FrancophonIA/ELRC3.0 huggingface dataset:
English: The follitropin beta in Fertavid is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Danish: Follitropin beta i Fertavid produceres ved hjælp af en metode kaldet "rekombinant DNA-teknologi".
English: What benefit has Fertavid shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Fertavid?
English: How is Fertavid used?
Danish: Hvordan anvendes Fertavid?
English: How does Fertavid work?
Danish: Hvordan virker Fertavid?
English: What you need to know before you take [x]
Danish: Det skal du vide, før du begynder at tage [x]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktoplysningerne kan opdateres efterfølgende af de relevante myndigheder i medlemsstaten, i samarbejde med referencemedlemsstaten, hvis det er relevant, i overensstemmelse med afsnit III, kapitel 4 i Direktiv 2001/83/EF.
English: • Oral contraception
Danish: • Orale præventionsmidler
English: [x] is a medicinal product o to prevent pregnancy (contraceptive “pill”).
Danish: [x] er et lægemiddel o til at forhindre graviditet (p-pille).
English: The decision to prescribe [x] should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [x] compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
Danish: I forbindelse med beslutningen om at ordinere [x] skal der tages hensyn til den enkelte kvindes aktuelle risikofaktorer, især risikofaktorer for venøs tromboemboli (VTE), samt til, hvordan risikoen for VTE ved [x] er sammenlignet med andre kombinerede hormonelle præventionsmidler (se pkt.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Danish: De eksisterende produktoplysninger skal ændres (henholdsvis indsætning, erstatning eller sletning af tekst) så de svarer til nedenstående vedtagne tekst.
English: • Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive.
Danish: • Behandling af moderat akne efter manglende effekt af egnede topiske behandlinger eller behandling med orale antibiotika hos kvinder, der vælger at tage et oralt præventionsmiddel.
English: Women should be assessed 3-6 months after treatment initiation and periodically thereafter to review the need for continuation of treatment.
Danish: Kvinder bør evalueres 3-6 måneder efter behandlingsstart og regelmæssigt derefter for at gennemgå behovet for fortsat behandling.
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Danish: Ændringerne i de relevante afsnit i produktresumé og indlægsseddel er resultatet af referral-proceduren.
English: o For treatment of women with moderate acne who agree to receive a contraceptive pill after failure of suitable local or oral antibiotic treatments.
Danish: o til behandling af kvinder med moderat akne, der accepterer at tage en p-pille efter manglende effekt af egnede behandlinger med lokale eller orale antibiotika.
English: You should discuss with your doctor the need to continue your treatment three to six months after the start and regularly thereafter.
Danish: Tal med din læge om behovet for at fortsætte behandlingen tre til seks måneder efter behandlingsstart og regelmæssigt derefter.
English: Section 4.1 Therapeutic indications The acne indication should be revised to read as follows:
Danish: Punkt 4.1 Terapeutiske indikationer Indikationen for akne skal ændres til følgende:
English: C. Package Leaflet This wording regarding the acne indication should be revised to read as follows:
Danish: C. Indlægsseddel Teksten vedrørende indikationen for akne skal ændres til følgende:
English: Your acne will usually improve between three and six months of treatment, and could continue to improve even after six months.
Danish: Din akne vil sædvanligvis bedres i løbet af tre til seks måneders behandling, og bedringen kan endda fortsætte efter seks måneder.
English: Annex III Amendments to relevant sections of the Product Information
Danish: Bilag III Ændringer af relevante punkter i produktresuméet og i indlægssedlerne
English: Apparent improvement of acne usually takes at least three months and further improvement has been reported after six months of treatment.
Danish: I forbindelse med indikationen for akne skal doseringen ændres med tilføjelse af følgende tekst: Synlig forbedring af akne tager sædvanligvis mindst tre måneder, og der er indberettet yderligere forbedring efter seks måneders behandling.
English: Amendments to relevant sections of the Product Information
Danish: Ændringer af relevante punkter i produktresuméet og i indlægssedlerne
English: The applicant was requested to provide the following information:
Danish: Ansøgeren blev bedt om at forelægge følgende oplysninger:
English: Ireland considers that, due to the absence of efficacy documentation it cannot be assumed that the product is efficacious and that this as such presents a potential serious risk to animal health.
