Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - rituximab, quantity: 1600 mg - injection - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections - mabthera sc 1600 mg is indicated for the treatment of patients with cd20 positive chronic lymphocytic leukaemia (cll) in combination with chemotherapy.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - tocilizumab, quantity: 162 mg - injection, solution - excipient ingredients: polysorbate 80; arginine; arginine hydrochloride; methionine; histidine; histidine hydrochloride monohydrate; water for injections - rheumatoid arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients in combination with methotrexate (mtx) or other non-biological disease-modifying anti-rheumatic drugs (dmards) in case of either an inadequate response or intolerance to previous therapy with one or more dmards.,actemra is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 pharmacodynamic properties, clinical trials) in combination with mtx in those not previously treated with mtx.,in the two groups of patients above, actemra can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate.,actemra has been shown to inhibit the progression of joint damage in adults, as measured by x-ray, when given in combination with methotrexate.,giant cell arteritis (sc formulations only),actemra is indicated for the treatment of giant cell arteritis (gca) in adult patients.,polyarticular juvenile idiopathic arthritis (iv and sc formulations),actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (mtx). actemra can be given alone or in combination with mtx.,systemic juvenile idiopathic arthritis (iv and sc formulations),intravenous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.,subcutaneous formulation,actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.,actemra iv and sc can be given alone or in combination with methotrexate (mtx).

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab, quantity: 600 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine hydrochloride monohydrate; histidine; trehalose dihydrate; methionine; polysorbate 20; water for injections - early breast cancer: herceptin sc is indicated for the treatment of her2-positive localised breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.,locally advanced breast cancer: herceptin sc is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin.,metastatic breast cancer: herceptin sc is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress her2:,- as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;,- in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or,- in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - rituximab, quantity: 1400 mg - injection - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride; trehalose dihydrate; methionine; polysorbate 80; water for injections - mabthera sc 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, - cd 20 positive, diffuse large b-cell non-hodgkin's lymphoma, in combination with chemotherapy.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 171 mg - injection, powder for - excipient ingredients: sodium hydroxide; sucrose; polysorbate 20; succinic acid - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab emtansine, quantity: 106 mg - injection, powder for - excipient ingredients: sucrose; polysorbate 20; succinic acid; sodium hydroxide - early breast cancer,kadcyla, as a single agent, is indicated for the adjuvant treatment of patients with her2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.,metastatic breast cancer,kadcyla, as a single agent, is indicated for the treatment of patients with her2-positive metastatic (stage iv) breast cancer who previously received trastuzumab and a taxane, separately or in combination. patients should have either:,? received prior therapy for metastatic disease, or,? developed disease recurrence during or within six months of completing adjuvant therapy.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - trastuzumab, quantity: 60 mg - injection, powder for - excipient ingredients: histidine hydrochloride monohydrate; polysorbate 20; trehalose dihydrate; histidine - early breast cancer. herceptin is indicated for the treatment of patients with her2 positive localised breast cancer following surgery, and in assocoation with chemotherapy and, if applicable, radiotherapy. locally advanced breast cancer.herceptin is indicated for the treatment of her2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant herceptin. metastatic breast cancer. herceptin is 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. herceptin is 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 gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.05 mg - injection, solution - excipient ingredients: sodium sulfate; monobasic sodium phosphate monohydrate; poloxamer; methionine; mannitol; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.03 mg - injection, solution - excipient ingredients: mannitol; sodium sulfate; poloxamer; methionine; monobasic sodium phosphate monohydrate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.12 mg - injection, solution - excipient ingredients: sodium sulfate; monobasic sodium phosphate monohydrate; poloxamer; methionine; mannitol; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).