Tsjekkia - tsjekkisk - SUKL (Státní ústav pro kontrolu léčiv)

teva pharmaceuticals cr, s.r.o., praha array - 76 amfotericin b - koncentrát pro infuzní disperzi - 5mg/ml - amfotericin b

USA - engelsk - NLM (National Library of Medicine)

leadiant biosciences, inc. - amphotericin b (unii: 7xu7a7droe) (amphotericin b - unii:7xu7a7droe), dimyristoylphosphatidylcholine, dl- (unii: u86zgc74v5) (dimyristoylphosphatidylcholine, dl- - unii:u86zgc74v5), dimyristoylphosphatidylglycerol, dl- (unii: bi71wt9p3r) (dimyristoylphosphatidylglycerol, dl- - unii:bi71wt9p3r) - amphotericin b 5 mg in 1 ml - abelcet ® is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin b therapy. this is based on open-label treatment of patients judged by their physicians to be intolerant to or failing conventional amphotericin b therapy (see description of clinical studies). description of clinical studies fungal infections data from 473 patients were pooled from three open-label studies in which abelcet ® was provided for the treatment of patients with invasive fungal infections who were judged by their physicians to be refractory to or intolerant of conventional amphotericin b, or who had preexisting nephrotoxicity. results of these studies demonstrated effectiveness of abelcet ® in the treatment of invasive fungal infections as a second line therapy. patients were defined by their individual physician as being refractory to or failing conventional amphotericin b therapy based on overall clinical judgement after receiving a minimu

Spania - spansk - AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

teva pharma s.l.u. - amfotericina b - concentrado para dispersiÓn para perfusiÓn - 100 mg - amfotericina b 5 mg - amfotericina b

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - amphotericin b (amphotericin) -

Nederland - nederlandsk - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

teva nederland b.v. swensweg 5 2031 ga haarlem - amfotericine b 5 mg/ml - concentraat voor oplossing voor infusie - l-alpha-dimyristoylphosphatidylcholine (ri) ; l-alpha-dimyristoylphosphatidylglycerol ( as sodium ammonium salt) (ri) ; natriumchloride ; stikstof (head space) (e 941) ; water, gezuiverd, - amphotericin b

Belgia - nederlandsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - amfotericine b 100 mg/20 ml - concentraat voor dispersie voor infusie - 5 mg/ml - amfotericine b 5 mg/ml - amphotericin b

Brasil - portugisisk - ANVISA (Agência Nacional de Vigilância Sanitária)

teva farmacÊutica ltda. - anfotericina b - anti-fungicos

Belgia - fransk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - amphotéricine b 100 mg/20 ml - dispersion à diluer pour perfusion - 5 mg/ml - amphotéricine b 5 mg/ml - amphotericin b

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

orphan australia pty ltd - amphotericin -

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - amphotericin b 5 mg/ml (as a lipid complex; for manufacture see dmf tt60-104-24-4);   - emulsion for infusion - 5 mg/ml - active: amphotericin b 5 mg/ml (as a lipid complex; for manufacture see dmf tt60-104-24-4)   excipient: dimyristoylphosphatidylcholine dimyristoylphosphatidylglycerol as sodium and ammonium salts sodium chloride water for injection - abelcet is indicated for the treatment of invasive fungal disease caused by organisms susceptible to amphotericin b.