natgillin/translations-raw huggingface dataset:
Hvis disse reaktioner opstår, skal anidulafungin seponeres og passende behandling iværksættes. 
If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
Krav til fortynding ved ECALTA-administration 
Dilution requirements for ECALTA administration
Som for enhver overdosering er behandling generelt understøttende efter behov. 
As with any overdose, general supportive measures should be utilised as necessary.
256 patienter i alderen 16-91 år blev randomiseret til behandling, og fik mindst én dosis af studiemedicinen. 
Two hundred and fifty-six patients, ranging from 16 to 91 years in age, were randomised to treatment and received at least one dose of study medication.
ECALTA vil altid blive blandet og givet til dig af en læge eller sygeplejerske (der findes mere information om blanding i slutningen af denne information under ”Følgende oplysninger er tiltænkt læger og sundhedspersonale”). 
ECALTA will always be prepared and given to you by a doctor or a healthcare professional (there is more information about the method of preparation at the end of the leaflet in the section for medical and healthcare professionals only).
I patientstudier med gentagne doser var lægemiddelclearance en anelse hurtigere hos mænd (ca. 22 %). 
In multiple-dose patient studies, drug clearance was slightly faster (approximately 22%) in men.
In vitro-forsøg udelukker ikke fuldt ud mulige in vivo-interaktioner. 
Of note, in vitro studies do not fully exclude possible in vivo interactions.
Behandling med ECALTA bør initieres af en læge med erfaring i behandling af invasive svampeinfektioner. 
Treatment with ECALTA should be initiated by a physician experienced in the management of invasive fungal infections.
Succesfuldt globalt respons ved EOIVT 
Global Response of Success at EOIVT
Yderligere data for neutropene patienter 
Additional Data in Neutropenic Patients
ECALTA hører til gruppen af medicin, der kaldes echinocandiner. 
ECALTA belongs to a group of medicines called echinocandins.
Opbevares i køleskab (2 ºC-8 ºC). 
Store in a refrigerator (2C - 8C).
De fleste af patienterne havde kun candidæmi (84,8 %; 39/46). 
The majority of patients had candidemia only (84.8%; 39/46).
6 ugers opfølgning Kalkuleret som anidulafungin minus fluconazol Med eller uden samtidig candidæmi c 
6 Week Follow-up Calculated as anidulafungin minus fluconazole With or without concurrent candidaemia c
ECALTA indeholder det aktive stof anidulafungin og bruges hos voksne til at behandle en type af svampeinfektion i blodet eller andre indre organer, som kaldes invasiv candidiasis. 
ECALTA contains the active substance anidulafungin and is prescribed in adults to treat a type of fungal infection of the blood or other internal organs called invasive candidiasis.
Global succes i MITT-populationen: primære og sekundære endemål Anidulafungin Fluconazol 
Global success in the MITT population: primary and secondary endpoints Anidulafungin Fluconazole
Behandlingen blev givet i mindst 14 dage og ikke mere end 42 dage. 
Treatment was administered for at least 14 and not more than 42 days.
ECALTA hindrer normal udvikling af svampens cellevæg. 
ECALTA prevents normal development of fungal cell walls.
21 patienter (16,3 %) havde samtidig candidæmi. 
Twenty one (16.3%) had concomitant candidemia.
De patienter, der fik mindst én dosis af studielægemidlet, og som havde en positiv dyrkning for Candida-arter fra et normalt sterilt sted, før de indgik i studiet, blev inkluderet i den modificerede intent-to-treat (MITT)-population. 
Patients who received at least one dose of study medicinal products and who had a positive culture for Candida species from a normally sterile site before study entry were included in the modified intentto-treat (MITT) population.
Anafylaktiske reaktioner, herunder shock, er rapporteret efter brug af anidulafungin. 
Anaphylactic reactions, including shock, were reported with the use of anidulafungin.
Patienterne blev fulgt i 6 uger efter afslutning af al behandling. 
Patients were followed for six weeks beyond the end of all therapy.
Overfølsomhed over for andre lægemidler af echinocandin-klassen. 
Hypersensitivity to other medicinal products of the echinocandin class.
ECALTA kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Ingen særlige forholdsregler vedrørende destruktion. 
There are no special requirements for disposal.
pH i den rekonstituerede opløsning er 3,5-5,5. 
The reconstituted solution has a pH of 3.5 to 5.5.
