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

sun pharma anz pty ltd - esomeprazole magnesium, quantity: 20.7 mg (equivalent: esomeprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: hyprolose; sodium stearylfumarate; hypromellose phthalate; macrogol 6000; diethyl phthalate; crospovidone; macrogol 400; microcrystalline cellulose; povidone; macrogol 4000; purified talc; titanium dioxide; hypromellose; iron oxide red; maize starch; sucrose - gastro-oesophageal reflux disease (gord),- treatment of erosive reflux oesophagitis,- long-term management of patients with healed oesophagitis to prevent relapse,- symptomatic treatment of gastro-oesophageal reflux disease (gord),patients requiring nsaid therapy,- short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- healing of gastric ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy,- prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug nsaid (non-selective and cox-2 selective) therapy in patients at risk,prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution administered by intravenous infusion,pathological hypersecretory conditions including zollinger-ellison syndrome and idiopathic hypersecretion,in combination with appropriate antibiotics for:,- healing of duodenal ulcer associated with helicobacter pylori,- eradication of helicobacter pylori in patients with active or healed peptic ulcer

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 41.581 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium citrate dihydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, 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.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 20.79 mg - tablet, film coated - excipient ingredients: lactose monohydrate; sodium citrate dihydrate; magnesium stearate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, 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.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 5.198 mg - tablet, film coated - excipient ingredients: crospovidone; lactose monohydrate; microcrystalline cellulose; sodium citrate dihydrate; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, 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.

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

sun pharma anz pty ltd - rosuvastatin calcium, quantity: 10.395 mg - tablet, film coated - excipient ingredients: sodium citrate dihydrate; magnesium stearate; lactose monohydrate; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; iron oxide red; macrogol 400 - rosuvastatin should be used as an adjunct to diet when the response to diet and exercise is inadequate.,prevention of cardiovascular events,rosuvastatin is indicated for prevention of major cardiovascular events in men greater than or equal to 50 years old and women greater than or equal to 60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low hdl-c, smoking, or a family history of premature coronary heart disease). rosuvastatin is indicated to:,? reduce the risk of nonfatal myocardial infarction,? reduce the risk of nonfatal stroke,? reduce the risk of coronary artery revascularisation procedures.,in patients with hypercholesterolaemia,rosuvastatin is indicated for the treatment of hypercholesterolaemia (excluding heterozygous familial hypercholesterolaemia).,prior to initiating therapy with rosuvastatin, 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

douglas pharmaceuticals limited - cilastatin sodium 530.7mg equivalent to 500 mg cilastatin; imipenem monohydrate 530.1mg equivalent to 500 mg imipenem - powder for injection - 500mg/500mg - active: cilastatin sodium 530.7mg equivalent to 500 mg cilastatin imipenem monohydrate 530.1mg equivalent to 500 mg imipenem excipient: sodium bicarbonate - indicated for the treatment of the following infections due to susceptible organisms: · intra-abdominal infections · lower respiratory tract infections · gynaecological infections · septicaemia · genitourinary tract infections · bone and joint infections · skin and soft tissue infections · endocarditis indicated for the treatment of mixed infections caused by susceptible strains of aerobic and anaerobic bacteria. the majority of these mixed infections are associated with contamination by faecal flora or flora originating from the vagina, skin and mouth. in these mixed infections, bacteroides fragilis is the most commonly encountered anaerobic pathogen and is usually resistant to aminoglycosides, ephalosporins and penicillins. however, bacteroides fragilis is usually susceptible to imipenem and cilastatin combination. imipenem and cilastatin combination has demonstrated efficacy against many infections caused by aerobic and anaerobic gram-positive and gram-negative bacteria resistant to the cephalosporins, including cefazolin, cefoperazone, cephalothin, cefoxitin, cefotaxime, moxalactam, cefamandole, ceftazidime and ceftriaxone. similarly, many infections caused by organisms resistant to aminoglycosides (gentamicin, amikacin, tobramycin) and/or penicillins (ampicillin, carbenicillin, penicillin-g, ticarcillin, piperacillin, azlocillin, mezlocillin) responded to treatment imipenem and cilastatin. imipenem+cilastatin rbx is not indicated for the treatment of meningitis.

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

sun pharma anz pty ltd - bosentan monohydrate, quantity: 64.541 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; sodium starch glycollate type a; glycerol dibehenate; magnesium stearate; povidone; maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - bosentan is indicated 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

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

sun pharma anz pty ltd - bosentan monohydrate, quantity: 64.541 mg - tablet, film coated - excipient ingredients: pregelatinised maize starch; glycerol dibehenate; maize starch; sodium starch glycollate type a; magnesium stearate; povidone; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - bosentan is indicated 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

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

sun pharma anz pty ltd - bosentan monohydrate, quantity: 129.083 mg - tablet, film coated - excipient ingredients: sodium starch glycollate type a; glycerol dibehenate; povidone; maize starch; magnesium stearate; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - bosentan is indicated 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

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

sun pharma anz pty ltd - bosentan monohydrate, quantity: 129.083 mg - tablet, film coated - excipient ingredients: glycerol dibehenate; povidone; pregelatinised maize starch; magnesium stearate; sodium starch glycollate type a; maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; ethylcellulose - bosentan is indicated 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