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

bayer australia ltd - finerenone, quantity: 20 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; purified water; purified talc; titanium dioxide; iron oxide yellow - kerendia is indicated to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with type 2 diabetes, in addition to standard of care (see section 5.1 pharmacodynamic properties, clinical trials).

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

bayer australia ltd - finerenone, quantity: 10 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; croscarmellose sodium; hypromellose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; purified water; purified talc; titanium dioxide; iron oxide red - kerendia is indicated to delay progressive decline of kidney function and to reduce the risk of cardiovascular mortality and morbidity in adults with chronic kidney disease (with albuminuria) associated with type 2 diabetes, in addition to standard of care (see section 5.1 pharmacodynamic properties, clinical trials).

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

gilead sciences pty ltd - tenofovir alafenamide fumarate, quantity: 11.2 mg; emtricitabine, quantity: 200 mg; elvitegravir, quantity: 150 mg; cobicistat, quantity: 150 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake - genvoya is indicated as a single tablet regimen for the treatment of hiv-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (hiv-1 rna <50 copies/ml) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 pharmacodynamic properties, clinical trials). patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of genvoya. genvoya is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide hiv-1 reverse transcriptase inhibitors.

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

alphapharm pty ltd - spironolactone, quantity: 100 mg - tablet, uncoated - excipient ingredients: sunset yellow fcf aluminium lake; maize starch; povidone; magnesium stearate; peppermint oil; sodium starch glycollate; purified talc; erythrosine aluminium lake; polysorbate 80; quinoline yellow aluminium lake; lactose monohydrate; microcrystalline cellulose - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate; hirsutism. essential hypertension. spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. spironolactone enhances the effectiveness of other antihypertensive agents such as beta-blockers, vasodilators, etc. congestive cardiac failure. when used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. unlike conventional diuretics, spironolactone does not produce hypokalaemia. when administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia induced by these diuretics. the prevention of potassium loss is particularly important in the treatment of digitalised patients, since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. hepatic cirrhosis with ascites and oedema. when used alone, spironolactone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. it provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics, thus avoiding possible precipitation of hepatic coma. nephrotic syndrome. although glucocorticoids, whose anti-inflammatory activity appears to benefit the primary pathological process in the renal glomerulus, should probably be employed first, spironolactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. primary hyperaldosteronism. spironolactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. spironolactone may also be used for the short-term preoperative treatment of patients with primary hyperaldosteronism, long-term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). hirsutism in females. spironolactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. a reduction in hair growth, hair shaft diameter and hair pigmentation is seen. use of spiractin should be considered only after all other alternatives of non-drug therapy have been explored. for women of childbearing age, see contraindications and use in pregnancy.

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

alphapharm pty ltd - spironolactone, quantity: 25 mg - tablet, uncoated - excipient ingredients: quinoline yellow aluminium lake; peppermint oil; purified talc; sodium starch glycollate; lactose monohydrate; povidone; microcrystalline cellulose; magnesium stearate; polysorbate 80; sunset yellow fcf aluminium lake; erythrosine aluminium lake; maize starch - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver and nephrotic syndrome; diagnosis and treatment of primary aldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate; hirsutism. essential hypertension. spironolactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. spironolactone improves the hypotensive action of thiazide diuretics, while at the same time reducing or preventing potassium loss due to the thiazide. spironolactone enhances the effectiveness of other antihypertensive agents such as beta-blockers, vasodilators, etc. congestive cardiac failure. when used alone, spironolactone is effective in the management of oedema and sodium retention associated with congestive cardiac failure. spironolactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. unlike conventional diuretics, spironolactone does not produce hypokalaemia. when administered with a thiazide or other conventional diuretics, spironolactone offsets hypokalaemia induced by these diuretics. the prevention of potassium loss is particularly important in the treatment of digitalised patients, since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. hepatic cirrhosis with ascites and oedema. when used alone, spironolactone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. it provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics, thus avoiding possible precipitation of hepatic coma. nephrotic syndrome. although glucocorticoids, whose anti-inflammatory activity appears to benefit the primary pathological process in the renal glomerulus, should probably be employed first, spironolactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. primary hyperaldosteronism. spironolactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. spironolactone may also be used for the short-term preoperative treatment of patients with primary hyperaldosteronism, long-term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and long-term maintenance therapy for patients with bilateral micro- or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). hirsutism in females. spironolactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. a reduction in hair growth, hair shaft diameter and hair pigmentation is seen. use of spiractin should be considered only after all other alternatives of non-drug therapy have been explored. for women of childbearing age, see contraindications and use in pregnancy.

