FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aerivio Spiromax have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Aerivio Spiromax.
English: How has Aerivio Spiromax been studied?
Danish: Hvordan blev Aerivio Spiromax undersøgt?
English: As Aerivio Spiromax is only available in one high strength, its use in asthma has been restricted to
Danish: Spiromax kun fås i en enkelt, høj styrke, er dets anvendelse ved astma begrænset til patienter, der har sygdommen i svær grad.
English: How is Aerivio Spiromax used?
Danish: Hvordan anvendes Aerivio Spiromax?
English: For practical information about using Aerivio Spiromax, patients should read the package leaflet or
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Aerivio Spiromax, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scintimun on 11 January 2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Scintimun den 11. januar 2010.
English: The full EPAR for Scintimun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Scintimun findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance besilesomab.
Danish: Det indeholder det aktive stof besilesomab.
English: This is a summary of the European public assessment report (EPAR) for Scintimun.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Scintimun.
English: The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.
Danish: Den indsprøjtede mængde besilesomab varierer mellem 0,25 og 1 mg, alt efter, hvor meget radioaktivitet der kræves.
English: A risk management plan has been developed to ensure that Scintimun is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Scintimun anvendes så sikkert som muligt.
English: In addition the company that makes Scintimun will make sure that all doctors who are expected to use it are provided with a letter explaining the risks associated with the medicine.
Danish: Desuden vil den virksomhed, der fremstiller Scintimun, sørge for, at alle læger, som forventes at bruge det, får tilsendt et brev, der forklarer, hvilke risici der er forbundet med lægemidlet.
English: As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.
Danish: Ligesom det er tilfældet med alle radioaktive stoffer, der anvendes i lægemidler, bør patienterne eksponeres for den lavest mulige dosis Scintimun.
English: Patients limbs were then scanned and the images obtained using both techniques were compared.
Danish: Patientens lemmer blev efterfølgende skannet, hvorefter de billeder, der blev taget ved hjælp af begge teknikker, blev sammenlignet.
English: Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.
Danish: Scintimun må kun anvendes på hospitaler med en nuklearmedicinsk afdeling og må kun håndteres af autoriseret personale.
English: What measures are being taken to ensure the safe and effective use of Scintimun?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Scintimun?
English: Other information about Scintimun
Danish: Andre oplysninger om Scintimun
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Scintimun.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Scintimun skal anvendes.
English: For more information about treatment with Scintimun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Scintimun, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Radiolabelling is a technique where a substance is labelled with a radioactive compound.
Danish: Radiomærkning er en teknik, hvor et stof mærkes med et radioaktivt præparat.
English: Scintimun is for diagnostic use only.
Danish: Scintimun er udelukkende til diagnostisk brug.
English: It is used to locate areas of infection or inflammation in adults with suspected osteomyelitis (bone infection) in the limbs, in combination with other appropriate imaging methods.
Danish: Det anvendes til at lokalisere områder med infektion eller betændelse hos voksne med formodet osteomyelitis (knogleinfektion) i lemmerne i kombination med andre egnede billedmetoder.
English: Scintimun is not used on its own, but must be radiolabelled before use.
Danish: Scintimun anvendes ikke alene, men skal radiomærkes før brug.
English: Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).
Danish: Scintimun bør ikke anvendes til diagnosticering af diabetisk fodinfektion (en infektion, som optræder i fødderne hos diabetespatienter).
English: Three to six hours after the injection, the doctor takes a scan of the limbs to locate the areas in the bones affected by osteomyelitis.
Danish: Tre til seks timer efter indsprøjtningen skanner lægen lemmerne for at lokalisere de områder i knoglerne, der er ramt af osteomyelitis.
English: The solution is given to the patient as one injection into a vein.
Danish: Opløsningen gives til patienten som en indsprøjtning i en blodåre.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scintimun, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Scintimun, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The active substance in Scintimun, besilesomab, is a monoclonal antibody.
Danish: Det aktive stof i Scintimun, besilesomab, er et monoklonalt antistof.
English: The most common side effect with Scintimun (seen in more than 1 patient in 10) is the production of anti-mouse antibodies.
Danish: De hyppigste bivirkninger ved Scintimun (som optræder hos flere end 1 ud af 10 patienter) er udvikling af antimus-antistoffer.
English: As large numbers of granulocytes gather at the site of an infection, the radioactivity will accumulate in areas affected by osteomyelitis, where it can be detected by scans.
Danish: Da et stort antal granulocytter samler sig på et infektionssted, vil radioaktiviteten ophobes i områder, der er ramt af osteomyelitis, hvor den kan påvises ved skanninger.
English: Scintimun must not be used in patients who have tested positive for human anti-mouse antibody (HAMA) and must not be used in pregnant women.