Danish: Irland finder, at det på grund af manglende dokumentation for virkning ikke kan antages, at lægemidlet er effektivt, og at dette som sådan udgør en potentiel alvorlig risiko for dyrs sundhed.
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Danish: I henhold til artikel 33, stk. 4, i Rådets direktiv 2001/82/EF, med senere ændringer, blev sagen indbragt for CVMP.
English: Conclusions and Recommendations
Danish: Konklusioner og anbefalinger
English: A List of Questions was adopted by CVMP and sent to the applicant on 12 December 2007.
Danish: CVMP vedtog en liste med spørgsmål, der blev sendt til ansøgeren den 12. december 2007.
English: CVMP started the referral procedure on 11 December 2007 and agreed on a 37 day time frame.
Danish: CVMP indledte indbringelsesproceduren den 11. december 2007 og blev enige om en tidsfrist på 37 dage.
English: Calves and pigs oral
Danish: Kalve og svin
English: The aim of the assessment is to establish whether marketing authorisations of veterinary medicinal products included in the referral procedure should be maintained, suspended, varied or revoked with view to the grounds for referral.
Danish: Formålet med vurderingen var at fastslå, om markedsføringstilladelserne for de veterinærlægemidler, der var omfattet af indbringelsesproceduren, skulle opretholdes, suspenderes, ændres eller tilbagekaldes under hensyntagen til begrundelserne for indbringelsen.
English: Alternatively Solacyl can also be administered with the drinking water as pulse medication.
Danish: Alternativt kan Solacyl også indgives med drikkevandet som pulsmedicinering.
English: The applicant submitted written responses to the List of Questions on 10 January 2008 and the clock was re-started.
Danish: Den 10. januar 2008 indsendte ansøgeren skriftlige svar på spørgsmålene, og uret blev startet igen.
English: Administration: orally in drinking water.
Danish: Administration: oralt i drikkevand.
English: The application dossier and any data added to it up to Day 60 of the referral procedure in CMD(v) to be provided to all CVMP Members and the EMEA.
Danish: Dossieret i forbindelse med ansøgningen og alle data, der er føjet hertil op til dag 60 i indbringelsesproceduren for CMD(v), skal forelægges samtlige CVMP's medlemmer og EMEA.
English: In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and the supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Danish: Som svar på spørgsmål 1 forelagde ansøgeren en kopi af det originale dossier indsendt til støtte for ansøgningen via den decentraliserede procedure og de supplerende data indsendt under den decentraliserede procedure som svar på vurderingen af fase I og fase II-dataene, og den efterfølgende indbringelsesprocedure for CMD(v).
English: Half of the calculated total daily amount of powder is mixed with 5-10 litres of clean water and stirred until evenly dispersed.
Danish: Halvdelen af den beregnede samlede daglige mængde pulver blandes med 5-10 liter rent vand og omrøres, indtil det er jævnt dispergeret.
English: Administration: orally in drinking water or milk(replacer).
Danish: Administration: oralt i drikkevand eller mælk (mælkeerstatning).
English: Solacyl powder for oral solution powder
Danish: Solacyl pulver til oral opløsning
English: This solution is then added, whilst stirring, into an amount of drinking water that will be consumed within approximately 3-4 hours and administered twice daily.
Danish: Denne opløsning tilsættes derefter under omrøring til en mængde drikkevand svarende til, hvad der vil blive brugt i løbet af ca. 3-4 timer, og gives to gange dagligt.
English: The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 26 November 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Solacyl 100% powder for oral solution.
Danish: Nederlandene, der er referencemedlemsstat i den decentraliserede procedure, underrettede den 26. november 2007 EMEA om, at den veterinærmedicinske koordinationsgruppe for den gensidige anerkendelsesprocedure og den decentraliserede godkendelsesprocedure (CMD(v)) ikke nåede til enighed med hensyn til Solacyl 100 % pulver til oral opløsning.
English: The objections raised by Ireland should not prevent the granting of a marketing authorisation for Solacyl 100% powder for oral solution for calves and pigs.
