Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

janssen-cilag international nv - darunavir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). in deciding to initiate treatment with prezista co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens:for the treatment of hiv 1 infection in antiretroviral treatment (art) experienced adult patients, including those that have been highly pre treated. for the treatment of hiv 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. in deciding to initiate treatment with prezista co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. genotypic or phenotypic testing (when available) and treatment history should guide the use of prezista. prezista, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (hiv 1) infection. prezista, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (hiv 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). prezista 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of hiv 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (art) naïve. art experienced with no darunavir resistance associated mutations (drv rams) and who have plasma hiv 1 rna < 100,000 copies/ml and cd4+ cell count ≥ 100 cells x 106/l. in deciding to initiate treatment with prezista in such art experienced patients, genotypic testing should guide the use of prezista.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - sveppalyf fyrir almenn nota - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

janssen-cilag international nv - canagliflozin - sykursýki, tegund 2 - lyf notuð við sykursýki - invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes. for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lyf notuð við sykursýki - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 og 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Īslande - īslandiešu - LYFJASTOFNUN (Icelandic Medicines Agency)

fresenius kabi ab - natrii ascorbas inn; thiaminum nítrat; natrii riboflavinophosphas; natrii pantothenas; pyridoxinum hýdróklóríð; biotinum inn; cyanocobalaminum inn; acidum folicum inn; nicotinamidum inn - innrennslisstofn, lausn

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

eli lilly nederland b.v. - tadalafil - háþrýstingur, lungnabólga - Þvaglát - adultstreatment of pulmonary arterial hypertension (pah) classified as who functional class ii and iii, to improve exercise capacity (see section 5. verkun hefur verið sýnd í sjálfvakta pah (ipah) og í pah í tengslum við krabbameinsvaldandi sjúkdóma. paediatric populationtreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (pah) classified as who functional class ii and iii.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

accord healthcare s.l.u. - síldenafílsítrat - háþrýstingur, lungnabólga - Þvaglát - adultstreatment fullorðinna sjúklinga með lungum háþrýsting flokkast sem hagnýtur ii og iii, til að bæta æfing getu. verkun hefur verið sýnd í frumum lungnaháþrýstingi og lungnaháþrýstingi sem tengist bandvefssjúkdómum. börn populationtreatment af börnum sjúklinga á aldrinum 1 ár til 17 ára gamall með lungum háþrýsting. virkni í varðar endurbætur á æfingu getu eða lungum haemodynamics hefur verið sýnt fram í aðal lungum blóðþrýsting og lungnaháþrýstingi tengslum með meðfæddan hjartasjúkdóm.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

viatris limited - síldenafílsítrat - háþrýstingur, lungnabólga - Þvaglát - adultstreatment fullorðinna sjúklinga með lungum háþrýsting flokkast sem hagnýtur ii og iii, til að bæta æfing getu. verkun hefur verið sýnd í frumum lungnaháþrýstingi og lungnaháþrýstingi sem tengist bandvefssjúkdómum. börn populationtreatment af börnum sjúklinga á aldrinum 1 ár til 17 ára gamall með lungum háþrýsting. verkun með tilliti til endurbóta á æfingargetu eða lungnablóðþrýstingi hefur sést við frumháþrýstingi og lungnaháþrýstingi sem tengist meðfæddan hjartasjúkdóm (sjá kafla 5.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

mylan pharmaceuticals limited - olanzapin - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine er ætlað fyrir meðferð geðklofa. olanzapin er virkt í að viðhalda klínískum endurbætur á áframhaldandi meðferð í sjúklingum sem hafa sýnt upphaflega meðferð svar. olanzapin er ætlað fyrir meðferð í meðallagi til alvarlega oflæti þættinum. Í sjúklingar sem oflæti þáttur hefur brugðist að olanzapin meðferð, olanzapin er ætlað til að fyrirbyggja endurkomu í sjúklinga með geðhvarfasýki.

Eiropas Savienība - īslandiešu - EMA (European Medicines Agency)

glenmark arzneimittel gmbh - olanzapin - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine er ætlað fyrir meðferð geðklofa. olanzapin er virkt í að viðhalda klínískum endurbætur á áframhaldandi meðferð í sjúklingum sem hafa sýnt upphaflega meðferð svar. olanzapin er ætlað fyrir meðferð í meðallagi til alvarlega oflæti þættinum. Í sjúklingar sem oflæti þáttur hefur brugðist að olanzapin meðferð, olanzapin er ætlað til að fyrirbyggja endurkomu í sjúklinga með geðhvarfasýki.