Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - simvastatin, quantity: 80.1 mg - tablet - excipient ingredients: lactose monohydrate; magnesium stearate; citric acid; pregelatinised maize starch; microcrystalline cellulose; butylated hydroxyanisole; ascorbic acid; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - simvastatin, quantity: 20 mg - tablet - excipient ingredients: microcrystalline cellulose; butylated hydroxyanisole; pregelatinised maize starch; lactose monohydrate; ascorbic acid; citric acid; magnesium stearate; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - simvastatin, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; citric acid; ascorbic acid; butylated hydroxyanisole; pregelatinised maize starch; titanium dioxide; hypromellose; hyprolose; iron oxide yellow; iron oxide red; iron oxide black - simvastatin-drla is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with simvastatin-drla, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated. simvastatin-drla is indicated in patients at high risk of chd (with or without hypercholesterolaemia), including patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing chd to reduce the risk of cardiovascular death, major cardiovascular events including stroke, and hospitalisation due to angina pectoris. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking. simvastatin-drla is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-mena

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - pregabalin, quantity: 25 mg - capsule, hard - excipient ingredients: purified talc; titanium dioxide; sodium lauryl sulfate; lactose monohydrate; gelatin; purified water; maize starch - pregabalin-drla (pregabalin) is indicated for the treatment of neuropathic pain in adults.,pregabalin-drla (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - pregabalin, quantity: 75 mg - capsule, hard - excipient ingredients: iron oxide red; gelatin; lactose monohydrate; titanium dioxide; maize starch; sodium lauryl sulfate; purified water; purified talc - pregabalin-drla (pregabalin) is indicated for the treatment of neuropathic pain in adults.,pregabalin-drla (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - pregabalin, quantity: 300 mg - capsule, hard - excipient ingredients: iron oxide red; purified talc; gelatin; lactose monohydrate; sodium lauryl sulfate; maize starch; titanium dioxide; purified water - pregabalin-drla (pregabalin) is indicated for the treatment of neuropathic pain in adults.,pregabalin-drla (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - pregabalin, quantity: 150 mg - capsule, hard - excipient ingredients: gelatin; sodium lauryl sulfate; maize starch; lactose monohydrate; titanium dioxide; purified water; purified talc - pregabalin-drla (pregabalin) is indicated for the treatment of neuropathic pain in adults.,pregabalin-drla (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 119.47 mg (equivalent: imatinib, qty 100 mg) - capsule, hard - excipient ingredients: crospovidone; sodium stearylfumarate; gelatin; titanium dioxide; purified water; iron oxide yellow; sodium lauryl sulfate; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 59.735 mg (equivalent: imatinib, qty 50 mg) - capsule, hard - excipient ingredients: sodium stearylfumarate; gelatin; sodium lauryl sulfate; titanium dioxide; purified water; iron oxide yellow; crospovidone; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; iron oxide red; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)

Australien - engelska - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - imatinib mesilate, quantity: 477.88 mg - capsule, hard - excipient ingredients: crospovidone; purified water; titanium dioxide; sodium stearylfumarate; sodium lauryl sulfate; gelatin; iron oxide yellow; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; shellac; ethanol absolute; ammonia - indicated for the: ,? treatment of patients with chronic myeloid leukaemia (cml) ,? treatment of adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy,? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ,? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ,? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ,? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ,? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp). ? treatment of patients with kit (cd117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist) ? adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of kit (cd117)-positive primary gist (see dosage and administration and clinical trials)