Evropska unija - slovenščina - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections  4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 in 5. 1):- invasive aspergillosisnoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (gvhd) and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (see sections 4. 2 in 5. 1):- invasive aspergillosis in patients with disease that is refractory to amphotericin b or itraconazole or in patients who are intolerant of these medicinal products;- fusariosis in patients with disease that is refractory to amphotericin b or in patients who are intolerant of amphotericin b;- chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;- coccidioidomycosis in patients with disease that is refractory to amphotericin b, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2  years of age:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high  risk of developing invasive fungal infections;- haematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high  risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis. please refer to the summary of product characteristics of noxafil oral suspension for use in oropharyngeal candidiasis.  noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5. 1):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:- patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- hematopoietic stem cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. please refer to the summary of product characteristics of noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.

Evropska unija - slovenščina - EMA (European Medicines Agency)

csl behring gmbh - humani normalni imunoglobulin (ivig) - purpura, thrombocytopenic, idiopathic; bone marrow transplantation; immunologic deficiency syndromes; guillain-barre syndrome; mucocutaneous lymph node syndrome - imunski sera in imunoglobulini, - nadomestno zdravljenje pri odraslih in otrok in mladostnikov (0-18 let) v:primarne imunske pomanjkljivosti (pid) sindromov s slabšo proizvodnjo protiteles;hypogammaglobulinaemia in ponavljajoče se bakterijske okužbe pri bolnikih s kronično limfocitno levkemijo, pri katerih profilaktičnih antibiotikov ni uspelo;hypogammaglobulinaemia in ponavljajoče se bakterijske okužbe v planota-faza-več-plazmocitom bolnikih, ki so se odzvali na pnevmokokna imunizacijo;hypogammaglobulinaemia pri bolnikih po allogeneic haematopoietic-matičnih-celic presaditev (hsct);prirojene pomoČi z ponavljajoče se bakterijske okužbe. immunomodulation pri odraslih in otrok in mladostnikov (0-18 let) v:primarna imunska trombocitopenija (itp), pri bolnikih z visokim tveganjem za krvavitve ali pred operacijo, da se popravi trombocitov štetje;guillain-barré sindrom;kawasaki bolezni, kronične vnetne demielinizirajoče polyneuropathy (cidp). le omejene izkušnje je na voljo za uporabo intravenskih imunoglobulini pri otrocih s cidp.

Evropska unija - slovenščina - EMA (European Medicines Agency)

schering-plough europe - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotiki za sistemsko uporabo - posakonazol sp je indiciran za uporabo pri zdravljenju naslednjih glivičnih okužb pri odraslih (glejte poglavje 5). 1):- invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b ali pri bolnikih, ki so nestrpne amphotericin b;- chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin b, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. posaconazole sp je tudi navedeno, za profilaksa invazivnih glivičnih okužb pri naslednjih bolnikih:- bolniki, ki prejemajo odpust-indukcijske kemoterapijo za akutno myelogenous levkemijo (aml) ali myelodysplastic sindromov (mds) pričakuje, da bo rezultat v daljšem neutropenia in ki areat visoko tveganje za nastanek invazivnih glivičnih okužb;- hematopoietic matičnih celic za presajanje (hsct) prejemniki, ki so v visoki odmerki imunosupresivna terapija za cepljene (graft versus host disease in pri katerih obstaja visoko tveganje za nastanek invazivnih glivičnih okužb,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

serb sa - hidroksokobalamin - zastrupitev - vsi drugi terapevtski izdelki - zdravljenje znanih ali sumljivih zastrupitev s cianidi. cyanokit je treba dajati skupaj z ustreznimi dekontaminacijo in podporne ukrepe,.

Evropska unija - slovenščina - EMA (European Medicines Agency)

astrazeneca ab - fulvestrant - neoplazme dojke - endokrini terapije, anti-estrogene - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. v pre - ali perimenopausal ženske, kombinacija zdravljenja z palbociclib je treba v kombinaciji z luteinizirajoči hormon sproščujoči hormon (lhrh) agonist.

Evropska unija - slovenščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - fulvestrant - neoplazme dojke - endokrini terapija - fulvestrant je primerna za zdravljenje estrogen receptor pozitivno, lokalno napredno ali metastatskega raka dojke pri ženskah po menopavzi:ne prej, zdravljenih z endokrinih terapije, orwith ponovitve bolezni na ali po adjuvant anti-estrogen terapije, ali napredovanja bolezni na antiestrogen terapija.

Evropska unija - slovenščina - EMA (European Medicines Agency)

teva b.v. - salmeterol, fluticasone propionat - pulmonary disease, chronic obstructive; asthma - zdravila za obstruktivne pljučne bolezni, - airexar spiromax je indicirano za uporabo pri odraslih, starih 18 let in več, samo. asthmaairexar spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist. kronična obstruktivna pljučna bolezen (kopb)airexar spiromax je primerna za simptomatsko zdravljenje bolnikov s kopb s fev1.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - eptifibatid - miokardni infarkt - antitrombotična sredstva - zdravilo eptifibatide accord je namenjeno uporabi z acetilsalicilno kislino in nefrakcioniranim heparinom. eptifibatide soglasju je navedena za preprečevanje zgodnje miokardni infarkt pri odraslih, ki predstavljajo z nestabilno angino pektoris ali ne-q-val, miokardni infarkt, z zadnjo epizodo bolečine v prsih, ki se pojavljajo v 24 urah in z elektrokardiograma (ekg), ki se s spremembami in/ali zvišan srčni encimi. bolniki najbolj verjetno, da koristi od eptifibatide soglasju zdravljenje, so tiste z visokim tveganjem za razvoj miokardnega infarkta v prvih 3-4 dni po nastopu akutne angina simptomov, vključno z, na primer tiste, ki jih je verjetno, da opravijo zgodnji ptca (perkutana transluminal koronarno angioplastiko).

Evropska unija - slovenščina - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - eptifibatid - angina, unstable; myocardial infarction - antitrombotična sredstva - integrilin je namenjen uporabi z acetilsalicilno kislino in nefrakcioniranim heparinom. integrilin je indicirano za preprečevanje zgodnje miokardni infarkt pri bolnikih, ki predstavljajo z nestabilno angino pektoris ali ne-q-val, miokardni infarkt z zadnjo epizodo bolečine v prsih, ki se pojavljajo v 24 urah in z ekg spremembe in / ali zvišan srčni encimi. bolniki najbolj verjetno, da koristi od integrilin zdravljenje, so tiste z visokim tveganjem za razvoj miokardnega infarkta v prvih 3-4 dni po nastopu akutne angina simptomov, vključno z, na primer tiste, ki jih je verjetno, da opravijo zgodnji perkutani transluminal koronarno angioplastiko (ptca).

Evropska unija - slovenščina - EMA (European Medicines Agency)

novartis europharm limited - travoprost - ocular hypertension; glaucoma, open-angle - ophthalmologicals, antiglaucoma preparations and miotics - zmanjšanje zvišanega očesnega tlaka pri odraslih bolnikih z očesno hipertenzijo ali glavkomom odprtega zakotja (glejte poglavje 5. znižanje zvišanega očesnega tlaka pri pediatričnih bolnikih, starih od 3 let < 18 let, s očesni hipertenzijo ali glavkom pediatričnih.