FrancophonIA/ELRC3.0 huggingface dataset:
English: The first study compared the effects of Zerit taken alone with those of zidovudine (another antiviral medicine) in 822 HIV-infected patients who had been taking zidovudine for at least six months.
Danish: I den første undersøgelse blev virkningen af Zerit målt alene sammenlignet med virkningen af zidovudin (et andet antiviralt lægemiddel) hos 822 hiv-inficerede patienter, som havde taget zidovudin i mindst seks måneder.
English: What is Zerit used for?
Danish: Hvad anvendes Zerit til?
English: What benefit has Zerit shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zerit?
English: How has Zerit been studied?
Danish: Hvordan blev Zerit undersøgt?
English: How is Zerit used?
Danish: Hvordan anvendes Zerit?
English: How does Zerit work?
Danish: Hvordan virker Zerit?
English: Slovenia).
Danish: Slovenien).
English: The European Commission issued an EU-wide legally binding decision on 12 January 2015.
Danish: Europa-Kommissionen vedtog den 12. januar 2015 en afgørelse, der er retligt bindende i hele EU.
English: What is Seasonique?
Danish: Hvad er Seasonique?
English: Why was Seasonique reviewed?
Danish: Hvorfor blev Seasonique vurderet igen?
English: It is available as blister packs containing 91 tablets to be taken once a day in the order shown on the pack.
Danish: De fås i blisterpakning med 91 tabletter, som tages én gang dagligt i den rækkefølge, der er angivet på pakningen.
English: However, the Member States were not able to reach an agreement and the French medicines agency referred the matter to the CHMP for arbitration on 3 February 2014.
Danish: Medlemsstaterne var imidlertid ikke i stand til at nå til enighed, og den franske lægemiddelstyrelse indbragte derfor sagen for CHMP til voldgift den 3. februar 2014.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view to granting a marketing authorisation that will be valid in that country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and
Danish: Ved denne procedure vurderer én medlemsstat (»referencemedlemsstaten«, her Frankrig) et lægemiddel med henblik på udstedelse af en markedsføringstilladelse, der er gyldig i det pågældende land foruden i andre medlemsstater (de »berørte medlemsstater«, her Østrig, Belgien, Tyskland, Italien, Polen, Rumænien, Slovakiet og
English: Teva Pharma submitted an application to the French medicines agency (ANSM) for Seasonique to be authorised in a decentralised procedure.
Danish: Teva Pharma indgav en ansøgning til det franske lægemiddelagentur (ANSM) for at få Seasonique godkendt ved en decentral procedure.
English: After evaluating data from studies and post-marketing data from outside the EU, the CHMP was of the view that there was adequate evidence that Seasonique is an effective contraceptive.
Danish: Efter at have vurderet data fra undersøgelser og data efter markedsføring fra lande uden for EU var CHMP er den opfattelse, at der var tilstrækkelig dokumentation for, at Seasonique er et effektivt præventionsmiddel.
English: On 26 June 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the oral contraceptive Seasonique.
Danish: Den 26. juni 2014 gennemførte Det Europæiske Lægemiddelagentur en voldgiftsprocedure efter en uoverensstemmelse blandt medlemsstaterne i EU om godkendelse af det orale antikonceptionsmiddel Seasonique.
English: For 84 days the woman takes the tablets containing levonorgestrel and ethinylestradiol and then for the remaining 7 days she takes tablets containing only ethinylestradiol.
Danish: I 84 dage skal kvinden tage tabletterne med levonorgestrel og ethinylestradiol, og i de resterende 7 dage skal hun tage de tabletter, der kun indeholder ethinylestradiol.
English: Because the treatment cycle of 91 days is longer than that of most other combined contraceptives (which is normally 28 days), Seasonique is known as an extended cycle oral contraceptive.
Danish: Da behandlingscyklussen på 91 dage er længere end for de fleste andre kombinerede præventionsmidler (som normalt er 28 dage), kaldes Seasonique P-piller med forlænget cyklus.
