Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - topiramate, quantity: 100 mg - tablet, film coated - excipient ingredients: magnesium stearate; pregelatinised maize starch; sodium starch glycollate; microcrystalline cellulose; lactose monohydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - epilepsy: topiramate is indicated in adults and children 2 years and over: ? as monotherapy in patients with newly diagnosed epilepsy ? for conversion to monotherapy in patients with epilepsy ? as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine: topiramate is indicated for the prophylaxis of migraine headache in adults.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - topiramate, quantity: 50 mg - tablet, film coated - excipient ingredients: lactose monohydrate; pregelatinised maize starch; sodium starch glycollate; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; polysorbate 80; iron oxide yellow; macrogol 400 - epilepsy: topiramate is indicated in adults and children 2 years and over: ? as monotherapy in patients with newly diagnosed epilepsy ? for conversion to monotherapy in patients with epilepsy ? as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine: topiramate is indicated for the prophylaxis of migraine headache in adults.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

avallon pharmaceuticals pty ltd - topiramate, quantity: 25 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate; microcrystalline cellulose; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400 - epilepsy: topiramate is indicated in adults and children 2 years and over: ? as monotherapy in patients with newly diagnosed epilepsy ? for conversion to monotherapy in patients with epilepsy ? as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome.,migraine: topiramate is indicated for the prophylaxis of migraine headache in adults.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: sodium lauryl sulfate; lactose monohydrate; magnesium stearate; microcrystalline cellulose; crospovidone; hypromellose; croscarmellose sodium - adults (? 18 years) primary hypercholesterolaemia,akm ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),akm ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,akm ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; hypromellose; crospovidone; lactose monohydrate; magnesium stearate; croscarmellose sodium; sodium lauryl sulfate - adults (? 18 years) primary hypercholesterolaemia,akm ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),akm ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,akm ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),akm ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; hypromellose; lactose monohydrate; croscarmellose sodium; crospovidone; magnesium stearate - adults (? 18 years) primary hypercholesterolaemia,pharmacor ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),pharmacor ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,pharmacor ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

pharmacor pty ltd - ezetimibe, quantity: 10 mg - tablet - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; croscarmellose sodium; lactose monohydrate; crospovidone; hypromellose; magnesium stearate - adults (? 18 years) primary hypercholesterolaemia,pharmacor ezetimibe administered alone, or with an hmg-coa reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe, administered with a statin, is indicated for patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).,homozygous sitosterolaemia (phytosterolaemia),pharmacor ezetimibe is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.,prevention of cardiovascular disease,pharmacor ezetimibe, is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) in need of additional lowering of ldl-c in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy (see section 5.1 pharmacodynamic properties, clinical trials).,children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year postmenarche),heterozygous familial hypercholesterolaemia (hefh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated as an adjunctive therapy to diet in adolescent patients (10-17 years old) with heterozygous familial hypercholesterolaemia where use of a combination product is appropriate:,? patients not appropriately controlled with a statin or ezetimibe alone ? patients already treated with a statin and ezetimibe,homozygous familial hypercholesterolaemia (hofh),pharmacor ezetimibe co-administered with simvastatin (doses up to 40 mg) is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g. ldl apheresis)

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - linezolid, quantity: 600 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; hyprolose; magnesium stearate; maize starch; sodium starch glycollate type a; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000 - linezolid ca is indicated for the treatment of suspected or proven infections due to gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant staphylococcus species and vancomycin resistant enterococcus species.,linezolid ca is active against gram-positive bacteria only. ,linezolid ca has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram- negative pathogen is documented or suspected.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - linezolid, quantity: 600 mg - tablet, film coated - excipient ingredients: magnesium stearate; sodium starch glycollate type a; hyprolose; microcrystalline cellulose; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3000 - linezolid ca is indicated for the treatment of suspected or proven infections due to gram positive organisms resistant to multiple classes of antibiotics, including methicillin resistant staphylococcus species and vancomycin resistant enterococcus species.,linezolid ca is active against gram-positive bacteria only. ,linezolid ca has no clinical activity against gram-negative pathogens. specific gram-negative therapy is required if a concomitant gram- negative pathogen is documented or suspected.

Αυστραλία - Αγγλικά - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - bosentan monohydrate, quantity: 129.082 mg - tablet, film coated - excipient ingredients: maize starch; pregelatinised maize starch; sodium starch glycollate type a; povidone; glycerol dibehenate; magnesium stearate; hypromellose; titanium dioxide; triacetin; purified talc; iron oxide yellow; iron oxide red; ethylcellulose; cetyl alcohol; sodium lauryl sulfate - for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including eisenmenger?s physiology,in patients with who functional class ii, iii or iv symptoms