Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
tranexamic acid, Quantity: 500 mg
Pfizer Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; purified talc; magnesium stearate; colloidal anhydrous silica; povidone; hyprolose; titanium dioxide; macrogol 8000; vanillin; basic butylated methacrylate copolymer
Oral
100 tablets, 20 tablets (sample pack)
Medicine Registered
(S4) Prescription Only Medicine
Hereditary angioneurotic oedema. Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery. Menorrhagia.
Visual Identification: A white, capsular, film-coated tablet. Each tablet is engraved with a score and with arcs above and below the letters CY; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
1991-09-05
CYKLOKAPRON _Tranexamic acid Tablets and Solution for Injection_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions people ask about CYKLOKAPRON. It does not contain all the information that is known about CYKLOKAPRON. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you using CYKLOKAPRON against the benefits they expect it will 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 USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. 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 Przeczytaj cały dokument
Version: pfpcyklt10822 Supersedes: pfpcyklt10622 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – CYKLOKAPRON ® (TRANEXAMIC ACID) TABLETS 1. NAME OF THE MEDICINE Tranexamic acid. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Cyklokapron tablet contains 500 mg of tranexamic acid. 3. PHARMACEUTICAL FORM Cyklokapron is available as film coated tablets. Cyklokapron is a white, capsule shaped tablet with a score on one side and "CY" within upper and lower arcs on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ORAL ADMINISTRATION Hereditary angioneurotic oedema. Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery. Menorrhagia. 4.2 DOSE AND METHOD OF ADMINISTRATION ORAL ADMINISTRATION TRAUMATIC HYPHAEMA 1.0 to 1.5 g every 8 hours for six to seven days. MENORRHAGIA Two tablets (1 g) four times a day, increasing to three tablets (1.5 g) four times a day if needed, for four days. Treatment should be initiated at the onset of visible bleeding, and continued for the first 4 days of the menstrual cycle. Patients should be assessed after three months of treatment. No efficacy data are available from randomised, controlled clinical trials for treatment beyond three menstrual cycles. Version: pfpcyklt10822 Supersedes: pfpcyklt10622 Page 2 of 11 HEREDITARY ANGIONEUROTIC OEDEMA Patients who can sense the onset of attacks are best treated intermittently with 2 - 3 tablets, 2 - 3 times a day until symptoms subside. Others should be treated continuously with the same dose. PROSTATECTOMY 1 g orally six hours pre-operatively followed by 1 g orally 3 to 4 times a day until macroscopic haematuria is no longer present. Treatment beyond two weeks is not recommended. PATIENTS WITH ESTABLISHED COAGULOPATHIES UNDERGOING MINOR SURGERY CONISATION OF THE CERVIX 1.0 to 1.5g (2 to 3 tablets) every 8 to 12 hours for 12 days post-operatively. DENTAL OPERATIONS/EXTRACTION 25 mg/kg is given orally two hours before operation. Factor VIII and Factor IX should be Przeczytaj cały dokument