FrancophonIA/ELRC3.0 huggingface dataset:
English: International non-proprietary name (INN): gusperimus
Danish: Internationalt fællesnavn (INN): gusperimus
English: If left untreated, it can result in organ damage or death.
Danish: Hvis det ikke behandles, kan det medføre organbeskadigelse eller dødelig udgang.
English: The effects of Spanidin were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Spanidin blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The CHMP normally takes up to 210 days to evaluate a new application.
Danish: CHMP er normalt op til 210 dage om at vurdere en ny ansøgning.
English: It contains the active substance gusperimus.
Danish: Det indeholder det aktive stof gusperimus.
English: How is Spanidin expected to work?
Danish: Hvordan forventes Spanidin at virke?
English: The main measure of effectiveness was the number of patients who stayed in remission (with no signs of active disease) for at least two months during treatment.
Danish: Den vigtigste målestok for virkningen var antallet af patienter, som forblev i remission (uden tegn på aktiv sygdom) i mindst to måneder i løbet af behandlingen.
English: What was Spanidin expected to be used for?
Danish: Hvad forventedes Spanidin anvendt til?
English: The CHMP noted that an additional study would be necessary to overcome these concerns.
Danish: CHMP bemærkede, at det var nødvendigt med en yderligere undersøgelse for at afhjælpe disse betænkeligheder.
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Danish: Brevet fra virksomheden, hvori EMEA underrettes om tilbagetrækning af ansøgningen, kan ses her.
English: The application was at day 194 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 194, da virksomheden trak sin ansøgning tilbage.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, bedes du kontakte den læge, der giver dig behandlingen..
English: Spanidin was designated as an orphan medicine on 29 March
Danish: Spanidin blev udpeget som lægemiddel til sjældne sygdomme den 29. marts 2001.
English: This causes a range of symptoms that mainly affect the airways, lungs and kidneys.
Danish: Dette medfører en række symptomer, som hovedsagelig påvirker luftvejene, lungerne og nyrerne.
English: What were the main concerns of the CHMP at that time?
Danish: Hvori bestod CHMP's vigtigste betænkeligheder på daværende tidspunkt ?
English: In addition, Spanidin was not compared with any other treatment, so it was not possible to distinguish the effects of Spanidin and of steroids.
Danish: Desuden blev Spanidin ikke sammenlignet med nogen anden behandling, så det var umuligt at skelne mellem virkningerne af Spanidin og virkningerne af steroider.
English: They received Spanidin for six ‘cycles', with each cycle consisting of three weeks ‘on' treatment followed by one week ‘off'.
Danish: De modtog Spanidin i seks ‘cyklusser', hvor hver cyklus bestod af tre ugers behandling efterfulgt af en uge uden behandling.
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a license.
Danish: Efter at CHMP har afgivet sin udtalelse, er Europa-Kommissionen sædvanligvis ca. to måneder om at udstede tilladelsen.
English: In particular, the study included some patients who could have taken other treatments for their disease, so could not be considered to be ‘refractory'.
Danish: Først og fremmest omfattede undersøgelsen visse patienter, som kunne have modtaget andre behandlinger for deres sygdom, og derfor ikke kunne anses for at være 'refraktære'.
English: On 17 June 2008, Euro Nippon Kayaku GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Spanidin, for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Danish: Den 17. juni 2008 meddelte virksomheden Euro Nippon Kayaku GmbH officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at det ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Spanidin til induktion af remission hos voksne, der lider af klinisk refraktær Wegeners granulomatose.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that a benefit of Spanidin had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved Spanidin ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
English: The CHMP was concerned that the main study was not sufficient to demonstrate the effectiveness of Spanidin, because of the way it was designed and carried out.
Danish: CHMP udtrykte bekymring over, at hovedundersøgelsen ikke i tilstrækkelig grad påviste virkningen af Spanidin på grund af den måde, den var blevet tilrettelagt og gennemført på.
English: What were the reasons given by the company to withdraw the application?
Danish: Hvilke begrundelser gav virksomheden for tilbagetrækningen af ansøgningen?
English: Spanidin was not compared with any other treatment in this study, but the patients could take corticosteroids (a group of immunosuppressive medicines) in addition to Spanidin.
Danish: Spanidin blev ikke sammenlignet med nogen anden behandling i denne undersøgelse, men patienterne kunne tage corticosteroider (en gruppe immunsuppressive lægemidler) i tillæg til Spanidin.
English: The active substance in Spanidin, gusperimus, is an immunosuppressive medicine, which means that it reduces the activity of the immune system (the body's natural defences).
