FrancophonIA/ELRC3.0 huggingface dataset:
English: Written explanations were provided by the marketing authorisation holder on 11 April 2011.
Danish: Indehaveren af markedsføringstilladelsen afgav skriftlige redegørelser den 11. april 2011.
English: The application was submitted as a generic of the reference product, Synulox Palatable Tablets 50 mg marketed by Pfizer Ltd.
Danish: Ansøgningen blev indgivet som en generisk ansøgning, idet referencelægemidlet var Synulox, velsmagende tabletter, 50 mg, der markedsføres af Pfizer Ltd.
English: The summary of product characteristics, labelling and package leaflet are provided in Annex III.
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: Clavudale 50 mg is intended for the treatment of pathogen-specific skin infections, infections of the oral cavity, urinary tract infections, respiratory disease and enteritis.
Danish: Clavudale, 50 mg, er bestemt til behandling af patogenspecifikke hudinfektioner, infektioner i mundhulen, urinvejsinfektioner, luftvejssygdomme og enteritis.
English: Clavudale 50 mg tablet for cats and dogs and associated names (Clavudale 50 mg) contains amoxicillin and clavulanic acid.
Danish: Clavudale, tabletter, 50 mg, til katte og hunde, og relaterede navne (Clavudale 50 mg) indeholder amoxicillin og clavulansyre.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Clavudale 50 mg tablet for cats and dogs and associated
Danish: På grundlag af vurderingen af rapportørens gennemgang af de aktuelt foreliggende data fandt CVMP, at benefit/risk-forholdet for Clavudale, tabletter, 50 mg til katte og hunde, og relaterede navne, er positivt, og vedtog derfor den 6. april 2011 en udtalelse med anbefaling om udstedelse af markedsføringstilladelse.
English: Ref. EMEA/CHMP/384877/2008
Danish: EMEA/CHMP/556332/2008
English: It is available as film coated tablets, oro-dispersible tablets (rapidly disintegrating) and oral solution.
Danish: Det fås som filmovertrukne tabletter, smeltetabletter (hurtigtopløsende) og oral opløsning.
English: Risperdal and associated names is as an antipsychotic, indicated for the treatment of schizophrenia, manic episodes associated with bipolar disorders, persistent aggression in patients with moderate to severe Alzheimer's dementia and treatment of persistent aggression in conduct disorder in children.
Danish: Risperdal og tilknyttede navne er et antipsykotikum, som er indiceret til behandling af skizofreni, maniske episoder i forbindelse med bipolar sygdom, persisterende aggression hos patienter med moderat til svær Alzheimer-demens og persisterende aggression i forbindelse med adfærdsforstyrrelser hos børn.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal and associated names International Non-Proprietary Name (INN): risperidone
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 30 OM Risperdal og tilknyttede navne Internationalt fællesnavn (INN): risperidon
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amended SPC, Labelling and Package Leaflet in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og det ændrede produktresume og den ændrede indlægsseddel og etikettering i bilag III.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal and associated names approved across EU Member States, with respect to the indications, the posology and method of administration, the contra-indications, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Danish: Grundlaget for indbringelsen af sagen var, at der var afvigelser mellem de produktresuméer, der var godkendt for Risperdal og tilknyttede navne i EU-medlemsstaterne, med hensyn til indikationer, dosering og indgivelsesmåde, kontraindikationer, særlige advarsler og forsigtighedsregler vedrørende brugen og interaktionen med andre lægemidler og andre former for interaktion.
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal and associated names.
Danish: Den 24. juli 2007 indbragte Europa-Kommissionen en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF, med senere ændringer, med henblik på harmonisering af de nationalt godkendte produktresuméer (SPC), indlægsseddel og etikettering for lægemidlet Risperdal og tilknyttede navne.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal and associated names.
Danish: CHMP afgav en positiv udtalelse den 24. juli 2008, hvori udvalget anbefalede harmonisering af produktresumé, etikettering og indlægsseddel for Risperdal og tilknyttede navne.
English: OS (months)
Danish: Samlet overlevelse (måneder)
English: You should tell your doctor:
Danish: Du skal fortælle din læge:
English: - corresponds to percentage below threshold.
Danish: - Svarer til procentdel under tærskelværdien
English: Caution should be exercised in such situations.
Danish: Der skal iagttages forsigtighed i sådanne situationer.