English: The Committee therefore concluded that the benefits of Seasonique outweigh its risks and recommended that marketing authorisation be granted in the reference and concerned Member States.
Danish: Udvalget konkluderede derfor, at fordelene ved Seasonique opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse i referencemedlemsstaten og de berørte medlemsstater.
English: Seasonique is an oral contraceptive for women.
Danish: Seasonique er et oralt antikonceptionsmiddel (P-pille) til kvinder.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the following EU Member States: Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Seasonique opvejer risiciene, og at der kan udstedes markedsføringstilladelse i Frankrig og i EUmedlemsstaterne Østrig, Belgien, Tyskland, Italien, Polen, Rumænien, Slovakiet og Slovenien.
English: Combined hormonal contraceptives work by stopping the release of eggs from the ovaries and by causing changes in the cervix and the lining of the womb that make it harder for a sperm to reach an egg and for a fertilised egg to implant in the womb.
Danish: P-piller af kombinationstypen virker ved at standse frigivelsen af æg fra æggestokkene og ved at bevirke ændringer i livmoderhalsen og livmoderslimhinden, der gør det sværere for en sædcelle at nå frem til ægget og for det befrugtede æg at vokse fast i livmoderen.
English: 12 January 2015
Danish: Den 12. januar 2015 EMA/42159/2015
English: The grounds for the referral related to concerns raised by the German medicines agency about the effectiveness of Seasonique in preventing pregnancy and the irregular bleeding experienced by women taking the contraceptive.
Danish: Begrundelsen for indbringelsen var den tyske lægemiddelstyrelses betænkeligheder ved effektiviteten af Seasonique til forebyggelse af graviditet og ved de uregelmæssige blødninger hos de kvinder, der brugte P-pillerne.
English: Women taking Seasonique will have longer intervals between withdrawal bleeding but may experience more irregular bleeding.
Danish: Ved brug af Seasonique er der længere mellem bortfaldsblødningerne, men blødningerne kan være mere uregelmæssige.
English: Levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen) are both hormones and Seasonique is what is known as a ‘combined hormonal contraceptive'.
Danish: Både levonorgestrel (et progestogen) og ethinylestradiol (et østrogen) er hormoner, og Seasonique er således P-piller af kombinationstypen.
English: The Committee also noted that the irregular bleeding reported with Seasonique has not made women less likely to keep to their treatment and adequate information about the risk of irregular bleeding is included in the package leaflet.
Danish: Udvalget bemærkede også, at de uregelmæssige blødninger, der beskrives i forbindelse med Seasonique, ikke har gjort det sværere for kvinderne at fortsætte med behandlingen.
English: The dose and duration of treatment is based on the patient's body weight and on the medicine used in combination with it.
Danish: Dosen og varigheden af behandlingen beregnes efter patientens legemsvægt og det lægemiddel, der anvendes i kombination hermed.
English: Treatment should be started and monitored by a doctor who has experience in the management of chronic hepatitis C.
Danish: Behandlingen bør indledes og overvåges af en læge med erfaring i behandling for kronisk hepatitis C.
English: The full EPAR for Ribavirin Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ribavirin Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore, the CHMP's view was that, as for Rebetol, the benefits outweigh the identified risks.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Rebetol.
English: Ribavirin Teva Pharma B.V. is used in patients who have not been treated before for all types of hepatitis C except for genotype 1, as long as the liver is still working normally and hepatitis C virus can be found in the blood.
Danish: anvendes hos ikke tidligere behandlede patienter mod alle typer hepatitis C, undtagen genotype 1, så længe leveren stadig fungerer normalt, og der forekommer hepatitis Cvirus i blodet.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Rebetol and do not need to be repeated for Ribavirin Teva Pharma B.V.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Rebetol, og det er ikke nødvendigt at gentage disse med Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V. must never be used on its own but only together with interferon alfa 2b (another medicine used in hepatitis).