Danish: Det aktive stof i Spanidin, gusperimus, er et immunosuppressivt lægemiddel, hvilket betyder at det dæmper immunsystemets aktiviteter (kroppens naturlige forsvar).
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Danish: Efter at CHMP havde vurderet virksomhedens besvarelse af spørgsmålene på listen, var der fortsat visse uafklarede spørgsmål.
English: In this disease, the immune system attacks neutrophils (a type of white blood cell), causing inflammation of small and medium-sized blood vessels and the formation of granulomas (clumps of white blood cells).
Danish: Ved denne sygdom angriber immunsystemet neutrofiler (en form for hvide blodceller), hvilket forårsager inflammation i de små og mellemstore blodkar og dannelse af granulomer (klumper af hvide blodceller).
English: Wegener's granulomatosis is a rare, auto-immune disease (a disease which is caused by the body's own defence system attacking normal tissue).
Danish: Wegeners granulomatose er en sjælden autoimmun sygdom (en sygdom, som forårsages af kroppens eget forsvarssystem, der angriber normalt væv).
English: What documentation did the company present to support its application to the CHMP?
Danish: Hvilken dokumentation fremlagde virksomheden i forbindelse med ansøgningen til CHMP?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Spanidin could not have been approved for the induction of remission in adult patients suffering from clinically refractory Wegener's granulomatosis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Spanidin ikke kunne være blevet godkendt til induktion af remission hos voksne patienter med klinisk refraktær Wegeners granulomatose.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Danish: Efter gennemgang af den oprindelige dokumentation udarbejder CHMP på dag 120 en liste over spørgsmål, som sendes til virksomheden.
English: The CHMP was also concerned that the study included some patients for whom induction treatment was not necessary, and others who did not have the symptoms of ‘classic' Wegener's granulomatosis affecting the airways, lungs or kidneys.
Danish: CHMP var også bekymret over at undersøgelsen omfattede patienter, som ikke havde brug for induktionsbehandling og andre, som ikke havde symptomer på ‘klassisk' Wegeners granulomatose, som påvirker luftvejene, lungerne og nyrerne.
English: Spanidin was expected to be used to control the symptoms of Wegener's granulomatosis in patients who were not responding to other treatments.
Danish: Spanidin forventedes anvendt til at kontrollere symptomer på Wegeners granulomatose hos patienter, der ikke responderede på andre behandlinger.
English: It is expected to work in Wegener's granulomatosis by disrupting the growth and activity of white blood cells called lymphocytes, which are involved in the inflammation process.
Danish: Ved Wegeners granulomatose forventes det at virke ved at forstyrre væksten og aktiviteten af de hvide blodceller, som kaldes lymfocytter og som medvirker ved inflammationsprocessen.
English: Spanidin is a powder that is made up into a solution for injection.
Danish: Spanidin er et pulver, der anvendes til fremstilling af en injektionsvæske, opløsning.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag 180.
English: Spanidin has been studied in one main study involving 45 patients with Wegener's granulomatosis who were ‘refractory' (not responding) to standard treatment.
Danish: Spanidin er blevet undersøgt i en hovedundersøgelse af 45 patienter med Wegeners granulomatose, som var 'refraktære' (ikke reagerede på) standardbehandling.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Spanidin?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Spanidin eller i programmer for anvendelse med særlig udleveringstilladelse?
English: This study would need to involve patients who are truly refractory to other treatments, or it would need to compare Spanidin directly with cyclophosphamide (the standard treatment for inducing remission in Wegener's granulomatosis).
Danish: Denne undersøgelse skulle omfatte patienter, der med sikkerhed var refraktære over for andre behandlinger eller sammenligne Spanidin direkte med cyclophosphamid (standardbehandling for induktion af remission ved Wegeners granulomatose).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Spanidin.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser med Spanidin eller i programmer for anvendelse med særlig udleveringstilladelse.
English: By reducing the number of lymphocytes and interfering with the way they work, Spanidin is expected to reduce the inflammation in the blood vessels that causes the symptoms of the disease.
Danish: Spanidin forventes at reducere inflammationen, som er årsag til symptomerne på sygdommen, ved at reducere antallet af lymfocytter og påvirke den måde de virker på.
English: This reaction may be life-threatening.
Danish: Denne reaktion kan være livstruende.
English: 24 June 2016
Danish: 24. juni 2016
English: • bad taste in your mouth
Danish: • dårlig smag i munden
English: Elderly patients (≥65 years)
Danish: Ældre patienter (≥65 år)
English: Reconstitution time is less than 2 minutes.