English: ● At the request of the European Medicines Agency
Danish: • på anmodning fra Det Europæiske Lægemiddelagentur.
English: The study did not meet its primary endpoint.
Danish: Studiet opfyldte ikke dets primære endepunkt.
English: Independent Review **
Danish: Uafhængigt review **
English: What Tarceva contains:
Danish: Tarceva indeholder:
English: In some cases dose reduction may be necessary.
Danish: I nogle tilfælde kan det blive nødvendigt at reducere dosis.
English: Demographic characteristics were well balanced between the two treatment groups.
Danish: De demografiske karakteristika var velafbalancerede mellem de to behandlingsgrupper.
English: There was no change to Tmax or half-life.
Danish: Der var ingen ændring i Tmax eller halveringstiden.
English: Plasma protein binding is approximately 95%.
Danish: Plasmaproteinbindingen er ca. 95 %.
English: Tarceva is indicated for adults.
Danish: Tarceva er indiceret til voksne.
English: Date of first authorization: 19 September 2005 Date of latest renewal: 2 July 2010
Danish: Dato for første markedsføringstilladelse: 19. september 2005 Dato for sidste genregistrering: 2. juli 2010
English: Best Overall Response Rate (CR/PR)
Danish: Bedste samlede responsrate (CR/PR)
English: The treatment with this medicine is not recommended for children and adolescents.
Danish: Behandling med denne medicin anbefales ikke til børn og unge.
English: This protein is known to be involved in the growth and spread of cancer cells.
Danish: Dette protein er involveret i væksten og spredningen af kræftceller.
English: The exposure after an oral dose may be increased by food.
Danish: Eksponeringen efter en oral dosis kan øges ved indtagelse af føde.
English: Contact your doctor as soon as possible if you suffer from any of the below side effects.
Danish: Kontakt din læge hurtigst muligt, hvis du oplever en af nedenstående bivirkninger.
English: This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Danish: Denne sygdom kan også kædes sammen med den naturlige fremadskriden af din sygdom og kan i nogle tilfælde have dødelig udgang.
English: No new covariate effects were identified.
Danish: Der blev ikke fundet nye kovariante virkninger.
English: The effect on overall survival was explored across different patient subsets.
Danish: Virkningen på samlet overlevelse blev undersøgt i forskellige patientundergrupper.
English: NCI-CTC Grade
Danish: NCI-CTC grad
English: Red blood cell parameters were decreased and white blood cells, primarily neutrophils, were increased.
Danish: De røde blodlegemeparametre var nedsatte og antallet af hvide blodlegemer, primært neutrofile, var forøget.
English: EGFR is expressed on the cell surface of normal cells and cancer cells.
Danish: EGFR udtrykkes på celleoverfladen af normale celler og cancerceller.
English: 1 In clinical study PA.3.
Danish: I klinisk studie PA.3.
English: Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
Danish: Behandlingen bør kun fortsættes hos gravide, hvis fordelen for moderen opvejer risikoen for fostret.
English: A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Danish: Et studie hos raske frivillige estimerede den absolutte biotilgængelighed til 59 %.
English: These were very common in clinical study PA.3 and common in clinical study BR.21.
Danish: Disse var meget almindelige i klinisk studie PA.3 og almindelige i klinisk studie BR.21.
English: The clinical relevance of these differences is unclear.
Danish: Den kliniske relevans af disse forskelle er uklar.
English: Patients in this study were not selected based on EGFR mutation status.
Danish: Patienterne som indgik i dette studie var ikke valgt baseret på deres EGFR mutationsstatus.
English: Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Danish: Baseret på populationsfarmakokinetiske analyser synes tilstedeværelsen af et opioid at øge eksponeringen med ca. 11 %.
English: No studies have been conducted to assess the impact of Tarceva on milk production or its presence in breast milk.
Danish: Der er ikke lavet studier for at undersøge virkningen af Tarceva på mælkeproduktionen eller tilstedeværelsen i human mælk.
English: Tarceva has not been studied in patients under the age of 18 years.
Danish: Tarceva er ikke undersøgt hos patienter under 18 år.
English: It is not known whether Tarceva has a different effect if your liver or kidneys are not functioning normally.
Danish: Det vides ikke, om Tarceva virker anderledes, hvis din lever eller nyrer ikke fungerer normalt.
English: Less than 2% of the orally administered dose is excreted as parent substance.
