Австралия - английски - Department of Health (Therapeutic Goods Administration)

csl behring australia pty ltd - normal immunoglobulin, quantity: 60 mg/ml - injection, solution - excipient ingredients: water for injections; human immunoglobulin a; maltose - intragam p is indicated in replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. indications as at 21 july 2000: replacement igg therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; congenital acquired immune deficiency syndrome with recurrent infections. immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp), in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogenic bone marrow transplantation; kawasaki disease. indications as at 25 february 2003: for replacement immunoglobulin g (igg) therapy in: primary immunodeficiency; myeloma and chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections, and; congenital acquired immune deficiency syndrome with recurrent infections. for immunomodulatory therapy in: idiopathic thrombocytopenic purpura (itp) in adults or children at high risk of bleeding or prior to surgery to correct platelet count; allogeneic bone marrow transplantation; kawasaki disease, and; guillain-barre syndrome (gbs).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: crospovidone; sodium stearylfumarate; gelatin; titanium dioxide; purified water; iron oxide yellow; sodium lauryl sulfate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 59.735 mg (equivalent: imatinib, qty 50 mg) - capsule, hard - excipient ingredients: sodium stearylfumarate; gelatin; sodium lauryl sulfate; titanium dioxide; purified water; iron oxide yellow; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; iron oxide red; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 477.88 mg - capsule, hard - excipient ingredients: crospovidone; purified water; titanium dioxide; sodium stearylfumarate; sodium lauryl sulfate; gelatin; iron oxide yellow; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 59.735 mg (equivalent: imatinib, qty 50 mg) - capsule, hard - excipient ingredients: gelatin; titanium dioxide; iron oxide yellow; sodium lauryl sulfate; sodium stearylfumarate; purified water; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; iron oxide red; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 477.88 mg (equivalent: imatinib, qty 400 mg) - capsule, hard - excipient ingredients: purified water; titanium dioxide; sodium lauryl sulfate; gelatin; sodium stearylfumarate; crospovidone; iron oxide yellow; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: purified water; gelatin; crospovidone; titanium dioxide; iron oxide yellow; sodium lauryl sulfate; sodium stearylfumarate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Австралия - английски - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; dibasic sodium phosphate; polysorbate 20; trehalose dihydrate - metastatic colorectal cancer bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevaciptin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevaciptin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevaciptin (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevaciptin (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - bevacizumab, quantity: 25 mg/ml - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; trehalose dihydrate; dibasic sodium phosphate; polysorbate 20 - metastatic colorectal cancer bevaciptin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. locally recurrent or metastatic breast cancer bevaciptin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated (see section 5.1 clinical trials). advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) bevaciptin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer. advanced and/or metastatic renal cell cancer bevaciptin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer. grade iv glioma bevaciptin (bevacizumab) as a single agent, is indicated for the treatment of patients with grade iv glioma after relapse or disease progression after standard therapy, including chemotherapy. epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel, is indicated for first- line treatment of patients with advanced (figo stages iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer bevaciptin (bevacizumab) in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other vegf-targeted angiogenesis inhibitors. bevaciptin (bevacizumab) in combination with topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab. cervical cancer bevaciptin (bevacizumab) in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. bevaciptin (bevacizumab) in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

Австралия - английски - APVMA (Australian Pesticides and Veterinary Medicines Authority)

arysta lifescience australia pty ltd - metalaxyl; ipconazole - microencapsulated - metalaxyl phenylamide active 20.0 g/l; ipconazole ungrouped active 25.0 g/l - fungicide - barley | oats | wheat - bunt | covered stinking smut | flag smut on cereal | loose smut - ustilago avenae | rhizoctonia solani - suppression | wilt rootrot or damping off | damping-off | pythium root rot | pythium soil fungus | rhizoctania hypocotyl rot | seedborne flag smut | seedling root rot | soil fungi | soilborne flag smut | trilletia tritici | ustilago hordei | ustilago nuda (tritici)