Европейский союз - словенский - EMA (European Medicines Agency)

genzyme europe bv - sevelamerijev klorid - hyperphosphatemia; renal dialysis - vsi drugi terapevtski izdelki - tasermity je indicirano za nadzor nad hyperphosphataemia pri odraslih bolnikih, ki prejemajo hemodializni ali peritonealno dializo. sevelamer hidroklorid uporabljati v okviru več terapevtski pristop, ki bi lahko vključevali kalcija, 1,25-dihidroksi vitamina d3 ali eden od njegovih analogov, za nadzor nad razvojem bolezni ledvic kosti.

Европейский союз - словенский - EMA (European Medicines Agency)

pfizer europe ma eeig - tigecycline - bacterial infections; skin diseases, bacterial; soft tissue infections - antibacterials za sistemsko uporabo, - tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: , complicated skin and soft tissue infections (cssti), excluding diabetic foot infections, complicated intra-abdominal infections (ciai) , tygacil should be used only in situations where other alternative antibiotics are not suitable. upoštevati je treba uradne smernice za ustrezno uporabo protibakterijsko agenti. ustrezno uporabo protibakterijsko agenti.

Европейский союз - словенский - EMA (European Medicines Agency)

united therapeutics europe ltd - dinutuximab - neuroblastom - antineoplastična sredstva - unituxin je indicirano za zdravljenje z visokim tveganjem neuroblastoma pri bolnikih, starih 12 mesecev, da 17years, ki so predhodno prejeli indukcijska kemoterapija in doseči vsaj delni odgovor, sledi myeloablative terapije in avtologna izvornih celic presaditev (asct). uporablja se v kombinaciji z granulocitnim makrofagom, ki spodbuja kolonijo (gm-csf), interlevkin-2 (il-2) in izotretinoin.

Европейский союз - словенский - EMA (European Medicines Agency)

schering-plough europe - interferon alfa-2b - hepatitis c, chronic; hepatitis b, chronic - immunostimulants, - kronični hepatitis b: zdravljenje odraslih bolnikov s kroničnim hepatitisom b, povezanih z dokazi, hepatitis b virusno replikacijo (prisotnost hbv-dna in hbeag), povišana alanin aminotransferase (alt) in histologically dokazano aktivno vnetje jeter in/ali fibroza. kronični hepatitis c:odrasli bolniki:introna je indiciran za zdravljenje odraslih bolnikov s kroničnim hepatitisom c, ki so povišani transaminases brez jeter decompensation in ki so pozitivne za serum hcv-rna ali anti-hcv (glej poglavje 4. najboljši način za uporabo introna v ta navedba je v kombinaciji z ribavirin. chidren in mladostniki:introna je namenjen za uporabo v kombinaciji režim z ribavirin, za zdravljenje otrok in mladostnikov 3 let starosti in starejših, ki imajo kronični hepatitis c, ki še niso bila obdelana, brez jeter decompensation, in ki so pozitivne za serum hcv-rna. odločitev za zdravljenje mora biti vložena na podlagi primera, ob upoštevanju kakršne koli dokaze o napredovanja bolezni, kot so vnetje jeter in fibroza, kot tudi prognostic dejavnikov za odgovor, hcv genotip in virusno obremenitev. pričakovano korist zdravljenja je treba pretehtati varnost ugotovitve opaženi pri pediatričnih bolnikov v kliničnih preskušanjih (glej točki 4. 4, 4. 8 in 5.

Европейский союз - словенский - EMA (European Medicines Agency)

mendelikabs europe ltd - nitizinon - tyrosinemias - drugi zdravljene bolezni prebavil in presnove izdelki, - zdravljenje odraslih in pediatričnih bolnikov s katero je bila potrjena diagnoza dedne tipografije tipa 1 (ht 1) v kombinaciji s prehransko omejitvijo tirozina in fenilalanina.

Европейский союз - словенский - EMA (European Medicines Agency)

cycle pharmaceuticals (europe) ltd - nitizinon - tyrosinemias - drugi zdravljene bolezni prebavil in presnove izdelki, - za zdravljenje odraslih in pediatričnih bolnikih s potrjeno diagnozo dedno tyrosinemia tip 1 (ht-1) v kombinaciji z prehranskih omejitev tirozin in fenilalanin.

Европейский союз - словенский - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - bolezen tipa ii za shranjevanje glikogena - drugi proizvodi prebavnega trakta in metabolizma - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

Европейский союз - словенский - 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.

Словения - словенский - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

kapsula - lansoprazol

Словения - словенский - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

kapsula - lansoprazol