FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study in 89 children aged between 2 and 12 years the results were similar: 77% of patients on Viread had a viral load reduced to below 400 copies/ml after 48 weeks compared with 7% of patients on placebo.
Danish: Lignende resultater sås i et studie blandt 89 børn i alderen 2-12 år: Hos 77 % af de patienter, der tog Viread, faldt virusbelastningen til under 400 kopier/ml efter 48 uger sammenlignet med 7 % af de patienter, der tog placebo.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viread have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Viread.
English: A study in 106 adolescents with either HBeAg-negative or HBeAg-positive hepatitis B compared Viread with placebo and found that in 88% of patients taking Viread the viral load reduced to below 400 copies/ml after 72 weeks compared with 0% of those taking placebo.
Danish: I et studie blandt 106 unge med enten HBeAg-negativ eller HBeAg-positiv hepatitis B blev Viread sammenlignet med placebo.
English: How does Viread work?
Danish: Hvordan virker Viread?
English: --1 Recombinant verotoxin 2e of E. coli……………..RP* ≥ 1.50 * RP - relative potency (ELISA)
Danish: --1 Rekombinant verotoksin 2e fra E. coli ................................................... RP* ≥ 1,50 * RP - relativ styrke (ELISA)
English: 10 vials
Danish: 0 dage
English: Strength Pharmaceutical form
Danish: Lægemiddelform Dyrearter, som lægemidlet er beregnet til
English: A procedure under Article 29(4) was therefore triggered in February 2012.
Danish: En procedure under artikel 29, stk. 4, blev derfor iværksat i februar 2012.
English: Overall summary of the scientific evaluation of Mometasone Furoate Sandoz and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Mometasonfuroat Sandoz og tilknyttede navne (se bilag I)
English: Scientific conclusions and grounds for positive opinion
Danish: Videnskabelige konklusioner og begrundelser for positiv udtalelse
English: Grounds for positive opinion
Danish: Begrundelser for positiv udtalelse
English: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Danish: Mometasonfuroat er et topisk glukokortikosteroid med lokale antiinflammatoriske egenskaber ved doser, der ikke er systemisk aktive.
English: • the CHMP assessed the entirety of the data submitted by the Applicant,
Danish: • CHMP vurderede de af ansøgeren indsendte data i deres helhed
English: 1 Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1, January 2009)
Danish: 1 Retningslinjer for kravene til klinisk dokumentation for oralt inhalerede produkter (OIP), inklusive kravene til påvisning af terapeutisk ækvivalens mellem to inhalerede produkter til brug ved behandling af astma og kronisk obstruktiv lungesygdom (KOL) hos voksne og til brug ved behandling af astma hos børn og unge (CPMP/EWP/4151/00 Rev. den 1. januar 2009)
English: However, in this specific case, the CHMP considered the adequacy of the applied statistical methods to be of secondary importance compared to the evaluation of the available in vitro data, as supported by the available in vivo data, which was considered sufficient to reach a conclusion.
Danish: Men i dette specifikke tilfælde vurderede CHMP tilstrækkeligheden af de anvendte statistiske metoder som værende af sekundær vigtighed sammenlignet med evalueringen af de tilgængelige in vitro-data, understøttet af de tilgængelige in vivo-data, der blev vurderet som tilstrækkelige til at nå til en konklusion.
English: The CHMP also discussed the objections raised regarding the statistical methodology used for the in vitro comparison.
Danish: CHMP diskuterede også indvendingerne mod den statistiske metodologi, der blev anvendt til in vitro-sammenligningen.
English: The CHMP noted that the Applicant had received scientific advice from the CHMP on the clinical program, stating that for locally applied, locally acting products containing known constituents, an in vitro approach could in principle be used for demonstration of equivalence, provided that this approach is justified.
Danish: CHMP bemærkede, at ansøgeren havde modtaget videnskabelig rådgivning fra CHMP vedrørende det kliniske program, som fastsatte, at for lokalt anvendte, lokalvirkende produkter, der indeholder kendte indholdsstoffer, kan en in vitro-fremgangsmåde i princippet bruges til at påvise ækvivalens, såfremt den pågældende fremgangsmåde er berettiget.
English: This was further supported by the clinical data obtained with the Device 1 spray pump.
Danish: Dette blev yderligere understøttet af de kliniske data, der blev indhentet med Type 1-spraypumpen.