Ubetydelige mængder af radioaktivt lægemiddelderivat blev genfundet i blod, urin og fæces 8 uger efter dosisindgift. 
Negligible amounts of drug-derived radioactivity were recovered in blood, urine, and faeces 8 weeks post-dose.
Infektionen forårsages af svampeceller (gærceller), som kaldes Candida. 
The infection is caused by fungal cells (yeasts) called Candida.
Mindre end 1 % af den indgivne radioaktive dosis blev udskilt i urinen, hvilket tyder på en ubetydelig renal clearance. 
Less than 1% of the administered radioactive dose was excreted in the urine, indicating negligible renal clearance.
Nogle rotter i middeldosis-gruppen oplevede de samme reaktioner, men kun efter administration af anæstesi. 
Some rats in the mid dose group experienced similar reactions but only after administration of anaesthesia.
Rekonstitutionstiden kan være op til 5 minutter. 
The reconstitution time can be up to 5 minutes.
ECALTAs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of ECALTA in children and adolescents below 18 years have not been established.
De fleste af patienterne havde kun candidæmi (85,7 %). 
The majority of patients had candidemia only (85.7%).
Der er ikke udført langtidsstudier med dyr til vurdering af anidulafungins karcinogenicitet. 
Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of anidulafungin.
Ca. 30 % af den indgivne radioaktive dosis blev udskilt i fæces over 9 dage, heraf mindre end 10 % som intakt lægemiddelstof. 
Approximately 30% of the administered radioactive dose was eliminated in the faeces over 9 days, of which less than 10% was intact drug.
Anidulafungin har en overvejende eliminationshalveringstid på ca. 24 timer, som karakteriserer størstedelen af plasmakoncentrations-tidsprofilen, og har en halveringstid på 40-50 timer, som karakteriserer eliminationsfasen. 
Anidulafungin has a predominant elimination half-life of approximately 24 hours that characterizes the majority of the plasma concentration-time profile, and a terminal half-life of 40-50 hours that characterises the terminal elimination phase of the profile.
Behandlingen kan initieres før dyrkningsresultat foreligger, og behandlingen kan herefter justeres, når resultaterne foreligger. 
Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
Hvis du har glemt at få ECALTADa du vil få denne medicin under tæt medicinsk overvågning, er det mindre sandsynligt, at en dosis vil blive glemt. 
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Anidulafungin producerede ikke nogen lægemiddelrelateret toksitet for udvikling hos rotter ved den højeste undersøgte dosis. 
Anidulafungin did not produce any drug-related developmental toxicity in rats at the highest dose tested.
Effekten af ECALTA er kun blevet vurderet hos et begrænset antal neutropene patienter (se pkt. 
The efficacy of ECALTA has only been evaluated in a limited number of neutropenic patients (see section 5.1).
Mortalitet uanset årsag frem til dag 28 var 10/35 (28,6 %). 
All-cause mortality by Day 28 was 10/35 (28.6%).
Dette fører til hæmning af dannelsen af 1,3--D-glucan, der er en essentiel bestanddel af svampens cellevæg. 
This results in inhibition of the formation of 1,3--D-glucan, an essential component of the fungal cell wall.
Behandlingsvarighed Svampebehandling bør sædvanligvis fortsættes i mindst 14 dage efter sidste positive dyrkning. 
Duration of treatment In general, antifungal therapy should continue for at least 14 days after the last positive culture.
En standardiseret teknik til test af Candida-arters følsomhed over for anidulafungin og af de respektive grænseværdier er blevet defineret af EUCAST (European Committee on Antimicrobial Susceptibility Testing). 
A standardized technique for testing the susceptibility of Candida species to anidulafungin as well as the respective interpretative breakpoints has been established by European Committee on Antimicrobial Susceptibility Testing (EUCAST).
C) anidulafungin (~88 mg) givet til raske forsøgspersoner. 
C) anidulafungin (~88 mg) was administered to healthy subjects.
Behandling med anidulafungin forlængede overlevelsen og reducerede også organskaden af Candida-arter, når den blev målt ved intervaller fra 24-96 timer efter sidste behandling. 
Anidulafungin treatment prolonged survival and also reduced the organ burden of Candida species, when determined at intervals from 24 to 96 hours after the last treatment.
Anidulafungin er et semisyntetisk echinocandin, et lipopeptid syntetiseret fra et fermenteringsprodukt af Aspergillus nidulans. 
Anidulafungin is a semi-synthetic echinocandin, a lipopeptide synthesised from a fermentation product of Aspergillus nidulans.
