Ireland - English - HPRA (Health Products Regulatory Authority)

janssen-cilag ltd - pancreatin - capsule - 387.45 milligram

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - pancrelipase 193.8mg (lipase 5.6k, amylase 3.2k, protease 0.35k, (bp units)) - capsule - 193.8 mg - active: pancrelipase 193.8mg (lipase 5.6k, amylase 3.2k, protease 0.35k, (bp units)) excipient: cellacefate diethyl phthalate gelatin povidone purified talc sodium starch glycolate sugar spheres

Canada - English - Health Canada

mcneil pharmaceutical, division of ortho-mcneil inc. - lipase; amylase; protease - capsule (enteric-coated) - 4000unit; 20000unit; 25000unit - lipase 4000unit; amylase 20000unit; protease 25000unit - digestants

Canada - English - Health Canada

janssen inc - lipase; amylase; protease - capsule (sustained-release) - 4500unit; 20000unit; 25000unit - lipase 4500unit; amylase 20000unit; protease 25000unit - digestants

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

janssen-cilag ltd - amylase; lipase; protease - gastro-resistant capsule - 2900unit ; 5000unit ; 330unit

European Union - English - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - linagliptin, metformin - diabetes mellitus, type 2 - drugs used in diabetes, - treatment of adult patients with type-2 diabetes mellitus:jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.

European Union - English - EMA (European Medicines Agency)

mylan s.a.s. - lopinavir/ritonavir - hiv infections - antivirals for systemic use, - lopinavir/ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv-1) infected adults, adolescents and children above the age of 2 years.the choice of lopinavir/ritonavir to treat protease inhibitor experienced hiv-1 infected patients should be based on individual viral resistance testing and treatment history of patients.

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - efavirenz, emtricitabine, tenofovir disoproxil, phosphate - hiv infections - antivirals for systemic use, - efavirenz/emtricitabine/tenofovir disoproxil zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. it is indicated for the treatment of human immunodeficiency virus-1 (hiv-1) infection in adults aged 18 years and over with virologic suppression to hiv-1 rna levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in efavirenz/emtricitabine/tenofovir disoproxil zentiva prior to initiation of their first antiretroviral treatment regimen., the demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavir

European Union - English - EMA (European Medicines Agency)

intervet international bv - live attenuated avian infectious bronchitis virus variant strain 4-91 - immunologicals for aves - chicken - active immunisation of chickens to reduce the respiratory signs of infectious bronchitis caused by the variant strain ib 4-91.

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

american health packaging - phytonadione (unii: a034se7857) (phytonadione - unii:a034se7857) - phytonadione tablets are indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors ii, vii, ix and x when caused by vitamin k deficiency or interference with vitamin k activity. - anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. - hypoprothrombinemia secondary to antibacterial therapy. - hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin k, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis. - other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin k metabolism, e.g., salicylates. phytonadione tablets are contraindicated in patients with a history of a hypersensitivity reaction to phytonadione or inactive ingredients [see description (11)] . risk summary published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see data] . there are maternal and fetal risks associated with vitamin k deficiency during pregnancy [see clinical considerations] . animal reproduction studies have not been conducted with phytonadione. the estimated background risk for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with vitamin k deficiency hypoprothrombinemia may be at increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. subclinical vitamin k deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. data human data phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma. administration of vitamin k1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. however, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding. animal data in pregnant rats receiving vitamin k1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer. risk summary phytonadione is present in breastmilk. there are no data on the effects of phytonadione on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the clinical need for phytonadione and any potential adverse effects on the breastfed child from phytonadione or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established with phytonadione. hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, have been reported with vitamin k. clinical studies of phytonadione 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.