Evropská unie - slovenština - EMA (European Medicines Agency)

viatris limited - dapagliflozin - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lieky používané pri cukrovke - type 2 diabetes mellitusdapagliflozin viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance. - in addition to other medicinal products for the treatment of type 2 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 a 5. heart failuredapagliflozin viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction. chronic kidney diseasedapagliflozin viatris is indicated in adults for the treatment of chronic kidney disease.

Evropská unie - slovenština - EMA (European Medicines Agency)

mylan pharmaceuticals limited - darunavir - hiv infekcie - antivirotiká na systémové použitie - darunavir, 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 (see section 4. darunavir mylan 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4. 2):na liečbu hiv-1 infekcie v antiretrovirálnej liečby (umenia)-skúsený dospelých pacientov, vrátane tých, ktoré boli vysoko upravená. na liečbu hiv-1 infekcie u pediatrických pacientov vo veku od 3 rokov a najmenej na 15 kg telesnej hmotnosti. pri rozhodovaní, či začať liečbu s darunavir spoločne spravované s nízkymi dávkami ritonavirom, starostlivo by sa mali zvážiť liečbu histórii jednotlivých pacientov a vzory mutácie spojené s rôznymi látkami. genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4. 2, 4. 4 a 5. darunavir spoločne spravované s nízkymi dávkami ritonavirom je indikovaný v kombinácii s inými antiretrovirálnej lieky na liečbu pacientov so vírus ľudského imunodeficiencie (hiv-1) infekcie.  darunavir 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) (see section 4.  darunavir mylan 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 (see section 4.  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. pri rozhodovaní, či začať liečbu s darunavir v takýchto umenie-skúsený pacientov, genotypic testovanie by sa malo riadiť použitie darunavir (pozri časť 4. 2, 4. 3, 4. 4 a 5.

Evropská unie - slovenština - EMA (European Medicines Agency)

mylan pharmaceuticals limited - emtricitabine, tenofovir disoproxil maleate - hiv infekcie - antivirotiká na systémové použitie - treatment of hiv-1 infection:emtricitabine/tenofovir disoproxil mylan is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults (see section 5. emtricitabine/tenofovir disoproxil mylan is also indicated for the treatment of hiv-1 infected adolescents, with nrti resistance or toxicities precluding the use of first line agents, (see sections 4. 2, 4. 4 a 5. pre-exposure prophylaxis (prep):emtricitabine/tenofovir disoproxil mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults and adolescents at high risk (see sections 4. 2, 4. 4 a 5.

Slovensko - slovenština - ŠÚKL (Štátny ústav pre kontrolu liečiv)

btl industries limited 161 cleveland way sg1 6bu steveage, hertfordshire spojené kráľovstvo veľkej británie a severného Írska -

Evropská unie - slovenština - EMA (European Medicines Agency)

novartis europharm limited - tislelizumab - esophageal squamous cell carcinoma - antineoplastické činidlá - oesophageal squamous cell carcinoma (oscc) tevimbra as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Evropská unie - slovenština - EMA (European Medicines Agency)

glaxo group ltd. - amprenavir - hiv infekcie - antivirotiká na systémové použitie - agenerase, v kombinácii s inými antiretrovirálnej agentov, je indikovaný na liečbu inhibítorov proteináz (pi) zažil hiv-1 infikovaných dospelých a deti vo veku od 4 rokov. agenerase kapsúl, ktoré by mali byť bežne podávané s nízkymi dávkami ritonavirom ako pharmacokinetic enhancer z amprenavir (pozri časť 4. 2 a 4. výber amprenaviru by mal byť založený na individuálnom skúšaní vírusovej rezistencie a histórii liečby pacientov (pozri časť 5). výhody agenerase ritonavir nebola preukázaná v pi jozefa pacientov (pozri časť 5.

Evropská unie - slovenština - EMA (European Medicines Agency)

actavis group ptc ehf    - pioglitazón hydrochlorid - diabetes mellitus, typ 2 - lieky používané pri cukrovke - pioglitazone is indicated as second or third line treatment of type-2 diabetes mellitus as described below:as monotherapy:in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance;as dual oral therapy in combination with:metformin, in adult patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin;a sulphonylurea, only in adult patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite maximal tolerated dose of monotherapy with a sulphonylurea;as triple oral therapy in combination with:metformin and a sulphonylurea, in adult patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy. pioglitazone je tiež uvedené, pre kombináciu s inzulínu v typu 2 diabetes mellitus dospelých pacientov s nedostatočnou glykemický kontroly na inzulínu, pre ktorých je metformín je nevhodné, pretože kontraindikácii alebo neznášanlivosti. po začatí liečby s pioglitazone, pacienti by mali byť preskúmané po 3 až 6 mesiacov na posúdenie primeranosti odpoveď na liečbu (e. zníženie hba1c). u pacientov, ktorí nedokážu zobraziť primeranú odpoveď, pioglitazone by mali byť ukončené. z hľadiska potenciálnych rizík s dlhodobou liečbou, prescribers by mal potvrdiť na následné bežné recenzie, ktoré v prospech pioglitazone je zachovaná.

Evropská unie - slovenština - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - roztrúsená skleróza - selektívne imunosupresíva - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 a 5. 1), , or, patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Evropská unie - slovenština - EMA (European Medicines Agency)

viiv healthcare bv - lamivudine, zidovudine - hiv infekcie - antivirotiká na systémové použitie - combivir is indicated in antiretroviral combination therapy for the treatment of human immunodeficiency virus (hiv) infection.

Evropská unie - slovenština - EMA (European Medicines Agency)

gilead sciences ireland uc, galapagos nv - filgotinib maleate - artritída, reumatoidná artritída - imunosupresíva - rheumatoid arthritisjyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). jyseleca may be used as monotherapy or in combination with methotrexate (mtx). ulcerative colitisjyseleca is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent.