Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Tranexamic acid 500mg
Boucher & Muir (NZ) Ltd t/a Mercury Pharma (NZ)
Tranexamic acid 500 mg
500 mg
Film coated tablet
Active: Tranexamic acid 500mg Excipient: Basic butylated methacrylate copolymer Colloidal silicon dioxide Croscarmellose sodium Isopropyl alcohol Macrogol 8000 Magnesium stearate Microcrystalline cellulose Povidone Purified talc Purified water Titanium dioxide Vanillin
Blister pack, PVC film/aluminium, 60 tablets
Prescription
Prescription
Asahi Kasei Finechem Co Ltd
Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: -prostatectomy and bladder surgery -menorrhagia -epistaxis -conisation of the cervix - management of dental extraction in patients with coagulopathies - ulcerative colitis - haematuria (Tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma) -gastrointestinal haemorrhage General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery: - in obstetrical complications such as abruptio placentae and post-partum haemorrhage - in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase Hereditary angioneurotic oedema. For the reduction of peri– and post-operative blood loss and the need for blood transfusion in adult patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. For the reduction of peri- and post-operative blood loss and the need for blood transfusion in paediatric patients undergoing cardiac surgery.
Package - Contents - Shelf Life: Blister pack, PVC film/aluminium - 60 tablets - 36 months from date of manufacture stored at or below 25°C
2009-11-09
1 TRANEXAMIC ACID TABLETS Consumer Medicine Information TRANEXAMIC ACID TABLETS _TRANEXAMIC ACID _ Film-coated tablets, 500 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Tranexamic Acid Tablets. This leaflet answers some common questions about Tranexamic Acid Tablets. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Tranexamic Acid Tablets against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT TRANEXAMIC ACID TABLETS ARE USED FOR Tranexamic Acid Tablets contain tranexamic acid. Tranexamic acid belongs to a group of medicines called antifibrinolytic agents that work by slowing the processes that cause bleeding. Tranexamic Acid Tablets are used to treat and prevent excessive bleeding in patients: • with blood clotting disorders • who are having surgery or dental extraction • with conditions such as heavy periods, nose bleeds, ulcerative colitis, bleeding into the urine or intestines, inflammation of the colon and bowel, Tranexamic Acid Tablets may also be used to treat hereditary angioneurotic oedema (periodic swelling of the throat). 2 TRANEXAMIC ACID TABLETS Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Tranexamic Acid Tablets are only available with a doctor's prescription. Tranexamic Acid Tablets are not addictive. BEFORE YOU TAKE TRANEXAMIC ACID TABLETS _ _ Tranexamic Acid Tablets are not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE TRANEXAMIC ACID TABLETS IF YOU: ▪ are being treated for a stroke ▪ have a hist Lesen Sie das vollständige Dokument
1 TRANEXAMIC ACID TABLETS TRANEXAMIC ACID FILM-COATED TABLETS 500 MG NEW ZEALAND DATA SHEET 1 TRANEXAMIC ACID TABLETS TRANEXAMIC ACID TABLETS 500 mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg tranexamic acid. For the full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Tranexamic Acid Tablets are white to off-white, film-coated, oblong tablets of 6 mm, marked on one side with ‘TA500’ with a break-line on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: menorrhagia epistaxis conisation of the cervix management of dental extraction in patients with coagulopathies ulcerative colitis haematuria (tranexamic acid therapy is not indicated in haematuria caused by diseases of the renal parenchyma – see also Section 4.4) gastrointestinal haemorrhage. Hereditary angioneurotic oedema. 2 TRANEXAMIC ACID TABLETS TRANEXAMIC ACID FILM-COATED TABLETS 500 MG 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE Adults The recommended standard dose is 2-3 tablets of 0.5 g, taken two to three times daily. For the indications listed below the following doses are recommended. _MENORRHAGIA _ 1-1.5 g orally three to four times daily for 3-4 days. Tranexamic acid therapy is initiated when bleeding has become profuse. _EPISTAXIS _ 1.5 g orally three times daily for 4-10 days. _HAEMATURIA _ 1-1.5 g orally two to three times daily until macroscopic haematuria is no longer present. _CONISATION OF THE CERVIX _ 1.5 g orally three times a day for 12-14 days post-operatively. _DENTAL SURGERY IN PATIENTS WITH COAGULOPATHIES (ORAL POST-SURGERY ADMINISTRATION ONLY) _ After surgery (when intravenous injection of tranexamic acid is administered immediately before surgery), 25 mg per kg body weight given orally three to four times daily for 6-8 days. It may be necessary to administer coagulation factor con Lesen Sie das vollständige Dokument