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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 1000 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

boehringer ingelheim pty ltd - empagliflozin, quantity: 5 mg; metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: maize starch; copovidone; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 400 - jardiamet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate (see sections 4.2 dose and method of administration and 5.1 pharmacodynamic properties - clinical trials).,empagliflozin is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death (see section 5.1 pharmacodynamic properties - clinical trials).,to prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

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

janssen-cilag pty ltd - ibrutinib, quantity: 140 mg - capsule, hard - excipient ingredients: croscarmellose sodium; microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; titanium dioxide; potable water; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; shellac; sulfuric acid - imbruvica is indicated for the treatment of patients with mcl who have received at least one prior therapy.,imbruvica as a single agent is indicated for the treatment of adult patients with waldenstr?m?s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.,imbruvica in combination with rituximab is indicated for the treatment of adult patients with waldenstrom?s macroglobulinaemia (wm).,imbruvica as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll).,imbruvica as a single agent or in combination with bendamustine and rituximab (br) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (cll/sll) who have received at least one prior therapy.

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

alphapharm pty ltd - metformin hydrochloride, quantity: 1000 mg - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; carmellose sodium - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. diaformin xr and diaformin xr 1000 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

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

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: silicon dioxide; magnesium stearate; sodium starch glycollate type a; hypromellose phthalate; gelatin; brilliant blue fcf; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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

mayne pharma international pty ltd - itraconazole, quantity: 50 mg - capsule - excipient ingredients: sodium starch glycollate type a; titanium dioxide; brilliant blue fcf; hypromellose phthalate; silicon dioxide; magnesium stearate; gelatin; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - superficial mycoses: lozanoc is indicated, if external treatment is not effective or not appropriate, for the treatment of the following fungal infections: dermatomycoses (e.g. tinea corporis, tinea cruris, tinea pedis, tinea manus, tinea unguium) and pityriasis versicolor. systemic mycoses: lozanoc is indicated for the treatment of systemic mycoses, such as candidiasis, aspergillosis, and histoplasmosis. consideration should be given to official guidance on the appropriate use of antimycotic agents, and to the discussion of the pharmacodynamic properties (see pharmacology).

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

alphapharm pty ltd - metformin hydrochloride, quantity: 1000 mg - tablet, modified release - excipient ingredients: hypromellose; magnesium stearate; carmellose sodium - treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. diabex xr 500, diabex xr 750 or diabex xr 1000 may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.

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

sandoz pty ltd - metformin hydrochloride, quantity: 850 mg - tablet, film coated - excipient ingredients: sodium starch glycollate; titanium dioxide; magnesium stearate; maize starch; propylene glycol; hypromellose; purified talc; povidone; macrogol 6000; colloidal anhydrous silica - treatment of type 2 diabetes mellitus in adults, particularly in over weight patients, when dietary management and exercise alone, does not result in adequate glycaemic control. metformin may be used as initial treatment, or in sulphonylurea failures, either alone or in combination with a sulphonylurea and other oral agents or as adjuvant therapy in insulin dependent diabetes.

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

sandoz pty ltd - metformin hydrochloride, quantity: 500 mg - tablet, film coated - excipient ingredients: hypromellose; titanium dioxide; maize starch; povidone; colloidal anhydrous silica; magnesium stearate; sodium starch glycollate; propylene glycol; purified talc; macrogol 6000 - treatment of type 2 diabetes mellitus in adults, particularly in over weight patients, when dietary management and exercise alone, does not result in adequate glycaemic control. metformin may be used as initial treatment, or in sulphonylurea failures, either alone or in combination with a sulphonylurea and other oral agents or as adjuvant therapy in insulin dependent diabetes.