União Europeia - esloveno - EMA (European Medicines Agency)

teva pharma b.v. - leflunomid - artritis, revmatoidni - imunosupresivi - leflunomid je indiciran za zdravljenje odraslih bolnikov s aktivnega revmatoidnega artritisa kot "bolezen, ki spreminjajo antirevmatik drog" (dmard). nedavne ali sočasno zdravljenje z hepatotoxic ali haematotoxic dmards (e. metotreksat) lahko poveča tveganje za resne neželene učinke; zato je treba pri teh vidikih koristnosti / tveganja skrbno razmisliti o začetku zdravljenja z leflunomidom. poleg tega je prehod iz leflunomid na drugo dmard brez sledi postopek izpiranja lahko tudi poveča tveganje za resne neželene učinke, še dolgo po tem, ko je preklapljanje.

União Europeia - esloveno - 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.

União Europeia - esloveno - EMA (European Medicines Agency)

teva b.v. - zoledronska kislina - osteoporosis; osteitis deformans; osteoporosis, postmenopausal - zdravila za zdravljenje bolezni kosti - treatment of osteoporosis: , in post-menopausal women;, in men; , at increased risk of fracture including those with a recent low-trauma hip fracture. treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: , in post-menopausal women;, in men; , at increased risk of fracture. zdravljenje paget je bolezen kosti v odrasli.

União Europeia - esloveno - EMA (European Medicines Agency)

novartis europharm limited - glycopyrronium bromide, indacaterol (acetate), mometasone furoate - astma - zdravila za obstruktivne pljučne bolezni, - maintenance treatment of asthma in adults whose disease is not adequately controlled.

União Europeia - esloveno - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

União Europeia - esloveno - EMA (European Medicines Agency)

piramal critical care b.v. - sugammadex sodium - neuromuskularna blokada - sugamadeks - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

União Europeia - esloveno - EMA (European Medicines Agency)

extrovis eu ltd. - sugammadex sodium - neuromuskularna blokada - vsi drugi terapevtski izdelki - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

União Europeia - esloveno - EMA (European Medicines Agency)

merck sharp and dohme b.v - sitagliptin, metformin hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - za bolnike z tipa 2 sladkorna bolezen:efficib je indicirano kot dodatek k dieti in telesni za izboljšanje glycaemic nadzor pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom sam ali tistih, ki se že zdravijo z kombinacijo sitagliptin in metformin. efficib je navedeno v kombinaciji z sulfonil sečnine (i. trojna kombinacija terapija), kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in sulfonil sečnine. efficib je označen kot trojna kombinacija terapije z ppar agonist (i. a thiazolidinedione) kot dodatek k prehrani in vadbi pri bolnikih neustrezno nadzorovano na maksimalno dopustne odmerek metforminom in ppar agonist. efficib je prikazano tudi kot dodajte na insulin (i. , trojna kombinacija terapija), kot dodatek k prehrani in vadbi za izboljšanje glycaemic nadzor pri bolnikih, pri stabilen odmerek insulina in metforminom sam ne zagotavljajo ustrezne glycaemic nadzor.

União Europeia - esloveno - EMA (European Medicines Agency)

glaxosmithkline trading services limited - albiglutide - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - eperzan je primerna za zdravljenje diabetesa tipa 2 bolezni v odrasli za izboljšanje glycaemic nadzor:monotherapywhen dieto in telesno vadbo sam ne zagotavljajo ustrezne glycaemic nadzor pri bolnikih, za katere uporabo metformin je neprimerno zaradi kontraindikacije ali nestrpnosti. add-on kombinacija therapyin kombinaciji z drugimi glukoze-znižanje medicini, vključno z bazalni insulin, ko ti, skupaj z dieto in telesno vadbo, ne zagotavljajo ustrezne glycaemic nadzor (glej razdelek 4. 4 in 5. 1 za razpoložljive podatke o različnih kombinacijah).

União Europeia - esloveno - EMA (European Medicines Agency)

krka, d.d., novo mesto - pioglitazon hidroklorid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - pioglitazone je označen kot drugi ali tretji vrstici zdravljenje tip 2 sladkorne bolezni, kot je opisano spodaj:kot monotherapyin odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) neustrezno nadzorovane z dieto in telesno vadbo, za katere metformin ni primeren, ker kontraindikacije ali nestrpnosti;kot dvojno oralna terapija v kombinaciji withmetformin, pri odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) z nezadostno glycaemic nadzor kljub maksimalne dopustne odmerek monotherapy z metforminom;sulfonil sečnine, le pri odraslih bolnikih, ki pokažejo nestrpnost do metforminom ali za katere metformin je kontraindiciran, z nezadostno glycaemic nadzor kljub maksimalne dopustne odmerek monotherapy z sulfonil sečnine;kot trojna oralna terapija v kombinaciji withmetformin in sulfonil sečnine, pri odraslih bolnikih (zlasti prekomerno telesno težo bolnikov) z nezadostno glycaemic nadzor kljub dvojno oralna terapija. pioglitazone je prikazano tudi za kombinacijo z insulina v vrsto 2 sladkorna bolezen pri odraslih bolnikih z nezadostno glycaemic nadzor na insulin, za katere metformin ni primeren, ker kontraindikacije ali nestrpnosti. po začetku terapije z pioglitazone, bolnike je treba pregledati in po 3 do 6 mesecev, da oceni ustreznost odziva na zdravljenje (e. zmanjšanje hba1c). pri bolnikih, ki ne kažejo ustrezen odgovor, pioglitazone, je treba prekiniti,. v luči možnih tveganj z dolgotrajna terapija, predpisovalce morajo potrditi na kasnejše redne preglede, da je korist pioglitazone je ohranjena.