Danish: må aldrig anvendes alene, men kun sammen med interferon alfa 2b (et andet lægemiddel mod hepatitis).
English: The active substance in Ribavirin Teva Pharma B.V., ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Danish: Det aktive stof i Ribavirin Teva Pharma B.V., ribavirin, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
English: For more information about treatment with Ribavirin Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ribavirin Teva Pharma B.V., kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Ribavirin Teva Pharma B.V. can also be used in adults (aged 18 years and older) whose disease has come back after previous treatment.
Danish: kan også anvendes hos voksne (i alderen 18 år og derover), hos hvem sygdommen er vendt tilbage efter tidligere behandling.
English: This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ribavirin Teva Pharma B.V.
English: As for every medicine, the company provided studies on the quality of Ribavirin Teva Pharma B.V.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V.is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Danish: menes at gribe ind i produktionen eller virkningen af viralt DNA og RNA, som er nødvendige for virussers overlevelse og formering.
English: For practical information about using Ribavirin Teva Pharma B.V., patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ribavirin Teva Pharma B.V., kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The dose may need to be adjusted for patients who experience side effects.
Danish: I tilfælde af bivirkninger kan det være nødvendigt at justere dosen.
English: Ribavirin Teva Pharma B.V. is taken with food each day in two divided doses (morning and evening).
Danish: tages i to doser hver dag i forbindelse med et måltid (morgen og aften).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ribavirin Teva Pharma B.V.
English: Because Ribavirin Teva Pharma B.V. 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: er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What measures are being taken to ensure the safe and effective use of Ribavirin Teva Pharma B.V.?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ribavirin Teva Pharma B.V.
English: What is Ribavirin Teva Pharma B.V. and what is it used for?
Danish: Hvad er Ribavirin Teva Pharma B.V., og hvad anvendes det til?
English: Ribavirin Teva Pharma B.V. available as tablets (200 and 400 mg).
Danish: leveres som tabletter (200 mg og 400 mg).
English: Ribavirin Teva Pharma B.V. is a medicine used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Danish: er et lægemiddel til behandling af patienter i alderen tre år og derover med kronisk hepatitis C (leverbetændelse forårsaget af hepatitis C-virus).
English: This means that Ribavirin Teva Pharma B.V. contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Danish: er identisk med et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Rebetol.
English: Ribavirin Teva Pharma B.V. on its own has no effect on eliminating the hepatitis C virus from the body.
Danish: uden virkning med hensyn til at udrydde hepatitis C-virus i kroppen.
English: Other information about Ribavirin Teva Pharma B.V.
Danish: Andre oplysninger om Ribavirin Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva Pharma B.V. on 1 July 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ribavirin Teva Pharma B.V.
English: What are the benefits and risks of Ribavirin Teva Pharma B.V.?
Danish: Hvilken fordel og risiko er der forbundet med Ribavirin Teva Pharma B.V.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ribavirin Teva Pharma B.V. have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ribavirin Teva Pharma B.V.
English: It is not intended to provide practical advice on how to use Ribavirin Teva Pharma B.V.
Danish: Det er ikke en praktisk vejledning i, hvordan Ribavirin Teva Pharma B.V.
English: How is Ribavirin Teva Pharma B.V. used?
Danish: Hvordan anvendes Ribavirin Teva Pharma B.V.
English: Why is Ribavirin Teva Pharma B.V. approved?
Danish: Hvorfor blev Ribavirin Teva Pharma B.V.
English: The Committee recommended that Ribavirin Teva Pharma B.V. be approved for use in the EU.
Danish: Udvalget anbefalede, at Ribavirin Teva Pharma B.V.
English: How does Ribavirin Teva Pharma B.V. work?
Danish: Hvordan virker Ribavirin Teva Pharma B.V.
English: How has Ribavirin Teva Pharma B.V. been studied?
Danish: Hvordan blev Ribavirin Teva Pharma B.V.
