FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Danish: Varigheden af micafungindoseringen i disse rottestudier (6 måneder) overskred den normale varighed for micafungindosering hos patienter (se pkt.
English: Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
Danish: Samtidig administration af micafungin og amphotericin B-desoxycholat var forbundet med en 30 % øgning i amphotericin B-deoxycholat eksponeringen.
English: Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p<0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Danish: Micafungin viste en mindre middelværdisreduktion i den estimerede glomerulære filtrationshastighed under behandlingen (P<0,001) og en lavere forekomst af infusionsrelaterede reaktioner (P=0,001) sammenlignet med liposomalt amphotericin B.
English: The majority of hepatic adverse reactions were mild and moderate.
Danish: Størstedelen af disse bivirkninger var lette eller moderate.
English: Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
Danish: Det kan derfor forventes, at disse bivirkninger kan forekomme hos mennesker ved klinisk brug af micafungin.
English: Micafungin was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests, including an in vitro study on unscheduled DNA synthesis using rat hepatocytes.
Danish: Micafungin var ikke mutagent eller klastogent i et arsenal af standardundersøgelser omfattende både in vitro og in vivo tests, herunder et in vitro studie ”Unscheduled DNA Synthesis” med hepatocytter fra rotter.
English: These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.
Danish: Disse data er utilstrækkelige til at kunne anbefale en dosis i patienter med svært nedsat leverfunktion.
English: Elderly: When administered as a single 1-hour infusion of 50 mg the pharmacokinetics of micafungin in the elderly (aged 66-78 years) were similar to those in young (20-24 years) subjects.
Danish: Ældre: Når micafungin indgives som en enkelt 1-times infusion på 50 mg, svarer farmakokinetikken hos ældre (66-78 år) til, hvad man finder hos yngre voksne (20-24 år).
English: The MAH should agree the final content, format and distribution modalities of the Prescriber checklist with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Danish: Indehaveren af markedsføringstilladelsen skal nå til enighed med den relevante nationale myndighed i hver enkelt medlemsstat om det endelige indhold samt format og distributionsform for tjeklisten til ordinerende læger og sikre, at materialet indeholder de nedenfor beskrevne hovedelementer.
English: Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests.
Danish: Fortæl Deres læge, om De har alvorlige leverproblemer (f.eks. leversvigt eller leverbetændelse) eller har haft en unormal leverfunktionstest.
English: Adults, adolescents ≥ 16 years of age and elderly: - Treatment of invasive candidiasis.
Danish: Voksne, unge ≥ 16 år og hos ældre: - Behandling af invasiv candidiasis.
English: Children (including neonates) and adolescents < 16 years of age: - Treatment of invasive candidiasis.
Danish: Børn (inklusive nyfødte) og unge < 16 år: - Behandling af invasiv candidiasis.
English: Testicular toxicity was observed in animal studies (see section 5.3).
Danish: Testikeltoksicitet blev observeret i dyrestudier (se pkt.
English: The toxicology of micafungin following repeated intravenous dosing in rats and/or dogs showed adverse responses in liver, urinary tract, red blood cells, and male reproductive organs.
Danish: Micafungins toksicitet efter gentagen intravenøs dosering hos rotter og/eller hunde viste bivirkninger i lever, urinveje, røde blodlegemer og mandlige kønsorganer.
English: • To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
Danish: • Til behandling af voksne, unge, børn og nyfødte, der har en alvorlig svampeinfektion, også kaldet ”invasiv candidiasis” (svampeinfektion, som spreder til hele kroppen).
English: Injection-site reactions None of the injection-site adverse reactions were treatment limiting.
Danish: Reaktioner på injektionsstedet Ingen af bivirkningerne på injektionsstedet var begrænsende for behandlingen.
English: Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Danish: Eksfoliative hudreaktioner, såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse er blevet rapporteret.
English: Micafungin is unlikely to have an effect on driving or using machines.
Danish: Micafungin vil højst sandsynligt ikke have indflydelse på kørsel eller betjening af maskiner.
English: Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida.
Danish: Mycamine bruges til at behandle svampeinfektioner forårsaget af svampe- eller gærceller kaldet Candida.
