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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 86.76 mg (equivalent: atorvastatin, qty 80 mg) - tablet, film coated - excipient ingredients: magnesium stearate; lactose monohydrate; calcium carbonate; hyprolose; microcrystalline cellulose; polysorbate 80; croscarmellose sodium; titanium dioxide; macrogol 8000; hypromellose; purified talc; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 43.38 mg (equivalent: atorvastatin, qty 40 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; lactose monohydrate; polysorbate 80; croscarmellose sodium; magnesium stearate; hyprolose; candelilla wax; calcium carbonate; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 21.69 mg (equivalent: atorvastatin, qty 20 mg) - tablet, film coated - excipient ingredients: candelilla wax; lactose monohydrate; croscarmellose sodium; polysorbate 80; hyprolose; magnesium stearate; calcium carbonate; microcrystalline cellulose; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

arrotex pharmaceuticals pty ltd - atorvastatin calcium trihydrate, quantity: 10.845 mg (equivalent: atorvastatin, qty 10 mg) - tablet, film coated - excipient ingredients: candelilla wax; croscarmellose sodium; magnesium stearate; hyprolose; lactose monohydrate; microcrystalline cellulose; calcium carbonate; polysorbate 80; purified water; sodium chloride; dimeticone 100; benzoic acid; sorbic acid; methylcellulose; polysorbate 65; glyceryl distearate; silicon dioxide; dimeticonol; peg-4 stearate; titanium dioxide; macrogol 8000; hypromellose; purified talc - as an adjunct to diet for the treatment of patients with hypercholesterolaemia. prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy and alcoholism) should be identified and treated.,indicated in hypertensive patients with multiple risk factors for coronary heart disease (chd), which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic chd (see clinical trials, prevention of cardiovascular disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke. these effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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

hope pharmaceuticals pty ltd - sodium nitrite, quantity: 300 mg - solution - excipient ingredients: water for injections - sodium nitrite injection is indicated as an antidote in the treatment of cyanide poisoning, in conjunction with sodium thiosulfate.

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

juno pharmaceuticals pty ltd - amiodarone hydrochloride, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 80; water for injections; benzyl alcohol; hydrochloric acid; sodium hydroxide - severe cases of tachyarrhythmias (eg. wolff-parkinson-white syndrome, supraventricular, nodal and ventricular tachyardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. treatment should be initiated in hospital. it is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest x-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.,amiodarone hhh injection may be used for treatment initiated in a hospital for severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy and when a rapid response is required. amiodarone hhh injection should only be used where facilities exist for cardiac monitoring and defibrillation should the need arise.

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

juno pharmaceuticals pty ltd - amiodarone hydrochloride, quantity: 150 mg - injection, solution - excipient ingredients: polysorbate 80; benzyl alcohol; water for injections; hydrochloric acid; sodium hydroxide - severe cases of tachyarrhythmias (eg. wolff-parkinson-white syndrome, supraventricular, nodal and ventricular tachyardias, atrial flutter and fibrillation, ventricular fibrillation) not responding to other therapy. treatment should be initiated in hospital. it is recommended that the patient should be regularly monitored for possible toxicity (eg. thyroid function, chest x-ray, ophthalmological examination, liver function etc.) during the entire course of therapy and for several months after discontinuation.,amiodarone gh injection may be used for treatment initiated in a hospital for severe cases of tachyarrhythmias (atrial, junctional and ventricular) not responding to other therapy and when a rapid response is required. amiodarone gh injection should only be used where facilities exist for cardiac monitoring and defibrillation should the need arise.