English: In addition, the objecting CMS raised concerns regarding the statistical methodology applied.
Danish: Derudover påpegede CMS'erne problemer ved den anvendte, statistiske metodologi.
English: The objecting CMS considered that the available in vitro data is not a valid surrogate for the equivalence of the products, as the comparison was performed using the Population Bioequivalence (PBE) method, which consists of an aggregate criterion where the differences in means can be compensated by the differences in variability.
Danish: De indsigende CMS'er vurderede, at de tilgængelige in vitro-data ikke er en gyldig erstatning for ækvivalensen af produkterne, eftersom sammenligningen var udført ved hjælp af populationsbioækvivalens-metoden (PBE-metoden), som består af et samlet kriterium, hvor forskellene i fremgangsmåder kan kompenseres ved forskellene i variabilitet.
English: • the CHMP considered the benefit-risk of the proposed products to be positive, the CHMP has recommended the granting of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III for Mometasone Furoate Sandoz and associated names (see Annex I).
Danish: • CHMP vurderede benefit/risk-forholdet for de foreslåede produkter som værende positiv har CHMP anbefalet at udstede markedsføringstilladelse, for hvilken produktresuméet, etiketteringen og indlægssedlen forbliver i henhold til de endelige udgaver, der blev opnået via koordinationsgruppens procedure, som nævnt i bilag III, for Mometasonfuroat Sandoz og tilknyttede navne (se bilag I).
English: The Applicant submitted an application for Mometasone Furoate Sandoz 50 mcg/dose, in the treatment of the symptoms of seasonal allergic or perennial rhinitis and of nasal polyps, as a nasal spray with two different spray pump devices (Device 1 and Device 2).
Danish: Ansøgeren har indsendt en ansøgning for Mometasonfurorat Sandoz 50 µg/dosis til behandling af symptomerne på allergisk eller kronisk rhinitis og næsepolypper i form af næsespray med to forskellige spraypumpetyper (Pumpetype 1 og Pumpetype 2).
English: The CHMP considered that this was supported by the evidence of equivalent therapeutic efficacy obtained from the phase III clinical study comparing the proposed product with the Device 1 spray pump and the reference product.
Danish: CHMP vurderede, at dette var understøttet af evidens for en ækvivalent, terapeutisk virkning indhentet fra den kliniske fase III-undersøgelse, der sammenlignede det foreslåede produkt med Type 1-spraypumpen og referenceproduktet.
English: The PBE method may therefore be more permissive than the Average Bioequivalence (ABE) method described in the CHMP's Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP).1 While noting that the Applicant had presented justifications for the use of PBE and that this use was pre-specified where
Danish: PBE-metoden kan derfor være mere tolerant end gennemsnitsbioækvivalens-metoden (ABE-metoden), som er beskrevet i CHMP's Guideline on the Requirements for Clinical Documentation for Orally Inhaled Products (OIP).1 Mens CHMP bemærkede, at ansøgeren havde fremlagt berettigelse for brug af
English: Because of the low systemic bioavailability and the poor absorption from the gastrointestinal tract of mometasone furoate, the Applicant decided not to perform any pharmacokinetic or pharmacodynamic studies and instead performed comparative in vitro studies between the proposed and the reference products for both spray pump delivery devices.
Danish: På grund af den lave systemiske biotilgængelighed og den ringe absorption af mometasonfuroat i mave-tarm-kanalen, besluttede ansøgeren at undlade at udføre farmakokinetiske og farmakodynamiske undersøgelser og i stedet udføre komparative in vitro-undersøgelser af det foreslåede produkt og referenceprodukterne for begge spraypumpetyper.
English: While the reference member state considered both devices to be approvable, the objecting concerned member state (CMS) did not consider in vitro data to be a valid surrogate of equivalence for nasal suspensions and therefore considered that equivalence had not been demonstrated for Device 2.
Danish: Selv om referencemedlemslandet vurderede, at begge pumpetyper kunne godkendes, anså de øvrige medlemslande (CMS'er) ikke in vitro-dataene som en gyldig erstatning for ækvivalens for nasale suspensioner og vurderede derfor, at ækvivalens ikke er påvist for type 2-pumpen.
