FrancophonIA/ELRC3.0 huggingface dataset:
English: Some cancers can make proteins called PD-L1 and PD-L2 that combine with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Danish: Nogle kræftformer kan danne såkaldte PD-L1- og PD-L2-proteiner, der i kombination med PD-1 indvirker på visse celler i immunsystemet (kroppens naturlige forsvar) ved at afbryde deres aktivitet og forhindre dem i angribe kræften.
English: There are no consequences on the use of Keytruda in its authorised uses.
Danish: Afgørelsen vil ikke få konsekvenser for brugen af Keytruda i de godkendte indikationer.
English: Keytruda was also expected to be used in combination with the chemotherapy medicines pemetrexed and carboplatin in NSCLC patients with metastatic ‘non-squamous' NSCLC, irrespective of whether their tumour produced the PD-L1 protein.
Danish: Keytruda forventedes anvendt i kombination med kemoterapi-lægemidlerne pemetrexed og carboplatin hos NSCLC-patienter med metastatisk 'ikke-pladecelle'-NSCLC, uanset om deres tumor danner PD-L1proteinet.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Keytruda could not have been approved for the treatment of metastatic non-squamous NSCLC in combination with pemetrexed and carboplatin.
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 Keytruda ikke ville kunne være blevet godkendt til behandling af metastatisk ikke-pladecelle-NSCLC i tillæg til pemetrexed og carboplatin.
English: Keytruda is a cancer medicine already authorised for use on its own to treat NSCLC.
Danish: Keytruda er et kræftlægemiddel, der er godkendt til enkeltstofsbehandling af NSCLC.
English: What is happening with Keytruda in its authorised uses?
Danish: Hvad sker der med Keytruda i de godkendte indikationer?
English: By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.
Danish: Ved at blokere PD-1 forhindrer pembrolizumab kræften i at afbryde disse immuncellers aktivitet.
English: Package size
Danish: Emaballage Pakningsstørrelse
English: This summary was last updated in 11-2012.
Danish: Dette sammendrag blev sidst ajourført i 12-2012.
English: For the other infections, they are taken for five days.
Danish: Til de øvrige infektioner tages de i fem dage.
English: It must also not be used with a number of medicines.
Danish: Det må desuden ikke anvendes sammen med en række bestemte lægemidler.
English: These are closely related to the macrolides.
Danish: Disse er nært beslægtet med makrolider.
English: The full EPAR for Ketek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Ketek findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose of Ketek is 800 mg (two tablets) once a day.
Danish: Den anbefalede dosis Ketek er 800 mg (to tabletter) én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Ketek.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ketek.
English: For pneumonia, the tablets should be taken for seven to 10 days.
Danish: Til lungebetændelse skal tabletterne tages i syv til ti dage.
English: A lower dose may be needed in patients who have severe kidney problems.
Danish: Der kan være behov for en lavere dosis til patienter, som har svære nyreproblemer.
English: What is the risk associated with Ketek?
Danish: Hvilken risiko er der forbundet med Ketek?
English: Why has Ketek been approved?
Danish: Hvorfor blev Ketek godkendt?
English: The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea.
Danish: Den hyppigste bivirkning ved Ketek (som optræder hos flere end 1 ud af 10 patienter) er diarré.
English: However, the Committee noted that Ketek is associated with a greater risk of certain side effects than other antibiotics.
Danish: Udvalget anførte dog, at Ketek er forbundet med en større risiko for visse bivirkninger end andre antibiotika.
English: The CHMP concluded that Ketek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Ketek opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Ketek was as effective as the comparator antibiotics.
Danish: Ketek var lige så effektivt som de antibiotiske sammenligningspræparater.
English: Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision.
Danish: Nogle af disse bivirkninger kan være alvorlige, herunder en forværring af myasthenia gravis, forbigående bevidsthedstab og midlertidige synsforstyrrelser.
English: Telithromycin works by blocking the bacteria's ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria.
Danish: Telithromycin virker ved at blokere bakteriernes ribosomer (de dele af cellerne, hvor der dannes proteiner), hvilket hæmmer væksten af bakterier.
English: The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘satisfactory' reductions in the amount of bacteria detected in samples taken
Danish: Virkningen blev hovedsagelig bedømt på den andel af patienterne, som var helbredt ved behandlingens afslutning bestemt ved et fald i symptomerne, eller som havde et ”tilfredsstillende” fald i mængden af bakterier, der kunne påvises i prøver udtaget fra
English: Ketek is a medicine that contains the active substance telithromycin.
Danish: Ketek er et lægemiddel, der indeholder det aktive stof telithromycin.
English: Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.
Danish: Den ordinerende læge bør tage hensyn til den officielle vejledning i brug af antibakterielle stoffer og til frekvensen af lokal resistens over for antibiotika.
