Travatan Европска Унија - Словачки - EMA (European Medicines Agency)

travatan

novartis europharm limited - travoprost - glaucoma, open-angle; ocular hypertension - oftalmologiká - zníženie zvýšeného vnútroočného tlaku u dospelých pacientov s očnou hypertenziou alebo glaukómom s otvoreným uhlom (pozri časť 5. pokles zvýšený vnútroočný tlak v pediatrických pacientov vo veku od 2 mesiacov do < 18 rokov s očné hypertenzia alebo detskej glaukóm (pozri časť 5.

Truvada Европска Унија - Словачки - EMA (European Medicines Agency)

truvada

gilead sciences ireland uc - emtricitabine, tenofovir disoproxil fumarate - hiv infekcie - antivirotiká na systémové použitie - treatment of hiv-1 infection: , truvada is indicated in antiretroviral combination therapy for the treatment of hiv-1 infected adults. , truvada je tiež indikovaný na liečbu hiv-1 infikovaný dospievajúcich, s nrti odpor alebo toxicity vylučujúce použitie prvý riadok agentov, vo veku 12 až < 18 rokov. , pre-exposure prophylaxis (prep): , truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired hiv-1 infection in adults at high risk.

ViraferonPeg Европска Унија - Словачки - EMA (European Medicines Agency)

viraferonpeg

merck sharp dohme ltd  - peginterferon alfa-2b - hepatitída c, chronická - immunostimulants, - adults (tritherapy)viraferonpeg in combination with ribavirin and boceprevir (tritherapy) is indicated for the treatment of chronic-hepatitis-c (chc) genotype-1 infection in adult patients (18 years of age and older) with compensated liver disease who are previously untreated or who have failed previous therapy. prosím, pozrite si ribavirin a boceprevir súhrnov charakteristických vlastností lieku (smpcs), keď viraferonpeg je možné použiť v kombinácii s týmito liekmi. adults (bitherapy and monotherapy)viraferonpeg is indicated for the treatment of adult patients (18 years of age and older) with chc who are positive for hepatitis-c-virus rna (hcv-rna), including patients with compensated cirrhosis and / or co-infected with clinically stable hiv. viraferonpeg v kombinácii s ribavirin (bitherapy) je indikovaný na liečbu chc infekcie u dospelých pacientov, ktorí sa predtým neliečených vrátane pacientov s klinicky stabilnom hiv co-infekcie a u dospelých pacientov, ktorí zlyhali predchádzajúce liečby s interferónom alfa (pegylated alebo non-pegylated) a ribavirin kombinácia terapie alebo interferónom alfa monotherapy. interferón monotherapy, vrátane viraferonpeg, je indikovaná hlavne v prípade neznášanlivosti alebo kontraindikáciou na ribavirin. prosím, pozrite si ribavirin smpc, keď viraferonpeg je možné použiť v kombinácii s ribavirin. paediatric population (bitherapy)viraferonpeg is indicated in a combination regimen with ribavirin for the treatment of children three years of age and older and adolescents, who have chronic hepatitis c, previously untreated, without liver decompensation, and who are positive for hcv-rna. pri rozhodovaní nie odložiť liečbu až do dospelosti, je dôležité vziať do úvahy, že kombinovaná liečba vyvolaných a inhibícia rastu, ktoré môžu byť nezvratné v niektorých pacientov. rozhodnutie na liečbu by mala byť predložená na prípad od prípadu. prosím, pozrite si ribavirin smpc pre kapsuly alebo perorálny roztok, keď viraferonpeg je možné použiť v kombinácii s ribavirin.

Volibris Европска Унија - Словачки - EMA (European Medicines Agency)

volibris

glaxosmithkline (ireland) limited - ambrisentan - hypertenzia, pľúca - antihypertenzív, - volibris is indicated for treatment of pulmonary arterial hypertension (pah) in adult patients of who functional class (fc) ii to iii, including use in combination treatment (see section 5.  efficacy has been shown in idiopathic pah (ipah) and in pah associated with connective tissue disease. volibris is indicated for treatment of pah in adolescents and children (aged 8 to less than 18 years) of who functional class (fc) ii to iii including use in combination treatment. efficacy has been shown in ipah, familial, corrected congenital and in pah associated with connective tissue disease (see section 5.