English: Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
Danish: Alvorlige reaktioner (f.eks. anafylaktoide reaktioner 0,2 %, 6/3028) blev sjældent indberettet under behandling med micafungin og kun hos patienter med alvorlige underliggende sygdomme (f.eks. fremskreden AIDS og maligne tilstande), som kræver samtidig behandling med flere lægemidler.
English: There are currently insufficient data available for the use of micafungin in patients with severe hepatic impairment and its use is not recommended in these patients (see sections 4.4 and 5.2).
Danish: Der er i øjeblikket ikke tilstrækkelig med data for brug af micafungin hos patienter med svært nedsat leverfunktion, og brug til disse patienter kan ikke anbefales (se pkt.
English: ≥ 1/100 to < 1/10
Danish: ≥1/100 til <1/10
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet, efter hvor alvorlige de er.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.
Danish: Det skal besluttes, om amning skal fortsætte/ophøre eller behandling med Mycamine skal fortsætte/ophøre, idet der tages hensyn til fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
Danish: I et andet 26 ugers studie var forekomsten af hyperplasi af overgangsepitelet i urinblæren betydelig lavere.
English: In standard safety pharmacology tests, cardiovascular and histamine releasing effects of micafungin were evident and appeared to be time above threshold dependent.
Danish: I standardundersøgelser af sikkerhedsfarmakologi blev der set kardiovaskulære og histaminfrigørende effekter af micafungin, og de viste sig at være tidsafhængige over en vis tærskel.
English: Patients with renal impairment: Severe renal impairment (Glomerular Filtration Rate [GFR] < 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
Danish: Patienter med nedsat nyrefunktion: Svært nedsat nyrefunktion (Glomerular Filtration Rate [GFR] < 30 ml/min) påvirkede ikke farmakokinetikken af micafungin signifikant.
English: The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.
Danish: Hyppigheden af visse bivirkninger (angivet i nedenstående tabel) var større hos børn end hos voksne patienter.
English: If central nervous system (CNS) infection is suspected, a higher dosage (e.g. 10 mg/kg) should be used due to the dose-dependent penetration of micafungin into the CNS (see section 5.2).
Danish: Hvis der er mistanke om infektion i centralnervesystemet (CNS), bør en højere dosis (f.eks.10 mg/kg) anvendes på grund af den dosisafhængige penetrering af micafungin ind i CNS (se pkt.
English: Animal studies have shown excretion of micafungin in breast milk.
Danish: Dyrestudier har vist, at micafungin udskilles i mælk.
English: The mean period of treatment was 19 days for micafungin and 18 days for fluconazole in the adult population (N=798) and 23 days for both treatment arms in the paediatric population (N=84).
Danish: Den gennemsnitlige behandlingsperiode var 19 dage for micafungin og 18 dage for fluconazol i den voksne population (N=798), og 23 dage for begge behandlingsarme i børnegruppen (N=84).
English: The plasma exposure at the assumed threshold for tumour development in rats (i.e. the dose where no FAH and liver tumours were detected) was in the same range as the clinical exposure.
Danish: Plasmaeksponeringen ved den formodede tærskelværdi for tumorudvikling hos rotter (dvs. den dosis, hvor der ikke blev fundet FAH og levertumorer) lå inden for det kliniske eksponeringsinterval.
English: The diluted infusion solution should be used immediately.
Danish: Den fortyndede infusionsopløsning bør anvendes straks.
English: Cardiac disorders tachycardia, palpitations, bradycardia
Danish: Hjerte takykardi, palpitationer, bradykardi
English: During treatment your liver functions will be monitored more closely.
Danish: Deres leverfunktion vil blive nøjere overvåget under behandlingen.
English: The median treatment duration was 14 days and the median average daily dose was 150 mg for micafungin (N=260) and 200 mg for fluconazole (N=258).
Danish: Den gennemsnitlige behandlingsvarighed var 14 dage, og den gennemsnitlige daglige dosis var 150 mg for micafungin (N=260) og 200 mg for fluconazol (N=258).