Stati Uniti - inglese - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 1.667 mg in 1 ml - sandostatin lar depot 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with sandostatin injection has been shown to be effective and tolerated. long-term maintenance therapy in acromegalic patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy, is not an option. the goal of treatment in acromegaly is to reduce gh and igf-1 levels to normal [see clinical studies (14), dosage and administration (2)] . long-term treatment of the severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. long-term treatment of the profuse watery diarrhea associated with vip-secreting tumors. in patients with carcinoid syndrome and vipomas, the effect of sandostatin injection and sandostatin lar depot on tumor size, rate of growth and development of metastases, has not been determined. none. risk summary the limited data with sandostatin lar depot in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, no adverse developmental effects were observed with intravenous administration of octreotide to pregnant rats and rabbits during organogenesis at doses 7- and 13-times, respectively the maximum recommended human dose (mrhd) of 1.5 mg/day based on body surface area (bsa). transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at intravenous doses below the mrhd based on bsa (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of octreotide up to 1 mg/kg/day during the period of organogenesis. a slight reduction in body weight gain was noted in pregnant rats at 0.1 and 1 mg/kg/day. there were no maternal effects in rabbits or embryo-fetal effects in either species up to the maximum dose tested. at 1 mg/kg/day in rats and rabbits, the dose multiple was approximately 7- and 13-times, respectively, at the highest recommended human dose of 1.5 mg/day based on bsa. in a pre- and post-natal development rat study at intravenous doses of 0.02-1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of growth hormone inhibition by octreotide. the doses attributed to the delayed growth are below the human dose of 1.5 mg/day, based on bsa. risk summary there is no information available on the presence of sandostatin lar depot in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. studies show that octreotide administered subcutaneously passes into the milk of lactating rats; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sandostatin lar depot, and any potential adverse effects on the breastfed child from sandostatin lar depot or from the underlying maternal condition. data following a subcutaneous dose (1 mg/kg) of octreotide to lactating rats, transfer of octreotide into milk was observed at a low concentration compared to plasma (milk/plasma ratio of 0.009). discuss the potential for unintended pregnancy with premenopausal women as the therapeutic benefits of a reduction in gh levels and normalization of insulin-like growth factor 1 (igf-1) concentration in acromegalic females treated with octreotide may lead to improved fertility. safety and efficacy of sandostatin lar depot in the pediatric population have not been demonstrated. no formal controlled clinical trials have been performed to evaluate the safety and effectiveness of sandostatin lar depot in pediatric patients under 6 years of age. in postmarketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with sandostatin use in children, most notably in children under 2 years of age. the relationship of these events to octreotide acetate has not been established as the majority of these pediatric patients had serious underlying comorbid conditions. the efficacy and safety of sandostatin lar depot was examined in a single randomized, double-blind, placebo-controlled, 6-month pharmacokinetics study in 60 pediatric patients age 6 to 17 years with hypothalamic obesity resulting from cranial insult. the mean octreotide concentration after 6 doses of 40 mg sandostatin lar depot administered by im injection every four weeks was approximately 3 ng/ml. steady-state concentrations were achieved after 3 injections of a 40-mg dose. mean bmi increased 0.1 kg/m2 in sandostatin lar depot-treated subjects compared to 0.0 kg/m2 in saline control-treated subjects. efficacy was not demonstrated. diarrhea occurred in 11 of 30 (37%) patients treated with sandostatin lar depot. no unexpected adverse events were observed. however, with sandostatin lar depot 40 mg once a month, the incidence of new cholelithiasis in this pediatric population (33%) was higher than that seen in other adult indications, such as acromegaly (22%) or malignant carcinoid syndrome (24%), where sandostatin lar depot was dosed at 10 mg to 30 mg once a month. clinical studies of sandostatin did not include sufficient numbers of subjects age 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with renal failure requiring dialysis, the starting dose should be 10 mg. this dose should be up titrated based on clinical response and speed of response as deemed necessary by the physician. in patients with mild, moderate, or severe renal impairment there is no need to adjust the starting dose of sandostatin. the maintenance dose should be adjusted thereafter based on clinical response and tolerability as in nonrenal patients [see clinical pharmacology (12)] . in patients with established liver cirrhosis, the starting dose should be 10 mg. this dose should be up titrated based on clinical response and speed of response as deemed necessary by the physician. once at a higher dose, patient should be maintained or dose adjusted based on response and tolerability as in any noncirrhotic patients [see clinical pharmacology (12)] .

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

novartis pharmaceuticals australia pty ltd - valsartan, quantity: 320 mg - tablet, film coated - excipient ingredients: crospovidone; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; titanium dioxide; macrogol 8000; hypromellose; iron oxide yellow; iron oxide red; iron oxide black - treatment of hypertension. treatment of heart failure (nyha class ii-iv) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ace inhibitors. to improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see "clinical trials").

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

arrotex pharmaceuticals pty ltd - enalapril maleate, quantity: 5 mg - tablet, uncoated - excipient ingredients: sodium bicarbonate; lactose monohydrate; pregelatinised maize starch; maize starch; magnesium stearate - hypertension. all grades of essential hypertension; renovascular hypertension. congestive heart failure. treatment of all degrees of symptomatic heart failure. in such patients it is recommended that enalapril be administered together with a diuretic. left ventricular dysfunction. all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence of severity of obvious symptoms of heart failure.