FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Genvoya, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Genvoya fremgår af indlægssedlen.
English: Genvoya elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide
Danish: Genvoya elvitegravir / cobicistat / emtricitabin / tenofoviralafenamid
English: Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Danish: Tenofoviralafenamid er et forstadium (et "prodrug"), der i kroppen omdannes til det aktive stof tenofovir.
English: For practical information about using Genvoya, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Genvoya, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Tenofovir and emtricitabine are related antiviral agents called reverse transcriptase inhibitors.
Danish: Tenofovir og emtricitabin er beslægtede antivirale lægemidler af typen reverse transkriptasehæmmere.
English: This boosts elvitegravir's antiviral effect.
Danish: Dette forstærker elvitegravirs virkning mod virus.
English: After 48 weeks a viral load of less than 50 copies/ml was seen in 97% (932 of 959) of patients switched to Genvoya and 93% (444 of 477) of patients who continued with their usual treatment.
Danish: Efter 48 uger havde 97 % (932 af 959) af de patienter, der skiftede til Genvoya, en virusbelastning på under 50 kopier/ml, sammenholdt med 93 % (404 af 477) af dem, der fortsatte med deres sædvanlige behandling.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Genvoya 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 Genvoya.
English: In studies, the effectiveness of Genvoya was high and comparable to that of a medicine containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Danish: I undersøgelserne var effektiviteten af Genvoya høj og sammenlignelig med effektiviteten af et lægemiddel indeholdende elvitegravir, cobicistat, emtricitabin og tenofovirdisoproxil.
English: Genvoya is an antiviral medicine used to treat individuals infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Genvoya er et lægemiddel mod virus og anvendes til behandling af voksne, som er smittet med HIV-1 (humant immundefektvirus type 1).
English: How is Genvoya used?
Danish: Hvordan anvendes Genvoya?
English: In both studies, Genvoya was compared with another antiviral medicine which contained the active ingredients elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil.
Danish: I begge undersøgelser blev Genvoya sammenlignet med et andet virusmiddel, der indeholdt de aktive stoffer elvitegravir, cobicistat, emtricitabin og tenofovirdisoproxil.
English: What benefits of Genvoya have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Genvoya?
English: Genvoya contains the active substances elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.
Danish: Genvoya indeholder de aktive stoffer elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid.
English: How does Genvoya work?
Danish: Hvordan virker Genvoya?
English: This study also involved 23 children aged 8 to 11 years weighing at least 25 kg, and showed that after 48 weeks of treatment with Genvoya the viral load was reduced to less than 50 copies/ml in all patients.
Danish: Denne undersøgelse omfattede også 23 børn i alderen 8-11 år,som vejede mindst 25 kg.
English: Elvitegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Danish: Det antivirale stof elvitegravir er en såkaldt integrasehæmmer.
English: In all other EU-countries, approval has been granted through national procedures.
Danish: I alle andre EU-lande er godkendelse sket via nationale procedurer.
English: Stability
Danish: Stabilitet
English: In all cases the results were within the approved specifications.
Danish: I alle tilfælde lå resultaterne inden for de godkendte specifikationer.
English: Arimidex was first approved on 1995 in the UK and via a MRP procedure in Austria, Germany, Italy, Portugal and Spain.
Danish: Arimidex blev godkendt første gang i Det Forenede Kongerige i 1995 og via en gensidig anerkendelsesprocedure i Østrig, Tyskland, Italien, Portugal og Spanien.
English: Identical wording for this indication exists in 19 out of the 29 countries where Arimidex is approved.
Danish: Identisk ordlyd for denne indikation findes i 19 ud af de 29 lande, hvor Arimidex er godkendt.
English: A subheading on fertility was also introduced.
Danish: Der blev også indført en underoverskrift om fertilitet.
English: Overall summary of the scientific evaluation of Arimidex
Danish: Samlet resumé af den videnskabelige vurdering af Arimidex
English: Long-term safety data in children and adolescents are not available.
