Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Tranexamic acid 100 mg/mL
Pfizer New Zealand Limited
Tranexamic acid 100 mg/mL
100 mg/mL
Solution for injection
Active: Tranexamic acid 100 mg/mL Excipient: Water for injection
Ampoule, 5mL, 10 dose units
Prescription
Prescription
Kyowa Pharma Chemical 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 · 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.
Package - Contents - Shelf Life: Ampoule, 5mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 10mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light
1988-07-14
CYKLOKAPRON 1 CYKLOKAPRON _Tranexamic acid Tablets and Solution for Injection_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CYKLOKAPRON. It does not contain all the available information and it 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 being treated with CYKLOKAPRON against the benefits it is expected to have for you. Please read this leaflet carefully and follow the instructions given to you by your doctor and the advice contained in this leaflet. IF YOU HAVE ANY CONCERNS ABOUT BEING TREATED WITH THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT CYKLOKAPRON IS USED FOR CYKLOKAPRON Tablets are used to prevent excessive bleeding in patients with: traumatic hyphaema (bleeding into the front part of the eye) blood clotting disorders, who are having minor surgery heavy periods hereditary angioneurotic oedema (periodic swelling of the throat) CYKLOKAPRON Solution for Injection is used to reduce bleeding and the need for transfusion of blood in patients undergoing heart surgery, total knee replacement and total hip replacement surgery. HOW CYKLOKAPRON WORKS CYKLOKAPRON contains tranexamic acid. Tranexamic acid is an antifibrinolytic that works by slowing the processes that cause bleeding. BEFORE TREATMENT WITH CYKLOKAPRON _WHEN CYKLOKAPRON MUST _ _NOT BE USED_ CYKLOKAPRON must not be used if you: have an allergy to tranexamic acid or any of the ingredients listed at the end of this leaflet. are being treated for stroke are being treated for blood clots in your legs, lungs or anywhere else in your body. have a problem with colour vision that developed after you were born. DO NOT USE CYKLOKAPRON AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK. Medicine taken after the expiry date has passed may not work as well. DO NOT USE CYKLOKAPRON IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMP Soma hati kamili
Version:: pfdcykla10421 Supersedes: pfdcykla10817 Page 1 of 20 NEW ZEALAND DATA SHEET 1. PRODUCT NAME CYKLOKAPRON ® 500 mg tablets. CYKLOKAPRON ® 100 mg/mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 500 mg tablet contains 500 mg tranexamic acid. Each 5 mL ampoule contains 500 mg of tranexamic acid and 5 mL water for injections. Each 10 mL ampoule contains 1000 mg tranexamic acid and 10 mL water for injections. For the full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM CYKLOKAPRON 500 mg tablets are white, capsule shaped, film coated, engraved CY within arcs, dimensions 8.0 mm x 18.0 mm. CYKLOKAPRON Solution for injection is a sterile, clear and colourless solution, containing 100 mg/mL tranexamic acid. 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: • 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 (also see Section 4.4)). • 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 Version:: pfdcykla10421 Supersedes: pfdcykla10817 Page 2 of 20 • 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. 4.2 DOSE AND METH Soma hati kamili