Danish: Mindre end 2 % af den oralt administrerede dosis udskilles som moderstoffet.
English: PFS (median in months)
Danish: PFS (median i måneder)
English: The benefit is mostly driven by the presence of a low pain intensity score.
Danish: Den gavnlige virkning ses ved tilstedeværelsen af en lav smerte-intensitetsscore.
English: The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigatorassessed (response rate 11.2%).
Danish: De første 330 patienter blev vurderet centralt (responsrate 6,2 %); 401 patienter blev vurderet af investigator (responsrate 11,2 %).
English: Survival was evaluated in the intent-to-treat population based on follow-up survival data.
Danish: Overlevelsen blev evalueret hos intent-to-treat-populationen på grundlag af follow-upoverlevelsesdata.
English: About two-thirds of the patients were male and approximately one-third had a baseline ECOG performance status (PS) of 2, and 9% had a baseline ECOG PS of 3.
Danish: Ca. to tredjedele af patienterne var mænd og ca. en tredjedel havde en baseline ECOG performance status (PS) på 2 og 9 % havde en baseline ECOG PS på 3.
English: The clinical relevance of this increase has not been established.
Danish: Den kliniske betydning af denne stigning er ikke blevet fastslået.
English: If necessary the dose of erlotinib should be reduced, particularly if toxicity is observed.
Danish: Om nødvendigt skal dosis af erlotinib reduceres, specielt hvis der observeres toksicitet.
English: Progression Free Survival (PFS, median in months)* Investigator Assessed **
Danish: Progressionsfri overlevelse (PFS, median i måneder)* Investigatorvurderet **
English: If you become pregnant while you are being treated with Tarceva, immediately inform your doctor who will decide if the treatment should be continued.
Danish: Hvis du bliver gravid, mens du behandles med Tarceva, skal du omgående informere din læge, som vil beslutte, om behandlingen skal stoppes.
English: Erlotinib tested negative in conventional genotoxicity studies.
Danish: Erlotinib blev testet negativ i konventionelle genotoksicitetsstudier.
English: PFS (median in months), Investigator assessed p<0.0001
Danish: PFS (median i måneder), Investigatorvurderet p<0,0001
English: A higher incidence of ILD (approximately 5% with a mortality rate of 1.5%) is seen among patients in studies conducted in Japan.
Danish: Forekomsten af ILD var højere (ca. 5 % med dødelighed på 1,5 %) hos patienter i studier, som blev udført i Japan.
English: Symptoms started from a few days to several months after initiating Tarceva therapy.
Danish: Symptomerne opstod få dage til flere måneder efter påbegyndelsen af behandlingen med Tarceva.
English: It can also be prescribed if previous chemotherapy has not helped to stop your disease.
Danish: Det kan også ordineres, hvis tidligere kemoterapi ikke har kunnet stoppe sygdommen.
English: The consequences of this interaction for e.g. CNS toxicity have not been established.
Danish: Konsekvenserne af denne interaktion for f.eks. CNS-toksicitet kendes ikke.
English: Therefore, in such patients, periodic liver function testing should be considered.
Danish: Hos disse patienter bør det derfor overvejes at teste leverfunktionen periodisk.
English: In clinical practice, there may be other co-factors leading to an increased exposure to carboplatin like renal impairment.
Danish: I klinisk praksis kan der være andre co-faktorer, der medfører en øget eksponering for carboplatin, så som nyreinsufficiens.
English: Potential interactions may occur with active substances which are metabolised by, or are inhibitors or inducers of, these enzymes.
Danish: Der kan forekomme potentielle interaktioner med aktive stoffer, som metaboliseres af eller er hæmmere eller induktorer af disse enzymer.
English: There are no adequate data for the use of erlotinib in pregnant women.
Danish: Der er utilstrækkelige data for anvendelse af erlotinib til gravide kvinder.
English: You are advised to stop smoking if you are treated with Tarceva as smoking could decrease the amount of your medicine in the blood.
Danish: Du tilrådes at stoppe med at ryge, hvis du behandles med Tarceva, da rygning kan nedsætte mængden af medicin i blodet.