Danish: Der foreligger ingen data vedrørende sikkerheden på langt sigt hos børn og unge.
English: The remaining 10 countries do not currently have wording to this effect.
Danish: De resterende 10 lande har i øjeblikket ingen beskrivelse af denne virkning.
English: General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Danish: Generel støttebehandling, herunder hyppig overvågning af vitale tegn, og tæt observation af patienten er indiceret.
English: The active substance is stable under the conditions specified in the dossier.
Danish: Det aktive stof er stabilt under de forhold, som er anført i dossieret.
English: There is no specific antidote to overdose and treatment must be symptomatic.
Danish: Der findes ingen specifik antidot mod overdosering, og behandlingen skal være symptomatisk.
English: Treatment should be based on a benefit-risk evaluation for the individual patient.
Danish: Behandlingen skal baseres på en vurdering af fordele og risici for den enkelte patient.
English: The indications were essentially the same but worded differently in the various countries.
Danish: Indikationerne var i al væsentlighed de samme, men formuleret forskelligt i de forskellige lande.
English: The list of manufacturers in the harmonised version of the dossier has been updated and the sites no longer in use have not been included.
Danish: Listen over fremstillere i den harmoniserede udgave af dossieret er opdateret, og de centre, som ikke længere er i brug, er ikke inkluderet.
English: Section 4.5 Interaction with other medicinal products and other forms of interaction
Danish: Punkt 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: This product contains lactose.
Danish: Dette lægemiddel indeholder lactose.
English: Arimidex tablets are very stable under the conditions recommended in the product information, i.e. “store under 30°C”
Danish: Arimidex-tabletter er meget stabile under de forhold, der anbefales i produktinformationen, dvs. ”opbevares ved temperaturer under 30 °C”.
English: The majority of the Member States currently have the same wording or wording within the same meaning with respect of this indication.
Danish: De fleste af medlemsstaterne har i øjeblikket den samme formulering eller en formulering med samme betydning med hensyn til denne indikation.
English: Section 4.6 Fertility, pregnancy and lactation
Danish: Punkt 4.6 Fertilitet, graviditet og amning
English: The Committee considered that most of the contraindications proposed were not appropriate as such, given that they reflected the lack of relevant data rather than absolute contraindications.
Danish: Udvalget var af den opfattelse, at de fleste af de foreslåede kontraindikationer ikke var relevante som sådan, da de afspejlede manglen på relevante data, mere end de var absolutte kontraindikationer.
English: Anastrozole inhibits CYPs 1A2, 2C8/9 and 3A4 in vitro.
Danish: Anastrozol hæmmer CYP 1A2, 2C8/9 og 3A4 in vitro.
English: In the management of an overdose, consideration should be given to the possibility that multiple agents may have been taken.
Danish: Ved behandling af en overdosis skal man overveje muligheden for, at der er blevet taget flere lægemidler.
English: Section 4.9 Overdose
Danish: Punkt 4.9 Overdosering
English: The effect of potent CYP inhibitors is unknown.
Danish: Virkningen af potente CYP-hæmmere er ukendt.
English: Specifications
Danish: Specifikationer
English: Other changes were introduced in the description of the clinical trials supporting the indication to clarify and streamline the information for the prescriber.
Danish: Der blev indført andre ændringer i beskrivelsen af de kliniske undersøgelser, som understøtter indikationen, for at tydeliggøre og strømline informationen til den ordinerende læge.
English: There is limited clinical experience of accidental overdose.
Danish: Der er begrænset klinisk erfaring med utilsigtet overdosering.
English: Patients presenting with confirmed coronary disease or risk factors should undergo lipid monitoring and should be treated according to the guidelines in force'.
Danish: Patienter, som præsenterer sig med bekræftet koronarsygdom eller risikofaktorer forbundet hermed, bør gennemgå lipidmonitorering og bør behandles i henhold til gældende retningslinjer".