Danish: De indsigelser, som Irland rejste, bør ikke forhindre udstedelse af markedsføringstilladelse for Solacyl 100 % pulver til oral opløsning til kalve og svin.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE INSERT
Danish: BILAG III PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJE OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE
English: Pigs: 35 mg sodium salicylate per kg bodyweight per day, for 3 to 5 days.
Danish: Svin: 35 mg natriumsalicylat pr. kg legemsvægt pr. dag i 3-5 dage.
English: Calves: 20 mg sodium salicylate per kg bodyweight twice daily, for 1 to 3 days.
Danish: Kalve: 20 mg natriumsalicylat pr. kg legemsvægt to gange dagligt i 1-3 dage.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the versions agreed by the Reference Member State and Concerned Member States (except Ireland) at day 210 of the decentralised procedure.
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de udgaver, der er fastlagt på dag 210 i den decentraliserede procedure af referencemedlemsstaten og de berørte medlemsstater (undtagen Irland).
English: CVMP noted that Solacyl 100% powder for oral solution is a generic of Natrium salicylaat (authorised in The Netherlands) and that the concerns raised by Ireland could only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Danish: CVMP bemærkede, at Solacyl 100 % pulver til oral opløsning er en generisk udgave af natriumsalicylat, der er godkendt i Nederlandene, og at de betænkeligheder, som Irland rejste, kun kan behandles inden for rammerne af denne procedure, hvis forskelle på de to lægemidler skulle ligge til grund for forskellige konklusioner med hensyn til sikkerhed eller virkning.
English: It is recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Danish: Det anbefales, at Solacyl 100 % pulver til oral opløsning til kalve og svin efterkommer resultatet af indbringelsesproceduren i henhold til artikel 35, stk. 2, for orale, opløselige pulvere, der indeholder natriumsalicylat.
English: Solacyl 100% powder for oral solution proved to be essentially similar to the reference product, Natrium salicylaat 100%.
Danish: Solacyl 100 % pulver til oral opløsning viste sig i det væsentlige at svare til referencelægemidlet natriumsalicylat 100 %.
English: In response to question 2, the applicant answered that Solacyl 100% powder for oral solution is identical to the reference product and that there is no reason to reach different conclusions on the efficacy of the two products.
Danish: Som svar på spørgsmål 2 svarede ansøgeren, at Solacyl 100 % pulver til oral opløsning er identisk med referencelægemidlet, og at der ikke er grundlag for at nå til forskellige konklusioner med hensyn til virkningen af de to lægemidler.
English: To indicate and to substantiate where necessary, any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Danish: Angivelse af og om nødvendigt dokumentation for enhver forskel mellem Solacyl 100 % pulver og referencelægemidlet, der kunne ligge til grund for forskellige konklusioner med hensyn til virkningen af de to lægemidler.
English: On the basis of the grounds for referral CVMP considered any differences between Solacyl 100% powder and the reference product that could justify different conclusions on the efficacy for the two products.
Danish: På basis af begrundelserne for indbringelsesproceduren vurderede CVMP de forskelle mellem Solacyl 100 % pulver og referencelægemidlet, der kunne ligge til grund for forskellige konklusioner med hensyn til virkningen af de to lægemidler.
English: Frequency and route of administration
Danish: Dyrearter Doseringshyppighed og indgivelsesvej
English: Date of first authorisation: 20 December 2012 Date of latest renewal: 18 September 2017
Danish: Dato for første markedsføringstilladelse: 20. december 2012 Dato for seneste fornyelse: 18. september 2017
English: You should continue taking your tablets.
Danish: Du skal fortsætte med at tage dine tabletter.
English: From these informative cases, only 14 cases were described in detail as they are considered as informative positive cases.
Danish: Ud af disse informative tilfælde blev kun 14 tilfælde beskrevet detaljeret, da de betragtes som informative positive tilfælde.
English: Treatment for overdose should be symptomatic and supportive.
Danish: Behandling af overdosering bør være symptomatisk og støttende.
English: Each carton contains one bottle.
Danish: Hver pakning indeholder ét glas.
English: 95% Confidence Interval
Danish: 95 % konfidensinterval
English: Effect of food on absorption
Danish: Virkningen af mad på absorption
English: These metabolites are not pharmacologically active.
