오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - rivaroxaban, quantity: 2.5 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; hypromellose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - te-rivaroxaban is indicated for:,? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks).,? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe.,? in combination with aspirin, for the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - rivaroxaban, quantity: 15 mg - tablet, film coated - excipient ingredients: hypromellose; sodium lauryl sulfate; lactose monohydrate; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - te-rivaroxaban is indicated for:,? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks).,? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe.,? in combination with aspirin, for the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - rivaroxaban, quantity: 20 mg - tablet, film coated - excipient ingredients: magnesium stearate; hypromellose; sodium lauryl sulfate; lactose monohydrate; croscarmellose sodium; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350 - te-rivaroxaban is indicated for:,? prevention of venous thromboembolism (vte) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks).,? prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.,? treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe) and for the prevention of recurrent dvt and pe.,? in combination with aspirin, for the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (cad) and/or peripheral artery disease (pad).

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - sitagliptin malate, quantity: 66.46 mg (equivalent: sitagliptin, qty 50 mg) - tablet, film coated - excipient ingredients: magnesium stearate; calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - te-sitagliptin (sitagliptin malate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.]

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - sitagliptin malate, quantity: 33.23 mg (equivalent: sitagliptin, qty 25 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - te-sitagliptin (sitagliptin malate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.]

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - sitagliptin malate, quantity: 132.92 mg (equivalent: sitagliptin, qty 100 mg) - tablet, film coated - excipient ingredients: calcium hydrogen phosphate; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350 - te-sitagliptin (sitagliptin malate) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:,- monotherapy when metformin is considered inappropriate due to intolerance; or,- in combination with other anti-hyperglycaemic agents, including insulin,[see 5.1 pharmacodynamic properties, clinical trials, 4.5 interactions with other medicines and other forms of interactions for available data on different add-on combination therapies.]

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - fingolimod hydrochloride, quantity: 560 microgram (equivalent: fingolimod, qty 500 microgram) - capsule, hard - excipient ingredients: pregelatinised maize starch; iron oxide yellow; sodium lauryl sulfate; gelatin; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - te-fingolimod is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - abiraterone acetate, quantity: 500 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium lauryl sulfate; croscarmellose sodium; microcrystalline cellulose; povidone; magnesium stearate; colloidal anhydrous silica; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - te-abiraterone is indicated in combination with prednisolone for the treatment of:,? newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (adt), or,? patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mcrpc) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (adt) or,? patients with mcrpc who have received prior chemotherapy containing a taxane

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

wai shun pty ltd - polygonum aviculare, quantity: 26 mg; cinnamomum cassia, quantity: 56 mg (equivalent: coumarin, qty 6 microgram; equivalent: cassia oil, qty 16 microgram); glycyrrhiza uralensis, quantity: 19 mg; polyporus umbellatus, quantity: 26 mg; alpinia oxyphylla, quantity: 22 mg; cyathula officinalis, quantity: 84 mg; citrus reticulata, quantity: 124 mg (equivalent: oxedrine, qty 0 mg); pyrrosia sheareri, quantity: 23 mg; pinus massoniana, quantity: 39 mg; sinapis alba, quantity: 26 mg (equivalent: allyl isothiocyanate, qty 13 microgram); plantago asiatica, quantity: 55 mg - capsule, hard - excipient ingredients: gelatin - helps reduce occurrence of medically diagnosed cystitis ; helps decrease/reduce/relieve burning sensation/irritation upon urination associated with medically diagnosed cystitis

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - lenalidomide hydrochloride monohydrate, quantity: 12.1 mg - capsule - excipient ingredients: titanium dioxide; microcrystalline cellulose; iron oxide yellow; gelatin; indigo blue; croscarmellose sodium; purified talc; colloidal anhydrous silica; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - multiple myeloma (mm),te-lenalidomide is indicated for the treatment of multiple myeloma.,myelodysplastic syndromes (mds),te-lenalidomide is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.