Sveits - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - bevacizumabum - solution à diluer pour perfusion - bevacizumabum 100 mg, trehalosum dihydricum, natrii dihydrogenophosphas monohydricus, dinatrii phosphas, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 4 ml corresp. natrium 5.44 mg. - onkologikum - biotechnologika

Sveits - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - bevacizumabum - solution à diluer pour perfusion - bevacizumabum 400 mg, trehalosum dihydricum, natrii dihydrogenophosphas monohydricus, dinatrii phosphas, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 16 ml corresp. natrium 21.76 mg. - onkologikum - biotechnologika

Sveits - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - bevacizumabum - konzentrat zur herstellung einer infusionslösung - bevacizumabum 100 mg, trehalosum dihydricum, natrii dihydrogenophosphas monohydricus, dinatrii phosphas, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 4 ml corresp. natrium 5.44 mg. - onkologikum - biotechnologika

Sveits - tysk - Swissmedic (Swiss Agency for Therapeutic Products)

teva pharma ag - bevacizumabum - konzentrat zur herstellung einer infusionslösung - bevacizumabum 400 mg, trehalosum dihydricum, natrii dihydrogenophosphas monohydricus, dinatrii phosphas, polysorbatum 20, aqua ad iniectabile q.s. ad solutionem pro 16 ml corresp. natrium 21.76 mg. - onkologikum - biotechnologika

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

roche products pty ltd - bevacizumab, quantity: 400 mg - injection, concentrated - excipient ingredients: water for injections; monobasic sodium phosphate monohydrate; trehalose dihydrate; polysorbate 20; dibasic sodium phosphate heptahydrate - ? metastatic colorectai cancer avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. ? locally recurrent or metastatic breast cancer avastin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated.(see clinical trials). ? advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) avastin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous non-small cell lung cancer. ? advanced and/or metastatic renai cell cancer avastin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer ? grade iv glioma avastin (bevacizumab) as a single agent, is indicated for t

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

roche products pty ltd - bevacizumab, quantity: 100 mg - injection, concentrated - excipient ingredients: monobasic sodium phosphate monohydrate; water for injections; polysorbate 20; trehalose dihydrate; dibasic sodium phosphate heptahydrate - ? metastatic colorectai cancer avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer. ? locally recurrent or metastatic breast cancer avastin (bevacizumab) in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated.(see clinical trials). ? advanced, metastatic or recurrent non-squamous non-small cell lung cancer (nsclc) avastin (bevacizumab), in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous non-small cell lung cancer. ? advanced and/or metastatic renai cell cancer avastin (bevacizumab) in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer ? grade iv glioma avastin (bevacizumab) as a single agent, is indicated for t

USA - engelsk - NLM (National Library of Medicine)