English: All but two of the studies compared Ketek with other antibiotics.
Danish: I alle undersøgelserne undtagen to blev Ketek sammenlignet med andre antibiotika.
English: It is used when betalactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.
Danish: Det anvendes, når beta-laktamer ikke egner sig, i lande eller regioner, hvor der er høj resistens over for
English: The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ketolides'.
Danish: Det aktive stof i Ketek, telithromycin, er et antibiotikum tilhørende gruppen af ”ketolider”.
English: • acute sinusitis (short-lived infection of the sinuses, air-filled passageways in the bones around the
Danish: • akut sinusitis (kortvarig infektion af bihulerne, de luftfyldte passager i knoglerne rundt om næse og
English: How is Ketek used?
Danish: Hvordan anvendes Ketek?
English: It must not be used in patients with myasthenia gravis (a disease of the nerves causing muscle weakness), or who have had hepatitis (inflammation of the liver) or jaundice when they have taken telithromycin in the past.
Danish: Det må ikke anvendes til patienter med myasthenia gravis (en nervesygdom, som giver muskelsvaghed), eller som tidligere har haft hepatitis (leverbetændelse) eller gulsot, hvor de har fået telithromycin.
English: It is also used to treat adults with the following infections when they are caused by bacteria that are or could be resistant (insensitive) to beta-lactams or macrolides (types of antibiotic):
Danish: Det anvendes også til at behandle voksne med følgende infektioner, når de skyldes bakterier, som er eller kunne være resistente (ikke-modtagelige) over for beta-laktamer eller makrolider (former for
English: For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment.
Danish: Til lungebetændelse og kronisk bronkitis var Ketek lige så effektivt som clarithromycin, trovafloxacin, amoxicillin/clavulaninsyre og cefuroxim axetil, da mellem 82 og 95 % af patienterne ikke havde nogen symptomer ved behandlingens afslutning.
English: Ketek must not be used in people who are hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients.
Danish: Ketek må ikke anvendes til personer, der er overfølsomme (allergiske) over for telithromycin, makrolider eller andre af indholdsstofferne.
English: Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes.
Danish: Ketek anvendes også til behandling af patienter på 12 år og derover, som har tonsillitis eller pharyngitis (betændelse i mandler eller hals), der skyldes bakterien Streptococcus pyogenes.
English: In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/clavulanic acid.
Danish: Til patienter med akut sinusitis førte behandlingsforløb med Ketek af fem og ti dages varighed til tilsvarende helbredelsesprocenter, hvilket svarer til dem, der kunne iagttages med amoxicillin/clavulaninsyre.
English: • acute exacerbation (flare-up) of chronic bronchitis (long-lasting inflammation of the airways in the
Danish: • akut eksacerbation (opblussen) af kronisk bronkitis (langvarig betændelse i luftvejene i lungerne).
English: Therefore, the Committee decided that its use should be reserved to the treatment of communityacquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/pharyngitis when these antibiotics
Danish: Udvalget besluttede derfor, at brugen af lægemidlet skulle være forbeholdt behandling af lungebetændelse erhvervet uden for hospital, behandling af bronkitis og sinusitis, når disse skyldtes bakterier, som er resistente over for antibiotika indeholdende beta-laktamer eller makrolider, og behandling af tonsillitis/pharyngitis, når disse antibiotika ikke kan anvendes.
English: For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels
Danish: Til tonsillitis eller pharyngitis havde mellem 84 og 92 % af de patienter, der fik Ketek, penicillin eller clarithromycin, et tilfredsstillende fald i bakteriemængden i prøver udtaget fra halsen.
English: For more information about treatment with Ketek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ketek, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: What benefit has Ketek shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Ketek?
English: Ketek must not be taken by patients with a history or a family history of ‘long QT syndrome' or with ‘acquired QT interval prolongation' (disruption of the heartbeat).
Danish: Ketek må ikke tages af patienter med familiær disposition for ”langt QT syndrom” eller denne sygdom i anamnesen eller med ”erhvervet forlængelse af QT
English: Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness.
Danish: Det kan reducere de potentielle bivirkninger såsom synsforstyrrelser og bevidsthedstab at tage Ketek ved sengetid.
English: For the full list of all side effects reported with Ketek, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved Ketek fremgår af indlægssedlen.
English: The full list of bacteria against which Ketek is active can be found in the summary of product characteristics (also
Danish: Den fuldstændige liste over de bakterier, som Ketek virker mod, findes i produktresuméet (også en del af denne EPAR).
English: Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis.
Danish: Der blev gennemført ti hovedundersøgelser af Ketek hos mere end 4 000 patienter i alt. I fire af undersøgelserne så man på lægemidlets virkning ved behandling af mild til moderat lungebetændelse erhvervet uden for hospital, i to andre så man på akut sinusitis, i to så man på akutte eksacerbationer af kronisk bronchitis, og i to så man på tonsillitis eller pharyngitis.
