FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee recommended that Pregabalin Zentiva be approved for use in the EU.
Danish: Udvalget anbefalede, at Pregabalin Zentiva godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Pregabalin Zentiva is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Pregabalin Zentiva anvendes så sikkert som muligt.
English: This means that Pregabalin Zentiva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: Det betyder, at Pregabalin Zentiva er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Lyrica.
English: The maximum dose is 600 mg per
Danish: Den maksimale dosis er 600 mg dagligt.
English: The active substance in Pregabalin Zentiva, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Zentiva, pregabalin, minder i sin struktur om kroppens egen "neurotransmitter" gamma-aminosmørsyre (GABA), men dets biologiske virkninger er meget anderledes.
English: Pregabalin Zentiva is a ‘generic medicine'.
Danish: Pregabalin Zentiva er et "generisk lægemiddel".
English: Pregabalin Zentiva contains the active substance pregabalin.
Danish: Pregabalin Zentiva indeholder det aktive stof pregabalin.
English: Pregabalin Zentiva is a medicine used to treat adults with the following conditions:
Danish: Pregabalin Zentiva er et lægemiddel til behandling af voksne med følgende tilstande:
English: • epilepsy, where it is used as an ‘add-on' to existing treatment in patients who have partial seizures
Danish: • epilepsi, hvor det gives som tillægsbehandling til patienter med partielle anfald (epileptiske anfald,
English: Other information about Pregabalin Zentiva
Danish: Andre oplysninger om Pregabalin Zentiva
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Zentiva has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pregabalin Zentiva er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Pregabalin Zentiva, 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 Pregabalin Zentiva, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What is Pregabalin Zentiva and what is it used for?
Danish: Hvad er Pregabalin Zentiva, og hvad anvendes det til?
English: What measures are being taken to ensure the safe and effective use of Pregabalin Zentiva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Zentiva?
English: (epileptic fits starting in one specific part of the brain) that cannot be controlled with their current treatment;
Danish: der begynder i en bestemt del af hjernen), når anfaldene ikke kan kontrolleres med patientens nuværende behandling
English: For more information about treatment with Pregabalin Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pregabalin Zentiva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Pregabalin Zentiva.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Zentiva bør anvendes.
English: What are the benefits and risks of Pregabalin Zentiva?
Danish: Hvilken fordel og risiko er der forbundet med Pregabalin Zentiva?
English: Because Pregabalin Zentiva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Pregabalin Zentiva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Pregabalin Zentiva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Lyrica.
Danish: Da Pregabalin Zentiva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Lyrica.
English: Why is Pregabalin Zentiva approved?
Danish: Hvorfor blev Pregabalin Zentiva godkendt?
English: For practical information about using Pregabalin Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Zentiva, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Pregabalin Zentiva used?
Danish: Hvordan anvendes Pregabalin Zentiva?
English: How has Pregabalin Zentiva been studied?
Danish: Hvordan blev Pregabalin Zentiva undersøgt?
English: How does Pregabalin Zentiva work?
Danish: Hvordan virker Pregabalin Zentiva?
English: CONCLUSIONS ON <SIMILARITY AND DEROGATION> <AND> < THE REQUEST FOR ONE-YEAR <MARKETING PROTECTION> <DATA EXCLUSIVITY>> PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: KONKLUSIONER VEDRØRENDE <SIMILARITET> <OG> <UNDTAGELSE> <OG> <ANMODNING OM <MARKEDSFØRINGSBESKYTTELSE> <DATABESKYTTELSE> I ET ÅR> FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: <the applicant could establish in the application that the medicinal product, although similar to <authorised orphan medicinal product>, is safer, more effective or otherwise clinically superior (as defined in Article 3 of Commission Regulation (EC) No. 847/2000) for the same therapeutic indication>.
