natgillin/translations-raw huggingface dataset:
Alt rekonstitueret koncentrat bør udtages fra hvert hætteglas og returneres til den infusionsflaske/pose, hvorfra det oprindeligt blev udtaget. 
All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
I et spontant tilfælde blev der indberettet administration af en dosis på 16 mg/kg/dag til et nyfødt barn. 
In one spontaneous case, it was reported a dosage of 16 mg/kg/day was administered in a newborn patient.
Prøver til svampekulturer og andre relevante laboratorietests (inklusive histopatologi) bør tages før behandling for at isolere og identificere de(n) sygdomsfremkaldende organisme(r). 
Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s).
Patienter bør imidlertid informeres om, at svimmelhed er rapporteret under behandling med micafungin (se pkt. 
However, patients should be informed that dizziness has been reported during treatment with micafungin (see section
Hos kaniner forekom der en abort ved 32 mg/kg/dag. 
One abortion occurred in rabbits at 32 mg/kg/day.
Mycamine må ikke blandes med eller indgives sammen med andre lægemidler end de nedenfor nævnte. 
Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below.
I det kliniske studie var vellykket resultat numerisk en anelse lavere for C. tropicalis end for C. albicans ved begge doser (100 og 150 mg daglig). 
In the clinical study, successful outcome was numerically slightly lower for C. tropicalis than for C. albicans at both dosages (100 and 150 mg daily).
Mycamine bør ikke bruges under graviditet, medmindre det er strengt nødvendigt. 
Mycamine should not be used during pregnancy unless clearly necessary.
Eksponering (AUC) for itraconazol, sirolimus og nifedipin viste en let øgning i forbindelse med micafungin (henholdsvis 22 %, 21 % og 18 %). 
Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Mycamine er effektivt til at behandle systemiske infektioner (infektioner, der har spredt sig i hele kroppen). 
Mycamine is effective in treating systemic infections (those that have penetrated within the body).
Ikke anvendt lægemiddel samt affald heraf skal destrueres i henhold til lokale retningslinjer. 
Any unused product or waste material should be disposed of in accordance with local requirements.
Behandlingssucces var signifikant højere for micafungin end for fluconazol (1,6 % versus 2,4 % påviste infektioner). 
The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Et tilstrækkeligt antal hætteglas med Mycamine skal rekonstitueres for at kunne få den tilstrækkelige dosis i mg (se nedenstående tabel). 
A sufficient number of vials of Mycamine must be reconstituted to obtain the required dose in mg (see table below).
Hvis De får et allergisk anfald eller en alvorlig hudreaktion (f.eks. blæredannelse og afskalning af huden), skal De straks fortælle det til lægen eller sundhedspersonalet. 
If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or nurse immediately
Micafungin har et lavt interaktionspotentiale med lægemidler, som omdannes via CYP3A- medierede nedbrydningsveje. 
Micafungin has a low potential for interactions with medicines metabolised via CYP3A mediated pathways.
Der blev ikke indberettet bivirkninger i forbindelse med denne høje dosis. 
No adverse reactions associated with this high dose were noted.
Infektionsbehandlingen bør fortsætte i mindst en uge, efter at to på hinanden følgende negative blodprøver er taget, og efter at kliniske symptomer fra infektionen er ophørt. 
The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
Vægt havde betydning for clearance, idet gennemsnitsværdien af vægt-justeret clearance var 1,35 gange højere hos yngre børn (4 måneder-5 år) og 1,14 gange højere hos pædiatriske patienter i alderen 6-11 år. 
Clearance was influenced by weight, with mean values of weight-adjusted clearance 1.35 times higher in the younger children (4 months to 5 years) and 1.14 times higher in paediatric patients aged 6 to 11 years.
Den gennemsnitlige vægtjusterede clearance hos børn under 4 måneder er ca. 2,6 gange højere end hos ældre børn (12-16 år) og 2,3 gange højere end hos voksne. 
