Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Reteplase
Teva Pharma Australia Pty Ltd
Registered
RAPILYSIN pronounced RAP-EE-LIE-SIN _contains the active ingredient _ _reteplase_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RAPILYSIN injection. It does not contain all the available information. 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 taking RAPILYSIN against the benefits they expect it will 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 need to read it again. WHAT RAPILYSIN IS USED FOR RAPILYSIN contains the active ingredient reteplase. RAPILYSIN is used to treat acute myocardial infarctions (also called “heart attacks”). This condition occurs when the blood flow to part of the heart is blocked. This blockage causes that part of the heart muscle (called the myocardium) to start to die. RAPILYSIN works by dissolving the blood clot that is blocking your heart blood vessel. It is best given within six hours of the start of any heart symptoms. If a myocardial infarction is not treated quickly, then it may lead to minor to severe heart damage and sometimes, death. There are many different types of medicines used to treat myocardial infarctions. RAPILYSIN belongs to a group of medicines called thrombolytics. RAPILYSIN is related to a normal substance found in the blood. RAPILYSIN only acts for a short period of time to dissolve clots. Your doctor, however, may have prescribed RAPILYSIN for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY RAPILYSIN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor’s prescription. BEFORE YOU ARE GIVEN RAPILYSIN _WHEN YOU MUST NOT _ _HAVE_ _RAPILYSIN_ DO NOT USE RAPILYSIN IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO RAPILYSIN OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET 2. YOU HAVE HAD PROLONGED HEART MASSAGE (ALSO CALLED CPR) IN THE LAST 10 DAYS 3. YOU HAVE A TENDENCY Les hele dokumentet
RAPILYSIN ® PRODUCT INFORMATION - 1 (10) RAPILYSIN ® Reteplase: Recombinant Plasminogen Activator (rbe) DESCRIPTION RAPILYSIN is a sterile, purified, stable recombinant plasminogen activator (rbe), (reteplase), concentrate produced from genetically engineered E Coli cells containing a cloned human gene for part of the plasminogen activator protein structure. RAPILYSIN is a highly purified single chain protein with a molecular weight of 39 kD. Reteplase is obtained by genetic engineering technology, and is a variant of plasminogen activator comprising only the kringle 2 and protease domains. RAPILYSIN is a lyophilised powder for reconstitution prior to injection. RAPILYSIN is reconstituted with sterile Water for injections. Potency is expressed in units (U) using a reference standard which is specific for reteplase, and is not comparable for units used for other thrombolytic agents. 10 units of reteplase correspond to 17.4 mg of reteplase protein mass. _ _ COMPOSITION Each single use vial of lyophilisate powder for injection contains the active ingredient reteplase (plasminogen activator) 10U (rDNA) nominal activity. Each vial also contains the excipients potassium phosphate dibasic, phosphoric acid, tranexamic acid, sucrose and polysorbate 80. Each single use pre-filled syringe with solvent for reconstitution contains sterile Water for injections 10mL. RAPILYSIN contains no preservatives. PHARMACOLOGY PHARMACODYNAMICS Reteplase is recombinant plasminogen activator which catalyses the cleavage of endogenous plasminogen to generate plasmin. Plasmin in turn degrades fibrinogen and fibrin, which is a component of the matrix of the thrombi, thereby exerting its thrombolytic effect. Reteplase (10 + 10 U) dose dependently reduces plasma fibrinogen levels by about 75 to 90%. The fibrinogen level normalises within 2 days. As with other plasminogen activators a rebound phenomenon then occurs during which fibrinogen levels reach a maximum within 9 days and remain elevated for up to 18 days. RAPILYSIN ® PRODUC Les hele dokumentet