Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - caspofungin asetat - candidiasis; aspergillosis - sveppalyf fyrir almenn nota - meðferð innrásar sveppasýkingu í fullorðinn eða börn sjúklingar. meðferð innrásar aspergillosis í fullorðinn eða börn sjúklingum sem svarar til eða þola amfótericín b, fitu blöndum amfótericín b og/eða ítrakónazól. 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. reynslunni meðferð fyrir ráð sveppasýkingu (eins og candida eða aspergillus) í hita, neutropaenic fullorðinn eða börn sjúklingar.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pfizer europe ma eeig - vórikónazól - candidiasis; mycoses; aspergillosis - sveppalyf fyrir almenn nota - voriconazole, er vítt svið, triazole mikla umboðsmanni og er ætlað í fullorðna og börn sem eru 2 ár og yfir, sem hér segir:meðferð innrásar aspergillosis;meðferð í candidaemianon-daufkyrningafæð sjúklingar;meðferð flúkónazól-þola alvarleg innrásar candida sýkingum (þar á meðal c. krusei);meðferð alvarleg sveppasýkingu af völdum scedosporium spp. og fusarium spp. fylgjast skal gefa fyrst og fremst að sjúklingar með versnandi, hugsanlega lífshættuleg sýkingum. fyrirbyggja innrásar sveppasýkingu í mikilli hættu ósamgena blóðmyndandi stafa klefi grætt (hsct) viðtakendur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

recordati ireland ltd. - lídókaín, prilocaine - kynferðisleg truflun, lífeðlisfræðileg - svæfingarlyf - meðferð aðal ótímabært sáðlát í fullorðnum körlum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

accord healthcare s.l.u. - vórikónazól - aspergillosis; candidiasis; mycoses - sveppalyf fyrir almenn nota, tríazólafleiður - voriconazole er breiða, triazole mikla umboðsmanni og er ætlað í fullorðna og börn sem eru tvö ár og yfir, sem hér segir:meðferð innrásar aspergillosis;meðferð hefja ekki daufkyrningafæð sjúklingar;meðferð flúkónazól-þola alvarleg innrásar candida sýkingum (þar á meðal c. krusei);meðferð alvarleg sveppasýkingu af völdum scedosporium spp. og fusarium spp. voriconazole vegum ætti að vera gefið fyrst og fremst að sjúklingar með versnandi, hugsanlega lífshættuleg sýkingum.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

hikma farmaceutica (portugal) s.a. - vórikónazól - bacterial infections and mycoses; aspergillosis; candidiasis - sveppalyf fyrir almenn nota - voriconazole er vítt svið, triazole mikla umboðsmanni og er ætlað í fullorðna og börn sem eru 2 ár og yfir, sem hér segir:meðferð innrásar aspergillosis;meðferð hefja ekki daufkyrningafæð sjúklingar;meðferð flúkónazól-þola alvarleg innrásar candida sýkingum (þar á meðal c. krusei);meðferð alvarleg sveppasýkingu af völdum scedosporium spp. og fusarium spp. voriconazole skal gefa fyrst og fremst að sjúklingar með versnandi, hugsanlega lífshættuleg sýkingum. fyrirbyggja innrásar sveppasýkingu í mikilli hættu ósamgena blóðmyndandi stafa klefi grætt (hsct)viðtakendur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

les laboratoires servier - trifluridine, tipiracil stutt og long-term - litlaræxli - Æxlishemjandi lyf - colorectal cancerlonsurf is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (crc) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and/or anti-egfr agents. lonsurf is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (crc) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti egfr agentsgastric cancerlonsurf is indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - sveppalyf fyrir almenn nota - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pfizer europe ma eeig - anidulafungin - candidiasis - sveppalyf fyrir almenn nota - meðferð innrásar sveppasýkingu í fullorðna og börn sjúklinga á aldrinum 1 mánuð til að < 18 ára.