Mean weight-adjusted clearance in children less than 4 months of age is approximately 2.6-fold greater than older children (12-16 years) and 2.3-fold greater than in adults.
Dosisjustering af micafungin er ikke nødvendig ved samtidig administration af disse lægemidler. 
No micafungin dose adjustments are necessary when these medicines are administered concomitantly.
Micafungin udviser fungicid effekt på de fleste Candida-arter og hæmmer kraftigt aktivt voksende hyfer af Aspergillus-arter. 
Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.
Efter rekonstitution og fortynding skal opløsningen administreres ved intravenøs infusion over ca. 1 time. 
After reconstitution and dilution, the solution should be administered by intravenous infusion over approximately 1 hour.
- Behandling af candidiasis i øsofagus hos patienter, hvor intravenøs behandling er passende. 
- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
Behandling af invasiv candidiasis 
Treatment of invasive candidiasis
Behandling med Mycamine bør initieres af en læge med erfaring i behandling af systemiske svampeinfektioner. 
Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections.
Micafungin kan muligvis påvirke fertiliteten hos mænd. 
Micafungin may have the potential to affect male fertility in humans.
Påviste Aspergillus-infektioner blev observeret hos 1 versus 7 patienter og påvist, eller mulig udvikling af Candida-infektioner blev observeret i henholdsvis 4 versus 2 patienter i micafungin- og fluconazol-grupperne. 
Breakthrough Aspergillus infections were observed in 1 versus 7 patients, and proven or probable breakthrough Candida infections were observed in 4 versus 2 patients in the micafungin and fluconazole groups, respectively.
Reduceret følsomhed over for echinocandiner har været associeret med mutationer i Fks1og Fks2-generne, som koder for en større subunit i glukansyntase. 
Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.
• Til behandling af voksne og unge ≥ 16 år, som har en svampeinfektion i spiserøret (øsofagus), hvor en behandling givet ind i en vene (intravenøs) er egnet. 
• To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate.
• Til at forhindre Candida infektion hos patienter, der skal gennemgå en knoglemarvstransplantation eller som forventes at have neutropeni (lave niveauer af neutrofiler, en type hvide blodlegemer) i 10 dage eller mere. 
• To prevent infection with Candida in patients who are having a bone-marrow transplant or who are expected to have a neutropenia (low levels of neutrophils, a type of white blood cell) for 10 days or more.
Candidæmi og invasiv Candidiasis: Micafungin (100 mg/dag eller 2 mg/kg/dag) var lige så effektivt og bedre tolereret end liposomalt amphotericin B (3 mg/kg) som førstevalgsbehandling af candidæmi og invasiv candidiasis i et randomiseret, dobbeltblindt, multinationalt non-inferioritetsstudie. 
Candidaemia and Invasive Candidiasis: Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study.
Børn: Hos pædiatriske patienter var AUC proportional med dosis over et interval på 0,5-4 mg/kg. 
Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
Profylakse: Micafungin var mere effektiv end fluconazol til at forhindre invasive svampeinfektioner i en patientgruppe med højere risiko for at udvikle en systemisk svampeinfektion (patienter der gennemgår en hæmatopoetisk stamcelletransplantation [HSCT] i et randomiseret, dobbeltblindt multicenterstudie). 
Prophylaxis: Micafungin was more effective than fluconazole in preventing invasive fungal infections in a population of patients at high risk of developing a systemic fungal infection (patients undergoing haematopoietic stem cell transplantation [HSCT] in a randomised, double-blind, multicentre study).
Efter indgift af enkelt intravenøs dosis af 14C-micafungin (25 mg) til raske personer genfindes 11,6 % i urinen og 71,0 % i fæces efter 28 dage. 
Following a single intravenous dose of 14C-micafungin (25 mg) to healthy volunteers, 11.6% of the radioactivity was recovered in the urine and 71.0% in the faeces over 28 days.
Hvis De ønsker yderligere oplysninger om Mycamine, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen: 
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Leverfunktionen bør overvåges nøje under behandlingen med micafungin. 
Liver function should be carefully monitored during micafungin treatment.