Danish: Disse metabolitter er ikke farmakologisk aktive.
English: MedDRA System organ class
Danish: MedDRA Systemorgan klasse
English: After first opening of the bottle, the tablets can be stored for 6 months.
Danish: Efter første åbning af glasset kan tabletterne opbevares i 6 måneder.
English: - if you have kidney or liver problems.
Danish: - hvis du har nyre- eller leverproblemer.
English: Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B.
Danish: Mild: Child-Pugh-klasse A; Moderat: Child-Pugh-klasse B. 3.
English: In the phase 3 studies, mirabegron was administered with or without food and demonstrated both safety and efficacy.
Danish: I fase 3-studierne blev mirabegron administreret med eller uden mad og udviste både sikkerhed og virkning.
English: EXP Use within 6 months after opening of the bottle
Danish: EXP: Anvendes inden for 6 måneder efter åbning af glasset
English: Results for QTcF and QTcIf were consistent with QTcI.
Danish: Resultaterne for QTcF og QTcIf var i overensstemmelse med dem for QTcI.
English: Gender differences in Cmax and AUC are attributed to differences in body weight and bioavailability.
Danish: Kønsforskelle i Cmax og AUC tilskrives forskelle i kropsvægt og biotilgængelighed.
English: Tell your doctor right away if you are unable to empty your bladder.
Danish: Fortæl straks lægen, hvis du ikke kan tømme din blære.
English: A randomized, active controlled, long term study demonstrated that efficacy was maintained throughout a 1-year treatment period.
Danish: Et randomiseret aktivt kontrolleret langtidsstudie påviste, at virkningen blev opretholdt under hele forløbet af en 1-års behandlingsperiode.
English: Genotoxicity and carcinogenicity studies have shown no genotoxic or carcinogenic potential in vivo.
Danish: Genotoksicitets- og karcinogenicitetsstudier har ikke påvist genotoksisk eller karcinogent potentiale in vivo.
English: The terminal elimination half-life (t1/2) is approximately 50 hours.
Danish: Den terminale eliminationshalveringstid (t1/2) er ca. 50 timer.
English: It is recommended that your doctor check your blood pressure while you are taking Mirabegron
Danish: Det anbefales, at din læge kontrollerer dit blodtryk, når du tager Mirabegron.
English: From the 138 cases identified, none was considered as an index case by the MAH and only 55 cases were classified as informative.
Danish: Ud af de 138 tilfælde, der blev identificeret, blev ingen anset som indeks-tilfælde af indehaveren af markedsføringstilladelsen, og kun 55 tilfælde blev klassificeret som informative.
English: Most of patients are elderly patients according to the information included in the EVDAs but there are also non-elderly patients.
Danish: De fleste patienter er ældre patienter ifølge oplysningerne inkluderet i EVDA'erne, men der er også yngre patienter.
English: If you get headaches, especially sudden, migraine-like (throbbing) headaches, tell your doctor.
Danish: Hvis du oplever hovedpine, især pludselig, migræne-lignende (dunkende) hovedpine, så kontakt din læge.
English: 3 years Shelf life after first opening of the bottle: 6 months
Danish: 3 år Opbevaringstid efter første åbning af glasset: 6 måneder
English: In one study, 495 patients received an active control (tolterodine prolonged release formulation).
Danish: I ét studie fik 495 patienter en aktiv kontrol (tolterodindepotformulering).
English: If you are pregnant, think you may be pregnant or are planning to have a baby you should not take Betmiga.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, må du ikke tage Betmiga.
English: Two major metabolites were observed in human plasma; both are phase 2 glucuronides representing 16% and 11% of total exposure.
Danish: Der blev observeret to væsentlige metabolitter i humant plasma; begge er fase 2-glucuronider, som udgør 16 % og 11 % af den samlede eksponering.
English: Therefore, mirabegron can be taken with or without food at the recommended dose.
Danish: Mirabegron kan derfor tages med eller uden mad i den anbefalede dosis.
English: This medicinal product is not recommended during pregnancy.
Danish: Dette lægemiddel bør ikke anvendes under graviditet.
English: Cumulatively and according to the summary tabulations, confusional state was the most frequently serious Psychiatric disorder reported (37 serious reports, 18.5% of the serious psychiatric disorder reported.