English: Mycamine contains sodium
Danish: Mycamine indeholder natrium
English: Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Danish: Mycamine kaldes et svampemiddel, fordi det bruges til behandling af infektioner forårsaget af svampeceller.
English: 2 mg/kg/day *Micafungin dosed at 4 mg/kg in children less than 4 months approximates drug exposures achieved in adults receiving 100 mg/day for the treatment of invasive candidiasis.
Danish: 2 mg/kg/dag *Micafungin dosis på 4 mg/kg til børn under 4 måneder approksimerer lægemiddeleksponering hos voksne der fik 100 mg/dag til behandling af invasiv candidiasis.
English: Mycamine should therefore only be used if other antifungals are not appropriate.
Danish: Mycamine bør derfor kun anvendes, hvis andre antimykotika ikke er hensigtsmæssige.
English: Drug interaction studies in healthy human subjects were conducted to evaluate the potential for interaction between micafungin and mycophenolate mofetil, ciclosporin, tacrolimus, prednisolone, sirolimus, nifedipine, fluconazole, ritonavir, rifampicin, itraconazole, voriconazole and amphotericin B. In these studies, no evidence of altered pharmacokinetics of micafungin was observed.
Danish: Der er udført interaktionsstudier hos raske frivillige for at undersøge interaktionspotentialet mellem micafungin og mykofenolatmofetil, ciklosporin, takrolimus, prednisolon, sirolimus, nifedipin, fluconazol, ritonavir, rifampicin, itraconazol, voriconazol og amphotericin B. I disse studier blev der ikke fundet bevis for, at farmakokinetikken af micafungin blev påvirket.
English: In juvenile dogs, 39 weeks treatment did not induce lesions in the testis and epididymides in a dose dependent manner at the end of treatment but after a treatment free period of 13 weeks a dose dependent increase in these lesions were noted in the treated recovery groups.
Danish: Hos unge hunde medførte 39 ugers behandling ikke dosisafhængige læsioner i testikler og bitestikler ved slutningen af behandlingen, men efter en behandlingsfri periode på 13 uger blev der fundet en dosisafhængig øgning af disse læsioner i de behandlede grupper.
English: The MAH shall ensure that prior to prescribing of the product prescribers will receive the prescriber checklist.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at ordinerende læger modtager tjeklisten for læger inden produktet udskrives.
English: In rats, signs of haemolytic anaemia were observed after repeated bolus injection of micafungin.
Danish: Hos rotter blev tegn på hæmolytisk anæmi observeret efter gentagen bolusinjektion af micafungin.
English: Micafungin has no or negligible influence on the ability to drive or use machines.
Danish: Micafungin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The assumed threshold for tumour development in rats is approximately in the range of clinical exposure.
Danish: Den formodede tærskelværdi for tumorudvikling hos rotter var omtrent i samme størrelsesorden som klinisk eksponering.
English: There was a fixed daily dose of 50 mg (1.0 mg/kg) for micafungin and 400 mg (8 mg/kg) for fluconazole.
Danish: Der var en fast daglig dosis på 50 mg (1,0 mg/kg) med micafungin og 400 mg (8 mg/kg) med fluconazol.
English: It is especially important to inform your doctor if you are using amphotericin B desoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressant) or nifedipine (calcium channel blocker used to treat high blood pressure).
Danish: Det er særlig vigtigt, at De fortæller Deres læge, hvis De får medicin, der indeholder amphotericin Bdeoxycholat eller itraconazol (mod svampeinfektioner), sirolimus (undertrykker immunsystemet) eller nifedipin (calciumkanalblokker til behandling af forhøjet blodtryk).
English: Pack size: packs of 1 vial.
Danish: Pakningsstørrelse: Pakninger med 1 hætteglas.
English: MICs for C. krusei are approximately 3 two-fold dilution steps higher than those for C. albicans and, similarly, those for C. guilliermondii are approximately 8 two-fold dilutions higher.
Danish: MICs for C. krusei er cirka 3 to-fold fortyndingstrin højere end for C. albicans, og tilsvarende er det for C. guilliermondii cirka 8 to-fold fortyndingstrin højere.
English: However, once these results become available, antifungal therapy should be adjusted accordingly.