Danish: Scintimun må ikke anvendes hos patienter, der er testet positive for humant antimus-antistof (HAMA), og det må ikke anvendes til gravide kvinder.
English: What is the risk associated with Scintimun?
Danish: Hvilken risiko er der forbundet med Scintimun?
English: Besilesomab has been designed to attach to an antigen called NCA-95, which is found on the surface of granulocytes, a type of white blood cell involved in inflammation and fighting infection.
Danish: Besilesomab er opbygget, så det binder sig til et antigen kaldet NCA-95, som findes på overfladen af granulocytter, der er en type hvide blodlegemer, som spiller en rolle i forbindelse med betændelse og bekæmpelse af infektion.
English: When the radiolabelled medicine is injected into the patient, the monoclonal antibody carries the radioactivity to the target antigen on the granulocytes.
Danish: Når det radiomærkede lægemiddel indsprøjtes i patienten, fører det monoklonale antistof radioaktiviteten hen til målantigenet på granulocytterne.
English: In one main study in 130 patients who had or were suspected to have osteomyelitis in their limbs, radiolabelled Scintimun was compared with a standard diagnostic technique using the patients' own white blood cells that were radiolabelled before being injected back into the patient.
Danish: I en hovedundersøgelse af 130 patienter, som havde eller formodedes at have osteomyelitis i lemmerne, blev radiomærket Scintimun sammenlignet med en standarddiagnoseteknik, hvor patienten fik indsprøjtet sine egne hvide blodlegemer, efter at de var blevet radiomærket.
English: The main measure of effectiveness for Scintimun was based on how much the assessment of the images obtained with Scintimun agreed with that obtained with the radiolabelled white blood cells.
Danish: Det primære effektmål for Scintimun var baseret på, hvor meget vurderingen af de billeder, der var taget med Scintimun, lignede vurderingen af de billeder, der var taget med de radiomærkede hvide blodlegemer.
English: Scintimun produced comparable results to the radiolabelled white blood cells when used to diagnose and locate osteomyelitis in limbs.
Danish: Scintimun gav næsten de samme resultater som de radiomærkede hvide blodlegemer, når det blev anvendt til diagnosticering og lokalisering af osteomyelitis i lemmerne.
English: Why has Scintimun been approved?
Danish: Hvorfor blev Scintimun godkendt?
English: The images will show where besilesomab has accumulated, which the doctor will use to locate the areas of infection or inflammation.
Danish: Billederne vil vise, hvor besilesomab har ophobet sig, og lægen vil bruge dette til at lokalisere de områder, hvor der er infektion eller betændelse.
English: A radioactive Scintimun solution is made by mixing the powder and solvent provided in the kit and then radiolabelling it with technetium (99mTc).
Danish: En radioaktiv Scintimun-opløsning fremstilles ved at blande pulveret og solvensen, som sættet indeholder, og herefter radiomærke det med technetium (99mTc).
English: For the full list of all side effects reported with Scintimun, see the package leaflet.
Danish: Den fuldstændige liste over alle indberettede bivirkninger ved Scintimun fremgår af indlægssedlen.
English: Scintimun is a kit for the preparation of a radioactive solution for injection.
Danish: Scintimun er et sæt til fremstilling af en radioaktiv injektionsvæske, opløsning.
English: Scintimun must not be used in people who are hypersensitive (allergic) to besilesomab, to other mouse antibodies or to any of the other ingredients.
Danish: Scintimun må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for besilesomab, andre antistoffer fra mus eller andre af indholdsstofferne.
English: When Scintimun is radiolabelled, the radioactive compound technetium (99mTc) becomes attached to besilesomab.
Danish: Når Scintimun radiomærkes, binder den radioaktive forbindelse technetium (99mTc) sig til besilesomab.
English: What is Scintimun?
Danish: Hvad er Scintimun?
English: Scintimun is radiolabelled by mixing it with a solution of radioactive technetium (99mTc).
Danish: Scintimun radiomærkes ved at blande det med en opløsning af radioaktivt technetium (99mTc).
English: What is Scintimun used for?
Danish: Hvad anvendes Scintimun til?
English: How has Scintimun been studied?
Danish: Hvordan blev Scintimun undersøgt?
English: How is Scintimun used?
Danish: Hvordan anvendes Scintimun?
English: What benefit has Scintimun shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Scintimun?
English: The CHMP decided that Scintimun's benefits are greater than its risks.
Danish: CHMP besluttede, at fordelene ved Scintimun opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Scintimun.
English: The agreement rate was 83%.
Danish: Overensstemmelsesraten var
English: How does Scintimun work?
Danish: Hvordan virker Scintimun?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 April 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21.
English: The company plans to include these data in a new marketing authorisation application in the EU.