Danish: <ansøgeren kan i sin ansøgning påvise, at lægemidlet, selv om det er similært med {det godkendte lægemiddel til sjældne sygdomme}, er sikrere, mere effektivt eller på anden vis klinisk overlegent (som defineret i artikel 3 i Kommissionens forordning (EC) nr. 847/2000) ved den samme terapeutiske indikation> <og>
English: [Art 74(a)- legal status switch]<Furthermore, the CHMP reviewed the data submitted by the Marketing Authorisation Holder, taking into account the provisions of Article 74(a) of Directive 2001/83/EC, and considers that the data submitted in support of the classification of {specify medicinal product name} as ‘medicinal product not subject to medical prescription' were significant as further explained in the European Public Assessment Report.>
Danish: [Art 74(a)- legal status switch]<Endvidere gennemgik CHMP de oplysninger, som indehaveren af markedsføringstilladelsen havde indsendt, jf. artikel 74, litra a, i direktiv 2001/83/EC, og er af den opfattelse, at de indsendte oplysninger er væsentlige og understøtter en klassificering af {lægemidlets navn} som et ikke-receptpligtigt lægemiddel.
English: The following convention has been used for the classification of frequency:
Danish: Følgende konvention er anvendt til klassifikation af hyppighed:
English: · Risk Management Plan (RMP)
Danish: · Risikostyringsplan (RMP)
English: Patients should be closely monitored.
Danish: Patienterne skal overvåges tæt.
English: ^ Data cut-off date of 19 September 2014
Danish: ^ Data cut-off dato 19. september 2014
English: On average, 94% of the dose was recovered within 17 days.
Danish: I gennemsnit kunne 94% af dosis genfindes inden for 17 dage.
English: They can be taken with or without food.
Danish: De kan tages sammen med eller uden mad.
English: Efficacy results are summarized in Table 5.
Danish: Effektresultaterne opsummeres i tabel 5.
English: The magnitude of interaction could potentially be lower in patients.
Danish: Omfanget af interaktionen kan potentielt være lavere hos patienter.
English: All Grades Grades 3-4 All Grades Grades 3-4
Danish: Alle grader Grad 3-4 Alle grader Grad 3-4
English: (20.3, NE)
Danish: (20,3; IE)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1048/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1048/001
English: Continue at current dose
Danish: Fortsæt med nuværende dosis
English: Cotellic is taken on a 28 day cycle.
Danish: Cotellic tages i en 28 dages cyklus.
English: Tell your doctor straight away if you get diarrhoea.
Danish: Fortæl straks lægen, hvis du får diarré.
English: Transparent PVC/PVDC blisters containing 21 tablets.
Danish: Gennemsigtige PVC/PVDC-blistere indeholdende 21 tabletter.
English: · Take the tablets every day for 21 days (called a “treatment period”).
Danish: · Tag tabletterne hver dag i 21 dage (kaldes en behandlingsperiode).
English: · Do not take this medicine after the expiry date which is stated on the blister and the carton after EXP.
Danish: · Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen og kartonen efter EXP.
English: Grade (CTC-AE)*
Danish: Grad (CTC-AE)*
English: Fatigue was observed at similar frequencies in both arms.
Danish: Træthed blev observeret med samme frekvenser i de 2 arme.
English: If doses are omitted for toxicity, these doses should not be replaced.
Danish: Hvis der undlades doser på grund af toksicitet, bør disse doser ikke erstattes.
English: Your doctor will do blood tests to monitor for this.
Danish: Din læge vil tage blodprøver for at monitorere dette.
English: Once the dose has been reduced, it should not be increased at a later time.
Danish: Når dosis én gang er reduceret, bør den ikke senere øges igen.
English: Each pack contains 63 tablets.
Danish: Hver pakning indeholder 63 tabletter.
English: Study NO25395 (BRIM7)
Danish: Studie NO25395 (BRIM7)
English: Mortality occurred in juvenile animals at a dose (3 mg/kg) which did not lead to mortalities in adult animals.
Danish: Der forekom dødsfald hos unge dyr i doser (3 mg/kg), som ikke medførte dødsfald hos voksne dyr.
English: The transport across the blood brain barrier is unknown.
Danish: Transporten over blodhjernebarrieren er ikke kendt.
English: Symptomatic regardless of LVEF Permanent discontinuation
Danish: Symptomatisk uanset LVEF Permanent seponering
English: There are no data from the use of Cotellic in pregnant women.
Danish: Der er ingen data fra anvendelse af Cotellic til gravide kvinder.
English: · Cotellic can be taken with or without food.
Danish: · Cotellic kan tages sammen med eller uden mad.