Danish: Rekonstitutionstiden er mindre end 2 minutter.
English: These show how well your kidneys are working.
Danish: De viser, hvor godt dine nyrer virker.
English: It is given as a drip into a vein - this will take about 2 hours.
Danish: Det gives som drop i en vene - dette vil tage ca. 2 timer.
English: This is because it is not known if the medicine is safe to use in these age groups.
Danish: Dette skyldes, at det ikke vides, om medicinen er sikker at bruge til denne aldergruppe.
English: A risk to newborns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: A course of treatment usually lasts from 5 to up to 14 days, depending on the type of infection you have and how you respond to treatment.
Danish: Et behandlingsforløb varer sædvanligvis fra 5 til 14 dage, afhængigt af den type infektion, du har, og hvordan du reagerer på behandlingen.
English: Complicated IAI
Danish: Kompliceret IAI
English: Total volume
Danish: Det totale volumen
English: Store in the original package in order to protect from light.
Danish: Opbevares i den originale pakning for at beskytte mod lys.
English: From a microbiological point of view, the medicinal product should be used immediately.
Danish: Ud fra en mikrobiologisk betragtning skal lægemidlet anvendes straks.
English: • severe allergic reaction (see Serious side effects, above)
Danish: • alvorlig allergisk reaktion (se Alvorlige bivirkninger ovenfor)
English: A white to yellow powder.
Danish: Hvidt til gult pulver.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinjer for hensigtsmæssig anvendelse af antibakterielle lægemidler.
English: Stevens-Johnson syndrome
Danish: Stevens-Johnsons syndrom
English: Coombs direct test positive
Danish: Positiv direkte Coombs test
English: The concentration time profiles are similar for ELF and plasma.
Danish: Koncentration-tid-profilerne er sammenlignelige for ELF og plasma.
English: • you have kidney problems - your doctor may give you a lower dose to make sure you don't get too much medicine.
Danish: • du har nyreproblemer - lægen vil muligvis give dig en lavere dosis for at sørge for, at du ikke får for meget medicin.
English: The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo this drug combination should be avoided.
Danish: Den kliniske relevans af dette er ukendt, men på grund af muligheden for antagonisme in vivo bør kombinationen undgås.
English: 2 hours
Danish: 2 timer
English: Other types of interaction
Danish: Andre typer interaktioner
English: Unknown (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: Not known: (frequency cannot be estimated from the available data)
Danish: Ikke kendt: (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Anvendes det ikke med det samme, er opbevaringstid og -forhold inden anvendelse brugerens ansvar.
English: Zavicefta should not be used in children and adolescents .
Danish: Zavicefta bør ikke anvendes til børn og unge.
English: Patients with limited treatment options
Danish: Patienter med begrænsede behandlingsmuligheder
English: • swelling under the skin, particularly lips and around the eyes
Danish: • hævelse under huden, især af læberne og omkring øjnene
English: It can kill many types of bacteria.
Danish: Medicinen kan slå mange typer bakterier ihjel.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Danish: Parenterale lægemidler skal efterses visuelt for partikler før administration.
English: Ceftazidime/avibactam should only be used during pregnancy if the potential benefit outweighs the possible risk.
Danish: Ceftazidim/avibactam bør kun anvendes under graviditet, hvis de potentielle fordele overstiger den mulige risiko
English: Very common (≥1/10)
Danish: Meget almindelig (≥1/10)
English: Each vial is for single use only.
Danish: Hvert hætteglas er kun til engangsbrug.
English: Do not use this medicine after the expiry date which is stated on the container.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen.
English: Alternatively they are stable for up to 24 hours under refrigerated storage.
Danish: Alternativt er den holdbar i op til 24 timer i køleskab.
English: Zavicefta can also affect the results of some urine tests for sugar.
Danish: Zavicefta kan også påvirke resultaterne af nogle urinprøver for sukker.
English: Common (≥1/100 and <1/10) Uncommon (≥1/1,000 and <1/100) Rare (≥1/10,000 and <1/1000) Very rare (<1/10,000)
Danish: Ikke almindelig (≥1/1.000 og <1/100) Sjælden (≥1/10.000 og <1/1000) Meget sjælden (<1/10.000)
English: Paediatric population Safety and efficacy in children and adolescents below 18 years of age have not yet been established.
Danish: Pædiatrisk population Zaviceftas sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Limitations of the clinical data
Danish: Begrænsninger i de kliniske data
English: Other infections
Danish: Andre infektioner
English: Every 8 hours
Danish: Hver 8. time
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du bruger dette lægemiddel.
