Israel - English - Ministry of Health

novartis israel ltd - ciclosporin - solution for infusion - ciclosporin 50 mg/ml - cyclosporin - cyclosporin - prophylaxis of organ rejection in kidney liver heart allogenic transplants in conjunction with corticosteroids. may also be used in the treatment of chronic rejection in patients previously treated with other immuno-suppressive agents. bone marrow transplantation.

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

pfizer australia pty ltd - oxaliplatin, quantity: 100 mg - injection, intravenous infusion - excipient ingredients: tartaric acid; water for injections; sodium hydroxide - oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour. - treatment of advanced colorectal cancer.

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

pfizer australia pty ltd - oxaliplatin, quantity: 50 mg - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; tartaric acid - oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour. - treatment of advanced colorectal cancer.

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

juno pharmaceuticals pty ltd - nimodipine, quantity: 10 mg - injection, intravenous infusion - excipient ingredients: citric acid; sodium citrate dihydrate; water for injections; ethanol; macrogol 400 - prophylaxis and treatment of ischaemic neurological deficits caused by cerebral vasospasm after subarachnoid haemorrhage following ruptured intracranial aneurysm, in patients who are in good neurological condition post-ictus, e.g., hunt and hess grades i-iii (see section 5.1 pharmacodynamic properties).

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - zoledronic acid monohydrate 4.3mg equivalent to zoledronic acid 4 mg - concentrate for infusion - 4 mg/5ml - active: zoledronic acid monohydrate 4.3mg equivalent to zoledronic acid 4 mg excipient: mannitol sodium citrate dihydrate water for injection - prevention of skeletal-related events (pathological fracture, spinal cord compression, radiation to bone or surgery to bone) in patients with advanced malignancies involving bone

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

pfizer australia pty ltd - levetiracetam, quantity: 500 mg - injection, concentrated - excipient ingredients: nitrogen; sodium acetate trihydrate; sodium chloride; glacial acetic acid; water for injections - hospira? levetiracetam concentrate for iv infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. levetiracetam is indicated for: use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation; monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy; add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy and add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy.

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

biogen australia pty ltd - natalizumab, quantity: 300 mg - injection, concentrated - excipient ingredients: polysorbate 80; sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate - tysabri (natalizumab) is indicated as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (ms) to delay the progression of physical disability and to reduce the frequency of relapse.

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

hospira australia pty ltd - cisplatin, quantity: 1 mg/ml - injection, intravenous infusion - excipient ingredients: mannitol; sodium chloride; water for injections; sodium hydroxide; hydrochloric acid - cisplatin is indicated in metastatic, non seminomatous germ cell carcinoma, advanced stage and refractory ovarian carcinoma, advanced stages of refractory bladder carcinoma, advanced stages of refractory bladder carcinoma and squamous cell carcinoma of the head and neck. cisplatin is indicated in combination with other antineoplastic agents for the treatment of metastatic testicular tumors.

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

wockhardt bio pty ltd - docetaxel, quantity: 160 mg - injection, concentrated - excipient ingredients: ethanol absolute; polysorbate 80; citric acid monohydrate - docetaxel concentrate for solution for infusion is indicated for;,breast cancer -,metastatic 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 ? 1cm and < 7cm. ,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)

wockhardt bio pty ltd - docetaxel, quantity: 20 mg - injection, concentrated - excipient ingredients: polysorbate 80; ethanol absolute; citric acid monohydrate - docetaxel concentrate for solution for infusion is indicated for;,breast cancer -,metastatic 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 ? 1cm and < 7cm. ,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.