Danish: Virksomheden har til hensigt at medtage disse data i sin nye ansøgning om markedsføringstilladelse i EU.
English: It works by blocking the production of bacterial proteins, thus preventing the growth of the bacteria.
Danish: Det virker ved at blokere bakteriernes proteindannelse og hæmmer derved deres vækst.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that its decision to withdraw is based on a request from the US FDA to provide additional safety data to support approval in the US.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at beslutningen om at trække ansøgningen tilbage bygger på en anmodning fra det amerikanske FDA om at fremlægge supplerende sikkerhedsdata til støtte for ansøgningen i USA.
English: There were also concerns that solithromycin could be harmful to the liver.
Danish: Der var desuden betænkelighed ved, at solithromycin kunne være skadeligt for leveren.
English: In addition, it had concerns about the manufacturing process of the active substance, which did not exclude the presence of impurities, and the test for ensuring sterility of the product for infusion was not considered valid.
Danish: Derudover havde udvalget betænkeligheder ved fremstillingsprocessen for det aktive stof, som ikke udelukkede tilstedeværelsen af urenheder, og testen til sikring af steriliteten af infusionslægemidlet blev ikke anset for valid.
English: No studies in patients with inhaled anthrax or inhaled tularaemia have been carried out and the company presented data from laboratory studies.
Danish: Der er ikke udført patientundersøgelser med inhalationserhvervet miltbrand eller inhalationserhvervet tularæmi, og virksomheden fremlagde data fra laboratorieundersøgelser.
English: The company presented data from three studies in a total of 1,855 patients with community-acquired pneumonia, in which Solithromycin Triskel EU Services was compared with other antibiotics (levofloxacin and moxifloxacin).
Danish: Virksomheden fremlagde data fra tre undersøgelser hos i alt 1 855 patienter med samfundserhvervet lungebetændelse, hvor Solithromycin Triskel EU Services blev sammenlignet med andre antibiotika (levofloxacin og moxifloxacin).
English: Solithromycin Triskel EU Services was expected to be used to treat the following bacterial infections:
Danish: Solithromycin Triskel EU Services forventedes anvendt til behandling af følgende bakterieinfektioner:
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Solithromycin Triskel EU Services og har behov for mere information om din behandling, kan du kontakte den læge, der behandler dig.
English: On 27 March 2017, Triskel EU Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Solithromycin Triskel EU Services, intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Danish: Den 27. marts 2017 meddelte Triskel EU Services Ltd officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Solithromycin Triskel EU Services til behandling af samfundserhvervet lungebetændelse, inhalationserhvervet miltbrand (anthrax) og inhalationserhvervet tularæmi.
English: Solithromycin Triskel EU Services is a medicine that contains the active substance solithromycin.
Danish: Solithromycin Triskel EU Services er et lægemiddel, der indeholder det aktive stof solithromycin.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Solithromycin Triskel EU Services did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Solithromycin Triskel EU Services ikke opvejede risiciene.
English: • inhaled tularaemia (another serious disease caught by inhaling bacteria).
Danish: • inhalationserhvervet tularæmi (en anden alvorlig sygdom, der erhverves ved indånding af bakterier)
English: • inhaled anthrax (the most serious form of anthrax caught by inhaling bacterial spores);
Danish: • inhalationserhvervet miltbrand (den alvorligste form for anthrax, erhvervet ved indånding af bakteriesporer)
English: It was to be available as capsules to be taken by mouth and as a powder to be made into a solution for infusion (drip) into a vein.
Danish: Det leveres som kapsler til indtagelse gennem munden og som et pulver, der efter opløsning i den medfølgende væske indgives med drop i en vene (ved infusion).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Solithromycin Triskel EU Services.
Danish: Virksomheden har til CHMP oplyst, at tilbagetrækningen ikke har konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Solithromycin Triskel EU Services.
English: • community-acquired pneumonia (an infection of the lungs caught outside of hospital);
Danish: • samfundserhvervet lungebetændelse (lungebetændelse erhvervet uden for hospitalet)
English: The active substance in Solithromycin Triskel EU Services, solithromycin, is a type of antibiotic similar to a group of antibiotics known as ‘macrolides'.
Danish: Det aktive stof i Solithromycin Triskel EU Services, solithromycin, er et antibiotikum, der svarer til antibiotika i gruppen makrolider.
English: The CHMP was concerned that not enough data had been provided to support use in inhaled anthrax and inhaled tularaemia.
Danish: CHMP var betænkeligt ved, at der ikke var forelagt tilstrækkelige data til at underbygge anvendelsen ved inhalationserhvervet miltbrand og inhalationserhvervet tularæmi.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Solithromycin Triskel EU Services could not have been approved for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Solithromycin Triskel EU Services ikke kunne være blevet godkendt til behandling af samfundserhvervet lungebetændelse, inhalationserhvervet miltbrand og inhalationserhvervet tularæmi.