English: Baseline ECOG performance status (PS) = 0 Baseline ECOG performance status (PS) = 1 Baseline ECOG performance status (PS) = 2 Metastatic disease at baseline
Danish: ECOG performance status (PS)= 0 ved baseline ECOG performance status (PS)= 1 ved baseline ECOG performance status (PS)= 2 ved baseline Metastserende sygdom ved baseline
English: PVC blister sealed with aluminium foil containing 30 tablets.
Danish: PVC-blister forseglet med alufolie indeholdende 30 tabletter.
English: Elderly population There have been no specific studies in elderly patients.
Danish: Den ældre population Der foreligger ingen specifikke studier hos ældre patienter.
English: Tarceva or placebo was taken orally once daily until disease progression or unacceptable toxicity.
Danish: Tarceva eller placebo blev taget oralt én gang daglig indtil sygdomsprogression eller uacceptabel toksicitet.
English: 90% of patients on Tarceva developed rash within the first 44 days.
Danish: 90 % af patienterne, der blev behandlet med Tarceva, fik udslæt inden for de første 44 dage.
English: Therefore, the time to reach steady state plasma concentration would be expected to occur in approximately 7-8 days.
Danish: Det forventes derfor, at plasmakoncentrationen i steady-state opnås efter ca. 7-8 dage.
English: Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Danish: Resultaterne er vist i nedenstående tabel (resultater for gruppen af patienter med metastatisk og lokalt fremskreden sygdom er taget fra en eksploratorisk undergruppeanalyse).
English: Avoid pregnancy while being treated with Tarceva.
Danish: Undgå graviditet, mens du bliver behandlet med Tarceva.
English: If your blood tests indicate severe changes in your liver function, your doctor may need to interrupt your treatment.
Danish: Hvis dine blodprøver viser alvorlige ændringer i din leverfunktion, kan din læge være nødt til at afbryde behandlingen
English: Cut-off date: April 2012
Danish: Skæringsdato: April 2012
English: A mild phototoxic skin reaction was observed in rats after UV irradiation.
Danish: Der er observeret en let fototoksisk hudreaktion hos rotter efter UV-bestråling.
English: Tarceva (months)
Danish: Tarceva (måneder)
English: First-Line Treatment of Patients with EGFR Mutations
Danish: Første-linje behandling af patienter med EGFR mutationer
English: -Stevens-Johnson syndrome/Toxic epidermal necrolysis7
Danish: - Stevens-Johnsons syndrom/ toksisk epidermal nekrolyse7
English: Caution should be observed when these active substances are combined with erlotinib.
Danish: Der skal iagttages forsigtighed, når disse aktive stoffer kombineres med erlotinib.
English: Glucuronidation disorder like Gilbert's syndrome Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert's syndrome.
Danish: Glukuronideringssygdom, såsom Gilberts syndrom Din læge vil behandle dig med forsigtighed, hvis du lider af en glukuronideringssygdom som Gilberts syndrom.
English: It is not known whether erlotinib is excreted in human milk.
Danish: Det vides ikke, om erlotinib udskilles i human mælk.
English: Patients with pancreatic cancer
Danish: Patienter med pancreascancer
English: Placebo (months)
Danish: Placebo (måneder)
English: Although statistically significant, the magnitude of this difference is not considered to be clinically relevant.
Danish: Selvom det er statistisk signifikant, bliver størrelsen af denne forskel ikke betragtet som klinisk relevant.
English: Due to the blocking of downstream-signaling, the proliferation of cells is stopped, and cell death is induced through the intrinsic apoptotic pathway.
Danish: På grund af blokering af den videre signalering stoppes celledelingen, og celledød induceres via den indre apoptotiske vej.
English: If you miss one or more doses of Tarceva, contact your doctor or pharmacist as soon as possible.
Danish: Hvis du glemmer en eller flere doser af Tarceva, skal du kontakte din læge eller apotek så snart som muligt.
English: Tarceva is a medicine used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor (EGFR).
Danish: Tarceva er et lægemiddel, som anvendes til behandling af kræft ved at forhindre aktiviteten af et protein, som kaldes epidermal vækstfaktorreceptor (EGFR).
English: If a plasma-based cfDNA test is used and the result is negative for activating mutations, perform a tissue test wherever possible due to the potential for false negative results from a plasma-based test.
Danish: Hvis en plasma-baseret cfDNA-test anvendes og resulstatet er negativt for aktiverende mutationer skal en vævsprøve foretages når det er muligt pga. potentielfalsk positive bestemmelser ved en plasmabaseret test.