English: In some patients, the creatinine clearance estimated from serum creatinine can change quickly, especially early in the course of treatment for the infection.
Danish: Hos nogle patienter kan kreatininclearance estimeret fra serumkreatinin ændre sig hurtigt, især tidligt i behandlingsforløbet.
English: This may affect you being able to drive, use tools or machines.
Danish: Dette kan påvirke din evne til at køre motorkøretøj, bruge værktøj og betjene maskiner.
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Overall, the safety profile in these 61 children was similar to that observed in the adult population with cIAI.
Danish: Sikkerhedsprofilen hos de 61 børn svarede samlet set til den profil, som blev observeret hos den voksne population med cIAI.
English: From a microbiological point of view, the medicinal product should be used immediately unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: Fra en mikrobiologisk synsvinkel skal lægemidlet anvendes med det samme, medmindre rekonstitution og fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: Zavicefta will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Danish: Du vil få Zavicefta af en læge eller sygeplejerske, så det er næppe sandsynligt, at du vil få en forkert dosis.
English: • infections caused by bacteria that other antibiotics may not be able to kill
Danish: • infektioner forårsaget af bakterier, som andre antibiotika ikke kan slå ihjel
English: Duration of treatment
Danish: Behandlings- varighed
English: Adverse reactions are classified according to frequency and System Organ Class.
Danish: Bivirkningerne er klassificeret efter hyppighed og systemorganklasse.
English: Zavicefta is administered by intravenous infusion over 120 minutes in an infusion volume of 100 mL.
Danish: Zavicefta administreres via intravenøs infusion over 120 minutter i et infusionsvolumen på 100 ml.
English: Vulvovaginal candidiasis and Oral candidiasis)
Danish: Candidiasis (inklusive vulvovaginal candidiasis og oral candidiasis)
English: This test looks for antibodies that fight against your red blood cells.
Danish: Denne prøve tester for antistoffer, der bekæmper dine røde blodlegemer.
English: The following adverse reactions have been reported with ceftazidime alone and/or identified during the Phase 2 and Phase 3 trials with Zavicefta.
Danish: Følgende bivirkninger er indberettet for ceftazidim alene og/eller identificeret i fase 2- og fase 3-studierne med Zavicefta.
English: There is a small possibility that you may get a different infection caused by another bacteria during or after treatment with Zavicefta.
Danish: Der er en lille risiko for, at du kan få en anden infektion, som er forårsaget af en anden bakterie under eller efter behandlingen med Zavicefta.
English: The maximum recommended daily dose of this medicinal product contains 444 mg sodium (found in table salt).
Danish: Den maksimale anbefalede daglige dosis af dette lægemiddel indeholder 444 mg natrium (som findes i bordsalt).
English: Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions:
Danish: Hyppighedskategorierne stammer fra bivirkninger og/eller potentielt klinisk signifikante laboratorieabnormiteter og er defineret i henhold til følgende konventioner:
English: If you have kidney problems your doctor may lower your dose.
Danish: Hvis du har nyreproblemer, kan lægen nedsætte din dosis.
English: The powder must be reconstituted with water for injections and the resulting concentrate must then be immediately diluted prior to use.
Danish: Pulveret skal rekonstitueres med vand til injektionsvæsker, og det resulterende koncentrat skal derefter straks fortyndes inden brug.
English: The following side effects may happen with this medicine:
Danish: Du kan få følgende bivirkninger af denne medicin:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes straks, er opbevaringstider og -forhold under brug brugerens ansvar og vil normalt ikke være længere end 24 timer ved 2-8 ºC, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Clinical efficacy against specific pathogens
Danish: Klinisk virkning mod specifikke patogener
English: The resulting solution should be administered over 120 minutes.
Danish: Den fremstillede opløsning skal indgives over 120 minutter.
English: The total time interval between starting reconstitution and completing preparation of the intravenous infusion should not exceed 30 minutes.
Danish: Det samlede tidsinterval mellem start på rekonstitution og færdiggørelse af den intravenøse infusion bør ikke overstige 30 minutter.
English: Plasma exposure levels at maternal and foetal NOAEL (100 mg/kg/day) indicate moderate to low margins of safety.
Danish: Plasma-eksponeringsniveauer ved maternel og føtal NOAEL (100 mg/kg dagligt) indikerer moderate til lave sikkerhedsmargener.
English: Uncommon Very rare
Danish: Ikke almindelig Meget sjælden Ikke kendt
English: Table 3 Frequency of adverse reactions by system organ class
Danish: Tabel 3 Hyppighed af bivirkninger efter systemorganklasse