English: Ketek is used to treat adults with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Danish: Ketek anvendes til at behandle voksne med mild til moderat lungebetændelse erhvervet uden for
English: It is available as tablets
Danish: Det fås som tabletter (400 mg).
English: For more information, see
Danish: De nærmere
English: The application was withdrawn at ‘day 120'.
Danish: Ansøgningen blev trukket tilbage på “dag 120”.
English: What is SecreFlo?
Danish: Hvad er SecreFlo?
English: This means that the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Danish: Det betyder, at CHMP havde vurderet den dokumentation, som virksomheden oprindelig havde fremlagt, og udarbejdet en liste med spørgsmål.
English: SecreFlo is a medicine that contains the active substance secretin human.
Danish: SecreFlo er et lægemiddel, der indeholder det aktive stof sekretin human.
English: The CHMP also noted that the clinical relevance of the study results was unclear.
Danish: CHMP bemærkede desuden, at den kliniske relevans af undersøgelsens resultater var uklar.
English: EMA/CHMP/602611/2012 EMEA/H/C/002027
Danish: EMEA/H/C/002027
English: What was SecreFlo expected to be used for?
Danish: Hvad forventedes SecreFlo anvendt til?
English: Images from the scans were read by expert radiologists without prior knowledge of the patients' condition and the results were compared with what was already known from other tests.
Danish: Billeder fra scanningerne blev vurderet af røntgenlæger uden forudgående kendskab til patientens tilstand, og resultatet blev sammenlignet med, hvad der allerede var kendt fra andre test.
English: How is SecreFlo expected to work?
Danish: Hvordan forventes SecreFlo at virke?
English: The Committee was concerned that there may not have been adequate safeguards to ensure that the final readings of the scans were not biased.
Danish: Udvalget var betænkeligt ved, at der muligvis ikke var truffet tilstrækkelige foranstaltninger til at sikre, at de endelige vurderinger af scanningerne ikke var behæftet med skævhed.
English: Another concern was the fact that patients in the study (patients with a history of acute pancreatitis) were not representative of patients for whom the medicine was intended (patients with known or suspected pancreatitis).
Danish: Endnu en betænkelighed var, at patienterne i undersøgelsen (patienter med tidligere akut bugspytkirtelbetændelse) ikke var repræsentative for de patienter, lægemidlet var bestemt til (patienter med kendt eller formodet bugspytkirtelbetændelse).
English: On 15 August 2012, Repligen Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for SecreFlo, intended for use in the detection of duct abnormalities in the pancreas.
Danish: Den 15. august 2012 meddelte Repligen Europe Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for SecreFlo til brug ved påvisning af forandringer i bugspytkirtelgangene.
English: The scans had had to be read a second time after initial readings were deemed unreliable.
Danish: Det havde været nødvendigt at vurdere scanningerne en ekstra gang, da de første vurderinger blev anset for at være upålidelige.
English: At the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that SecreFlo could not have been approved.
Danish: På tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at SecreFlo ikke kunne godkendes.
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 SecreFlo?
English: The company presented data from one main study, which involved 270 patients with a history of acute pancreatitis who had MRI scans with or without previous SecreFlo injections.
Danish: Virksomheden fremlagde data fra én hovedundersøgelse med 270 patienter, som tidligere havde haft akut bugspytkirtelbetændelse og fået foretaget MR-scanning med eller uden forudgående injektion af SecreFlo.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was based on the fact that the concerns raised by the CHMP could not be addressed in the available timeframe.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anfører virksomheden, at tilbagetrækningen skyldtes, at den ikke så sig i stand til at imødekomme CHMP's betænkeligheder inden for de fastsatte frister.
English: Being able to see abnormalities in the pancreatic ducts is important for making decisions on how to treat these patients.
Danish: Det er vigtigt at kunne se eventuelle forandringer i gangene i bugspytkirtlen, når der skal tages stilling til behandlingen af sådanne patienter.
English: SecreFlo was to be injected into a patient's vein just before undergoing a MRI scan.
Danish: SecreFlo skulle indsprøjtes i en vene på patienterne umiddelbart før MR-scanningen.
English: SecreFlo was expected to be used in patients undergoing magnetic resonance imaging (MRI, a type of scan where images of the internal organs are taken) to obtain a clearer image of their pancreas.
Danish: SecreFlo forventedes anvendt hos patienter, der får foretaget MR-scanning (en særlig type scanning, hvor der tages billeder af de indre organer) for at opnå et tydeligere billede af bugspytkirtlen.
English: The active substance in SecreFlo is a copy of human secretin, a natural hormone that stimulates the pancreas to secrete fluids into the small intestine.
