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

Canada - English - Health Canada

hoffmann-la roche limited - ranibizumab - solution - 100mg - ranibizumab 100mg

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

usv north america inc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - acromegaly octreotide acetate injection is indicated to reduce blood levels of growth hormone and igf-i (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. the goal is to achieve normalization of growth hormone and igf-i (somatomedin c) levels (see dosage and administration). in patients with acromegaly, octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces igf-i (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of growth hormone and igf-i (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in

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

usv north america inc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - acromegaly octreotide acetate injection is indicated to reduce blood levels of growth hormone and igf-i (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. the goal is to achieve normalization of growth hormone and igf-i (somatomedin c) levels (see dosage and administration ). in patients with acromegaly, octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces igf-i (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of growth hormone and igf-i (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not s

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

usv private limited - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with:  - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke

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

usv private limited - eptifibatide (unii: na8320j834) (eptifibatide - unii:na8320j834) - eptifibatide injection is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (mi) in patients with acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (pci). eptifibatide injection is indicated to decrease the rate of a combined endpoint of death, new mi, or need for urgent intervention in patients undergoing pci, including those undergoing intracoronary stenting [see clinical studies (14.1, 14.2)] . treatment with eptifibatide injection is contraindicated in patients with:  - a history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days - severe hypertension (systolic blood pressure >200 mm hg or diastolic blood pressure >110 mm hg) not adequately controlled on antihypertensive therapy - major surgery within the preceding 6 weeks - history of stroke within 30 days or any history of hemorrhagic stroke

Philippines - English - FDA (Food And Drug Administration)

st. raphael archangel pharmaceutical product distribution; importer: n/a; distributor: n/a - multivitamins , iron - capsule - formulation each capsule contains: ferrous sulfate (equivalent to 91.5 mg elemental iron)-305mg folic acid (vitamin b9)-1mg thiamine mononitrate (vitamin b1)-15mg riboflavin (vitamin b2)-10mg pyridoxine hydrochloride (vitamin b6)-10mg cyanocobalamin (vitamin b12)-10mcg

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

cipla malaysia sdn bhd - pegfilgrastim -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - etoricoxib -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - etoricoxib -