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

pfizer australia pty ltd - spironolactone, quantity: 100 mg - tablet, film coated - excipient ingredients: macrogol 400; maize starch; hypromellose; calcium sulfate dihydrate; povidone; magnesium stearate; titanium dioxide; purified water; iron oxide yellow; iron oxide red; industrial methylated spirit; flavour - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver, nephrotic syndrome; diagnosis and treatment of primary hyperaldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate, hirsutism. essential hypertension: aldactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. aldactone improves the hypotensive action of thiazide diuretics while at the same time reducing or preventing potassium loss due to the thiazide. aldactone enhances the effectiveness of other antihypertensive agents such as beta blockers, vasodilators etc. congestive cardiac failure: aldactone, when used alone, is effective in the management of oedema and sodium retention associated with congestive cardiac failure. aldactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. unlike conventional diuretics aldactone does not produce hypokalaemia. when administered with a thiazide or other conventional diuretics aldactone offsets hypokalaemia induced by these diuretics. the prevention of potassium loss is particularly important in the treatment of digitalized patients since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. hepatic cirrhosis with ascites and oedema: aldactone when used alone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. aldactone provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics thus avoiding possible precipitation of hepatic coma. nephrotic syndrome : although glucocorticoids, whose anti inflammatory activity appears to benefit the primary pathologic process in the renal glomerulus, should probably be employed first, aldactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. primary hyperaldosteronism: aldactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. aldactone may also be used for the short term pre operative treatment of patients with primary hyperaldosteronism, long term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and the long term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). hirsutism in females: aldactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. a reduction in hair growth, hair shaft diameter and hair pigmentation is seen. use of aldactone should be considered only after all other alternatives of non drug therapy have been explored. for women of child bearing age, see contraindications and precautions, use in pregnancy.

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

pfizer australia pty ltd - spironolactone, quantity: 25 mg - tablet, film coated - excipient ingredients: macrogol 400; hypromellose; maize starch; calcium sulfate dihydrate; magnesium stearate; povidone; flavour; titanium dioxide; purified water; iron oxide yellow; iron oxide red; industrial methylated spirit - essential hypertension; oedematous disorders such as oedema and ascites of congestive cardiac failure, cirrhosis of the liver, nephrotic syndrome; diagnosis and treatment of primary hyperaldosteronism; as adjunctive therapy in malignant hypertension; in diuretic induced hypokalaemia when other measures are considered inappropriate or inadequate; prophylaxis of hypokalaemia in patients taking digitalis when other measures are considered inadequate or inappropriate, hirsutism. essential hypertension: aldactone, when used alone, is effective in lowering both systolic and diastolic blood pressure. aldactone improves the hypotensive action of thiazide diuretics while at the same time reducing or preventing potassium loss due to the thiazide. aldactone enhances the effectiveness of other antihypertensive agents such as beta blockers, vasodilators etc. congestive cardiac failure: aldactone, when used alone, is effective in the management of oedema and sodium retention associated with congestive cardiac failure. aldactone may be used in combination with a thiazide or other conventional diuretics for achieving diuresis in patients whose oedema is resistant to a thiazide or other conventional diuretics. unlike conventional diuretics aldactone does not produce hypokalaemia. when administered with a thiazide or other conventional diuretics aldactone offsets hypokalaemia induced by these diuretics. the prevention of potassium loss is particularly important in the treatment of digitalized patients since digitalis intoxication may be precipitated if hypokalaemia is induced by conventional diuretic therapy. hepatic cirrhosis with ascites and oedema: aldactone when used alone is frequently adequate for the relief of ascites and oedema associated with hepatic cirrhosis. aldactone provides a mild and even diuresis and prevents excessive potassium excretion caused by thiazide diuretics thus avoiding possible precipitation of hepatic coma. nephrotic syndrome : although glucocorticoids, whose anti inflammatory activity appears to benefit the primary pathologic process in the renal glomerulus, should probably be employed first, aldactone either alone or in combination with a conventional diuretic is useful for inducing diuresis. primary hyperaldosteronism: aldactone may be used to establish the diagnosis of primary hyperaldosteronism by therapeutic trial. aldactone may also be used for the short term pre operative treatment of patients with primary hyperaldosteronism, long term maintenance therapy for patients with discrete aldosterone producing adrenal adenomas who are judged to be poor operative risks (or who decline surgery), and the long term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). hirsutism in females: aldactone is effective in the treatment of females with hirsutism, an androgen related increase in facial and body hair. a reduction in hair growth, hair shaft diameter and hair pigmentation is seen. use of aldactone should be considered only after all other alternatives of non drug therapy have been explored. for women of child bearing age, see contraindications and precautions, use in pregnancy.

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

ms health pty ltd - misoprostol, quantity: 200 microgram - tablet - excipient ingredients: hypromellose; microcrystalline cellulose; sodium starch glycollate; hydrogenated castor oil - gymiso is indicated in females of childbearing age for the medical termination of a developing intrauterine pregnancy in sequential combination with a mifepristone 200 mg tablet, up to 49 days of gestation.

Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - (blue tablet) estradiol hemihydrate 2.07mg equivalent to; (red tablet) estradiol hemihydrate 1.03mg equivalent to; (white tablet) estradiol as hemihydrate 2.07mg equivalent to; (white tablet) norethisterone acetate - tablet, film coated - 2 mg - (blue tablet) estradiol hemihydrate 2.07mg equivalent to 2 mg; (red tablet) estradiol hemihydrate 1.03mg equivalent to 1 mg; (white tablet) estradiol as hemihydrate 2.07mg equivalent to 2 mg; (white tablet) norethisterone acetate 1 mg

Ireland - English - HPRA (Health Products Regulatory Authority)

krka, d.d., novo mesto - milbemycin oxime; praziquantel - tablet - 12.5, 125.0 mg/tablet - milbemycin oxime, combinations - dogs - endectoparasiticides