Xarelto Европска Унија - Словачки - EMA (European Medicines Agency)

xarelto

bayer ag - rivaroxaban - arthroplasty, replacement; venous thromboembolism - antitrombotické činidlá - xarelto, spoločne spravované s acetylsalicylová (asa) sám alebo s asa plus klopidogrel alebo ticlopidine, je indikovaný na prevenciu atherothrombotic udalosti v dospelých pacientov po akútnej koronárnej syndróm (acs) so zvýšenou srdcovou biomarkery. xarelto, co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. prevencia žilovej tromboembólie (vte) u dospelých pacientov, ktorí podstúpili operáciu elek- tívneho výmeny bedrového alebo kolenného kĺbu. liečba hlbokej žilovej trombózy (dvt) a pľúcna embólia (pe), a prevencia opakujúcich sa dvt a pe u dospelých. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Innovax-ND-IBD Европска Унија - Словачки - EMA (European Medicines Agency)

innovax-nd-ibd

intervet international b.v. - bunka spojená s live rekombinantnej turecko herpesvirus (kmeň hvp360), vyjadriť syntézy bielkovín z nÁjsŤ vírus a vp2 bielkovín ibd vírus - herpes vírus vtáčej (marek choroba) + vtáčej infekčné bursal disease virus (gumboro choroba) + newcastle disease virus/paramyxovirus - chicken; embryonated chicken eggs - for active immunisation of one-day-old chicks or 18-19-day-old embryonated chicken eggs:to reduce mortality and clinical signs caused by newcastle disease (nd) virus,to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (ibd) virus,to reduce mortality, clinical signs and lesions caused by marek’s disease (md) virus.

Alkindi Европска Унија - Словачки - EMA (European Medicines Agency)

alkindi

diurnal europe b.v. - hydrokortizon - adrenálna nedostatočnosť - kortikosteroidy na systémové použitie - substitučná terapia z nedostatočnosť nadobličiek u dojčiat, detí a dospievajúcich (od narodenia do < 18 rokov).

Imfinzi Европска Унија - Словачки - EMA (European Medicines Agency)

imfinzi

astrazeneca ab - durvalumab - karcinóm, pľúc bez malých buniek - antineoplastické činidlá - non-small cell lung cancer (nsclc)imfinzi as monotherapy is indicated for the treatment of locally advanced, unresectable non small cell lung cancer (nsclc) in adults whose tumours express pd-l1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy (see section 5. imfinzi in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic nsclc with no sensitising egfr mutations or alk positive mutations. small cell lung cancer (sclc)imfinzi in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (es-sclc). biliary tract cancer (btc)imfinzi in combination with gemcitabine and cisplatin is indicated for the first line treatment of adults with unresectable or metastatic biliary tract cancer (btc). hepatocellular carcinoma (hcc)imfinzi in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (hcc).

Slenyto Европска Унија - Словачки - EMA (European Medicines Agency)

slenyto

rad neurim pharmaceuticals eec sarl - melatonín - sleep initiation and maintenance disorders; autistic disorder - psycholeptika - slenyto je indikovaný na liečbu nespavosti u detí a dospievajúcich vo veku 2-18 s autizmus spektrum poruchy (asd) a / alebo smith-magenis syndróm, kde spánku hygienické opatrenia boli nedostatočné.

Shingrix Европска Унија - Словачки - EMA (European Medicines Agency)

shingrix

glaxosmithkline biologicals sa - recombinant varicella zoster virus glycoprotein e - herpes zoster - vakcíny - shingrix is indicated for prevention of herpes zoster (hz) and post-herpetic neuralgia (phn), in:adults 50 years of age or older;adults 18 years of age or older at increased risk of hz. použitie shingrix by mali byť v súlade s oficiálne odporúčania.