English: • the CHMP therefore considered it adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products, based on the available in vitro evidence and further supported by the clinical data obtained using the proposed product fitted with the Device 1 spray pump,
Danish: • CHMP vurderede det derfor tilstrækkeligt påvist, at potentielle forskelle mellem det foreslåede produkt sammen med enten Type 1-pumpen eller Type 2-pumpen og referenceproduktet ikke påvirker sikkerheden og virkningen af de foreslåede produkter, baseret på den tilgængelige in vitro-evidens og yderligere understøttet af de kliniske data indhentet fra brug af det foreslåede produkt sammen med Type 1 spraypumpen
English: The Applicant provided in vitro data for both devices, however only Device 1 was investigated in vivo.
Danish: Ansøgeren har vedlagt in vitro-data for begge spraypumpetyper, men det er kun Pumpetype 1, der er blevet undersøgt in vivo.
English: As the CHMP considered the rate of dissolution to determine the availability of the active substance locally, the CHMP further concluded that the data confirmed that potential differences between the proposed and the reference products would not impact the benefit-risk of the proposed products.
Danish: Eftersom CHMP vurderede opløsningshastigheden for at bestemme tilgængeligheden af det aktive stof lokalt, konkluderede CHMP videre, at dataene bekræftede, at potentielle forskelle mellem de foreslåede produkter og referenceprodukterne ikke ville påvirke benefit/risk-forholdet for de foreslåede produkter.
English: • the CHMP considered that the results of the conducted in vitro comparisons confirm that the particle size distribution as well as the locations and patterns of deposition of the suspension in the nose of the proposed products and the reference product are comparable,
Danish: • CHMP vurderede, at resultaterne af de udførte in vitro-sammenligninger bekræfter, at partikelstørrelsesfordelingen samt suspensionens placeringer og aflejringsmønstre i næsen for de foreslåede produkter og referenceproduktet er sammenlignelige
English: Considering that particle size distribution is an adequate indicator of dissolubility, the CHMP therefore concluded that the dissolution properties of the proposed and the reference products are equivalent, independently of the spray pump device used.
Danish: I betragtning af, at distribution af partikelstørrelse er en tilstrækkelig indikator for opløselighed, konkluderede CHMP derfor, at opløselighedsegenskaberne for de foreslåede produkter og referenceprodukterne er ækvivalente, uafhængigt af anvendt spraypumpetype.
English: • the CHMP considered particle size distribution and location and pattern of deposition to be adequate indicators of dissolubility and therefore concluded that the proposed and the reference products have comparable dissolution properties,
Danish: • CHMP vurderede partikelstørrelsesfordeling, placering og aflejringsmønster for at være tilstrækkelige indikatorer for opløselighed og konkluderede derfor, at de foreslåede produkter og referenceprodukterne har sammenlignelige opløselighedsegenskaber
English: Having assessed the entirety of the available data, the CHMP concluded that the evidence of comparable particle size distribution as well as location and pattern of deposition between the proposed and the reference products indicates comparable dissolubility, which is in turn an indicator of comparable safety and efficacy.
Danish: Efter at have vurderet alle tilgængelige data i deres helhed konkluderede CHMP, at evidensen for sammenlignelig partikelstørrelsesfordeling samt placering og aflejringsmønster for de foreslåede produkter og referenceprodukterne indikerer sammenlignelig opløselighed, som igen er en indikator for sammenlignelig sikkerhed og virkning.
English: applied, the CHMP considered that the use of PBE in bioequivalence studies is not desirable as it may lead to the acceptance of higher levels of variability between drug products.
Danish: PBE-metoden, og at denne brug var præspecificeret ved anvendelse, vurderede CHMP, at brug af PBE-metoden i bioækvivalensundersøgelser ikke er ønskværdig, da det kan føre til godkendelse af højere niveauer af variabilitet blandt lægemiddelprodukter.
English: In conclusion, considering the total body of available evidence, the CHMP considered it to be adequately demonstrated that potential differences between the proposed product fitted either with the Device 1 pump or with the Device 2 pump and the reference product do not affect the safety and efficacy of the proposed products and that the benefit-risk of the proposed products is therefore positive.
Danish: Konklusionen er efter vurdering af al tilgængelig evidens, at CHMP anså det som tilstrækkeligt påvist, at potentielle forskelle mellem det foreslåede produkt sammen med enten Type 1-pumpen eller med Type 2-pumpen og referenceproduktet ikke påvirker sikkerheden og virkningen af de foreslåede produkter, og at benefit/risk-forholdet for de foreslåede produkter derfor er positiv.