ECALTA er ikke blevet undersøgt hos patienter med Candida endocarditis, osteomyelitis eller menigitis. 
ECALTA has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis.
Ved eksperimenter på dyr har disse mutationer imidlertid været forbundet med krydsresistens over for alle 3 echinocandiner, og derfor klassificeres sådanne isolater som echinocandin-resistente, indtil der er opnået mere klinisk erfaring med anidulafungin. 
However, in animal experiments these mutations confer cross resistance to all three echinocandins and therefore such isolates are classified as echinocandin resistant until further clinical experience are obtained concerning anidulafungin.
Dette lægemiddel må ikke blandes med andre lægemidler eller elektrolytter end dem, der er anført under pkt. 
This medicinal product must not be mixed with other medicinal products or electrolytes except those mentioned in section 6.6.
Udviklingspåvirkning, der er set hos kaniner (let reduceret fødselsvægt), opstod kun ved den højeste undersøgte dosis, der også producerede materneltoksicitet. 
Developmental effects observed in rabbits (slightly reduced foetal weights) occurred only at the highest dose tested, a dose that also produced maternal toxicity.
Behandlingen starter med 200 mg den første dag (startdosis). 
The treatment starts with 200 mg on the first day (loading dose).
ECALTA må ikke administreres som bolusinjektion. 
ECALTA must not be administered as a bolus injection.
Patienter med Candida-endocarditis, osteomyelitis eller meningitis eller patienter inficeret med C. krusei blev specifikt ekskluderet af studiet. 
Patients with Candida endocarditis, osteomyelitis or meningitis, or those with infection due to C. krusei, were specifically excluded from the study.
Du vil sædvanligvis blive behandlet i mindst 14 dage efter den sidste dag, hvor der er fundet Candida i blodet. 
In general, your treatment should continue for at least 14 days after the last day Candida was found in your blood.
Isolater med mutationer i hotspot-områderne i målgenet er blevet forbundet med klinisk svigt eller gennembrudsinfektion. 
Isolates with mutations in the hot spot regions of the target gene have been associated with clinical failures or breakthrough infections.
Patienter i begge behandlingsgrupper fik tilladelse til at skifte til oral fluconazol efter mindst 10 dages intravenøs behandling på betingelse af, at de kunne tåle orale lægemidler, og at de var afebrile i mindst 24 timer, samt at den seneste bloddyrkning var negativ for Candida-arter. 
Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intravenous therapy, provided that they were able to tolerate oral medicinal products and were afebrile for at least 24 hours, and that the most recent blood cultures were negative for Candida species.
In vitro-aktivitet 
Activity in vitro
3 hos 22 patienter eller klassificeret som neutropene ved baseline af investigator for 13 patienter. 
3 in 22 patients or classified by the investigator as neutropenic at baseline in 13 patients.
Anidulafungins in vitro-aktivitet over for forskellige Candida-arter er ikke ensartet. 
The in vitro activity of anidulafungin against Candida species is not uniform.
Derfor bør ECALTA ikke bruges under graviditet. 
Therefore ECALTA is not recommended during pregnancy.
Effektdata, både totalt og i forskellige undergrupper, ses i skema 3 nedenfor. 
Efficacy data, both overall and by various subgroups, are presented below in Table 3.
Parenteralt administreret anidulafungin var virksomt over for Candida-arter i immunkompetente og immunkompromitterede modeller med mus og kaniner. 
Parenterally administered anidulafungin was effective against Candida species in immunocompetent and immunocompromised mouse and rabbit models.
- Livstruende allergiske reaktioner 
- Life-threatening allergic reactions
Administration af anidulafungin til rotter tyder ikke på påvirkning af reproduktion, herunder fertilitet hos hanner og hunner. 
Administration of anidulafungin to rats did not indicate any effects on reproduction, including male and female fertility.
Succesfuld global responsrate a og mortalitet uanset årsag hos patienter med candidiasis i dybtliggende væv - samlet analyse MITT-population n/N (%) 
Rate of Successful Global Response a and All-Cause Mortality in Patients with Deep Tissue Candidiasis - Pooled Analysis MITT Population n/N (%)
Plasmakoncentrationen af anidulafungin var den samme hos raske mænd og kvinder. 
Plasma concentrations of anidulafungin in healthy men and women were similar.
