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

medis pharma pty ltd - simvastatin, quantity: 20 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: ascorbic acid; iron oxide black; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; hypromellose; lactose monohydrate; iron oxide yellow; iron oxide red; citric acid; butylated hydroxyanisole; propyl gallate - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-gx 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 ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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)

medis pharma pty ltd - simvastatin, quantity: 40 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: iron oxide red; lactose monohydrate; croscarmellose sodium; iron oxide yellow; hypromellose; magnesium stearate; citric acid; iron oxide black; microcrystalline cellulose; butylated hydroxyanisole; propyl gallate; ascorbic acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-gx 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 ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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)

medis pharma pty ltd - ezetimibe, quantity: 10 mg; simvastatin, quantity: 80 mg - tablet - excipient ingredients: magnesium stearate; hypromellose; iron oxide black; propyl gallate; croscarmellose sodium; iron oxide yellow; microcrystalline cellulose; lactose monohydrate; butylated hydroxyanisole; citric acid; iron oxide red; ascorbic acid - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-gx 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 ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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)

medis pharma pty ltd - simvastatin, quantity: 10 mg; ezetimibe, quantity: 10 mg - tablet - excipient ingredients: iron oxide yellow; lactose monohydrate; croscarmellose sodium; iron oxide black; iron oxide red; ascorbic acid; microcrystalline cellulose; magnesium stearate; citric acid; propyl gallate; hypromellose; butylated hydroxyanisole - adults (?18 years),prevention of cardiovascular disease ezetimibe/simvastatin-gx 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 ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx 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) ezetimibe/simvastatin-gx is indicated in adolescent patients (10-17 years old) with hofh. patients may also receive adjunctive treatments (e.g., ldl apheresis).

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

primary pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1) - carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see warnings; gastrointestinal bleeding, ulceration, and perforation ). diclofenac is indicated: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis - for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis diclofenac sodium delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product ( see warnings; anaphylactic reactions, serious skin reactions ). - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsa

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 53.3 mg (equivalent: lidocaine hydrochloride, qty 50 mg) - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride; sodium hydroxide - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 213.2 mg (equivalent: lidocaine hydrochloride, qty 200 mg) - injection, solution - excipient ingredients: water for injections; sodium chloride; hydrochloric acid; sodium hydroxide - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 21.32 mg (equivalent: lidocaine hydrochloride, qty 20 mg) - injection, solution - excipient ingredients: sodium hydroxide; sodium chloride; hydrochloric acid; water for injections - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 426.6 mg (equivalent: lidocaine hydrochloride, qty 400 mg) - injection, solution - excipient ingredients: sodium chloride; hydrochloric acid; water for injections; sodium hydroxide - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.

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

baxter healthcare pty ltd - lidocaine hydrochloride monohydrate, quantity: 106.65 mg (equivalent: lidocaine hydrochloride, qty 100 mg) - injection, solution - excipient ingredients: sodium chloride; sodium hydroxide; hydrochloric acid; water for injections - for production of local or regional anaesthesia by nerve block, infiltration injection, caudal or other epidural blocks. treatment or prophylaxis of life-threatening ventricular arrhythmias, including those associated with myocardial infarction, general anaesthesia in patients predisposed to ventricular arrhythmias, digitalis intoxication, or following resuscitation from cardiac arrest.