Palforzia Európska únia - slovenčina - EMA (European Medicines Agency)

palforzia

aimmune therapeutics ireland limited - defatted powder of arachis hypogaea l., semen (peanuts) - peanut hypersensitivity - allergens - palforzia is indicated for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. palforzia may be continued in patients 18 years of age and older. palforzia should be used in conjunction with a peanut-avoidant diet.

Vyvgart Európska únia - slovenčina - EMA (European Medicines Agency)

vyvgart

argenx - efgartigimod alfa - myasthenia gravis - imunosupresíva - vyvgart is indicated as an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gmg) who are anti acetylcholine receptor (achr) antibody positive.

Soliris Európska únia - slovenčina - EMA (European Medicines Agency)

soliris

alexion europe sas - eculizumab - hemoglobinúria, paroxysmálna - imunosupresíva - soliris je indikovaný u dospelých a detí na liečbu:paroxyzmálna nočné haemoglobinuria (pnh). dôkazy z klinických výhodou je preukázaná u pacientov s haemolysis s klinický príznak(s) svedčí o vysokej aktivity ochorenia, bez ohľadu na transfúziu históriu (pozri časť 5. atypické haemolytic-uremickým syndrómom (zariadenia). soliris je indikovaný u dospelých na liečbu:Žiaruvzdorné generalizované myasthenia gravis (gmg) u pacientov, ktorí sú anti-acetylcholínové receptory (achr) protilátky-pozitívne (pozri časť 5. neuromyelitis optica spektrum poruchy (nmosd) u pacientov, ktorí sú anti-aquaporin-4 (aqp4) protilátky-pozitívne s relapsujúcou priebeh ochorenia.

Ultomiris Európska únia - slovenčina - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinúria, paroxysmálna - selektívne imunosupresíva - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Jayempi Európska únia - slovenčina - EMA (European Medicines Agency)

jayempi

nova laboratories ireland limited - azathioprine - odmietnutie štepu - imunosupresíva - jayempi is indicated in combination with other immunosuppressive agents for the prophylaxis of transplant rejection in patients receiving allogenic kidney, liver, heart, lung or pancreas transplants. azathioprine is indicated in immunosuppressive regimens as an adjunct to immunosuppressive agents that form the mainstay of treatment (basis immunosuppression). jayempi is used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and/ or procedures which influence the immune response. jayempi is indicated in patients who are intolerant to glucocorticosteroids or if the therapeutic response is inadequate despite treatment with high doses of glucocorticosteroids, in the following diseases:severe active rheumatoid arthritis (chronic polyarthritis) that cannot be kept under control by less toxic agents (disease-modifying anti-rheumatic -medicinal products – dmards)auto-immune hepatitis systemic lupus erythematosusdermatomyositispolyarteritis nodosapemphigus vulgaris and bullous pemphigoidbehçet’s diseaserefractory auto-immune haemolytic anaemia, caused by warm igg antibodieschronic refractory idiopathic thrombocytopenic purpurajayempi is used for the treatment of moderately severe to severe forms of chronic inflammatory bowel disease (ibd) (crohn’s disease or ulcerative colitis) in patients in whom glucocorticosteroid therapy is necessary, but where glucocorticosteroids are not tolerated, or in whom the disease is untreatable with other common means of first choice. it is also indicated in adult patients in relapsing multiple sclerosis, if an immunomodulatory therapy is indicated but beta interferon therapy is not possible, or a stable course has been achieved with previous treatment with azathioprine. 3jayempi is indicated for the treatment of generalised myasthenia gravis. depending on the severity of the disease, jayempi should be given in combination with glucocorticosteroids because of slow onset of action at the beginning of treatment and the glucocorticosteroid dose should be gradually reduced after several months of treatment.

Drôt vodiaci ChoICE / ChoICE PT / Luge / Mailman / PT Graphix Slovensko - slovenčina - ŠÚKL (Štátny ústav pre kontrolu liečiv)

drôt vodiaci choice / choice pt / luge / mailman / pt graphix

boston scientific corporation 300 boston scientific way 01752 marlborough, ma spojené štáty americké -

Buccolam Európska únia - slovenčina - EMA (European Medicines Agency)

buccolam

neuraxpharm pharmaceuticals s.l. - midazolam - epilepsie - psycholeptika - liečba dlhodobých, akútnych, konvulzívnych záchvatov u dojčiat, batoľatých, detí a adolescentov (od troch mesiacov do menej ako 18 rokov). buccolam musia ich používať len rodičia / opatrovatelia, kde pacient bol diagnostikovaný majú epilepsiu. pre deti od troch do šiestich mesiacov veku, liečba by mala byť v nemocnici nastavenie, kde monitorovanie je možné a resuscitačného vybavenia je k dispozícii.

Kentera (previously Oxybutynin Nicobrand) Európska únia - slovenčina - EMA (European Medicines Agency)

kentera (previously oxybutynin nicobrand)

teva b.v.  - oxybutynín - inkontinencia moču, urge - urologika - symptomatická liečba urgentnej inkontinencie a / alebo zvýšenej frekvencie a naliehavosti moču, ktoré sa môžu vyskytnúť u dospelých pacientov s nestabilným močovým mechúrom.

Ketek Európska únia - slovenčina - EMA (European Medicines Agency)

ketek

aventis pharma s.a. - telitromycín - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - antibakteriálne pre systémové použitie, - pri predpisovaní keteku je potrebné zvážiť oficiálne usmernenie o vhodnom použití antiabakteriálnych látok a lokálnej prevalencii rezistencie. ketek je indikovaný na liečbu nasledujúcich infekcií:u pacientov 18 rokov a oldercommunity získané zápal pľúc, mierne alebo stredne. pri liečbe infekcií spôsobených známych alebo podozrivých beta-lactam - a / alebo macrolide-rezistentných kmeňov (podľa histórie pacientov alebo národné a / alebo regionálne odpor údajov), na ktoré sa vzťahuje antibakteriálne spektrum telithromycin:acute exacerbation chronickej bronchitídy;akútny zápal vedľajších nosových dutín;u pacientov 12 rokov a oldertonsillitis / pharyngitis spôsobené streptococcus pyogenes, ako alternatívu pri beta-lactam antibiotiká nie sú vhodné v krajinách / regiónoch s významným výskytom macrolide-odolné s. pyogenes, keď sprostredkovaný ermtr alebo mefa.