Liên Minh Châu Âu - Tiếng Thụy Điển - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika för systemisk användning - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 och 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 och 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. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk terapi. 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 och 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 och 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 och 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. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk terapi. 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 och 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 och 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. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk terapi. 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):- invasiv aspergillos hos patienter med sjukdom som är refraktära mot amfotericin b eller itrakonazol eller till patienter som är intoleranta mot dessa läkemedel, - fusariosis på patienter med den sjukdom som är refraktära mot amfotericin b eller till patienter som är intoleranta mot amfotericin b;- chromoblastomycosis och mycetoma på patienter med den sjukdom som är refraktära mot itrakonazol eller till patienter som är intoleranta mot itrakonazol;- coccidiomykos på patienter med den sjukdom som är refraktära mot amfotericin b, itrakonazol eller flukonazol eller till patienter som är intoleranta mot dessa läkemedel.- munhåla candidiasis: som första linjens behandling av patienter som har svår sjukdom eller nedsatt immunförsvar, i vilken respons till aktuell terapi väntas dålig. refraktäritet definieras som utveckling av infektion eller utebliven förbättring efter en vistelse på minst 7 dagar före terapeutiska doser av effektiv antimykotisk terapi. 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.

Liên Minh Châu Âu - Tiếng Thụy Điển - EMA (European Medicines Agency)

noden pharma dac - aliskiren - hypertension - agenter som verkar på renin-angiotensinsystemet - behandling av essentiell hypertoni.

Liên Minh Châu Âu - Tiếng Thụy Điển - EMA (European Medicines Agency)

noden pharma dac - aliskiren, hydroklortiazid - hypertension - agenter som verkar på renin-angiotensinsystemet - behandling av essentiell hypertoni hos vuxna. rasilez hct är indicerat för patienter vars blodtryck inte är tillräckligt kontrollerat på aliskiren eller hydroklortiazid används ensam. rasilez hct är indicerat som substitutions-behandling av patienter tillräckligt kontrollerat med aliskiren och hydroklortiazid, som ges parallellt på samma dos som i kombination.

Liên Minh Châu Âu - Tiếng Thụy Điển - EMA (European Medicines Agency)

pfizer europe ma eeig - vorikonazol - candidiasis; mycoses; aspergillosis - antimykotika för systemisk användning - vorikonazol är ett brett spektrum, triazol svampdödande agent och är indicerat för vuxna och barn i åldern 2 år och uppåt enligt följande: - behandling av invasiv aspergillos, behandling av i candidaemianon-neutropena patienter, behandling av flukonazol-resistenta allvarliga invasiva candida-infektioner (inklusive c. krusei);behandling av allvarliga svampinfektioner orsakade av scedosporium spp. och fusarium spp.. vfend bör ges främst till patienter med progressiva, möjligen livshotande infektioner. profylax av invasiva svampinfektioner i hög risk allogen hematopoetisk stamcellstransplantation (hsct) mottagare.

Thụy Điển - Tiếng Thụy Điển - Läkemedelsverket (Medical Products Agency)

acino ag - naloxonhydrokloriddihydrat; oxikodonhydroklorid - depottablett - 10 mg/5 mg - laktosmonohydrat hjälpämne; stearylalkohol hjälpämne; naloxonhydrokloriddihydrat 5,5 mg aktiv substans; oxikodonhydroklorid 10 mg aktiv substans

Thụy Điển - Tiếng Thụy Điển - Läkemedelsverket (Medical Products Agency)

acino ag - naloxonhydrokloriddihydrat; oxikodonhydroklorid - depottablett - 5 mg/2,5 mg - laktosmonohydrat hjälpämne; oxikodonhydroklorid 5 mg aktiv substans; naloxonhydrokloriddihydrat 2,75 mg aktiv substans; stearylalkohol hjälpämne

Thụy Điển - Tiếng Thụy Điển - Läkemedelsverket (Medical Products Agency)

acino ag - naloxonhydrokloriddihydrat; oxikodonhydroklorid - depottablett - 20 mg/10 mg - oxikodonhydroklorid 20 mg aktiv substans; stearylalkohol hjälpämne; naloxonhydrokloriddihydrat 11 mg aktiv substans

Thụy Điển - Tiếng Thụy Điển - Läkemedelsverket (Medical Products Agency)

acino ag - naloxonhydrokloriddihydrat; oxikodonhydroklorid - depottablett - 40 mg/20 mg - oxikodonhydroklorid 40 mg aktiv substans; naloxonhydrokloriddihydrat 22 mg aktiv substans; stearylalkohol hjälpämne

Thụy Điển - Tiếng Thụy Điển - Läkemedelsverket (Medical Products Agency)

acino ag - naloxonhydrokloriddihydrat; oxikodonhydroklorid - depottablett - 40 mg/20 mg - stearylalkohol hjälpämne; naloxonhydrokloriddihydrat 22 mg aktiv substans; oxikodonhydroklorid 40 mg aktiv substans

Thụy Điển - Tiếng Thụy Điển - Läkemedelsverket (Medical Products Agency)

acino ag - naloxonhydrokloriddihydrat; oxikodonhydroklorid - depottablett - 10 mg/5 mg - stearylalkohol hjälpämne; naloxonhydrokloriddihydrat 5,5 mg aktiv substans; oxikodonhydroklorid 10 mg aktiv substans; laktosmonohydrat hjälpämne