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

genentech, inc. - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - susvimo (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (amd) who have previously responded to at least two intravitreal injections of a vascular endothelial growth factor (vegf) inhibitor medication. susvimo (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. susvimo (ranibizumab injection) is contraindicated in patients with active intraocular inflammation. susvimo (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in susvimo (ranibizumab injection). risk summary there are no adequate and well-controlled studies of susvimo (ranibizumab injection) administration in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses up to 41 times the human exposure (based on serum levels following the re

Israel - English - Ministry of Health

novartis israel ltd - ranibizumab - solution for injection - ranibizumab 10 mg/ml - ranibizumab - ranibizumab - treatment of patients with neovascular (wet) age-related macular degeneration (amd). treatment of adult patients with visual impairment due to diabetic macular oedema (dme) . the treatment of visual impairement due to macular oedema secondary to retinal vein occlusion (rvo). the treatment of visual impaiment due to choroidal neovascularization (cnv) . lucentis is indicated in preterm infants for: the treatment of retinopathy of prematurity (rop) with zone i (stage 1+, 2+, 3 or 3+), zone ii (stage 3+) or ap-rop (aggressive posterior rop) disease.the treatment of proliferative diabetic retinopathy (pdr)

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

novartis pharmaceuticals australia pty ltd - ranibizumab, quantity: 1.65 mg - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20; water for injections - lucentis (ranibizumab) is indicated in adults for:,- the treatment of neovascular (wet) age-related macular degeneration (amd),- the treatment of visual impairment due to diabetic macular oedema (dme),- the treatment of proliferative diabetic retinopathy (pdr),- the treatment of visual impairment due to choroidal neovascularisation.,- the treatment of visual impairment due to choroidal neovascularisation (cnv) secondary to pathologic myopia (pm),- the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (rvo)

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

novartis pharmaceuticals australia pty ltd - ranibizumab, quantity: 2.3 mg - injection, solution - excipient ingredients: histidine; histidine hydrochloride monohydrate; trehalose dihydrate; polysorbate 20; water for injections - lucentis (ranibizumab) is indicated in adults for:,? the treatment of neovascular (wet) age-related macular degeneration (amd), ? the treatment of visual impairment due to diabetic macular oedema (dme), ? treatment of proliferative diabetic retinopathy (pdr), ? the treatment of visual impairment due to choroidal neovascularisation, ? the treatment of visual impairment due to choroidal neovascularisation (cnv) secondary to pathologic myopia (pm), ? the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (rvo).,lucentis is indicated in preterm infants for:,? the treatment of retinopathy of prematurity (rop) with zone i (stage 1+, 2+, 3 or 3+), zone ii (stage 3+) or ap-rop (aggressive posterior rop) disease.

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

genentech, inc. - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - ranibizumab 10 mg in 1 ml - lucentis is indicated for the treatment of patients with:           lucentis is contraindicated in patients with ocular or periocular infections. lucentis is contraindicated in patients with known hypersensitivity to ranibizumab or any of the excipients in lucentis. hypersensitivity reactions may manifest as severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of lucentis administration in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [cmax ]) after a single eye treatment at the recommended clinical dose. no skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see animal data] . animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. based on the anti-vegf mechanism of action for ranibizumab [see clinical pharmacology (12.1)] , treatment with lucentis may pose a risk to human embryofetal development. lucentis should be given to a pregnant woman only if clearly needed. data animal data an embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. pregnant animals received intravitreal injections of ranibizumab every 14 days starting on day 20 of gestation, until day 62 at doses of 0, 0.125, and 1 mg/eye. skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. the 1 mg/eye dose resulted in trough serum ranibizumab levels up to 13 times higher than predicted cmax levels with single eye treatment in humans. no skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures equivalent to single eye treatment in humans. no effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed. risk summary there are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production/excretion. because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when lucentis is administered to a nursing woman. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for lucentis and any potential adverse effects on the breastfed child from ranibizumab. infertility no studies on the effects of ranibizumab on fertility have been conducted and it is not known whether ranibizumab can affect reproduction capacity. based on the anti-vegf mechanism of action for ranibizumab, treatment with lucentis may pose a risk to reproductive capacity. the safety and effectiveness of lucentis in pediatric patients have not been established. in the clinical studies, approximately 76% (2449 of 3227) of patients randomized to treatment with lucentis were ≥ 65 years of age and approximately 51% (1644 of 3227) were ≥ 75 years of age [see clinical studies (14)]. no notable differences in efficacy or safety were seen with increasing age in these studies. age did not have a significant effect on systemic exposure.

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

senju pharmaceutical co.,ltd. - ranibizumab(genetical recombination)[ranibizumab biosimilar 1] - injection

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

senju pharmaceutical co.,ltd. - ranibizumab(genetical recombination)[ranibizumab biosimilar 1] - injection

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

senju pharmaceutical co.,ltd. - ranibizumab(genetical recombination)[ranibizumab biosimilar 1] - injection

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

senju pharmaceutical co.,ltd. - ranibizumab(genetical recombination)[ranibizumab biosimilar 1] - injection

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

coherus biosciences inc - ranibizumab (unii: zl1r02vt79) (ranibizumab - unii:zl1r02vt79) - cimerli is indicated for the treatment of patients with:           cimerli is contraindicated in patients with ocular or periocular infections. cimerli is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in cimerli. hypersensitivity reactions may manifest as severe intraocular inflammation. risk summary there are no adequate and well-controlled studies of ranibizumab products administered in pregnant women. administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [c max ]) after a single eye treatment at the recommended clinical dose. no skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see animal data]