLOKAPRON: • If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6). • If you currently have 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. Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and intracerebral application are not recommended. If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking C সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 02 August 2023 CRN00DF46 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cyklokapron 100 mg/mL solution for injection/infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL ampoule contains 500 mg tranexamic acid. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection/infusion. Clear, colourless solution with pH of 6.5-8.0. 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 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules 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 ampoule of 10 mL or 2 ampoules 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 patient with severe renal impairment (see section 4.3). For patients with mild to moderate renal impairment, the dosage of tranex সম্পূর্ণ নথি পড়ুন