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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 100 microgram/ml - injection, solution - excipient ingredients: water for injections; mannitol; sodium bicarbonate; lactic acid - for symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy or dopamine agonist treatment. sandostatin treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: carcinoid tumours with features of the carcinoid syndrome; vasoactive intestinal peptide secreting tumours (vipomas). sandostatin is not curative in these patients. for reduction of the incidence of complications following pancreatic surgery.

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 50 microgram/ml - injection, solution - excipient ingredients: water for injections; mannitol; lactic acid; sodium bicarbonate - for symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy or dopamine agonist treatment. sandostatin treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: carcinoid tumours with features of the carcinoid syndrome; vasoactive intestinal peptide secreting tumours (vipomas). sandostatin is not curative in these patients. for reduction of the incidence of complications following pancreatic surgery.

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 500 microgram/ml - injection, solution - excipient ingredients: lactic acid; mannitol; sodium bicarbonate; water for injections - for symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy or dopamine agonist treatment. sandostatin treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: carcinoid tumours with features of the carcinoid syndrome; vasoactive intestinal peptide secreting tumours (vipomas). sandostatin is not curative in these patients. for reduction of the incidence of complications following pancreatic surgery.

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 30 mg - injection, modified release - excipient ingredients: polyglactin glucose; mannitol - acromegaly: for the symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment, but who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,gastro-entero-pancreatic tumours: for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome; - vasoactive intestinal peptide secreting tumours (vipomas) in patients who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is not curative in these patients.,advanced neuroendocrine tumours of the midgut: treatment of patients with progression of well-differentiated, advanced neuroendocri

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 20 mg - injection, modified release - excipient ingredients: mannitol; polyglactin glucose - acromegaly: for the symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment, but who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,gastro-entero-pancreatic tumours: for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome; - vasoactive intestinal peptide secreting tumours (vipomas) in patients who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is not curative in these patients.,advanced neuroendocrine tumours of the midgut: treatment of patients with progression of well-differentiated, advanced neuroendocrin

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

novartis pharmaceuticals australia pty ltd - octreotide, quantity: 10 mg - injection, modified release - excipient ingredients: mannitol; polyglactin glucose - acromegaly: for the symptomatic control and reduction of growth hormone and igf-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment, but who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.,gastro-entero-pancreatic tumours: for the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system: - carcinoid tumours with features of the carcinoid syndrome; - vasoactive intestinal peptide secreting tumours (vipomas) in patients who are adequately controlled on subcutaneous treatment with sandostatin. sandostatin lar is not curative in these patients.,advanced neuroendocrine tumours of the midgut: treatment of patients with progression of well-differentiated, advanced neuroendocri

United States - English - 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)] .

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

novartis pharmaceuticals corporation - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - sandostatin injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. sandostatin injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. sandostatin injection is indicated for the treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors (vipomas)-secreting tumors. improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials performed with sandostatin injection; these trials were not optimally designed to detect such effects. sensitivity to this drug or any of its components. risk summary the limited data with sandostatin injection in pregnant women are insufficient to inform a drug-associated risk for

Israel - English - Ministry of Health

novartis israel ltd - octreotide - solution for injection / infusion - octreotide 0.1 mg/ml - octreotide - octreotide - prevention of complications following pancreatic surgery. symptomatic control and reduction of gh and igf-1plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery or in the interim period until radiotherapy becomes fully effective. relief of symptoms associated with functional gastroenteropancreatic endocrine tumours: - carcinoid tumours with features of the carcinoid syndrome - vipomas - glucagonomas - gastrinomas / zollinger-ellison syndrome usually in conjunction with proton pump inhibitors or h2- antagonist therapy - insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy - grfomas. sandostatin is not an antitumour therapy and is not curative in these patients.emergency management of bleeding gastro-oesophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.

Israel - English - Ministry of Health

novartis israel ltd - octreotide - solution for injection / infusion - octreotide 0.05 mg/ml - octreotide - octreotide - prevention of complications following pancreatic surgery. symptomatic control and reduction of gh and igf-1plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy. sandostatin treatment is also indicated for acromegalic patients unfit or unwilling to undergo surgery or in the interim period until radiotherapy becomes fully effective. relief of symptoms associated with functional gastroenteropancreatic endocrine tumours: - carcinoid tumours with features of the carcinoid syndrome - vipomas - glucagonomas - gastrinomas / zollinger-ellison syndrome usually in conjunction with proton pump inhibitors or h2- antagonist therapy - insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy - grfomas. sandostatin is not an antitumour therapy and is not curative in these patients.emergency management of bleeding gastro-oesophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.