natgillin/translations-raw huggingface dataset:
Det erstatter den manglende faktor IX i blodet, så blødningsforstyrrelsen midlertidigt er under kontrol.
The active substance in IXinity, trenonacog alfa, is a form of human factor IX that replaces the missing factor IX in the blood, temporarily controlling the bleeding disorder.
I et klinisk enkelt-dosisstudie blev radioaktivt mærket (
In a single-dose clinical study, radiolabeled (
Begge regimer er veltålte hos disse patienter.
Both regimens were welltolerated by these patients.
2 ugers opfølgning e
2 Week Follow-up e
Dato for første tilladelse: 20. september 2007 Dato for seneste fornyelse: 28. august 2017
Date of first authorisation: 20 September 2007 Date of latest renewal: 28 August 2017
Du må ikke få en dobbeltdosis af lægen.
You should not be given a double dose by doctor.
C. albicans Non-albicans arter
C. albicans Non-albicans species
Forskelle mellem grupper (95% CI)
Between group difference ( 95% CI)
Denne medicin indeholder fructose (en slags sukker).
This medicine contains fructose (a type of sugar).
Behandlingens varighed afhænger af patientens kliniske respons.
Duration of treatment should be based on the patient's clinical response.
Udløbsdatoen er den sidste dag i den nævnte måned.
The expiry data refers to the last day of that month.
Størstedelen af patienterne havde Apache II-score 20, og meget få var neutropene.
The majority of patients had Apache II scores ≤ 20 and very few were neutropenic.
De fleste kliniske tilfælde involverer behandling med caspofungin.
Most clinical cases involve caspofungin treatment.
98.3% konfidensinterval, justeret post-hoc for gentagne sammenligninger ved sekundære tidspunkter.
98.3% confidence intervals, adjusted post hoc for multiple comparisons of secondary time points.
Anidulafungin har en ubetydelig renal clearance (<1 %).
Anidulafungin has negligible renal clearance (<1%).
Anidulafungin er i udstrakt grad (>99 %) bundet til humane plasmaproteiner.
Anidulafungin is extensively bound (>99%) to human plasma proteins.
Et succesfuldt globalt respons krævede klinisk bedring og mikrobiologisk eradikation.
A successful global response required clinical improvement and microbiological eradication.
I alt 46 patienter blev inkluderet i analysen.
A total of 46 patients were included in the analysis.
Denne medicin bruges til at behandle alvorlige svampeinfektioner.
These medicines are used to treat serious fungal infections.
ECALTA er ikke dialyserbart.
ECALTA is not dialysable.
Den kliniske relevans af disse fund kan ses under ”Klinisk virkning og sikkerhed”.
For the clinical relevance of these findings see “Clinical efficacy and safety.”
Ved tilstedeværelse af ECALTA vil svampeceller have ufuldstændige eller defekte cellevægge, som gør dem svage eller ude af stand til at vokse.
In the presence of ECALTA, fungal cells have incomplete or defective cell walls, making them fragile or unable to grow.
Det er ukendt, om anidulafungin udskilles i human mælk.
It is unknown whether anidulafungin is excreted in human milk.
Det vil tage mindst 1½ time for vedligeholdelsesdosis og 3 timer for startdosis.
This will take at least 1.5 hours for the maintenance dose and 3 hours for the loading dose.
Clearance af anidulafungin er ca 1 l/time.
The clearance of anidulafungin is about 1 l/h.
I alt 129 patienter blev inkluderet i analysen.
A total of 129 patients were included in the analysis.
Den kliniske betydning heraf kendes ikke.
The clinical relevance of this is unknown.
Intra-abdominal Data for patienter med et enkelt patogen ved baseline.
Intra-abdominal Data presented for patients with a single baseline pathogen.
Mortalitet Anidulafungin Fluconazol
Mortality Anidulafungin Fluconazole
• når risikostyringssystemet ændres, særligt som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Nogle af disse bivirkninger vil blive registreret af din læge, mens din tilstand og reaktion på behandlingen overvåges.
Some of these side effects will be noted by your doctor while monitoring your response and condition.
K VALITATIV OG KVANTITATIV SAMMENSÆTNING
QUALITATIVE AND QUANTITATIVE COMPOSITION
Der blev observeret en lav interindividuel variation i systemisk eksponering (variationskoefficient på omtrent 25 %).
A low intersubject variability in systemic exposure (coefficient of variation ~25%) was observed.
ECALTA bør ikke anvendes under graviditeten medmindre fordelen for moderen er større end den potentielle risiko for fostret.
ECALTA is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Kontakt straks lægen, hvis du bliver gravid, mens du tager ECALTA.
Contact your doctor immediately if you become pregnant while taking ECALTA.
De fleste af patienterne havde kun candidæmi.
The majority of patients had candidemia only.
Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Andre Candida-arter
Candida albicans Candida glabrata Candida tropicalis Candida krusei Candida parapsilosis Other Candida spp.
Den gennemsnitlige APACHE II-score var 14,9 (spredning 2-44).
The mean APACHE II score was 14.9 (range, 2 - 44).
Der er ingen data fra anvendelse af anidulafungin til gravide kvinder.
There are no data from the use of anidulafungin in pregnant women.
I tabellen nedenfor er angivet, hvor meget volumen der kræves til hver dosis.
The table below provides the volumes required for each dose.
Total rekonstitueret volumen
Total reconstituted volume
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.