amneal pharmaceuticals llc - bevacizumab (unii: 2s9zzm9q9v) (bevacizumab - unii:2s9zzm9q9v) - alymsys, in combination with intravenous fluorouracil-based chemotherapy, is indicated for the first-or second-line treatment of patients with metastatic colorectal cancer (mcrc). alymsys, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with mcrc who have progressed on a first-line bevacizumab product-containing regimen. limitations of use: alymsys is not indicated for adjuvant treatment of colon cancer [see clinical studies (14.2)] . alymsys, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer (nsclc). alymsys is indicated for the treatment of recurrent glioblastoma (gbm) in adults. alymsys, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma (mrcc). alymsys, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. alymsys, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. none. risk summary based on findings from animal studies and their mechanism of action [see clinical pharmacology (12.1)] , bevacizumab products may cause fetal harm in pregnant women. limited postmarketing reports describe cases of fetal malformations with use of bevacizumab products in pregnancy; however, these reports are insufficient to determine drug-associated risks. in animal reproduction studies, intravenous administration of bevacizumab to pregnant rabbits every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects (see data) . furthermore, animal models link angiogenesis and vegf and vegfr2 to critical aspects of female reproduction, embryofetal development, and postnatal development. advise pregnant women of the potential risk to a fetus. 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 pregnant rabbits dosed with 10 mg/kg to 100 mg/kg bevacizumab (approximately 1 to 10 times the clinical dose of 10 mg/kg) every three days during the period of organogenesis (gestation day 6 to 18) exhibited decreases in maternal and fetal body weights and increased number of fetal resorptions. there were dose-related increases in the number of litters containing fetuses with any type of malformation (42% for the 0 mg/kg dose, 76% for the 30 mg/kg dose, and 95% for the 100 mg/kg dose) or fetal alterations (9% for the 0 mg/kg dose, 15% for the 30 mg/kg dose, and 61% for the 100 mg/kg dose). skeletal deformities were observed at all dose levels, with some abnormalities including meningocele observed only at the 100 mg/kg dose level. teratogenic effects included: reduced or irregular ossification in the skull, jaw, spine, ribs, tibia and bones of the paws; fontanel, rib and hindlimb deformities; corneal opacity; and absent hindlimb phalanges. risk summary no data are available regarding the presence of bevacizumab products in human milk, the effects on the breast fed infant, or the effects on milk production. human igg is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. because of the potential for serious adverse reactions in breastfed infants from bevacizumab products, advise women not to breastfeed during treatment with alymsys and for 6 months after the last dose. contraception females bevacizumab products may cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise females of reproductive potential to use effective contraception during treatment with alymsys and for 6 months after the last dose. infertility females bevacizumab products increase the risk of ovarian failure and may impair fertility. inform females of reproductive potential of the risk of ovarian failure prior to the first-dose of alymsys. long-term effects of bevacizumab products on fertility are not known. in a clinical study of 179 premenopausal women randomized to receive chemotherapy with or without bevacizumab, the incidence of ovarian failure was higher in patients who received bevacizumab with chemotherapy (34%) compared to patients who received chemotherapy alone (2%). after discontinuing bevacizumab with chemotherapy, recovery of ovarian function occurred in 22% of these patients [see warnings and precautions (5.11), adverse reactions (6.1)] . the safety and effectiveness of bevacizumab products in pediatric patients have not been established. in published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years who received bevacizumab. bevacizumab products are not approved for use in patients under the age of 18 years. antitumor activity was not observed among eight pediatric patients with relapsed gbm who received bevacizumab and irinotecan. addition of bevacizumab to standard of care did not result in improved event-free survival in pediatric patients enrolled in two randomized clinical studies, one in high grade glioma (n= 121) and one in metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma (n= 154). based on the population pharmacokinetics analysis of data from 152 pediatric and young adult patients with cancer (7 months to 21 years of age), bevacizumab clearance normalized by body weight in pediatrics was comparable to that in adults. juvenile animal toxicity data juvenile cynomolgus monkeys with open growth plates exhibited physeal dysplasia following 4 to 26 weeks exposure at 0.4 to 20 times the recommended human dose (based on mg/kg and exposure). the incidence and severity of physeal dysplasia were dose-related and were partially reversible upon cessation of treatment. in an exploratory pooled analysis of 1,745 patients from five randomized, controlled studies, 35% of patients were ≥65 years old. the overall incidence of ate was increased in all patients receiving bevacizumab with chemotherapy as compared to those receiving chemotherapy alone, regardless of age; however, the increase in the incidence of ate was greater in patients ≥65 years (8% vs. 3%) as compared to patients <65 years (2% vs. 1%) [see warnings and precautions (5.4)] .

Japan - engelsk - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo company, limited - bevacizumab (genetical recombination) [bevacizumab biosimilar 2] - injection

Japan - engelsk - すりの適正使用協議会 RAD-AR Council, Japan

daiichi sankyo company, limited - bevacizumab (genetical recombination) [bevacizumab biosimilar 2] - injection

Japan - engelsk - すりの適正使用協議会 RAD-AR Council, Japan

nichi-iko pharmaceutical co.,ltd - bevacizumab(genetical recombination)[bevacizumab biosimilar 3] - injection