English: · It can only be used in patients whose cancer has a change (mutation) in a protein called “BRAF”.
Danish: · Det kan kun bruges af patienter, hvis kræftsygdom har en ændring (mutation) i et protein, der kaldes BRAF.
English: No oxidative metabolites greater than 10% of total circulating radioactivity or human specific metabolites were observed in plasma.
Danish: Der er ikke observeret oxidative metabolitter på mere end 10% af den totale cirkulerende radioaktivitet eller humanspecifikke metabolitter i plasma.
English: The majority of events were Grade 1 or 2 and non-serious.
Danish: Størstedelen af bivirkningerne var af grad 1 eller 2 og ikke alvorlige.
English: No dose reduction.
Danish: Ingen dosisreduktion.
English: Changes in reported laboratory data
Danish: Ændringer i indberettede laboratoriedata
English: N/A = Not Applicable
Danish: N/A= Ikke relevant
English: Ask your doctor about the best contraception for you.
Danish: Spørg lægen, hvilken prævention der er bedst for dig.
English: Interrupt treatment for 4 weeks
Danish: Afbryd behandlingen i 4 uger
English: Patients with ECOG performance status 2 or higher were excluded from the study.
Danish: Patienter med ECOG-performancestatus 2 eller højere blev ekskluderet fra studiet.
English: · If you become pregnant during treatment with Cotellic or in the 3 months after your last dose, tell your doctor straight away.
Danish: · Hvis du bliver gravid, mens du er i behandling med Cotellic eller inden for 3 måneder efter din sidste dosis, skal du straks kontakte lægen.
English: Since food does not alter the pharmacokinetics of cobimetinib, it can be administered with or without food.
Danish: Da mad ikke ændrer cobimetinibs farmakokinetik, kan det administreres sammen med eller uden mad.
English: · Do not take a double dose to make up for a missed dose.
Danish: · Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Treatment with Cotellic should continue until the patient no longer derives benefit or until the development of unacceptable toxicity (see Table 1 below).
Danish: Behandlingen med Cotellic bør fortsætte, indtil patienten ikke længere har gavn af behandlingen, eller der udvikles uacceptabel toksicitet (se tabel 1 nedenfor).
English: Therefore, it may take up to 2 weeks following treatment cessation for cobimetinib to be completely removed from systemic circulation.
Danish: Det kan derfor tage op til 2 uger efter seponering, før cobimetinib er fuldstændigt fjernet fra den systemiske cirkulation.
English: If you take more Cotellic than you should, talk to a doctor straight away.
Danish: Hvis du har taget flere Cotellic, end du skulle, skal du straks kontakte en læge.
English: Additionally, for:
Danish: Derudover:
English: Interrupt treatment for 2 weeks
Danish: Afbryd behandlingen i 2 uger
English: Study GO28141 (coBRIM)
Danish: Studie GO28141 (coBRIM)
English: Grade 1 or Grade 2 (tolerable)
Danish: Grad 1 eller grad 2 (tolerabel)
English: Film coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol 3350
Danish: Filmovertræk Polyvinylalkohol Titandioxid (E171) Macrogol 3350
English: Malta (see Ireland)
Danish: Malta (see United Kingdom)
English: · This medicine does not require any special storage conditions.
Danish: · Dette lægemiddel kræver ikke særlige opbevaringsforhold.
English: The fraction absorbed was ~88% indicating high absorption and first pass metabolism.
Danish: Den absorberede fraktion var ~88%, hvilket tyder på høj absorption og første-passage-metabolisme.
English: Overall Survival (OS)g
Danish: Samlet overlevelse g
English: Diarrhoea (very common: may affect more than 1 in 10 people) Tell your doctor straight away if you get diarrhoea and follow your doctor's instructions for what to do to help prevent or treat diarrhoea.
Danish: Diarré (meget almindelig: kan optræde hos flere end 1 ud af 10 patienter) Fortæl straks lægen, hvis du får diarré, og følg lægens anvisning om, hvordan diarréen kan forhindres eller behandles.
English: Before starting treatment, your doctor will test for this mutation.
Danish: Før du begynder behandling, vil lægen undersøge, om du har denne mutation.
English: The mean accumulation ratio at steady state was approximately 2.4-fold.
