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

accord healthcare pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: citric acid; ethanol absolute; polysorbate 80 - breast cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous chemotherapy has failed. docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress her2 and who previously have not received chemotherapy for metastatic disease adjuvant treatment of breast cancer docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with node-positive breast cancer. doxorubicin and cyclophosphamide followed by docetaxel in combination with trastuzumab (ac-th) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2. docetaxel in combination with carboplatin and trastuzumab (tch) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress her2 docetaxel in combination with cyclophosphamide is indicated for the adjuvant treatment of operable breast cancer with a primary tumour of = 1 cm and < 7 cm. non small cell lung cancer docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer, including those who have failed platinum-based chemotherapy. ovarian cancer docetaxel is indicated for the treatment of metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. prostate cancer docetaxel is indicated for the treatment of patients with androgen independent (hormone refractory) prostate cancer. head and neck cancer docetaxel in combination with cisplatin and fluorouracil, is indicated as induction treatment prior to chemoradiotherapy, for the treatment of patients with locally advanced, squamous cell carcinoma of the head and neck, who have low probability of surgical cure, require organ preservation or where the tumour is technically unresectable.

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

accord healthcare pty ltd - paclitaxel, quantity: 30 mg - injection, concentrated - excipient ingredients: peg-35 castor oil; ethanol absolute - - primary treatment of ovarian cancer in combination with a platinum agent.. - treatment of metastatic carcinoma of the ovary after failure of standard therapy.. - treatment of metastatic carcinoma of the breast after failure of standard therapy.. - adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide.. - treatment of metastatic cancer of the breast, in combination with trastuzumab (herceptin?), in patients who have tumours that over-express her-2 and who have not received previous chemotherapy for their metastatic disease.. - in combination with gemcitabine (gemzar?), is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. . - for the treatment of non-small cell lung cancer (nsclc).

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

accord healthcare pty ltd - paclitaxel, quantity: 100 mg - injection, concentrated - excipient ingredients: ethanol absolute; peg-35 castor oil - - primary treatment of ovarian cancer in combination with a platinum agent.. - treatment of metastatic carcinoma of the ovary after failure of standard therapy.. - treatment of metastatic carcinoma of the breast after failure of standard therapy.. - adjuvant treatment of node-positive breast cancer administered sequentially to doxorubicin and cyclophosphamide.. - treatment of metastatic cancer of the breast, in combination with trastuzumab (herceptin?), in patients who have tumours that over-express her-2 and who have not received previous chemotherapy for their metastatic disease.. - in combination with gemcitabine (gemzar?), is indicated for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. prior chemotherapy should have included an anthracycline unless clinically contraindicated. . - for the treatment of non-small cell lung cancer (nsclc).

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - lacosamide - epilepsy - antiepileptics, - lacosamide accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.lacosamide accord is indicated as adjunctive therapy•         in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.•         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

European Union - English - EMA (European Medicines Agency)

accord healthcare s.l.u. - lenalidomide - multiple myeloma - immunosuppressants - multiple myelomalenalidomide accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.lenalidomide accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.lenalidomide accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.follicular lymphomalenalidomide accord in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

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

accord healthcare pty ltd - cytarabine, quantity: 5000 mg - injection, solution - excipient ingredients: trometamol; water for injections; macrogol 400 - 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: 1000 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: 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.