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

mayne pharma international pty ltd - morphine sulfate pentahydrate, quantity: 50 mg - capsule, modified release - excipient ingredients: hypromellose; methacrylic acid copolymer; gelatin; sucrose; purified talc; maize starch; purified water; ethylcellulose; diethyl phthalate; macrogol 6000; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - management of severe pain kapanol 10, 20, 50 and 100 mg capsules are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. kapanol is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. kapanol is not indicated as an as-needed (prn) analgesia.

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

mayne pharma international pty ltd - morphine sulfate pentahydrate, quantity: 20 mg - capsule, modified release - excipient ingredients: methacrylic acid copolymer; macrogol 6000; gelatin; purified water; diethyl phthalate; sucrose; ethylcellulose; maize starch; hypromellose; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - management of severe pain: kapanol 10, 20, 50 and 100 mg capsules are indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive, and ? requires daily, continuous, long-term treatment. kapanol is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. kapanol is not indicated as an as-needed (prn) analgesia.,symptom reduction of chronic breathlessness: kapanol 10 and 20 mg capsules are indicated for the symptomatic reduction of chronic breathlessness in the palliative care of patients with distressing breathlessness due to severe copd, cardiac failure, malignancy or other cause. kapanol should only be used after treatments for the underlying cause(s) of the breathlessness have been optimised and nonpharmacological treatments are not effective. treatment with kapanol in this setting should only be initiated by a specialist knowledgeable in its use.

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

bristol-myers squibb australia pty ltd - lomustine, quantity: 10 mg - capsule, hard - excipient ingredients: mannitol; gelatin; titanium dioxide; magnesium stearate; indigo carmine; butan-1-ol; shellac; iron oxide black - (1) brain tumours (primary and secondary). (2) hodgkin's disease (as secondary therapy). lomustine is used in addition to appropriate surgical and/or radiotherapeutic procedures or as a component of various chemotherapeutic regimens in the palliative treatment of primary and metastatic brain tumours. ceenu containing combinations should be used as alternative therapy in the treatment of disseminated hodgkin's disease in patients refractory to other established treatment regimens.

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

bristol-myers squibb australia pty ltd - lomustine, quantity: 40 mg - capsule, hard - excipient ingredients: gelatin; indigo carmine; magnesium stearate; mannitol; titanium dioxide; iron oxide yellow; butan-1-ol; shellac; iron oxide black - (1) brain tumours (primary and secondary). (2) hodgkin's disease (as secondary therapy). lomustine is used in addition to appropriate surgical and/or radiotherapeutic procedures or as a component of various chemotherapeutic regimens in the palliative treatment of primary and metastatic brain tumours. ceenu containing combinations should be used as alternative therapy in the treatment of disseminated hodgkin's disease in patients refractory to other established treatment regimens.

Israel - English - Ministry of Health

novartis israel ltd - ciclosporin - capsules - ciclosporin 100 mg - 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. endogenous uveitis. severe psoriasis above age 16 that did not respond to other treatment. atopic dermatitis in adults only up to 8 weeks for severe cases in which conventional therapy is ineffective or inappropriate. rheumatoid arthritis: severe cases in which standard treatments are ineffective or inappropriate. nephrotic syndrom type mcd (minimal change disease) in cases where conventional therapy has failed.

Israel - English - Ministry of Health

novartis israel ltd - ciclosporin - capsules - ciclosporin 25 mg - 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. endogenous uveitis. severe psoriasis above age 16 that did not respond to other treatment. atopic dermatitis in adults only up to 8 weeks for severe cases in which conventional therapy is ineffective or inappropriate. rheumatoid arthritis: severe cases in which standard treatments are ineffective or inappropriate. nephrotic syndrom type mcd (minimal change disease) in cases where conventional therapy has failed.

Israel - English - Ministry of Health

novartis israel ltd - ciclosporin - capsules - ciclosporin 50 mg - 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. endogenous uveitis. severe psoriasis above age 16 that did not respond to other treatment. atopic dermatitis in adults only up to 8 weeks for severe cases in which conventional therapy is ineffective or inappropriate. rheumatoid arthritis: severe cases in which standard treatments are ineffective or inappropriate. nephrotic syndrom type mcd (minimal change disease) in cases where conventional therapy has failed.

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

accelagen pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, enteric - excipient ingredients: magnesium stearate; titanium dioxide; croscarmellose sodium; microcrystalline cellulose; methacrylic acid copolymer; colloidal anhydrous silica; triethyl citrate; methacrylic acid - ethyl acrylate copolymer (1:1); gelatin; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

accelagen pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: purified talc; microcrystalline cellulose; gelatin; croscarmellose sodium; titanium dioxide; triethyl citrate; colloidal anhydrous silica; magnesium stearate; methacrylic acid copolymer; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

accelagen pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, enteric - excipient ingredients: colloidal anhydrous silica; microcrystalline cellulose; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; methacrylic acid copolymer; purified talc; titanium dioxide; gelatin; triethyl citrate; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - dimethyl fumarate msn is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.