Cayston Европейский союз - исландский - EMA (European Medicines Agency)

cayston

gilead sciences ireland uc - aztreonam lysín - cystic fibrosis; respiratory tract infections - sýklalyf fyrir almenn nota, - cayston er ætlað fyrir bælandi meðferð langvarandi lungum sýkingum vegna pseudomonas tilhneiging til að hætta í sjúklingar fengið lungnasjúkdóm (samanber) aldrinum 6 ára og eldri. Íhuga ætti að opinbera leiðsögn á réttri notkun af sýklalyfjum.

Farydak Европейский союз - исландский - EMA (European Medicines Agency)

farydak

pharmaand gmbh - vatnsfrí panóbínóstat laktat - mergæxli - Æxlishemjandi lyf - farydak, ásamt bortezomib og leiðbeina, er ætlað fyrir meðferð fullorðinn sjúklinga með fallið og/eða óviðráðanleg margar forráðamenn sem hafa fengið að minnsta kosti tvær áður en meðferð þar á meðal bortezomib og virkt efni. farydak, ásamt bortezomib og leiðbeina, er ætlað fyrir meðferð fullorðinn sjúklinga með fallið og/eða óviðráðanleg margar forráðamenn sem hafa fengið að minnsta kosti tvær áður en meðferð þar á meðal bortezomib og virkt efni.

Mycamine Европейский союз - исландский - EMA (European Medicines Agency)

mycamine

astellas pharma europe b.v. - micafungin - candidiasis - sveppalyf fyrir almenn nota - mycamine er ætlað til:fullorðnir, unglingum stærri 16 ára aldri og elderlytreatment af innrásar sveppasýkingu;meðferð oesophageal sveppasýkingu í sjúklingar sem gjöf meðferð er rétt;fyrirbyggja candidasýkingu í gangast undir ósamgena skurðaðgerðir stafa-klefi ígræðslu eða sjúklingum sem er gert ráð fyrir að hafa mæði í tengslum (alger ss telja < 500 frumur/míkról) fyrir 10 eða fleiri daga. börn (þar á meðal nýbura) og unglingar < 16 ára agetreatment af innrásar sveppasýkingu. fyrirbyggja candidasýkingu í gangast undir ósamgena skurðaðgerðir stafa-klefi ígræðslu eða sjúklingum sem er gert ráð fyrir að hafa mæði í tengslum (alger ss telja < 500 frumur/míkról) fyrir 10 eða fleiri daga. sú ákvörðun að nota mycamine ætti að taka með í reikninginn hugsanlega hættu fyrir þróun lifur æxli. mycamine ætti að því aðeins að nota ef önnur sveppalyf eru ekki viðeigandi.

Noxafil Европейский союз - исландский - EMA (European Medicines Agency)

noxafil

merck sharp and dohme b.v - posakónazól - candidiasis; mycoses; coccidioidomycosis; aspergillosis - sveppalyf fyrir almenn nota - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 og 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 og 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. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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 og 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 og 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 og 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. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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 og 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 og 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. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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):- 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;- oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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.

Solymbic Европейский союз - исландский - EMA (European Medicines Agency)

solymbic

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - Ónæmisbælandi lyf - vinsamlegast skoðaðu kafla 4. 1 af samantekt á eiginleikum vöru í upplýsingaskjalinu.

Cyltezo Европейский союз - исландский - EMA (European Medicines Agency)

cyltezo

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - Ónæmisbælandi lyf - vinsamlegast skoðaðu kafla 4. 1 af samantekt á eiginleikum vöru í upplýsingaskjalinu.