English: 10 ml
Danish: Hætteglas 10 ml
English: Your doctor will discuss this with you.
Danish: Din læge vil tale med dig om dette.
English: County Cork Ireland
Danish: County Cork Irland
English: It may also cause damage to your unborn baby.
Danish: Det kan også medføre skade på det ufødte barn.
English: The following convention has been used for classification of frequency:
Danish: Følgende konvention er brugt til klassificering af hyppighed:
English: There have been no studies performed with other routes of administration.
Danish: Der er ikke udført studier med andre administrationsveje.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk perspektiv skal produktet anvendes straks.
English: You should not use this medicine during pregnancy.
Danish: Du bør ikke bruge dette lægemiddel under graviditet.
English: Date of first authorisation: 19 December 2014 Date of latest renewal: 26 September 2019
Danish: Dato for første markedsføringstilladelse: 19. december 2014 Dato for seneste fornyelse: 26. september 2019
English: Avda de la Industria, 30
Danish: Avda de la Industria, 30 Alcobendas
English: System Organ Class (MedDRA)
Danish: Systemorganklasse (MedDRA)
English: This cancer treatment will be given to you by a doctor or nurse.
Danish: Denne kræftbehandling gives af en læge eller sygeplejerske.
English: Excretion in milk and oral absorption is expected to be low.
Danish: Udskillelse i mælk og oral absorption forventes at være lav.
English: A limited number of non-Caucasian, especially Black patients (2.6%) were included.
Danish: Der var inkluderet et begrænset antal af ikke-kaukasiere, specielt sorte patienter (2,6 %).
English: There are very limited efficacy and safety data available in these patients.
Danish: Der foreligger kun meget begrænsede effekt- og sikkerhedsdata for disse patienter.
English: The number of infusions you will receive depends on how you are responding to treatment.
Danish: Antallet af infusioner, som du vil få, afhænger af, hvordan du reagerer på behandlingen.
English: The following information is intended for healthcare professionals only:
Danish: Nedenstående oplysninger er kun tiltænkt læger og sundhedspersonale:
English: All medicinal products were administered intravenously.
Danish: Alle lægemidler blev administreret intravenøst.
English: It should not be administered as an intravenous bolus or push.
Danish: Det må ikke administreres som en intravenøs bolus eller push.
English: Cyramza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Danish: Cyramza må ikke gives til patienter under 18 år, da der ikke foreligger information om, hvordan det virker i denne aldersgruppe.
English: Treatment cycles on both arms were repeated every 2 weeks.
Danish: Behandlingsserierne i begge arme blev gentaget hver 2. uge.
English: There is no data on overdose in humans.
Danish: Der foreligger ingen data om overdosering hos mennesker.
English: In 32 of the 33 pre-specified sub-group analyses for OS, the HR was < 1.0.
Danish: I 32 af de 33 præspecificerede subgruppeanalyser af OS var HR < 1,0.
English: Alcobendas 28108 Madrid Spain
Danish: 28108 Madrid Spanien
English: - Elderly people with lung cancer: Your doctor will carefully evaluate the most appropriate treatment for you.
Danish: - Ældre personer med lungekræft: Din læge vil omhyggeligt vurdere, hvilken behandling der passer bedst til dig.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, før du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: <1.5 x upper limit of normal value (ULN)
Danish: < 1,5 x øvre normalgrænse (ULN)
English: The amount of protein in your urine will be checked regularly during treatment.
Danish: Mængden af protein i urinen kontrolleres regelmæssigt under behandlingen.
English: Aspartate aminotransferase (AST) /Alanine aminotransferase (ALT)
Danish: Asparat aminotransferase (AST)/ Alanin aminotransferase (ALT)
English: Tell your doctor if you experience any of the following other side effects:
Danish: Fortæl det til din læge, hvis du oplever nogen af følgende andre bivirkninger:
English: The final total volume in the container should be 250 ml.
