Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
Trastuzumab
Roche Products Pty Ltd
Medicine Registered
HERCEPTIN ® _Contains the active ingredient trastuzumab (rch)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about HERCEPTIN. 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 being given HERCEPTIN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT HERCEPTIN IS GIVEN FOR HERCEPTIN contains an active ingredient called trastuzumab. HERCEPTIN belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti- neoplastic agents. HERCEPTIN belongs to a class called monoclonal antibodies. Monoclonal antibodies are proteins made in a laboratory. These proteins are designed to recognise and bind to other unique proteins in the body. HERCEPTIN binds selectively to a protein called human epidermal growth factor receptor 2 (HER2). HER2 is found in large amounts on the surface of some cancer cells. When HERCEPTIN binds to HER2 it stops the growth and spread of the cancer cells. HERCEPTIN is used to treat breast and gastric cancer. It is only used in patients whose tumour has tested positive to HER2. HERCEPTIN may be used alone or with other medicines that treat breast cancer, such as an aromatase inhibitor (hormone receptor positive breast cancer) or a taxane (e.g. paclitaxel or docetaxel). For the treatment of gastric cancer HERCEPTIN is used with chemotherapy medicines cisplatin and capecitabine (or 5FU). For further information about the other medicines you are receiving with HERCEPTIN, please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY HERCEPTIN HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a docto Lestu allt skjalið
Herceptin PI 120810 1 of 33 CDS 12.0 NAME OF THE MEDICINE HERCEPTIN ® _trastuzumab _ CAS-180288-69-1 HERCEPTIN (trastuzumab) is a recombinant DNA-derived humanized monoclonal antibody that selectively targets the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). The antibody is an IgG 1 kappa that contains human framework regions with the complementarity-determining regions of a murine anti-p185 HER2 antibody that binds to HER2. Trastuzumab is composed of 1,328 amino acids and has a molecular weight of ~148 kDa. The humanized antibody against HER2 is produced by recombinant mammalian cells (Chinese hamster ovary (rch)) in suspension culture in a nutrient medium and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures. DESCRIPTION HERCEPTIN is a sterile, white to pale yellow, preservative-free lyophilized powder for intravenous (IV) infusion. HERCEPTIN is available as a single-dose vial containing 60 mg or 150 mg of trastuzumab with the following excipients: histidine hydrochloride, histidine, trehalose dihydrate and polysorbate 20. Reconstitution of the 60 mg vial with 3.0 mL of sterile water for injection yields 3.1 mL of a single- dose solution containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A volume overage of 7.5% ensures that the labelled dose can be withdrawn from each vial. Reconstitution of the 150 mg vial with 7.2 mL of sterile water for injection yields 7.4 mL of a single- dose solution containing approximately 21 mg/mL trastuzumab, at a pH of approximately 6.0. A volume overage of 4% ensures that the labelled dose can be withdrawn from each vial. PHARMACOLOGY PHARMACODYNAMICS The HER2 (or c-erbB2) proto-oncogene encodes for Lestu allt skjalið