Danish: Kumulativt og ifølge oversigterne var konfusionstilstanden den hyppigst rapporterede alvorlige psykiatriske lidelse (37 alvorlige rapporter, hvoraf 18,5 % af den alvorlige psykiatriske lidelse).
English: There are limited amount of data from the use of Betmiga in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af Betmiga til gravide kvinder.
English: Betmiga may affect the way other medicines work, and other medicines may affect how this medicine works.
Danish: Betmiga kan påvirke andre lægemidlers virkemåde, og andre lægemidler kan påvirke dette lægemiddels virkemåde.
English: Caution should be exercised when administering mirabegron in these patients.
Danish: Der bør udvises forsigtighed, når mirabegron administreres til disse patienter.
English: If it is less than 6 hours before your next scheduled dose, skip the dose and continue to take your medicine at the usual time.
Danish: Hvis der er mindre end 6 timer til din næste planlagte dosis, skal du springe den glemte dosis over og fortsætte med at tage din medicin på det sædvanlige tidspunkt.
English: Adults (including elderly patients) The recommended dose is 50 mg once daily
Danish: Voksne (herunder ældre patienter) Den anbefalede dosering er 50 mg én gang dagligt.
English: Mirabegron is transported and metabolised through multiple pathways.
Danish: Mirabegron transporteres og metaboliseres via flere pathways.
English: There is no information to suggest that this medicine affects your ability to drive or use machines.
Danish: Der er ingen oplysninger, der tyder på, at dette lægemiddel påvirker din evne til at føre motorkøretøj og betjene maskiner.
English: Effect on intraocular pressure (IOP)
Danish: Virkning på det intraokulære tryk (IOP)
English: You and your doctor should decide if you should take Betmiga or breastfeed.
Danish: Du og din læge skal beslutte, om du skal tage Betmiga eller amme.
English: If you have kidney or liver problems, your doctor may need to reduce your dose to one 25 mg tablet by mouth once daily.
Danish: Hvis du har nyre- eller leverproblemer, kan lægen være nødt til at reducere din dosis til én 25 mg tablet én gang dagligt.
English: This is an uncommon side effect (may affect up to 1 in 100 people), but if this side effect occurs, immediately stop taking the medicine and seek urgent medical advice.
Danish: Dette er en ikke almindelig bivirkning (kan forekomme hos op til 1 ud af 100 personer), men opstår denne bivirkning, skal du straks stoppe med at tage lægemidlet og med det samme kontakte lægen.
English: The safety and efficacy of mirabegron in children below 18 years of age have not yet been established.
Danish: Mirabegrons sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: You should take this medicine with liquids and swallow the tablet whole.
Danish: Du skal tage dette lægemiddel med væske og synke tabletten hel.
English: There was also a case with confirmed positive rechallenge of symptoms after starting mirabegron three times.
Danish: Der var også et tilfælde med bekræftet positiv rechallenge af symptomer efter initiering af mirabegron tre gange.
English: The tablet is to be taken with liquids, swallowed whole and is not to be chewed, divided, or crushed.
Danish: Tabletten skal tages med væske, synkes hel og må ikke tygges, deles eller knuses.
English: Tell your doctor about the medicines that you take.
Danish: Fortæl din læge, hvilken anden medicin, du tager.
English: Do not stop treatment with Betmiga early if you do not see an immediate effect.
Danish: Stands ikke behandlingen med Betmiga før tid, hvis du ikke straks oplever en virkning.
English: Serum digoxin concentrations should be monitored and used for titration of the digoxin dose to obtain the desired clinical effect.
Danish: Serumdigoxinkoncentrationerne bør monitoreres og anvendes til titrering af digoxindosis for at opnå den ønskede kliniske virkning.
English: The Cmax and AUC are approximately 40% to 50% higher in females than in males.
Danish: Cmax og AUC er ca. 40 % til 50 % højere hos kvinder end hos mænd.
English: Pre-clinical studies have identified target organs of toxicity that are consistent with clinical observations.
Danish: Prækliniske studier har identificeret målorganer for toksicitet, som er i overensstemmelse med kliniske observationer.
English: Pooled studies
Danish: Poolede studier