English: This was accepted but may need to be revised in the future as a consequence of an ongoing procedure under Art. 45 of Regulation 1901/2006 as amended specifically to assess this data.
Danish: Dette blev accepteret, men det kan blive nødvendigt at revidere det i fremtiden som følge af en løbende procedure i henhold til artikel 45 i forordning 1901/2006 med senere ændringer, som specifikt skal vurdere disse data.
English: One of the main inclusion criteria for this study was histologically proven operable invasive breast cancer.
Danish: Et af hovedinklusionskriterierne til denne undersøgelse var histologisk påvist, operabel invasiv brystcancer.
English: The CHMP considered also that a summary of the safety profile needed to be included in the beginning of the section in accordance to the SPC guideline.
Danish: CHMP vurderede også, at der skulle inkluderes et resumé af sikkerhedsprofilen i starten af afsnittet i overensstemmelse med produktresumévejledningen.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product,the European Commission notified the CHMP/European Medicines Agency of an official referral under Article 30 of Directive 2001/83/EC as amended, in order to resolve divergences amongst the nationally authorised SPCs and thus to harmonise its divergent SPCs across the EU.
Danish: På grund af de forskellige nationale beslutninger i medlemsstaterne vedrørende godkendelse af førnævnte lægemiddel indgav Europa-Kommissionen meddelelse til CHMP/EMA om en officiel indbringelse i henhold til artikel 30 i direktiv 2001/83/EF med senere ændringer for at løse divergenser mellem de nationalt godkendte produktresuméer og dermed harmonisere de divergerende produktresuméer i EU.
English: The drug product specification complies with all relevant guidelines and standards.
Danish: Lægemiddelspecifikationen følger alle relevante retningslinjer og standarder.
English: In a small number of countries the indication includes reference to the reduction in incidence of contra lateral breast cancer, based on a secondary endpoint of the previously mentioned ATAC study.
Danish: I et lille antal lande omfatter indikationen en henvisning til reduktion i forekomsten af kontralateral brystcancer, som er baseret på et sekundært endpoint i den tidligere nævnte ATAC-undersøgelse.
English: Clinical aspects
Danish: Kliniske aspekter
English: The majority of the European countries had identical wording included in this section.
Danish: De fleste europæiske lande havde en identisk formulering i dette afsnit.
English: Arimidex is contraindicated in:
Danish: Arimidex er kontraindiceret til:
English: Hypersensitivity to lactose
Danish: Overfølsomhed over for lactose
English: Stability data from production scale batches of the active substance and drug product which was already approved in some member states was presented.
Danish: Der blev fremlagt stabilitetsdata fra batch i produktionsstørrelse af det aktive stof og lægemiddel, som allerede er godkendt i nogle medlemsstater.
English: Quality aspects
Danish: Kvalitetsaspekter
English: Section 4.4 Special warnings and precautions for use
Danish: Punkt 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: A single dose of Arimidex that results in life-threatening symptoms has not been established.
Danish: En enkelt dosis Arimidex, der resulterer i livstruende symptomer, er ikke fastlagt.
English: The menopause should be defined biochemically (luteinizing-hormone [LH], follicle stimulating hormone [FSH], and/or estradiol levels) in any patient where there is doubt about menopausal status.
Danish: Menopausen bør defineres biokemisk (niveauer af luteiniserende hormon [LH], follikelstimulerende hormon [FSH] og/eller østradiol) hos alle patienter, hvor der er tvivl om menopausal status.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapps lactasemangel eller glucose/galactosemalabsorption bør ikke anvende dette lægemiddel.
English: Arimidex (anastrozole) is a highly selective non-steroidal aromatase inhibitor.
Danish: Arimidex (anastrozol) er en kraftigt selektiv, non-steroid aromatasehæmmer.
English: The Committee considered that available study results and current scientific knowledge allow for more detailed and informative wording on the potential for cytochrome P450 interactions.
