País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Abciximab
Eli Lilly Australia Pty Ltd
Medicine Registered
REOPRO(R) 1 REOPRO(R) _abciximab_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about REOPRO. It does not contain all the available information. It does not take the place of talking with your doctor or nurse. All medicines have risks and benefits. Your doctor has weighed the risks of you being given REOPRO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR NURSE. KEEP THIS LEAFLET. You may need to read it again. WHAT REOPRO IS USED FOR REOPRO belongs to a class of medicines called antithrombotics which help to prevent blood clots. REOPRO inhibits the aggregation of blood-clotting cells (called platelets) in the blood. REOPRO is used in patients with heart disease caused by poor blood flow in the arteries of the heart (known as ischaemic cardiac complications). REOPRO prevents the formation of blood clots in the heart that may occur during procedures to open blocked arteries in the heart (known as percutaneous coronary intervention). Examples of percutaneous coronary intervention procedures include balloon angioplasty, atherectomy and stent placement. REOPRO is also used in patients who have severe chest pain with heart disease (known as unstable angina), when percutaneous coronary intervention is planned. REOPRO may be started 18 to 24 hours prior to the planned intervention. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. YOUR DOCTOR MAY HAVE PRESCRIBED IT FOR ANOTHER REASON. There is not enough information to recommend the use of this medicine in children under the age of 18 years. BEFORE YOU HAVE REOPRO _WHEN YOU MUST NOT HAVE IT_ DO NOT HAVE REOPRO IF YOU HAVE AN ALLERGY TO: * any medicine containing abciximab * any of the ingredients listed at the end of this leaflet * specific disease-fighting protein substances (calle Leer el documento completo
1 ReoPro (abciximab)- Product Information v3.0 REOPRO ® (ABCIXIMAB RMC) NAME OF THE MEDICINE ReoPro ® (abciximab) The active ingredient is abciximab. DESCRIPTION ReoPro (abciximab rmc) is the Fab fragment of the chimeric monoclonal antibody 7E3 (c7E3 Fab). The chemical description of abciximab is: Immunoglobulin G (human-mouse monoclonal c7E3 clone p7E3V H hC H Fab fragment anti-human glycoprotein IIb/IIIa receptor), disulfide with human- mouse monoclonal c7E3 clone p7E3V _K_ hC _K_ light chain. The chimeric 7E3 antibody is produced by continuous perfusion in mammalian cell culture. The 47,615 dalton Fab fragment is purified from cell culture supernatant by a series of steps involving specific viral inactivation and removal procedures, digestion with papain and column chromatography. Each 5 mL single-use vial contains 10 mg abciximab, 6.75 mg dibasic sodium phosphate dihydrate, 1.65 mg monobasic sodium phosphate (monohydrate), 43.85 mg sodium chloride, 0.05 mg polysorbate 80 and water for injections, qs to 5.0 mL. No preservatives are added. PHARMACOLOGY ReoPro binds to the intact platelet GPIIb/IIIa receptor, which is a member of the integrin family of adhesion receptors and the major platelet surface receptor involved in platelet aggregation. ReoPro inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive molecules to GPIIb/IIIa receptor sites on activated platelets. The mechanism of action is thought to involve steric hindrance and/or conformational effects to block access of large molecules to the receptor rather than direct interaction with the RGD (arginine-glycine-aspartic acid) binding site of GPIIb/IIIa. ReoPro binds with similar affinity to the related integrin, v ß 3 , al Leer el documento completo