Samlet mortalitet i studiet Mortalitet under forsøgsbehandling Mortalitet tilskrevet Candida-infektion 
Overall study mortality Mortality during study therapy Mortality attributed to Candida infection
Tilfælde af signifikant leverdysfunktion, hepatitis og leversvigt var ikke almindelige i kliniske studier. 
Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials.
Steady state blev opnået den første dag efter en initialdosis (2 gange vedligeholdelsesdosis), og steady state Cmax og AUCss steg dosisproportionalt. 
Steady state was achieved on the first day after a loading dose (twice the maintenance dose), and steady state Cmax and AUCss increase in a dose-proportional manner.
De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at anidulafungin udskilles i mælk. 
Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.
ECALTA må ikke bruges til børn og unge under 18 år. 
ECALTA should not be given to patients under 18 years of age.
Bronkospasme, dyspnø 
Bronchospasm, Dyspnoea
Koncentrationen af anidulafungin faldt til under den nedre detektionsgrænse 6 dage efter dosisindgift. 
Anidulafungin concentrations fell below the lower limits of quantitation 6 days post-dose.
Farmakokinetikken af anidulafungin blev undersøgt efter mindst 5 daglige doser hos 24 immunkompromitterende børn (2-11 år) og unge (12-17 år) med neutropeni. 
The pharmacokinetics of anidulafungin after at least 5 daily doses were investigated in 24 immunocompromised paediatric (2 to 11 years old) and adolescent (12 to 17 years old) patients with neutropenia.
- Aktivt stof: anidulafungin. 
- The active substance is anidulafungin.
Anidulafungin er ikke et klinisk betydende substrat, en induktor eller hæmmer af cytochrom P450isoenzymerne (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A). 
Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A).
Mindste varighed af Infusionen 
Minimum duration of infusion
Patienter med stigning i leverenzymer under behandling med anidulafungin skal monitoreres for tegn på forværring af leverfunktionen og risk/benefit-forholdet ved fortsat anidulafungin-behandling vurderes. 
Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.
Bivirkningerne er opført i henhold til MedDRA og opdelt i henhold til følgende frekvens: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000) samt fra spontan rapportering angivet med frekvensen ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
The following table includes, the all-causality adverse reactions (MedDRA terms) from 840 subjects receiving 100 mg anidulafungin with frequency corresponding to very common (≥1/10), common (1/100 to <1/10), uncommon (1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and from spontaneous reports with frequency not known (cannot be estimated from the available data).
Anidulafungin metaboliseres ikke hepatisk. 
Anidulafungin is not hepatically metabolised.
Mortalitetsrater i både anidulafungingruppen og fluconazolgruppen er anført i skema 4 nedenfor. 
Mortality rates in both the anidulafungin and fluconazole arms are presented below in Table 4:
3 ved baseline) med invasiv candidiasis blev vurderet i et prospektivt, dobbeltblindt, randomiseret, kontrolleret studie. 
3 at baseline) with invasive candidiasis was assessed in a prospective, double-blind, randomized, controlled trial.
Eksperimentelle infektioner omfattede dissemineret C. albicans-infektion i neutropene kaniner, øsofageal/orofaryngeal-infektion af neutropene kaniner med fluconazol-resistente C. albicans og dissemineret infektion af neutropene mus med fluconazol-resistente C. glabrata. 
Experimental infections included disseminated C. albicans infection in neutropenic rabbits, oesophageal/oropharyngeal infection of neutropenic rabbits with fluconazole-resistant C. albicans and disseminated infection of neutropenic mice with fluconazole-resistant C. glabrata.
Studier af embryoets/fostrets udvikling blev udført med doser på 0,2-2 gange (rotter) og 1-4 gange (kaniner) den foreslåede terapeutiske vedligeholdelsesdosis på 100 mg/døgn. 
Embryo-foetal development studies were conducted with doses between 0.2- and 2-fold (rats) and between 1- and 4-fold (rabbits) the proposed therapeutic maintenance dose of 100 mg/day.
In vivo omdannes det ring-åbnede peptid efterfølgende til petid-nedbrydningsprodukter, og bliver hovedsageligt elimineret ved udskillelse gennem galden. 
In vivo, the ring-opened product is subsequently converted to peptidic degradants and eliminated mainly through biliary excretion.
Yderligere data for patienter med infektioner i dybtliggende væv 
Additional Data in Patients with Deep Tissue Infections
Steady state blev opnået den første dag efter initialdosis (dobbelt daglig vedligeholdelsesdosis). 
The steady state was achieved on the first day after a loading dose (twice the daily maintenance dose).