En endoskopisk grad på 0 (endoskopisk heling) ved slutningen af behandlingen blev observeret hos 87,7 % (228/260) og 88,0 % (227/258) af patienterne i henholdsvis micafungin- og fluconazolgrupperne (95 % KI for forskellen: [-5,9 %; 5,3 %]). 
An endoscopic grade of 0 (endoscopic cure) at the end of treatment was observed for 87.7% (228/260) and 88.0% (227/258) of patients in the micafungin and fluconazole groups, respectively (95% CI for difference: [-5.9%, 5.3%]).
Der er ikke udført standard carcinogenicitetsstudier, men udviklingen af FAH blev vurderet hos hunrotter efter 20 og 18 måneder efter afsluttet behandling, der havde varet henholdsvis 3 og 6 måneder. 
No standard carcinogenicity studies have been conducted but the development of FAH was assessed in female rats after up to 20 and 18 months after cessation of a 3 and 6 month treatment, respectively.
Candidiasis i øsofagus: I et randomiseret, dobbeltblindt studie med micafungin versus fluconazol som førstevalgsbehandling af candidiasis i øsofagus, modtog 518 patienter mindst én enkeltdosis forsøgsmedicin. 
Oesophageal Candidiasis: In a randomised, double-blind study of micafungin versus fluconazole in the first-line treatment of oesophageal candidiasis, 518 patients received at least a single dose of study drug.
Micafunginbehandling var forbundet med signifikant forværring af leverfunktion (forhøjet ALAT, ASAT eller total-bilirubin > 3 gange ULN) både hos raske frivillige og hos patienter. 
Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients.
10 ml type I-hætteglas med isobutylen-isopren (PTFE-lamineret) prop med "flip-off cap". 
10 ml Type I glass vial with an isobutylene-isoprene (PTFE-laminated) rubber stopper and a flip-off cap.
Sjældne tilfælde af hæmolyse, inklusive akut intravaskulær hæmolyse eller hæmolytisk anæmi, er blevet indberettet for patienter, som blev behandlet med micafungin. 
Rare cases of haemolysis, including acute intravascular haemolysis or haemolytic anaemia, have been reported in patients treated with micafungin.
Micafungin hæmmer ikke-kompetitivt syntesen af 1,3-β-D-glucan, der er en essentiel komponent i svampens cellevæg. 
Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Ældre børn (12-16 år) havde gennemsnitsclearanceværdier svarende til de værdier, man fandt hos voksne. 
Older children (12-16 years) had mean clearance values similar to those determined in adult patients.
Udviklingen af foci med ændrede hepatocytter (FAH) og hepatocellulære tumorer i rotter var afhængige af både dosis og af varigheden af micafunginbehandlingen. 
The development of foci of altered hepatocytes (FAH) and hepatocellular tumours in rats was dependent on both dose and duration of micafungin treatment.
Det vides ikke, om micafungin udskilles i human mælk. 
It is not known whether micafungin is excreted in human breast milk.
Det endokrine system hyperhidrose 
Endocrine disorders hyperhidrosis
Varigheden af micafungindoseringen i disse rottestudier (6 måneder) overskred den normale varighed for micafungindosering hos patienter (se pkt. 
The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Samtidig administration af micafungin og amphotericin B-desoxycholat var forbundet med en 30 % øgning i amphotericin B-deoxycholat eksponeringen. 
Co-administration of micafungin and amphotericin B desoxycholate was associated with a 30% increase in amphotericin B desoxycholate exposure.
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. 
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.
Størstedelen af disse bivirkninger var lette eller moderate. 
The majority of hepatic adverse reactions were mild and moderate.
Det kan derfor forventes, at disse bivirkninger kan forekomme hos mennesker ved klinisk brug af micafungin. 
Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
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. 
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.
Disse data er utilstrækkelige til at kunne anbefale en dosis i patienter med svært nedsat leverfunktion. 
These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.
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). 
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.
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. 
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.
