País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
Roche Products (Pty) Ltd
See ingredients
INFUSION (PARENTERAL)
EACH 5,0 ml SOLUTION CONTAINS TRASTUZUMAB 600,0 mg
Registered
2018-08-04
_ _ _ _ _ _ _Page 1 of 7 _ PATIENT INFORMATION LEAFLET SCHEDULING STATUS S4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM HERCEPTIN ® 21 MG/ML IV Infusion BACTERIOSTATIC WATER FOR INJECTION FOR HERCEPTIN ® Diluent for injection READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING HERCEPTIN 21 MG/ML IV - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or your pharmacist. - Herceptin 21 mg/ml IV has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT HERCEPTIN 21 MG/ML IV CONTAINS Herceptin 21 mg/ml IV contains 21 mg trastuzumab per ml. Herceptin 21 mg/ml IV contains the excipients αα-trehalose, l-histadine, polysorbate 20 and water for injection. Bacteriostatic Water for Injection for Herceptin: The solvent for reconstitution of Herceptin 21 mg/ml IV, contains bacteriostatic water with 1,1 % m/v benzyl alcohol, as preservative. WHAT HERCEPTIN 21 MG/ML IV IS USED FOR Herceptin 21 mg/ml IV contains the active substance trastuzumab, which is a humanised monoclonal antibody. Herceptin 21 mg/ml IV is used for the treatment of breast and gastric cancer if you have high levels of a protein called HER2 and your chemotherapy is finished. IF YOU HAVE METASTATIC BREAST CANCER (MBC), HERCEPTIN 21 MG/ML IV IS INDICATED: As monotherapy if you have received at least two chemotherapy regimens for your metastatic disease. In combination with paclitaxel or docetaxel if you have not received chemotherapy for your metastatic disease. in combination with an aromatase inhibitor if you have hormone-receptor positive metastatic breast cancer. _ _ _ _ _ _ _Page 2 of 7 _ IF YOU HAVE EARLY BREAST CANCER (EBC), HERCEPTIN 21 MG/ML IV IS INDICATED: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable); and in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. In combinatio Llegiu el document complet
_ _ _ _ _ _ _Page 1 of 23 _ WARNINGS CARDIOMYOPATHY: Herceptin 21 mg/ml IV administration can result in the development of ventricular dysfunction and congestive heart failure. Left ventricular function should be evaluated in all patients prior to and during treatment with Herceptin 21 mg/ml IV. Discontinuation of Herceptin 21 mg/ml IV treatment should be strongly considered in patients who develop a clinically significant decrease in left ventricular function. The incidence and severity of cardiac dysfunction was particularly high in patients who received Herceptin 21 mg/ml IV in combination with anthracyclines and cyclophosphamide (see WARNINGS AND SPECIAL PRECAUTIONS). HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS. Herceptin 21 mg/ml IV administration can result in severe hypersensitivity reactions (including anaphylaxis), infusion reactions and pulmonary events. These may be fatal. In most cases, symptoms occurred during or within 24 hours of administration of Herceptin 21 mg/ml IV. Herceptin 21 mg/ml IV infusion should be interrupted for patients experiencing dyspnoea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Herceptin 21 mg/ml IV should be strongly considered for patients who develop anaphylaxis, angioedema, or acute respiratory distress syndrome (see WARNINGS AND SPECIAL PRECAUTIONS). SCHEDULING STATUS S4 PROPRIETARY NAME AND DOSAGE FORM HERCEPTIN ® 21 MG/ML IV Infusion BACTERIOSTATIC WATER FOR INJECTION FOR HERCEPTIN ® Diluent for injection COMPOSITION Herceptin 21 mg/ml IV: Each multidose vial contains 440 mg of trastuzumab. Reconstituted Herceptin 21 mg/ml IV concentrate contains 21 mg/mℓ trastuzumab. Excipients: α,α-trehalose, l-histidine, polysorbate 20, water for injection. Bacteriostatic Water for Injection for Herceptin: Each vial contains 20 mℓ sterile bacteriostatic water for injection with 1,1 % m/v benzyl alcohol as preservative. _ _ _ _ _ _ _Page 2 of 23 _ Llegiu el document complet