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

arrotex pharmaceuticals pty ltd - risperidone, quantity: 1 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; colloidal anhydrous silica; magnesium stearate; hypromellose; maize starch; propylene glycol; purified talc; sodium lauryl sulfate - treatment of schizophrenia and related psychoses.,short term treatment of acute mania associated with bipolar 1 disorder (see dosage and administration: bipolar mania).,treatment of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe demetia of the alzheimer type). *(see dosage and administration: behavioural disturbances in dementia),risperidone is indicated for the treatment *(up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. *(see dosage and administration: behavioural disturbances in dementia),treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see clinical trials for maintenance data).,treatment of behavioural disorders associated with autism in children and adolescents (see clinical trials).

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

arrotex pharmaceuticals pty ltd - risperidone, quantity: 0.5 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; lactose monohydrate; hypromellose; iron oxide red; maize starch; propylene glycol; purified talc; sodium lauryl sulfate; titanium dioxide - treatment of schizophrenia and related psychoses.,short term treatment of acute mania associated with bipolar 1 disorder (see dosage and administration: bipolar mania).,treatment of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe demetia of the alzheimer type). *(see dosage and administration: behavioural disturbances in dementia),risperidone is indicated for the treatment *(up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. *(see dosage and administration: behavioural disturbances in dementia),treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see clinical trials for maintenance data).,treatment of behavioural disorders associated with autism in children and adolescents (see clinical trials).

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

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: lactose monohydrate; citric acid; magnesium stearate; iron oxide yellow; propyl gallate; hypromellose; iron oxide red; butylated hydroxyanisole; microcrystalline cellulose; croscarmellose sodium; iron oxide black; ascorbic acid - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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 clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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) apo-ezetimibe/simvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) apo-ezetimibe/simvastatin is indicated as 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: lactose monohydrate; butylated hydroxyanisole; hypromellose; iron oxide black; microcrystalline cellulose; propyl gallate; ascorbic acid; iron oxide yellow; croscarmellose sodium; citric acid; magnesium stearate; iron oxide red - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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 clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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) apo-ezetimibe/simvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) apo-ezetimibe/simvastatin is indicated as 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

arrotex pharmaceuticals pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: croscarmellose sodium; magnesium stearate; citric acid; hypromellose; lactose monohydrate; butylated hydroxyanisole; iron oxide yellow; microcrystalline cellulose; propyl gallate; ascorbic acid; iron oxide red; iron oxide black - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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 clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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) apo-ezetimibe/simvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) apo-ezetimibe/simvastatin is indicated as 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

arrotex pharmaceuticals pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 20 mg - tablet - excipient ingredients: lactose monohydrate; citric acid; propyl gallate; hypromellose; butylated hydroxyanisole; magnesium stearate; iron oxide black; croscarmellose sodium; iron oxide yellow; microcrystalline cellulose; ascorbic acid; iron oxide red - adults (?18 years),prevention of cardiovascular disease apo-ezetimibe/simvastatin is indicated in patients with coronary heart disease (chd) and a history of acute coronary syndrome (acs) taking their maximum tolerated dose of simvastatin and 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 clinical trials).,primary hypercholesterolaemia apo-ezetimibe/simvastatin is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia 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) apo-ezetimibe/simvastatin is indicated in patients with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis). children and adolescents 10-17 years (pubertal status: boys tanner stage ii and above and girls who are at least one year post- menarche),heterozygous familial hypercholesterolaemia (hefh) apo-ezetimibe/simvastatin is indicated as 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) apo-ezetimibe/simvastatin is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

organon pharma pty ltd - simvastatin, quantity: 20 mg - tablet, film coated - excipient ingredients: iron oxide yellow; ascorbic acid; hypromellose; hyprolose; citric acid monohydrate; pregelatinised maize starch; butylated hydroxyanisole; purified talc; iron oxide red; magnesium stearate; lactose monohydrate; titanium dioxide; microcrystalline cellulose - lipex is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with lipex, 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. lipex 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. lipex is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous

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

organon pharma pty ltd - simvastatin, quantity: 10 mg - tablet, film coated - excipient ingredients: iron oxide red; magnesium stearate; citric acid monohydrate; hypromellose; ascorbic acid; iron oxide yellow; hyprolose; lactose monohydrate; titanium dioxide; purified talc; pregelatinised maize starch; butylated hydroxyanisole; microcrystalline cellulose - lipex is indicated as an adjunct to diet for treatment of hypercholesterolaemia. prior to initiating therapy with lipex, 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. lipex 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. lipex is indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous

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

medtech products inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), dextromethorphan hydrobromide (unii: 9d2rti9kyh) (dextromethorphan - unii:7355x3rots), phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - pain reliever/fever reducer cough suppressant nasal decongestant - temporarily relieves common cold & flu symptoms: • nasal congestion • cough due to minor throat and bronchial irritation • fever • minor aches and pains • headache • sore throat • sinus congestion and pressure

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

medtech products inc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), caffeine (unii: 3g6a5w338e) (caffeine - unii:3g6a5w338e) - pain reliever/fever reducer pain reliever aid - temporary relieves minor aches and pains due to: ° headaches ° muscular aches ° minor arthritis pain ° colds - temporarily reduces fever