English: Similarly, the exposure to the active metabolite increased by about 60% and 48% for AUC and Cmax, respectively.
Danish: Ligeledes blev den aktive metabolits eksponering øget med 60 % og 48 % for henholdsvis AUC og Cmax.
English: • Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR`er)
English: In patients who do not develop rash within the first 4 - 8 weeks of treatment, further Tarceva treatment should be re-assessed (see section 5.1).
Danish: Hos patienter, som ikke får udslæt inden for de første 4-8 uger af behandlingen, skal den videre behandling med Tarceva genovervejes (se pkt.
English: Cut-off date: Aug 2010
Danish: Skæringsdato: Aug 2010
English: Cut-off date: Jan 2011
Danish: Skæringsdato: Jan 2011
English: -Keratitis -Conjunctivitis1
Danish: - Keratitis - Konjunctivitis1
English: It can be prescribed as initial therapy or as therapy if your disease remains largely unchanged after initial chemotherapy, provided your cancer cells have specific EGFR mutations.
Danish: Det kan ordineres, som indledende behandling eller som behandling, hvis din sygdom stort set forbliver uændret efter indledende kemoterapi, forudsat at dine kræftceller har specifikke EGFR-mutationer.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of 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 web-portal.
Danish: Indsendelsen af PSUR`er for dette lægemiddel skal være i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og enhver efterfølgende opdatering offentliggjort på den europæiske webportal for lægemidler.
English: Locally Advanced Population
Danish: Lokalt fremskreden population
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with Tarceva should be interrupted or discontinued.
Danish: Hvis diagnosen ulcerativ keratitis bekræftes, skal behandlingen med Tarceva afbrydes eller seponeres.
English: * Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis.
Danish: Svære infektioner, med eller uden neutropeni, har omfattet pneumoni, sepsis og cellulitis.
English: Metastatic Population
Danish: Metastatisk population
English: The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Danish: Den mediane responsvarighed var 34,3 uger, spændvidde: 9,7 til 57,6+ uger.
English: If you forget to take Tarceva
Danish: Hvis du har glemt at tage Tarceva
English: In some cases these medicines may reduce the efficacy or increase the side effects of Tarceva and your doctor may need to adjust your treatment.
Danish: Disse lægemidler kan i nogle tilfælde nedsætte virkningen eller øge bivirkningerne af Tarceva, og lægen kan blive nødt til at justere din behandling.
English: Such influence is supported by limited clinical data and preclinical studies showing EGFR degradation through the proteasome.
Danish: Denne påvirkning understøttes af begrænsede kliniske data og prækliniske studier, som viser nedbrydning af EGFR i proteasomet.
English: -Interstitial lung disease (ILD)3
Danish: - Interstitiel lungesygdom (ILD)3
English: Women of childbearing potential must be advised to avoid pregnancy while on Tarceva.
Danish: Kvinder i den fertile alder skal rådes til at undgå graviditet, mens de tager Tarceva.
English: Tell your doctor if you have severe pain in your abdomen.
Danish: Fortæl det til din læge, hvis du får stærke smerter i maven.
English: When prescribing Tarceva, factors associated with prolonged survival should be taken into account.
Danish: Når der ordineres Tarceva, skal der tages hensyn til faktorer forbundet med forlænget overlevelse.
English: • Severe blistering or peeling of skin (suggestive of Stevens-Johnson syndrome)
Danish: • Alvorlig blæredannelse eller afskalning af huden (kan tyde på Stevens-Johnson syndrom)
English: This effect was accompanied by a 24% increase in apparent erlotinib plasma clearance.
Danish: Denne virkning var ledsaget af en 24 % stigning i erlotinibs tilsyneladende plasmaclearance.
English: There are three main metabolic pathways identified: 1) O-demethylation of either side chain or both, followed by oxidation to the carboxylic acids; 2) oxidation of the acetylene moiety followed by hydrolysis to the aryl carboxylic acid; and 3) aromatic hydroxylation of the phenyl-acetylene moiety.
Danish: Der er identificeret tre hovedmetaboliske udskillelsesveje: 1) O-demetylering af en eller begge sidekæder, efterfulgt af oxidering til carboxylsyre; 2) oxidering af acetylengruppen efterfulgt af hydrolyse til arylcarboxylsyre; og 3) aromatisk hydroxylering af phenyl-acetylengruppen.