Den europeiske union - norsk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - splittet influensavirus, inaktivert, som inneholder antigen: a / vietnam / 1194/2004 (h5n1) som belastning brukt (nibrg-14) - influenza, human; immunization; disease outbreaks - vaksiner - profylakse av influensa i en offisielt erklært pandemisk situasjon. pandemisk influensavaksine bør brukes i henhold til offisiell veiledning.

Den europeiske union - dansk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - splittet influenzavirus, inaktiveret, indeholdende antigen: a / vietnam / 1194/2004 (h5n1) som brugt belastning (nibrg-14) - influenza, human; immunization; disease outbreaks - vacciner - aktiv immunisering mod h5n1-subtype af influenza a-virus. denne angivelse er baseret på immunogenicitet data fra raske forsøgspersoner i alderen fra 18 år og op efter administration af to doser vaccine, der er fremstillet af en/vietnam/1194/2004 nibrg-14 (h5n1) (se afsnit 5. prepandemic influenza vaccine (h5n1) (split virion, inaktiveret, adjuvanted) glaxosmithkline biologicals 3. 75 µg bør anvendes i overensstemmelse med officielle retningslinjer.

Den europeiske union - dansk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - splittet influenzavirus, inaktiveret, indeholdende antigen: a / vietnam / 1194/2004 (h5n1) som brugt belastning (nibrg-14) - influenza, human; immunization; disease outbreaks - vacciner - prophylax af influenza i en officielt erklæret pandemisk situation. pandemic influenza vaccine bør anvendes i overensstemmelse med officielle retningslinjer.

Den europeiske union - norsk - EMA (European Medicines Agency)

glaxosmithkline biologicals s.a. - splittet influensavirus inaktivert, inneholdende antigen tilsvarende a / california / 07/2009 (h1n1) -avledet stamme brukt nymc x-179a - influenza, human; immunization; disease outbreaks - influensavacciner - profylakse av influensa forårsaket av a (h1n1) v 2009 virus. pandemrix bør bare brukes dersom de anbefalte årlige trivalente / quadrivalente influensavaksinene ikke er tilgjengelige, og hvis immunisering mot (h1n1) v anses nødvendig (se avsnitt 4. 4 og 4. pandemrix skal være brukt i samsvar med offisielle veiledning.

Norge - norsk - Statens legemiddelverk

glaxosmithkline as - influensa a-virus (h1n1), inaktivert, splittvirus / influensa a-virus (h3n2), inaktivert, splittvirus / influensa b-virus, victoria-linje, inaktivert, splittvirus / influensa b-virus, yamagata-linje, inaktivert, splittvirus - injeksjonsvæske, suspensjon i ferdigfylt sprøyte - 15 mikrog ha / 15 mikrog ha / 15 mikrog ha / 15 mikrog ha

Den europeiske union - norsk - EMA (European Medicines Agency)

sanofi pasteur s.a. - influensa-virus (inaktivert, split) av følgende belastninger:a/california/7/2009 (h1n1)pdm09 - som belastning (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) - liknende stamme (en/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - som stamme (b/brisbane/60/2008, wild-type) - influenza, human; immunization - vaksiner - profylakse av influensa hos individer 60 år og eldre, spesielt hos de som har økt risiko for tilknyttede komplikasjoner. bruk av idflu bør være basert på offisielle anbefalinger.

Den europeiske union - norsk - EMA (European Medicines Agency)

sanofi pasteur europe - influensa-virus (inaktivert, split) av følgende belastninger:a/california/7/2009 (h1n1)pdm09 - som belastning (a/california/7/2009, nymc x-179a)a/hong kong/4801/2014 (h3n2) - liknende stamme (en/hong kong/4801/2014, nymc x-263b)b/brisbane/60/2008 - som stamme (b/brisbane/60/2008, wild-type) - influenza, human; immunization - vaksiner - profylakse av influensa hos individer 60 år og eldre, spesielt hos de som har økt risiko for tilknyttede komplikasjoner. bruk av intanza bør være basert på offisielle anbefalinger.

Norge - norsk - Statens legemiddelverk

sanofi pasteur europe - influensa a-virus (h1n1), inaktivert, splittvirus / influensa a-virus (h3n2), inaktivert, splittvirus / influensa b-virus (inaktivert, splittvirus) - injeksjonsvæske, suspensjon i ferdigfylt sprøyte - 15 mikrog/ sprøyte / 15 mikrog/ sprøyte / 15 mikrog/ sprøyte

Norge - norsk - Statens legemiddelverk

sanofi pasteur europe - influensa a-virus (h1n1), inaktivert, splittvirus / influensa a-virus (h3n2), inaktivert, splittvirus / influensa b-virus, victoria-linje, inaktivert, splittvirus / influensa b-virus, yamagata-linje, inaktivert, splittvirus - injeksjonsvæske, suspensjon i ferdigfylt sprøyte - 15 mikrog ha / 15 mikrog ha / 15 mikrog ha / 15 mikrog ha

Den europeiske union - norsk - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimykotika for systemisk bruk - 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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.