Canada - English - Health Canada

mont-pharma inc - octreotide (octreotide acetate) - solution - 200mcg - octreotide (octreotide acetate) 200mcg

Canada - English - Health Canada

mont-pharma inc - octreotide (octreotide acetate) - solution - 500mcg - octreotide (octreotide acetate) 500mcg

Canada - English - Health Canada

mont-pharma inc - octreotide (octreotide acetate) - solution - 50mcg - octreotide (octreotide acetate) 50mcg

Canada - English - Health Canada

mont-pharma inc - octreotide (octreotide acetate) - solution - 100mcg - octreotide (octreotide acetate) 100mcg

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

gland pharma limited - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide acetate 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. octreotide acetate injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. octreotide acetate 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 octreotide acetate 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 octreotide acetate injection 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 iv 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 iv 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   human data   in postmarketing data, a limited number of exposed pregnancies have been reported in patients with acromegaly. most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100 to 300 mcg/day of octreotide acetate injection or 20 mg to 30 mg once a month of octreotide acetate for injectable suspension, however some women elected to continue octreotide therapy throughout pregnancy. in cases with a known outcome, no congenital malformations were reported.  animal data   in embryo-fetal development studies in rats and rabbits, pregnant animals received iv 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 iv doses of 0.02 to 1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of gh 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 octreotide acetate injection 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 octreotide acetate injection, and any potential adverse effects on the breastfed child from octreotide acetate injection 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 octreotide acetate injection in the pediatric population have not been demonstrated. no formal controlled clinical trials have been performed to evaluate the safety and effectiveness of octreotide acetate injection in pediatric patients under age 6 years. in postmarketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with octreotide acetate injection use in children, most notably in children under 2 years of age. the relationship of these events to octreotide has not been established as the majority of these pediatric patients had serious underlying co-morbid conditions. the efficacy and safety of octreotide acetate injection using the octreotide acetate for injectable suspension formulation 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 octreotide acetate for injectable suspension administered by intramuscular (im) injection every 4 weeks was approximately 3 ng/ml. steady-state concentrations was achieved after 3 injections of a 40-mg dose. mean body mass index (bmi) increased 0.1 kg/m2 in octreotide acetate for injectable suspension-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 octreotide acetate for injectable suspension. no unexpected adverse events were observed. however, with octreotide acetate for injectable suspension at 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 octreotide acetate for injectable suspension was 10 mg to 30 mg once a month. clinical studies of octreotide acetate injection did not include sufficient numbers of subjects aged 65 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 severe renal failure requiring dialysis, the half-life of octreotide acetate may be increased, necessitating adjustment of the maintenance dosage. [see clinical pharmacology (12.3)] in patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage. [see clinical pharmacology (12.3)] .

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

gland pharma limited - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide acetate 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. octreotide acetate injection is indicated for treatment of severe diarrhea and flushing episodes associated with metastatic carcinoid tumors. octreotide acetate 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 octreotide acetate 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 octreotide acetate injection 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 iv 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 iv 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   human data in postmarketing data, a limited number of exposed pregnancies have been reported in patients with acromegaly. most women were exposed to octreotide during the first trimester of pregnancy at doses ranging from 100 to 300 mcg/day of octreotide acetate injection or 20 mg to 30 mg once a month of octreotide acetate for injectable suspension, however some women elected to continue octreotide therapy throughout pregnancy. in cases with a known outcome, no congenital malformations were reported.   animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received iv 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 iv doses of 0.02 to 1 mg/kg/day, a transient growth retardation of the offspring was observed at all doses which was possibly a consequence of gh 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 octreotide acetate injection 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 octreotide acetate injection, and any potential adverse effects on the breastfed child from octreotide acetate injection 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 octreotide acetate injection in the pediatric population have not been demonstrated. no formal controlled clinical trials have been performed to evaluate the safety and effectiveness of octreotide acetate injection in pediatric patients under age 6 years. in postmarketing reports, serious adverse events, including hypoxia, necrotizing enterocolitis, and death, have been reported with octreotide acetate injection use in children, most notably in children under 2 years of age. the relationship of these events to octreotide has not been established as the majority of these pediatric patients had serious underlying co-morbid conditions. the efficacy and safety of octreotide acetate injection using the octreotide acetate for injectable suspension formulation 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 octreotide acetate for injectable suspension administered by intramuscular (im) injection every 4 weeks was approximately 3 ng/ml. steady-state concentrations was achieved after 3 injections of a 40-mg dose. mean body mass index (bmi) increased 0.1 kg/m2 in octreotide acetate for injectable suspension-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 octreotide acetate for injectable suspension. no unexpected adverse events were observed. however, with octreotide acetate for injectable suspension at 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 octreotide acetate for injectable suspension was 10 mg to 30 mg once a month. clinical studies of octreotide acetate injection did not include sufficient numbers of subjects aged 65 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 severe renal failure requiring dialysis, the half-life of octreotide acetate may be increased, necessitating adjustment of the maintenance dosage. [see clinical pharmacology (12.3)] in patients with liver cirrhosis, the half-life of the drug may be increased, necessitating adjustment of the maintenance dosage. [see clinical pharmacology (12.3)] .

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - octreotide acetate - solution for injection - 50microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - octreotide acetate - solution for injection - 100microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - octreotide acetate - solution for injection - 500microgram/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sun pharmaceutical industries europe b.v. - octreotide acetate - solution for injection - 200microgram/1ml