Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
TRASTUZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L01FD01
SOLUTION FOR INFUSION
TRASTUZUMAB 440 MG/ML
I.V
Required
HOFFMANN LA ROCHE, SWITZERLAND
TRASTUZUMAB
TRASTUZUMAB
Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2: 1. As a single agent for the treatment of those patients who have received one or more chemotherapy regiments for their metastatic disease. 2. In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. Herceptin in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer. Early breast cancer (EBC) :Herceptin is indicated to treat patients with HER2-positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding Anthracyclines. Herceptin should only be used in patients whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.HER2 metastatic gastric cancer (mGC)Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay
2014-05-31
1 Herceptin 440mg I.V. Ver 8.0 HERCEPTIN ® 440 MG I.V. r Trastuzumab Powder and solvent for concentrate for solution for intravenous infusion 1. NAME OF THE MEDICINAL PRODUCT Herceptin ® 440 mg I.V., powder and solvent for concentrate for solution for intravenous infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 multidose vial contains 440 mg of trastuzumab. Trastuzumab is, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures. 1 vial of solvent contains Water for Injection containing 1.1% benzyl alcohol (Bacteriostatic Water for Injection). The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab. For a full list of excipients, (see section 6.1). 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Herceptin is a white to pale yellow lyophilised powder. The solvent is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Metastatic Breast Cancer (MBC) Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2; 1. As a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease. 2. In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. In combination with an aromatase inhibitor for the treatment of postmenopausal patient with hormone-receptor positive metastatic breast cancer. Early Breast Cancer (EBC) Herceptin is indicated to treat patients with HER2 positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. 2 Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurat Perskaitykite visą dokumentą
1 Herceptin 440mg I.V. Ver 10 HERCEPTIN ® 440 MG I.V. Trastuzumab Powder and solvent for concentrate for solution for intravenous infusion 1. NAME OF THE MEDICINAL PRODUCT Herceptin ® 440 mg I.V., powder and solvent for concentrate for solution for intravenous infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 multidose vial contains 440 mg of trastuzumab. Trastuzumab is, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity and ion exchange chromatography including specific viral inactivation and removal procedures. 1 vial of solvent contains Water for Injection containing 1.1% benzyl alcohol (Bacteriostatic Water for Injection). The reconstituted Herceptin solution contains 21 mg/ml of trastuzumab. For a full list of excipients, (see section 6.1). 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Herceptin is a white to pale yellow lyophilised powder. The solvent is a clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Metastatic Breast Cancer (MBC) Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2; 1. As a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease. 2. In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. 3. In combination with an aromatase inhibitor for the treatment of postmenopausal patient with hormone-receptor positive metastatic breast cancer. Early Breast Cancer (EBC) Herceptin is indicated to treat patients with HER2 positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines. Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and Perskaitykite visą dokumentą