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

csl behring australia pty ltd - normal immunoglobulin, quantity: 4 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 2 g - injection, solution - excipient ingredients: polysorbate 80; proline; water for injections - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

csl behring australia pty ltd - normal immunoglobulin, quantity: 1 g - injection, solution - excipient ingredients: water for injections; proline; polysorbate 80 - replacement therapy in adults and children in: - primary immunodeficiency disease (pid) and - symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. immunomodulatory therapy in: - chronic inflammatory demyelinating polyneuropathy (cidp) as maintenance therapy after stabilisation with ivig.

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

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; monobasic sodium phosphate dihydrate; water for injections; sodium chloride; sodium hydroxide; citric acid monohydrate; sodium citrate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80 - rheumatoid arthritis idacio is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties-clinical trials).,psoriasis in adults and children idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: sodium chloride; sodium citrate dihydrate; sodium hydroxide; water for injections; citric acid monohydrate; polysorbate 80; mannitol; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate - rheumatoid arthritis idacio is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties-clinical trials).,psoriasis in adults and children idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

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

fresenius kabi australia pty ltd - adalimumab, quantity: 40 mg - injection, solution - excipient ingredients: mannitol; citric acid monohydrate; sodium citrate dihydrate; sodium hydroxide; sodium chloride; water for injections; monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; polysorbate 80 - rheumatoid arthritis idacio is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis. this includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.,idacio can be used alone or in combination with methotrexate.,juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis idacio in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). idacio can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.,enthesitis-related arthritis idacio is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.,psoriatic arthritis idacio is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous dmards has been inadequate.,ankylosing spondylitis idacio is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.,crohn?s disease in adults and children (? 6 years) idacio is indicated for the treatment of moderate to severe crohn?s disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;,? who have had an inadequate response to conventional therapies or, ? who have lost response to or are intolerant to infliximab,ulcerative colitis idacio is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 pharmacodynamic properties-clinical trials).,psoriasis in adults and children idacio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.,idacio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.,hidradenitis suppurativa in adults and adolescents (from 12 years of age) idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.,uveitis idacio is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

United States - English - NLM (National Library of Medicine)

allergan, inc. - carboxymethylcellulose sodium (unii: k679obs311) (carboxymethylcellulose - unii:05jzi7b19x), glycerin (unii: pdc6a3c0ox) (glycerin - unii:pdc6a3c0ox), polysorbate 80 (unii: 6ozp39zg8h) (polysorbate 80 - unii:6ozp39zg8h) - eye lubricant eye lubricant eye lubricant - for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. - may be used as a protectant against further irritation.

United States - English - NLM (National Library of Medicine)

allergan, inc. - carboxymethylcellulose sodium (unii: k679obs311) (carboxymethylcellulose - unii:05jzi7b19x), glycerin (unii: pdc6a3c0ox) (glycerin - unii:pdc6a3c0ox), polysorbate 80 (unii: 6ozp39zg8h) (polysorbate 80 - unii:6ozp39zg8h) - eye lubricant eye lubricant eye lubricant - for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. - may be used as a protectant against further irritation.

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.