Danish: Den gennemsnitlige akkumuleringsratio ved steady-state er ca. 2,4 gange.
English: The tablets should be swallowed whole with water.
Danish: Tabletterne synkes hele med vand.
English: Avoid driving or using machines if you have problems with your vision or other problems that might affect your ability e.g. if you feel dizzy or tired.
Danish: Undgå at køre motorkøretøj eller anvende maskiner, hvis du har problemer med synet eller andre problemer, som kan påvirke din evne, f.eks. hvis du er svimmel eller træt.
English: Cotellic can cause increased levels of creatine phosphokinase, an enzyme that is found mainly in the muscle, heart, and brain.
Danish: Cotellic kan forårsage forhøjede niveauer af kreatinkinase, som er et enzym, der hovedsageligt findes i musker, hjerte og hjerne.
English: Patients should be advised not to drive or use machines if they experience visual disturbances or any other adverse effects that may affect their ability.
Danish: Patienterne skal rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de oplever synsforstyrrelser eller andre bivirkninger, som kan påvirke denne evne.
English: No preferential binding to human red blood cells was observed (blood to plasma ratio 0.93).
Danish: Der er ikke observeret selektiv binding til humane røde blodlegemer (blod-til-plasma-ratio 0,93).
English: Liver function test Increased ALP
Danish: Leverfunktionstest Forhøjet ALP
English: · It is used in combination with another anti-cancer medicine called vemurafenib.
Danish: · Det bruges sammen med et andet lægemiddel mod kræft, der hedder vemurafenib.
English: g The data cut-off date for the final OS analysis is 28 August 2015 and median follow-up was 18.5 months.
Danish: g Data cut-off dato for den endelig analyse for samlet overlevelse var 28. august 2015 og median opfølgning var 18,5 måneder-.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist 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 lægen eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: · After the 21 days, do not take any Cotellic tablets for 7 days.
Danish: · Efter de 21 dage skal du ikke tage Cotellic i 7 dage.
English: Global health status / health-related quality of life by patient-report were measured using the EORTC Quality of Life Questionnaire - Core 30 (QLQ-C30).
Danish: Generel helbredsstatus/helbredsrelateret livskvalitet indberettet af patienten blev målt ved hjælp af EORTC-skemaet Core 30 [Quality of Life Questionnaire (QLQ-) C30].
English: Cobimetinib is 94.8% bound to human plasma proteins in vitro.
Danish: Cobimetinib er 94,8% bundet til humane plasmaproteiner in vitro.
English: In case of vomiting after administration of Cotellic, the patient should not take an additional dose on that day and treatment should be continued as prescribed the following day.
Danish: I tilfælde af opkastning efter administration af Cotellic bør patienten ikke tage en yderligere dosis samme dag, men fortsætte behandlingen næste dag som foreskrevet.
English: Unchanged medicinal product in faeces and urine accounted for 6.6% and 1.6% of the administered dose, respectively, indicating that cobimetinib is primarily metabolised with minimal renal elimination.
Danish: Uomdannet lægemiddel i fæces og urin udgjorde henholdsvis 6,6% og 1,6% af den administrerede dosis, hvilket tyder på, at cobimetinib primært metaboliseres med minimal renal elimination.
English: All patients restarting treatment with a dose reduction of Cotellic should have LVEF measurements taken after approximately 2 weeks, 4 weeks, 10 weeks and 16 weeks, and then as clinically indicated.
Danish: Alle patienter, som genstarter Cotellic-behandling med dosisreduktion, skal have foretaget LVEFmåling efter ca. 2 uger, 4 uger, 10 uger og 16 uger og herefter som klinisk indiceret.
English: 1st occurrence: 40 mg nd occurrence: 20 mg rd occurrence: permanent discontinuation
Danish: 1. forekomst: 40 mg 2. forekomst: 20 mg 3. forekomst: permanent seponering
English: Cotellic should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Danish: Cotellic må ikke anvendes under graviditet, medmindre det er strengt nødvendigt og kun efter omhyggelig vurdering af moderens behov i forhold til risikoen for fostret.
English: The mean elimination half-life following oral dosing of cobimetinib was 43.6 hours (range: 23.1 to 69.6 hours).