Danish: Det aktive stof i SecreFlo er en kopi af humant sekretin, som er et naturligt hormon, der stimulerer bugspytkirtlen til at udskille bugspyt i tyndtarmen.
English: The main measures of effectiveness were based on the sensitivity of the scans (how well they detected abnormalities in the ducts) and their specificity (how well normal ducts were identified as normal).
Danish: Virkningen blev hovedsagelig bedømt på scanningernes følsomhed (dvs. hvor godt de var i stand til at påvise forandringer i kirtelgangene) og deres specificitet (dvs. hvor godt det var i stand til at identificere normale kirtelgange som normale).
English: The company informed the CHMP that there were no ongoing clinical trials with SecreFlo at the time of the withdrawal.
Danish: Virksomheden har til CHMP oplyst, at der på tilbagetrækningstidspunktet ikke var nogen igangværende kliniske undersøgelser med SecreFlo.
English: Withdrawal of the marketing authorisation application for SecreFlo (secretin human) EMA/602611/2012
Danish: Den 14. september 2012 EMA/602611/2012
English: It was to be used in patients with known or suspected pancreatitis (inflammation of the pancreas) so that abnormalities in the small ducts within the pancreas can be seen more clearly.
Danish: Det skulle anvendes hos patienter med kendt eller formodet bugspytkirtelbetændelse, således at forandringer i de små gange i bugspytkirtlen blev bedre synlige.
English: The medicine's use in visualising the pancreatic ducts is based on its action of stimulating fluid secretion, which causes the ducts in the pancreas to widen significantly and therefore appear more clearly in a scan.
Danish: Lægemidlets anvendelse til billeddannelse af bugspytkirtlens gange bygger på, at det stimulerer udskillelsen af bugspyt, hvorved bugspytkirtlens gange udvider sig betydeligt, så de træder tydeligere frem ved scanningen.
English: -- 1 Inactivated West Nile virus, strain VM-2: RP* 1.0-2.2/ml.
Danish: -- 1 Inaktiveret Vestnilvirus, stamme VM-2 RP* 1,0- 2,2 *Relativ styrke in vitro sammenlignet med en referencevaccine, der var påvist effektiv til heste.
English: Strength Pharmaceutical form
Danish: EU-nummer Særnavn Styrke Lægemiddelform
English: Unopened: 3 years
Danish: Uåbnet: 3 år
English: Your doctor will know about this.
Danish: Din læge ved mere om dette.
English: Therefore, no interaction is expected.
Danish: Derfor forventes der ingen interaktioner.
English: Component of a multipack, cannot be sold separately.
Danish: Del af multipakning, må ikke sælges separat.
English: The following instructions must be adhered to:
Danish: Følgende vejledning skal overholdes:
English: This leaflet was last revised in <date of Commission Decision>
Danish: Denne indlægsseddel blev senest ændret <dato for Kommissionens afgørelse>
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1018/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1018/001
English: See section 4.8 for further details regarding possible visual disturbances.
Danish: 4.8 for yderligere oplysninger vedrørende mulige synsforstyrrelser.
English: Prevention of miosis was confirmed in a categorical analysis.
Danish: Forebyggelse af miose blev bekræftet i en kategorisk analyse.
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Der er ikke udført interaktionsstudier.
English: Your doctor will decide if Omidria is suitable for you.
Danish: Lægen vil beslutte, om Omidria er rigtigt for dig.
English: Patients were randomised to either Omidria or placebo (1:1).
Danish: Patienterne blev randomiseret til enten Omidria eller placebo (1:1).
English: Before administering the medicinal product
Danish: Før administration af lægemidlet
English: A significant reduction in ocular pain during the initial 10-12 hours postoperatively was also demonstrated.
Danish: Der påvistes desuden en signifikant reduktion af den okulære smerte i løbet af de første 10-12 timer efter indgrebet.
English: Nineteen percent of cataracts were LOCS II Nuclear Grade 2 or 3.
Danish: 19 % af katarakttilfældene var LOCS II-kernegrad 2 eller 3.
English: Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these active substances.
Danish: Derfor skal Omidria anvendes med forsigtighed hos personer, der tidligere har udvist overfølsomhed over for disse aktive stoffer.
English: Each of these same findings was reported at a similar frequency in patients receiving placebo.
Danish: Hvert af disse samme fund blev indberettet med en ensartet hyppighed hos patienter, der fik placebo.
English: After dilution, chemical and physical in-use stability has been demonstrated for 6 hours at 25 ˚C.
Danish: Efter fortynding er der påvist kemisk og fysisk brugsholdbarhed i 6 timer ved 25 ˚C.
English: If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking 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: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 July 2015
Danish: Dato for første markedsføringstilladelse: 28. juli 2015