Fortæl Deres læge, om De har alvorlige leverproblemer (f.eks. leversvigt eller leverbetændelse) eller har haft en unormal leverfunktionstest. 
Please tell your doctor if you have severe liver problems (e.g. liver failure or hepatitis) or have had abnormal liver function tests.
Voksne, unge ≥ 16 år og hos ældre: - Behandling af invasiv candidiasis. 
Adults, adolescents ≥ 16 years of age and elderly: - Treatment of invasive candidiasis.
Børn (inklusive nyfødte) og unge < 16 år: - Behandling af invasiv candidiasis. 
Children (including neonates) and adolescents < 16 years of age: - Treatment of invasive candidiasis.
Testikeltoksicitet blev observeret i dyrestudier (se pkt. 
Testicular toxicity was observed in animal studies (see section 5.3).
Micafungins toksicitet efter gentagen intravenøs dosering hos rotter og/eller hunde viste bivirkninger i lever, urinveje, røde blodlegemer og mandlige kønsorganer. 
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.
• Til behandling af voksne, unge, børn og nyfødte, der har en alvorlig svampeinfektion, også kaldet ”invasiv candidiasis” (svampeinfektion, som spreder til hele kroppen). 
• To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
Reaktioner på injektionsstedet Ingen af bivirkningerne på injektionsstedet var begrænsende for behandlingen. 
Injection-site reactions None of the injection-site adverse reactions were treatment limiting.
Eksfoliative hudreaktioner, såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse er blevet rapporteret. 
Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Micafungin vil højst sandsynligt ikke have indflydelse på kørsel eller betjening af maskiner. 
Micafungin is unlikely to have an effect on driving or using machines.
Mycamine bruges til at behandle svampeinfektioner forårsaget af svampe- eller gærceller kaldet Candida. 
Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida.
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. 
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.
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. 
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).
≥1/100 til <1/10 
≥ 1/100 to < 1/10
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet, efter hvor alvorlige de er. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
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. 
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.
I et andet 26 ugers studie var forekomsten af hyperplasi af overgangsepitelet i urinblæren betydelig lavere. 
In a second 26-week study hyperplasia of transitional cells in the urinary bladder occurred with a much lower incidence.
I standardundersøgelser af sikkerhedsfarmakologi blev der set kardiovaskulære og histaminfrigørende effekter af micafungin, og de viste sig at være tidsafhængige over en vis tærskel. 
In standard safety pharmacology tests, cardiovascular and histamine releasing effects of micafungin were evident and appeared to be time above threshold dependent.
Patienter med nedsat nyrefunktion: Svært nedsat nyrefunktion (Glomerular Filtration Rate [GFR] < 30 ml/min) påvirkede ikke farmakokinetikken af micafungin signifikant. 
Patients with renal impairment: Severe renal impairment (Glomerular Filtration Rate [GFR] < 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
Hyppigheden af visse bivirkninger (angivet i nedenstående tabel) var større hos børn end hos voksne patienter. 
The incidence of some adverse reactions (listed in the table below) was higher in paediatric patients than in adult patients.
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. 
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).
Dyrestudier har vist, at micafungin udskilles i mælk. 
Animal studies have shown excretion of micafungin in breast milk.
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). 
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).
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. 
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.
Den fortyndede infusionsopløsning bør anvendes straks. 
The diluted infusion solution should be used immediately.
Hjerte takykardi, palpitationer, bradykardi 
Cardiac disorders tachycardia, palpitations, bradycardia
Deres leverfunktion vil blive nøjere overvåget under behandlingen. 
During treatment your liver functions will be monitored more closely.
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). 
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).
Mycamine indeholder natrium 
Mycamine contains sodium
Mycamine kaldes et svampemiddel, fordi det bruges til behandling af infektioner forårsaget af svampeceller. 
Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.
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. 
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.
Mycamine bør derfor kun anvendes, hvis andre antimykotika ikke er hensigtsmæssige. 
Mycamine should therefore only be used if other antifungals are not appropriate.
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. 
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.