Danish: Når resultaterne foreligger, bør den antimykotiske behandling justeres i overensstemmelse med resultaterne.
English: In repeated dose toxicity studies in rat signs of hepatotoxicity consisted of increased liver enzymes and degenerative changes of hepatocytes which were accompanied by signs of compensatory regeneration.
Danish: I gentagne toksicitetsstudier på rotter var symptomerne på levertoksicitet, forhøjede niveauer af leverenzymer og degenerative forandringer af hepatocytter, som blev ledsaget af symptomer på kompenserende regenerering.
English: Possible allergic-like symptoms
Danish: Allergilignende symptomer
English: Standard infusion (added up to 100 ml)
Danish: Standardinfusion (fyldt op til 100 ml) Slutkoncentration
English: 1 MICs for C. tropicalis are 1-2 two-fold dilution steps higher than for C albicans and C. glabrata.
Danish: 1 MICs for C. tropicalis er 1-2 to-fold fortyndingstrin højere end for C. albicans og C. glabrata.
English: 1 mg/kg/day *If the patient's response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
Danish: 1 mg/kg/dag *Hvis patientens respons er utilstrækkelig, f.eks. hvis kulturerne giver negative resultater, eller den kliniske tilstand ikke forbedres, kan dosis øges til 200 mg/dag hos patienter, der vejer > 40 kg eller 4 mg/kg/dag hos patienter, som vejer ≤ 40 kg.
English: ≥ 1/1,000 to < 1/100
Danish: ≥1/1.000 til <1/100
English: Mycamine contains no preservatives.
Danish: Mycamine indeholder ingen konserveringsmidler.
English: Since this may be of clinical significance this coadministration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4).
Danish: Da dette kan have klinisk betydning, bør samtidig administration kun ske, når fordelene klart opvejer risiciene og under omhyggelig monitorering af toksiciteten af amphotericin B-desoxycholat (se pkt.
English: In plasma, metabolites M-1 and M-2 were detected only at trace concentrations and metabolite M-5, the more abundant metabolite, accounted for a total of 6.5% relative to parent compound.
Danish: I plasma fandt man kun sporkoncentrationer af metabolitterne M-1 og M-2, mens M-5, den mere udtalte metabolit, fandtes i en mængde svarende til 6,5 % af den oprindelige substans.
English: Prophylaxis of Candida infections: Micafungin should be administered for at least one week after neutrophil recovery.
Danish: Profylakse mod Candida-infektioner: Micafungin bør administreres i mindst 1 uge, efter at neutrofiltallet er normaliseret.
English: Prophylaxis of Candida infection
Danish: Profylakse mod Candida-infektion
English: • Periodic Safety Update Reports
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er)
English: Blood and lymphatic system disorders common thrombocytopenia
Danish: Blod og lymfesystem almindelig trombocytopeni
English: Contents of the pack and other information What Mycamine contains
Danish: Pakningsstørrelser og yderligere oplysninger Mycamine indeholder:
English: Additionally, paediatric patients < 1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients (see section 4.4).
Danish: Desuden fik børn < 1 år ca. dobbelt så ofte en stigning i ALAT, ASAT og ALP end ældre børn (se pkt.
English: Additional side effects in children and adolescents
Danish: Hos børn og teenagere kan endvidere ses følgende bivirkninger
English: Micafungin may also cause severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Danish: Micafungin kan også forårsage alvorlig betændelse/udbrud i hud og slimhinder (Stevens-Johnsons syndrom og toksisk epidermal nekrolyse).
English: Talk to your doctor or pharmacist before using Mycamine - if you are allergic to any medicine - if you have haemolytic anaemia (anaemia due to breakdown of red blood cells) or haemolysis
Danish: Kontakt lægen eller apotekspersonalet, før De bruger Mycamine - hvis De er allergisk over for andre lægemidler - hvis De lider af hæmolytisk anæmi (blodmangel som skyldes nedbrydning af røde blodlegemer)
English: Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Danish: Mængde natriumchlorid (0,9 %) eller glucose (5 %), der skal tilsættes til hvert hætteglas
English: Psychiatric disorders insomnia, anxiety, confusion
Danish: Psykiske forstyrrelser insomni, angst, forvirring
English: FAH recorded after treatment for 13 weeks or longer persisted after a 13-week withdrawal period and developed into hepatocellular tumours following a treatment free period which covered the life span of rats.