English: Having assessed the performance of the spray pumps and the properties of the suspension in the spray, the CHMP agreed that there is adequate evidence of comparable particle size distribution of the active substance suspension between the proposed products and reference product, and also agreed that comparable locations and patterns of deposition were demonstrated.
Danish: Efter vurdering af spraypumpernes ydeevne og suspensionens egenskaber i sprayen vedtog CHMP, at der er tilstrækkeligt tegn på fordeling af sammenlignelige partikelstørrelser i suspensionen af det aktive stof for de foreslåede produkter og referenceproduktet.
English: 300 mg Powder for concentrate for solution for infusion
Danish: 300 mg Pulver til koncentrat til infusionsvæske, opløsning
English: MA (EU) number Invented name Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Navn Styrke Lægemiddelform Administration Emballage Pakningsstørrelse
English: Intravenous use vial (glass)
Danish: Intravenøs anvendelse hætteglas 1 hætteglas
English: The following information is intended for medical or healthcare professionals only.
Danish: Nedenstående oplysninger er udelukkende til læger og sundhedspersonale.
English: Adopted at the 8-11 July 2019 PRAC
Danish: Vedtaget på PRAC's møde den 8.-11. juli 2019
English: Not known (frequency cannot be estimated from the available data)
Danish: Hyppighed ikke kendt (kan ikke beregnes ud fra tilgængelige data)
English: Evaluation of experimental Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: En vurdering af eksperimentelle Dyrestudier viser hverken direkte eller indirekte skadevirkninger, hvad angår reproduktionstoksicitet.
English: It is recommended to ensure adequate fluid intake during treatment.
Danish: Det anbefales at sørge for tilstrækkelig væskeindtagelse under behandlingen.
English: In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10 000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)).
Danish: I et kohortestudie, der omfattede 1,8 millioner graviditeter, var anvendelse af ondansetron i første trimester forbundet med en øget risiko for læbe-ganespalte (3 yderligere tilfælde pr. 10.000 behandlede kvinder; justeret relativ risiko 1,24 (95 % KI 1,03-1,48)).
English: If you suffer from bleeding problems.
Danish: Hvis du har problemer med blødning.
English: The available epidemiological studies on cardiac malformations show conflicting results.
Danish: De tilgængelige epidemiologiske studier af hjertemisdannelser viser modstridende resultater.
English: 2 Indicated in neonates and children below 2 years
Danish: 2 Indiceret til nyfødte og børn under 2 år.
English: Other side effects with Inlyta may include:
Danish: Andre bivirkninger ved Inlyta kan være:
English: Take care to drink sufficient amount of liquid during treatment with mesalazine.
Danish: Sørg for at drikke tilstrækkeligt med væske under behandling med mesalazin.
English: It is not known if <product name> is safe during pregnancy.
Danish: Det vides ikke, om det er sikkert at anvende <produktnavn> under graviditet.
English: If you are already pregnant, think you are might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking <product name>.
Danish: Hvis du allerede er gravid, har mistanke om, at du er kan være gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du tager <produktnavn>.
English: Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content.
Danish: Der er rapporteret om tilfælde af nefrolitiasis ved anvendelse af mesalazin, herunder sten med et mesalazin-indhold på 100 %.
English: Section at the end of the package leaflet:
Danish: Afsnittet til sidst i indlægssedlen:
English: Ondansetron should not be used during the first trimester of pregnancy.
Danish: Ondansetron bør ikke anvendes i graviditetens første trimester.
English: Mesalazine - Nephrolithiasis (EPITT no 19405)
Danish: Mesalazin - nefrolitiasis (EPITT nr. 19405)
English: Axitinib has not been studied in patients who have evidence of untreated brain metastasis or recent active gastrointestinal bleeding, and should not be used in those patients.
Danish: Axitinib er ikke undersøgt hos patienter med ubehandlede hjernemetastaser eller nylig gastrointestinal blødning og bør ikke anvendes til disse patienter.
English: What you need to know before you take Inlyta
Danish: Det skal du vide, før du begynder at tage Inlyta
English: If any bleeding requires medical intervention, temporarily interrupt the axitinib dose.
Danish: Hvis der opstår blødning, som kræver medicinsk intervention, skal axitinib-behandlingen midlertidigt afbrydes.