Danish: Den gennemsnitlige eliminationshalveringstid efter oral dosering af cobimetinib var 43,6 timer (23,1 til 69,6 timer).
English: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: · på anmodning fra Det Europæiske Lægemiddelagentur · når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The volume of distribution was 1050 L in healthy subjects given an intravenous dose of 2 mg.
Danish: Fordelingsvolumenet er 1.050 l hos raske frivillige, der fik en intravenøs dosis på 2 mg.
English: 0.70 (95% CI: 0.55, 0.90) (p-value = 0.0050
Danish: 0,70 (95% konfidensinterval: 0,55; 0,90) (p-værdi = 0,0050e)
English: Treatment should be taken for 21 consecutive days followed by a 7-day break
Danish: Behandlingen skal tages i 21 på hinanden følgende dage efterfulgt af 7 dages pause
English: The safety and efficacy of Cotellic in non-Caucasian patients have not been established.
Danish: Cotellics sikkerhed og virkning til ikke-kaukasiske patienter er ikke klarlagt.
English: The median duration of response was 6.8 months.
Danish: Den mediane responsvarighed var 6,8 måneder.
English: · Periodic safety update reports
Danish: · Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Standard genotoxicity studies with cobimetinib were negative.
Danish: Standardmæssige genotoksicitetsstudier med cobimetinib var negative.
English: Mutation Test), unresectable or metastatic melanoma.
Danish: mutationstest), ikke-operabelt eller metastatisk melanom.
English: The apparent volume of distribution was 806 L in cancer patients based on population pharmacokinetic analysis.
Danish: Hos kræftpatienter var det tilsyneladende fordelingsvolumen 806 l, baseret på en farmakokinetisk populationsanalyse.
English: Lactose monohydrate Microcrystalline cellulose (E460) Croscarmellose sodium (E468) Magnesium stearate (E470b)
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose (E460) Croscarmellosenatrium (E468) Magnesiumstearat (E470b)
English: Baseline age and baseline body weight were identified as statistically significant covariates on cobimetinib clearance and volume of distribution respectively.
Danish: Baseline-alder og baselinekropsvægt er identificeret som statistisk signifikante covariater for henholdsvis cobimetinib-clearance og fordelingsvolumen.
English: Pharmacotherapeutic group: Antineoplastic agents, ATC code: L01XE38
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, ATC-kode:L01XE38.
English: If a dose is missed, it can be taken up to 12 hours prior to the next dose to maintain the once-daily regimen.
Danish: Hvis en dosis bliver glemt, kan den tages i op til 12 timer inden næste planlagte dosis for at opretholde et doseringsregime på én gang dagligt.
English: The median follow up was 14.2 months.
Danish: Median opfølgning var 14,2 måneder.
English: This change may have led to the development of melanoma.
Danish: Denne mutation kan være skyld i melanomet.
English: · Cotellic is not recommended during pregnancy - although the effects of Cotellic have not been studied in pregnant women, it may cause permanent harm or birth defects to an unborn baby.
Danish: · Det frarådes at tage Cotellic under graviditet - selvom Cotellic ikke er undersøgt hos gravide kvinder, kan det muligvis skade det ufødte barn og forårsage misdannelser.
English: Among patients who had progressed on vemurafenib (n=66), the objective response rate was 15%.
Danish: Blandt de patienter, der havde oplevet progression under behandling med vemurafenib (n=66), var den objektive responsrate 15%.
English: Cotellic is used to treat adult patients with a type of skin cancer called melanoma, that has spread to other parts of the body or cannot be removed by surgery.
Danish: Cotellic bruges til at behandle voksne patienter med en bestemt form for hudkræft, melanom, som har spredt sig til andre dele af kroppen eller ikke kan fjernes ved en operation.
English: Best Overall Response (BOR) Complete Response Partial Response
Danish: Bedste overordnede respons Komplet respons Partielt respons Stabil sygdom
English: No dose adjustment is required in patients aged ≥65 years old.
Danish: Dosisjustering er ikke nødvendig til patienter ≥ 65 år.
English: One pack size is available: 63 tablets (3 blisters of 21 tablets).
Danish: Der findes én pakningsstørrelse: 63 tabletter (3 blistere med 21 tabletter).