English: What is Solithromycin Triskel EU Services?
Danish: Hvad er Solithromycin Triskel EU Services?
English: How does Solithromycin Triskel EU Services work?
Danish: Hvordan virker Solithromycin Triskel EU Services?
English: What was Solithromycin Triskel EU Services expected to be used for?
Danish: Hvad forventedes Solithromycin Triskel EU Services anvendt til?
English: EMA/249992/2017
Danish: april 2017
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Solithromycin Triskel EU Services?
English: • development of 1 or more symptom from at least 2 of the following groups:
Danish: • Udvikling af et eller flere symptomer fra minimum 2 af følgende grupper:
English: 200 to <350
Danish: 200 til < 350
English: Therefore, the following should always be adhered to:
Danish: Derfor bør følgende altid overholdes:
English: This medicine is not for children under 12 years of age.
Danish: Dette lægemiddel er ikke til børn under 12 år.
English: Individual components have been investigated in adolescents (12 to 17 years).
Danish: De individuelle komponenter er blevet undersøgt hos unge (12-17 år).
English: (Complex binding to polyvalent ions)
Danish: (Kompleks binding til polyvalente ioner).
English: • The usual dose is one tablet once a day
Danish: • Den sædvanlige dosis er 1 tablet én gang daglig.
English: See Section 4 for more information.
Danish: Se punkt 4 for at få flere oplysninger.
English: African-American/African Heritage/Other Age (years)
Danish: Afroamerikansk/afrikansk oprindelse/andet Alder (år)
English: Median Age (years) Female
Danish: Medianalder (år) Kvinde
English: Push here (with Alert card attached)
Danish: Tryk her (med oplysningskort vedhæftet)
English: You may need extra check-ups, including blood tests, while you're taking your medicine.
Danish: Det kan være nødvendigt med ekstra undersøgelser, herunder blodprøver, mens du tager din medicin.
English: The difference in the endpoint remained statistically significant (p=0.006).
Danish: Forskellen i endepunktet forblev statistisk signifikant (p = 0,006).
English: The table should not be considered exhaustive but is representative of the classes studied.
Danish: Tabellen bør ikke betragtes som værende fuldstændig, men er repræsentativ for de lægemiddelklasser, der er undersøgt.
English: Reference should be made to treatment guidelines.
Danish: Der henvises til retningslinjerne for behandling.
English: In these cases the physician should refer to the individual product information for these medicinal products.
Danish: I disse tilfælde bør lægen henvise til produktinformationen for de individuelle lægemidler.
English: Hepatitis B co-infection was one of main exclusion criteria.
Danish: Hepatitis B-infektion var et af de vigtigste udelukkelseskriterier.
English: Tell your doctor if you are taking any of the medicines in the following list:
Danish: Fortæl lægen, hvis du tager nogen af de lægemidler, der står på følgende liste:
English: Interaction geometric mean change (%)
Danish: Interaktion geometrisk middelændring (%)
English: • if you have moderate or severe liver disease
Danish: • hvis du har en moderat eller alvorlig leversygdom
English: Pharmacokinetic parameters are comparable to those reported in adults.
Danish: De farmakokinetiske parametre kan sammenlignes med dem, der er rapporteret hos voksne.
English: All treatments were given open-label.
Danish: Alle behandlinger blev administreret som open label.
English: This is not considered clinically significant (see Absorption).
Danish: Dette anses ikke for at være klinisk signifikant (se 'Absorption').
English: The proportion with a positive HCV serology was 7%.
Danish: Andelen med en positiv HCVserologi var 7 %.
English: 85 days
Danish: 85 dage
English: * Adjusted for baseline stratification factors.
Danish: * Justeret for baseline-stratificeringsfaktorer.
English: Important information about the contents of Triumeq tablets.
Danish: Vigtig information om indholdet af Triumeq tabletter.
English: Detach this card and keep it with you at all times.
Danish: Tag kortet ud, og hav det altid på dig.
English: 30% of the body surface (toxic epidermal necrolysis)
Danish: 30 % af kroppens overflade (toksisk epidermal nekrolyse)
English: * Adjusted for baseline stratification factors, p=0.025.
Danish: * Justeret for baseline-stratificeringsfaktorer, p = 0,025.
English: This antiviral response was maintained for 3 to 4 days after the last dose in the 50 mg group.
Danish: Dette antivirale respons blev opretholdt i 3-4 dage efter administration af den sidste dosis hos 50 mggruppen.
English: Overall treatment differences at Week 96 are applicable to patients with high and low Baseline viral loads.
Danish: De samlede behandlingsforskelle ved uge 96 gælder for både patienter med høje og lave virale belastninger ved baseline.