Candidæmi og andre former for invasiv candidiasis Sikkerhed og effekt af anidulafungin er vurderet i et pivotal fase 3, randomiseret, dobbeltblindt, multicenter, multinationalt studie hos primært non-neutropene patienter med candidæmi og et begrænset antal patienter med Candida-infektioner i dybtliggende væv eller med abscesdannende tilstande. 
Candidaemia and other forms of Invasive Candidiasis The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, doubleblind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
- For lavt kaliumindhold i blodet (hypokaliæmi) - Diarré - Kvalme 
- Low blood potassium (hypokalaemia) - Diarrhoea - Nausea
Diarré, kvalme 
Diarrhoea, Nausea
Alle patienter blev behandlet i mindst 14 dage. 
All patients were treated for at least 14 days.
Dosisjustering er ikke nødvendig hos patienter med let, moderat eller svært nedsat leverfunktion. 
No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment.
Det er ikke sandsynligt, at anidulafungin vil have klinisk betydende effekt på metabolismen af lægemidler, der metaboliseres via cytochrom P450-isoenzymer. 
It is unlikely that anidulafungin will have clinically relevant effects on the metabolism of drugs metabolised by cytochrome P450 isoenzymes.
Anidulafungin er ikke dialyserbar, og kan gives uden hensyn til tidspunktet for hæmodialyse. 
Anidulafungin is not dialysable and may be administered without regard to the timing of hemodialysis.
Koncentration af infusionsopløsning er 0,77 mg/ml. 
Infusion solution concentration is 0.77 mg/mL
Det skal besluttes, om amning skal ophøre, eller behandling med ECALTA seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. 
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Ecalta therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Opløsningen bør kontrolleres visuelt for partikler og misfarvning før administration. 
The solution should be inspected visually for particulate matter and discoloration prior to administration.
Data for anvendelse af doser på 100 mg i mere end 35 dage er utilstrækkelige. 
There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
For instruktioner om rekonstitution af lægemidlet før administration, se pkt. 
For instructions on reconstitution of the medicinal product before administration (see section 6.6).
Hjælpestoffer, som behandleren skal være opmærksom på: Fructose 102,5 mg pr. hætteglas 
Excipient with known effect: Fructose 102.5 mg per vial
I den populationsfarmakokinetiske analyse var forskellen i den mediane clearance mellem ældregruppen (patienter ≥65 år, median CL=1,07 l/time) og ikke-ældregruppen (patienter <65 år, median CL=1,22 l/time) lille, mens spredningen af clearance var den samme. 
The population pharmacokinetic analysis showed that median clearance differed slightly between the elderly group (patients ≥ 65, median CL = 1.07 l/h) and the non-elderly group (patients < 65, median CL = 1.22 l/h), however the range of clearance was similar.
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgien 
Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium
Patienterne blev behandlet i mindst 14 dage. 
Patients were treated for at least 14 days.
Anidulafungins farmakokinetik er karakteriseret ved en hurtig distributionshalveringstid (0,5-1 time) og et fordelingsvolumen på 30-50 l, svarende til kroppens totale væskevolumen. 
The pharmacokinetics of anidulafungin are characterised by a rapid distribution half-life (0.5-1 hour) and a volume of distribution, 30-50 l, which is similar to total body fluid volume.
Spørg din læge eller apoteket til råds, før du tager nogen form for medicin. 
Ask your doctor or pharmacist for advice before taking any medicines.
Der er ikke observeret hepatisk metabolisme af anidulafungin. 
Hepatic metabolism of anidulafungin has not been observed.
3 eller hvide blodceller ≤ 500 celler/mm 
3 or WBC ≤ 500 cells/mm
EUCAST har ikke fastlagt ikke-artsrelaterede grænseværdier for anidulafungin. 
EUCAST has not determined non-species related breakpoints for anidulafungin
Anidulafungin udviser lineær farmakokinetik over et bredt spektrum af doser givet 1 gang dagligt (15130 mg). 
Anidulafungin displays linear pharmacokinetics across a wide range of once daily doses (15-130 mg).
5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.. 
Currently available data are described in section 5.2, but no recommendation on a posology can be made.
Virkningen af ECALTA på gravide kvinder kendes ikke. 
The effect of ECALTA in pregnant women is not known.
Brug ikke ECALTA efter den udløbsdato, der står på pakningen. 
Do not use this medicine after the expiry date which is stated on the label.