Danish: Udvalget vurderede, at foreliggende undersøgelsesresultater og den aktuelle videnskabelige viden tillader en mere detaljeret og informativ ordlyd vedrørende de potentielle cytochrom P450interaktioner.
English: Efficacy has not been demonstrated in estrogen receptor-negative patients unless they had a previous positive clinical response to tamoxifen.
Danish: Virkning er ikke påvist hos østrogenreceptornegative patienter, medmindre de tidligere har haft positiv klinisk respons på tamoxifen.
English: Vomiting may be induced if the patient is alert.
Danish: Der kan fremkaldes opkastning, hvis patienten er ved fuld bevidsthed.
English: The inclusion of the term ‘invasive' is supported by data from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) study in which 9366 patients were evaluated from 381 centres worldwide (3125 randomised to anastrozole 1 mg alone, 3116 randomised to tamoxifen 20 mg alone and 3125 randomised to anastrozole plus tamoxifen).
Danish: Inklusion af termen "invasiv" understøttes af data fra ATAC-undersøgelsen (Arimidex, Tamoxifen, alene eller i kombination), hvor 9 366 patienter fra 381 centre over hele verden blev evalueret (3 125 randomiseret til anastrozol 1 mg alene, 3 116 randomiseret til tamoxifen 20 mg alene og 3 125 randomiseret til anastrozol plus tamoxifen).
English: The active substance specification complies with all relevant guidelines and standards.
Danish: Specifikationen af det aktive stof følger alle relevante retningslinjer og standarder.
English: In animal studies, anastrozole demonstrated low acute toxicity.
Danish: I dyreforsøg viste anastrozol lav akut toksicitet.
English: Given that cimetidine is currently known to be a weak, unspecific cytochrome P450 inhibitor, it was considered more relevant to include reference to existing data on warfarin.
Danish: Da cimetidin i øjeblikket vides at være en svag, uspecifik cytochrom P450-hæmmer, ansås det for mere relevant at inkludere en henvisning til eksisterende data om warfarin.
English: Dialysis may be helpful because Arimidex is not highly protein bound.
Danish: Dialyse kan være nyttig, da Arimidex ikke bindes til protein i høj grad.
English: Treatment or prophylaxis for osteoporosis should be initiated as appropriate and carefully monitored.
Danish: Behandling eller profylakse af osteoporose skal igangsættes efter behov og omhyggeligt monitoreres.
English: As mentioned above, the wording of this paragraph may need to be revised in the future as a consequence of an ongoing procedure under Art. 45 of Regulation 1901/2006 as amended specifically to assess this set of paediatric data.
Danish: Som nævnt ovenfor kan det blive nødvendigt at revidere ordlyden af dette afsnit i fremtiden som følge af en løbende procedure i henhold til artikel 45 i forordning 1901/2006 med senere ændringer, som specifikt skal vurdere dette sæt pædiatriske data.
English: The proposed indication is supported by a phase III trial (Austrian Breast and Colorectal Cancer Study Group [ABCSG] 8) conducted in postmenopausal women with hormone receptor positive early breast cancer.
Danish: Den foreslåede indikation understøttes af en fase III-undersøgelse (østrigsk undersøgelsesgruppe for bryst- og kolorektalcancer [ABCSG] 8), som er udført hos postmenopausale kvinder med tidlig hormonreceptorpositiv brystcancer.
English: Arimidex should not be used in premenopausal women.
Danish: Arimidex bør ikke anvendes til præmenopausale kvinder.
English: Patients who switched to Arimidex after 2 years of adjuvant treatment with tamoxifen had a significant improvement in disease free survival compared to patients who remained on tamoxifen.
Danish: Patienter, som skiftede til Arimidex efter 2 års adjuverende behandling med tamoxifen, havde en signifikant forbedring i sygdomsfri overlevelse sammenlignet med patienter, som forblev på tamoxifen.
English: In addition, the Committee considered that the contraindication would be more appropriate for breastfeeding women rather than lactating women.
