Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - cytarabine, quantity: 500 mg - injection, solution - excipient ingredients: water for injections; macrogol 400; trometamol - cytarabine is indicated primarily for:,? induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.,it has also been found to be useful in the treatment of other leukaemias such as:,? acute lymphocytic leukaemia,? chronic myelocytic leukaemia (blast phase).,cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.,children with non-hodgkin?s lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine.,remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.,cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - cytarabine, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; macrogol 400; trometamol - cytarabine is indicated primarily for:,? induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.,it has also been found to be useful in the treatment of other leukaemias such as:,? acute lymphocytic leukaemia,? chronic myelocytic leukaemia (blast phase).,cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.,children with non-hodgkin?s lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine.,remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.,cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - cytarabine, quantity: 2000 mg - injection, solution - excipient ingredients: water for injections; macrogol 400; trometamol - cytarabine is indicated primarily for:,? induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.,it has also been found to be useful in the treatment of other leukaemias such as:,? acute lymphocytic leukaemia,? chronic myelocytic leukaemia (blast phase).,cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.,children with non-hodgkin?s lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine.,remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.,cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - cytarabine, quantity: 100 mg - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections; sodium hydroxide - cytarabine is indicated primarily for:,? induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.,it has also been found to be useful in the treatment of other leukaemias such as:,? acute lymphocytic leukaemia,? chronic myelocytic leukaemia (blast phase).,cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.,children with non-hodgkin?s lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine.,remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.,cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - cytarabine, quantity: 4000 mg - injection, solution - excipient ingredients: water for injections; macrogol 400; trometamol - cytarabine is indicated primarily for:,? induction and maintenance of remission in acute myelocytic leukaemia of both adults and children.,it has also been found to be useful in the treatment of other leukaemias such as:,? acute lymphocytic leukaemia,? chronic myelocytic leukaemia (blast phase).,cytarabine may be used alone or in combination with other antineoplastic agents, the best results are often obtained with combination therapy.,children with non-hodgkin?s lymphoma have benefited from a combination drug program (lsa2l2) that includes cytarabine.,remissions induced by cytarabine not followed by maintenance treatment have been brief. maintenance therapy has extended these and provided useful and comfortable remissions with relatively little toxicity.,cytarabine has been used intrathecally in meningeal leukaemia. focal leukaemic involvement of the central nervous system may not respond to intrathecal cytarabine and may better be treated with radiotherapy.

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatment of patients with her2 positive advanced adenocarcinoma of the stomach or gastrooesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - trastuzumab, quantity: 150 mg - injection, powder for - excipient ingredients: histidine hydrochloride; polysorbate 20; histidine; trehalose dihydrate - early breast cancer,indicated for the treatment of her2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer,indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant therapy.,metastatic breast cancer,indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,b) in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,c) in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.,advanced gastric cancer,indicated in combination with cisplatin and either capecitabine or 5-fu for the treatmen

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - rituximab, quantity: 100 mg - injection, concentrated - excipient ingredients: polysorbate 80; water for injections; sodium chloride; sodium citrate dihydrate - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.

Australia - English - Department of Health (Therapeutic Goods Administration)

celltrion healthcare australia pty ltd - rituximab, quantity: 500 mg - injection, concentrated - excipient ingredients: sodium citrate dihydrate; polysorbate 80; water for injections; sodium chloride - non-hodgkin?s lymphoma truxima is indicated for treatment of patients with: -cd20 positive, previously untreated, stage iii/iv follicular, b-cell non-hodgkin?s lymphoma; - cd20 positive, relapsed or refractory low grade or follicular, b-cell non-hodgkin's lymphoma; - cd20 positive, diffuse large b-cell non-hodgkin?s lymphoma, in combination with chemotherapy.,chronic lymphocytic leukaemia truxima is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.,rheumatoid arthritis truxima (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (tnf) inhibitor therapy. truxima has been shown to reduce the rate of progression of joint damage as measured by xray when given in combination with methotrexate.,granulomatosis with polyangiitis (wegener?s) (gpa) and microscopic polyangiitis (mpa) truxima in combination with glucocorticoids is indicated for the induction of remission in patients with severely active granulomatosis with polyangiitis (gpa, also known as wegener?s granulomatosis) and microscopic polyangiitis (mpa). the efficacy and safety of retreatment with rituximab have not been established.