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

pfizer australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: sulfuric acid; mannitol; water for injections; sodium hydroxide - vincristine sulfate is indicated in acute leukaemia - current practices of cancer chemotherapy involve the simultaneous use of several agents. for enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. it is rarely possible to achieve equally good results with single agent treatment. thus vincristine sulfate is often chosen as part of polychemotherapy because of its unique clinical toxicity (neuropathy). see dosage and administration for possible increased toxicity when used in combination therapy. it has been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non-hodgkin's malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, wilm's tumour, osteogenic sarcoma, mycosis fungoides, ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma

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

pfizer australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: water for injections; mannitol; sulfuric acid; sodium hydroxide - vincristine sulfate is indicated in acute leukaemia - current practices of cancer chemotherapy involve the simultaneous use of several agents. for enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. it is rarely possible to achieve equally good results with single agent treatment. thus vincristine sulfate is often chosen as part of polychemotherapy because of its unique clinical toxicity (neuropathy). see dosage and administration for possible increased toxicity when used in combination therapy. it has been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non-hodgkin's malignant lymphomas (lymphocytic, mixed-cell, histiocytic, undifferentiated, nodular and diffuse types), rhabdomyosarcoma, neuroblastoma, wilm's tumour, osteogenic sarcoma, mycosis fungoides, ewing's sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma

Israel - English - Ministry of Health

mbi pharma ltd., israel - dexamethasone phosphate ( as sodium phosphate ) - solution for injection / infusion - dexamethasone phosphate ( as sodium phosphate ) 4 mg/ml - dexamethasone - dexamethasone kern pharma is indicated in the treatment of:• endocrine diseases such as nonsuppurative thyroiditis, hypercalcaemia associated with cancer and congenital adrenal hyperplasia.• allergy: severe or disabling allergic conditions resistant to conventional treatments, as in: bronchial asthma, contact or atopical dermatitis, seasonal or perennial allergic rhinitis, hypersensitivity reactions to drugs.• ophtalmic: serious inflammatory and allergic processes, acute and chronic, affecting the eyes, such as: iritis and iridocyclitis, chorioretinitis, choroiditis and diffuse posterior uveitis, optical neuritis, allergic conjunctivitis, allergic marginal corneal ulcers.• inflammatory bowel dis.: systemic treatment in exacerbations of ulcerative colitis and regional enteritis.• dermatological diseases (pemphigus, stevens johnson syndrome, exfoliative dermatitis, severe psoriasis and mycosis fungoides) • respiratory diseases (symptomatic sarcoidosis, berylliosis, loeffler's syndrome)• haematological: acquired )autoimmune( haemolytic anaemia, idiopathic thrombocytopenic purpura in adult, pure red cell aplasia• nephrotic syndrome of the idioplathic type or that due to lupus erythematosus• cerebral edema caused by brain tumor, neurosurgery, brain abscess, bacterial meningitis• collagen diseases: active rheumatoid arthritis with severe progressive course, fast destructive remitting forms and / or extra-articular manifestations, juvenile idiopathic arthritis with severe systemic-onset form (still's disease) or locally with no control, rheumatic fever with carditis, dermatomyositis, polymyositis, sle, temporal arteritis.• infectious diseases: bacterial meningitis – adjunct to antibiotics in suspected pneumococcal meningitis and tb meningitis. severe infectious diseases with toxic states (eg tuberculosis, typhoid, brucellosis;. only with simultaneous anti-infective therapy)• fetal lung maturation• chemotherapy – associated nausea and vomiting• multiple myeloma – part of chemotherapy protocols (eg vad)• prevention and treatment of acute mountain sickness/hace

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

juniper biologics pty ltd - chlormethine hydrochloride, quantity: 0.2 mg/g (equivalent: chlormethine, qty 0.16 mg/g) - gel - excipient ingredients: butylated hydroxytoluene; disodium edetate; diethylene glycol monoethyl ether; isopropyl alcohol; hyprolose; lactic acid; propylene glycol; glycerol; menthol; sodium chloride - ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous t-cell lymphoma (mf-type ctcl) in adult patients.

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

pfizer australia pty ltd - methotrexate, quantity: 2.5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; maize starch; lactose monohydrate; polysorbate 80; microcrystalline cellulose; pregelatinised maize starch - antineoplastic chemotherapy: treatment of breast cancer, gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. palliation of acute and subacute lymphocytic leukaemia. greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. in combination with corticosteroids, methotrexate may be used for induction of remission. the drug is now most commonly used for the maintenance of induced remissions. methoblastin is also effective in the treatment of the advanced stages (iii and iv, peters staging system) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides. psoriasis chemotherapy: (see warnings box and precautions). because of the high risk attending to its use, methoblastin is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatolo

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

amdipharm mercury australia pty ltd - flumetasone pivalate, quantity: 0.2 mg/ml; clioquinol, quantity: 10 mg/ml - ear drops - excipient ingredients: macrogol 300 - this product accepted for registration/listing as 'currently supplied' at the time of commencement of the act. new indications were approved as specified in the letter of 29 june 1992 from dr alex proudfoot. indicated for the treatment of eczema of the external auditory meatus in which secondary infection with micro-organisms sensitive to clioquinol has occurred. otitis externa. otomycosis.

Israel - English - Ministry of Health

j-c health care ltd - miconazole - gel - miconazole 20 mg/g - miconazole - miconazole - oral mycosis (thrush) and fungal infections of the upper gastrointestinal tract. daktarin oral gel can be used for the prevention of oral thrush in patient receiving long-term treatment with antibiotics, steroids, cytotoxic and radiation therapy.

Canada - English - Health Canada

celltrion healthcare co ltd - infliximab - powder for solution - 100mg - infliximab 100mg - disease-modifying antirheumatic agents

Canada - English - Health Canada

celltrion healthcare co ltd - infliximab - powder for solution - 100mg - infliximab 100mg - disease-modifying antirheumatic agents

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

juno pharmaceuticals pty ltd - bleomycin sulfate, quantity: 15000 iu - injection, powder for - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - palliation and treatment adjuvant to surgery and radiation therapy of the following neoplasms: = squamous cell carcinoma of the skin, head and neck, and oesophagus (primary indication). = squamous cell carcinoma of the larynx, penis and uterine cervix. = squamous cell carcinoma of the bronchus (response infrequent). = choriocarcinoma and embryonal cell carcinoma of the testis. = advanced hodgkin's disease and other lymphomas. = mycosis fungoides.,note. use of bleomycin after radiation therapy is less successful than use before radiation therapy. bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.