Danish: Når FAH blev observeret efter behandling i 13 uger eller mere, var der stadig efter en 13-ugers seponeringsperiode FAH, som udviklede sig til hepatocellulære tumorer efter en behandlingsfri periode, som strakte sig over resten af rotternes levetid.
English: No impairment of male or female fertility was observed in the fertility and early embryonic development study in rats.
Danish: Der blev ikke observeret nedsat fertilitet hos hverken hanner eller hunner i de respektive fertilitets- og tidlige fosterundersøgelser af rotter.
English: The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4).
Danish: Beslutningen om at anvende Mycamine bør tage højde for den potentielle risiko for udvikling af levertumorer (se pkt.
English: The nature and incidence of adverse reactions were similar between treatment groups.
Danish: Type og forekomst af bivirkninger var ens for behandlingsgrupperne.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på den fremstiller der er ansvarlig for batchfrigivelse:
English: If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress.
Danish: Hvis patienten udvikler hududslæt, skal patienten overvåges nøje, og micafungin seponeres, såfremt læsionen udvikler sig.
English: The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies.
Danish: Den mest sandsynlige årsag var forskelle i de underliggende sygdomme hos børn < 1 år i forhold til voksne eller ældre børn i de kliniske studier.
English: ≥ 1/10,000 to
Danish: ≥1/10.000 til
English: PK/PD bridging study demonstrated dose-dependent penetration of micafungin into CNS with the minimum AUC of 170 µg*hr/L required to achieve maximum eradication of fungal burden in the CNS tissues.
Danish: Et farmakokinetisk/farmakodynamisk studie (PK/PD bridging study) viste dosisafhængig penetration af micafungin ind i CNS med et minimunskrav til AUC på 170 µg∙t/l for at opnå maksimal eradikation af svampeinfektionen i CNS-vævene.
English: In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3).
Danish: Dyrestudier har vist, at micafungin passerer placentabarrieren, og der blev påvist reproduktionstoksicitet (se pkt.
English: Other medicines and Mycamine
Danish: Brug af anden medicin sammen med Mycamine
English: Use in adults, adolescents ≥ 16 years of age and elderly
Danish: Anvendelse til voksne, unge ≥ 16 år og ældre
English: In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported.
Danish: I enkelte tilfælde er det blevet indberettet, at patienterne fik mere alvorligt nedsat leverfunktion, hepatit eller leversvigt, herunder letale tilfælde.
English: If this happens, your doctor may decide to monitor your kidney function more closely.
Danish: Deres læge beslutte at overvåge Deres nyrefunktion nøjere.
English: In a study performed in patients with severe hepatic impairment (ChildPugh score 10-12) (n=8), lower plasma concentrations of micafungin and higher plasma concentrations of the hydroxide metabolite (M-5) were seen compared to healthy subjects (n=8).
Danish: I et studie foretaget på patienter med svært nedsat leverfunktion (Child-Pughscore 10-12 (n=8), blev lave plasmakoncentrationer af micafungin og høje plasmakoncentrationer af den hydroxylerede metabolit (M-5) set i forhold til raske forsøgspersoner (n=8).
English: Reconstituted concentrate in vial
Danish: Rekonstitueret koncentrat i hætteglas
English: Oesophageal candidiasis: Micafungin should be administered for at least one week after resolution of clinical signs and symptoms.
Danish: Candidiasis i øsofagus: Micafungin bør administreres i mindst en uge, efter at kliniske symptomer er ophørt.
English: Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%).
Danish: De hyppigste var forhøjet fosfatase (AP) (2,7 %), ASAT (2,3 %), ALAT (2,0 %) og blod-bilirubin (1,6 %) samt unormal leverfunktionstest (1,5 %).
English: Paediatric patients < 1 year of age might be more prone to liver injury (see section 4.8).
Danish: Børn < 1 år er muligvis mere udsatte for leverskade (se pkt.