Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - everolimus, quantity: 7.5 mg - tablet - excipient ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate - the treatment of: - postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin - advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection - patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - everolimus, quantity: 5 mg - tablet - excipient ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate - the treatment of: - postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin - advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection - patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - everolimus, quantity: 2.5 mg - tablet - excipient ingredients: butylated hydroxytoluene; hypromellose; lactose monohydrate; lactose; crospovidone; magnesium stearate - the treatment of: - postmenopausal women with hormone receptor-positive, her2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole and anastrozole - progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (nets) of pancreatic origin - advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib - subependymal giant cell astrocytoma (sega) associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection - patients with tuberous sclerosis complex (tsc) who have renal angiomyolipoma not requiring immediate surgery.

Spojené státy - angličtina - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus is indicated for the treatment of adult patients with advanced rcc after failure of treatment with sunitinib or sorafenib. everolimus is indicated for the treatment of adult patients with renal angiomyolipoma and tsc, not requiring immediate surgery. everolimus is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see warnings and precautions (5.3)] . risk summary based on animal studies and the mechanism of action [see clinical pharmacology (12.1)] , everolimus can cause fetal harm when administered to a pregnant woman. there are limited case reports of everolimus use in pregnant women; however, these reports are not sufficient to inform about risks of birth defects or miscarriage. in animal studies, everolimus caused embryo-fetal toxicities in rats when administered during the period of organogenesis at maternal exposures that were lower than human exposures at the recommended dose of everolimus 10 mg orally once daily [see data]. advise pregnant women of the potential risk to the fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage is 2% to 4% and 15% to 20% of clinically recognized pregnancies, respectively. data animal data: in animal reproductive studies, oral administration of everolimus to female rats before mating and through organogenesis induced embryo-fetal toxicities, including increased resorption, pre-implantation and post-implantation loss, decreased numbers of live fetuses, malformation (e.g., sternal cleft), and retarded skeletal development. these effects occurred in the absence of maternal toxicities. embryo-fetal toxicities in rats occurred at doses ≥0.1 mg/kg (0.6 mg/m2 ) with resulting exposures of approximately 4% of the human exposure at the recommended dose of everolimus 10 mg orally once daily based on area under the curve (auc). in rabbits, embryo-toxicity evident as an increase in resorptions occurred at an oral dose of 0.8 mg/kg (9.6 mg/m2 ). the effect in rabbits occurred in the presence of maternal toxicities. in a pre- and post-natal development study in rats, animals were dosed from implantation through lactation. at the dose of ≥0.1 mg/kg (0.6 mg/m2 ), there were no adverse effects on delivery and lactation or signs of maternal toxicity; however, there were reductions in body weight (up to 9% reduction from the control) and in survival of offspring (~5% died or missing). there were no drug-related effects on the developmental parameters (morphological development, motor activity, learning, or fertility assessment) in the offspring. risk summary there are no data on the presence of everolimus or its metabolites in human milk, the effects of everolimus on the breastfed infant or on milk production. everolimus and its metabolites passed into the milk of lactating rats at a concentration 3.5 times higher than in maternal serum. because of the potential for serious adverse reactions in breastfed infants from everolimus, advise women not to breastfeed during treatment with everolimus and for 2 weeks after the last dose. pregnancy testing verify the pregnancy status of females of reproductive potential prior to starting everolimus [see use in specific populations (8.1)] . contraception everolimus can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)] . females: advise female patients of reproductive potential to use effective contraception during treatment with everolimus and for 8 weeks after the last dose. males: advise male patients with female partners of reproductive potential to use effective contraception during treatment with everolimus and for 4 weeks after the last dose. infertility females: menstrual irregularities, secondary amenorrhea, and increases in luteinizing hormone (lh) and follicle stimulating hormone (fsh) occurred in female patients taking everolimus. based on these findings, everolimus may impair fertility in female patients [see adverse reactions (6.1) and nonclinical toxicology (13.1)] . males: cases of reversible azoospermia have been reported in male patients taking everolimus. in male rats, sperm motility, sperm count, plasma testosterone levels and fertility were diminished at auc similar to those of the clinical dose of everolimus 10 mg orally once daily. based on these findings, everolimus may impair fertility in male patients [see nonclinical toxicology (13.1)] . the safety and effectiveness of everolimus in pediatric patients have not been established in: in record-1, 41% of patients with renal cell carcinoma treated with everolimus were ≥ 65 years of age, while 7% were ≥ 75 years of age. no overall differences in safety or effectiveness were observed between elderly and younger patients. everolimus exposure may increase in patients with hepatic impairment [see clinical pharmacology (12.3)] . for patients with rcc and tsc-associated renal angiomyolipoma who have hepatic impairment, reduce the everolimus dose as recommended [see dosage and administration (2.10)] .

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

rowex ltd - everolimus - tablet - 10 milligram(s) - everolimus; protein kinase inhibitors; everolimus

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

rowex ltd - everolimus - tablet - 2.5 milligram(s) - everolimus; protein kinase inhibitors; everolimus

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

rowex ltd - everolimus - tablet - 5 milligram(s) - everolimus; protein kinase inhibitors; everolimus

Izrael - angličtina - Ministry of Health

taro international ltd, israel - everolimus - tablets - everolimus 10 mg - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus taro is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of everolimus taro in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- everolimus taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- everolimus taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Izrael - angličtina - Ministry of Health

taro international ltd, israel - everolimus - tablets - everolimus 2.5 mg - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus taro is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of everolimus taro in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- everolimus taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- everolimus taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

Izrael - angličtina - Ministry of Health

taro international ltd, israel - everolimus - tablets - everolimus 5 mg - everolimus - - for the treatment of patients with sega associated with tuberous sclerosis complex (tsc) who require therapeutic intervention but are not candidates for curative surgical resection. the effectiveness of everolimus taro is based on an analysis of change in sega volume. clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.- treatment of progressive neuroendocrine tumors of pancreatic origin (pnet) in patients with unresectable, locally advanced or metastatic disease.the safety and effectiveness of everolimus taro in the treatment of patients with carcinoid tumors have not been established.- for the treatment of hormone receptor – positive, her2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression follwing a non – steroidal aromatase inhibitor.- everolimus taro is indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (tsc), not requiring immediate surgery. the effectiveness of everolimus taro in treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. further follow-up of patients is required to determine long-term outcomes.- everolimus taro is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vegf-targeted therapy.- treatment of unresectable, locally advanced or metastatic, well-differentiated (grade 1 or grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.