English: Ondansetron - Signal of birth defects following in-utero exposure during the first trimester of pregnancy arising from recent publications (EPITT no 19353)
Danish: Ondansetron - tegn på fødselsdefekter efter in uteroeksponering i første trimester af graviditeten ifølge nylige publikationer (EPITT nr. 19353)
English: Symptoms may include pain in sides of abdomen and blood in urine.
Danish: Symptomerne kan være smerter i siden af maven og blod i urinen.
English: However, as animal studies are not always predictive of human response the use of ondansetron in pregnancy is not recommended.
Danish: Men da dyrestudier ikke altid kan forudsige reaktionen hos mennesker, frarådes det at anvende ondansetron under graviditet.
English: Women of childbearing potential should consider the use of contraception.
Danish: Fertile kvinder bør overveje at bruge prævention.
English: Vascular Endothelial Growth Factor (VEGF) inhibitors for systemic administration3 - Artery dissections and aneurysms (EPITT no 19330)
Danish: Vaskulær endotelial vækstfaktor (VEGF)-hæmmere til systemisk administration3 - Arterielle dissektioner og aneurismer (EPITT nr. 19330)
English: Aflibercept (Zaltrap), bevacizumab, cabozantinib, nintedanib, pazopanib, ponatinib, ramucirumab, regorafenib, sorafenib, tivozanib, vandetanib Summary of product characteristics
Danish: Aflibercept (Zaltrap), bevacizumab, cabozantinib, nintedanib, pazopanib, ponatinib, ramucirumab, regorafenib, sorafenib, tivozanib, vandetanib Produktresumé
English: Inlyta may increase your chance of bleeding.
Danish: Inlyta kan øge blødningstendensen.
English: Special precautions for disposal and other handling:
Danish: Regler for bortskaffelse og anden håndtering:
English: Talk to your doctor or nurse before taking Inlyta:
Danish: Kontakt lægen eller sundhedspersonalet, før du tager Inlyta:
English: What you need to know before you take <product name> Warnings and precautions
Danish: Det skal du vide, før du begynder at tage <produktnavn> Advarsler og forsigtighedsregler
English: Summary of product characteristics (* include neonates and if product is indicated in such population) 4.2.
Danish: Produktresumé (* anfør nyfødte og, hvis produktet er indiceret til denne population) 4.2.
English: Talk to your doctor or nurse before taking <product name>:
Danish: Kontakt lægen eller apotekspersonalet, før du tager <produktnavn>:
English: Labelling text
Danish: Tekst på etiket
English: Parenteral nutrition products2 containing amino acids and/or lipids with or without admixture of vitamins and/or trace elements - Adverse outcomes in neonates treated with solutions not protected from light (EPITT no 19423)
Danish: Parenterale ernæringsprodukter2 indeholdende aminosyrer og/eller lipider med eller uden tilsætning af vitaminer og/eller sporstoffer - uønskede hændelser hos nyfødte, der behandles med opløsninger, som ikke beskyttes mod lys (EPITT nr. 19423)
English: Also, tell your doctor if you have been diagnosed with an aneurysm before taking this medicine.
Danish: Fortæl det også til lægen, hvis du har fået konstateret et aneurisme, før du tager dette lægemiddel.
English: Kidney stones may develop with use of mesalazine.
Danish: Der kan udvikles nyresten ved anvendelse af mesalazin.
English: Tell your doctor right away if you have any of these symptoms or a serious bleeding problem during treatment with Inlyta: black tarry stools, coughing up of blood or bloody sputum, or change in your mental status.
Danish: Fortæl det straks til lægen, hvis du får nogle af disse symptomer eller alvorlige blødninger under behandlingen med Inlyta: sort, klistret afføring, hoster blod eller blodigt slim op eller oplever ændringer i mental tilstand.
English: • kidney stones and associated kidney pain (see also section 2)
Danish: • nyresten og dermed forbundne nyresmerter (se også afsnit 2)
English: If you are a woman of childbearing potential you may be advised to use effective contraception.
Danish: Hvis du er en kvinde, der kan blive gravid, vil du måske blive rådet til at bruge sikker prævention.
English: the development of the embryo, or foetus, the course of gestation and periand post-natal development.
Danish: den embryo-føtale udvikling, drægtighedsperioden og den peri- og postnatale udvikling.