Danish: Den endelige totale mængde i beholderen skal være 250 ml.
English: In such cases, your doctor will perform regular blood tests to monitor the risk of bleeding.
Danish: I sådanne tilfælde vil lægen tage regelmæssige blodprøver for at overvåge risikoen for blødning.
English: In most cases hypertension was managed using standard antihypertensive treatment.
Danish: I de fleste tilfælde blev hypertension håndteret med standard antihypertensiv behandling.
English: These and other factors investigated had < 20 % effect on ramucirumab disposition.
Danish: Disse og andre undersøgte faktorer havde <20% effekt på ramucirumabs fordeling.
English: Pre-specified analyses for OS and PFS by stratification factors were performed.
Danish: Der blev udført præspecificerede analyser af OS og PFS i forhold til stratificeringsfaktorer.
English: Based on simulations using the PopPK model, steady state would be attained by the sixth dose.
Danish: Baseret på simuleringer ved brug af PopPK-modellen vil steady state være opnået ved den 6. dosis.
English: It is not known if the medicine passes into breast milk and could affect a breastfed baby.
Danish: Det vides ikke, om medicinen udskilles i brystmælk og dermed kan påvirke et ammende spædbarn.
English: Consider use of colonystimulating factor prior to next cycle.
Danish: Overvej brug af kolonistimulerende faktor før næste serie.
English: In case of overdose, supportive therapy should be used.
Danish: I tilfælde af overdosering skal der anvendes understøttende behandling.
English: Overall survival, months
Danish: Samlet overlevelse, måneder
English: A minimal grade of inflammation and/or mononuclear cell infiltration was seen in several organs.
Danish: En minimal grad af inflammation og/eller mononukleær celleinfiltration blev set i flere organer.
English: Median OS in patients who did not experience neutropenia was 10.7 months in both arms.
Danish: Median OS for de patienter, der ikke fik neutropeni, var 10,7 måneder i begge arme.
English: By attaching to ‘VEGF receptor 2' and blocking it the medicine cuts off the blood supply to the cancer cells.
Danish: Ved at binde sig til ”VEGF receptor 2” og blokere den, afskærer medicinen blodforsyningen til kræftcellerne.
English: Antibodies are principally cleared by catabolism.
Danish: Antistoffer fjernes hovedsageligt ved katabolisme.
English: The majority of events occurred during or following a first or second ramucirumab infusion.
Danish: Størstedelen af hændelserne forekom under eller efter den første eller anden infusion af ramucirumab.
English: After dilution and preparation, the medicine must be used immediately.
Danish: Efter fortynding og klargøring skal lægemidlet anvendes straks.
English: Improvements in OS and PFS were consistently observed in pre-specified subgroups based on age, sex, race and in most other pre-specified subgroups.
Danish: Forbedringer i OS og PFS blev observeret konsistent i præspecificerede delgrupper baseret på alder, køn, race og i de fleste andre præspecificerede delgrupper.
English: The primary endpoint was OS and secondary endpoints included PFS.
Danish: Det primære endepunkt var OS, og de sekundære endepunkter omfattede PFS.
English: Please read the package leaflets for the other medicines that are part of your treatment, to see if they are suitable for you.
Danish: Du bør læse indlægssedlerne for de andre lægemidler, som er en del af din behandling, så du kan vurdere, om de er passende for dig.
English: It is recommended that treatment be continued until disease progression or until unacceptable toxicity has occurred.
Danish: Det anbefales at fortsætte behandlingen indtil sygdomsprogression eller uacceptabel toksicitet.
English: This one sub-group is a group which can be considered to have aggressive disease that is relatively refractory to first-line treatment.
Danish: Denne ene subgruppe er en gruppe, hvis sygdom må anses for at være aggressiv og relativt refraktær i forhold til førstelinjebehandling.
English: Talk to your doctor about the best contraception for you.
Danish: Tal med din læge om, hvad der er det bedste svangerskabsforebyggende middel for dig.