Danish: Desuden mente udvalget, at kontraindikationen ville være mere relevant for ammende kvinder end for lakterende kvinder.
English: Estrone is subsequently converted to estradiol.
Danish: Østron omdannes efterfølgende til østradiol.
English: Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer.
Danish: Reduktion af østradiolniveauer i blodet har en påvist gavnlig virkning hos kvinder med brystcancer.
English: ‘Premenopausal women' and ‘patients with concomitant tamoxifen therapy' were deleted from this section and information moved to section 4.4.
Danish: "Præmenopausale kvinder" og "patienter med samtidig tamoxifenbehandling" blev slettet fra dette punkt og oplysningerne flyttet til pkt.
English: Section 4.1 Therapeutic indications
Danish: Punkt 4.1 Terapeutiske indikationer
English: Therefore, the CHMP concluded that the lack of data in moderate to severe hepatic impairment should be highlighted, but that considering the fact that the product is a potentially life-saving treatment, a warning rather than a contraindication was appropriate.
Danish: Derfor konkluderede CHMP, at manglen på data ved moderat til svært nedsat leverfunktion skal påpeges, men i betragtning af, at lægemidlet er en potentielt livreddende behandling, var det relevant med en advarsel snarere end en kontraindikation.
English: Arimidex has no or negligible influence on the ability to drive and use machines.
Danish: Arimidex påvirker ikke eller i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: However, CHMP considered that this could be misinterpreted as implying an effect in hormone receptor negative patients, when in fact it merely reflects the inclusion criteria of clinical studies.
Danish: CHMP vurderede dog, at dette kunne misfortolkes som en antydning af virkning hos hormonreceptornegative patienter, selvom teksten faktisk kun afspejler inklusionskriterierne i kliniske undersøgelser.
English: The wording on posology did not differ significantly across Member States, but recommendations on use in renal and hepatic impairment were not harmonised.
Danish: Ordlyden vedrørende dosering var ikke signifikant forskellig i medlemsstaterne, men anbefalinger vedrørende anvendelse hos patienter med nedsat nyre- og leverfunktion var ikke harmoniseret.
English: There were no clinically significant interactions with bisphosphonates (see section 5.1).
Danish: Der var ingen klinisk signifikante interaktioner med bisfosfonater (se pkt.
English: The MAH presented a proposal for section 4.3 which was based on the currently existing contraindications in the different countries.
Danish: 4.3, som var baseret på de nuværende kontraindikationer i de forskellige lande.
English: In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues.
Danish: Hos postmenopausale kvinder produceres østradiol primært ved omdannelse af androstenedion til østron via aromataseenzymkomplekset i perifere væv.
English: Cimetidine, a weak, unspecific inhibitor of CYP enzymes, did not affect the plasma concentrations of anastrozole.
Danish: Cimetidin, som er en svag, uspecifik hæmmer af CYP-enzymer, påvirkede ikke plasmakoncentrationerne af anastrozol.
English: Women with osteoporosis or at risk of osteoporosis, should have their bone mineral density formally assessed at the commencement of treatment and at regular intervals thereafter.
Danish: Kvinder med osteoporose eller med risiko for osteoporose bør gennemgå en formel vurdering af deres knoglemineraldensitet ved behandlingens begyndelse og med regelmæssige intervaller derefter.
English: However, asthenia and somnolence have been reported with the use of Arimidex and caution should be observed when driving or operating machinery while such symptoms persist.
Danish: Der foreligger dog indberetninger om asteni og somnolens i forbindelse med anvendelse af Arimidex, og der bør udvises forsigtighed ved kørsel eller arbejde med maskiner, hvis sådanne symptomer varer ved.
English: The effects of Arimidex on fertility in humans have not been studied.
Danish: Arimidex' virkning på fertiliteten hos mennesker er ikke undersøgt.
English: The active substance specification has been harmonised and includes the following tests: description, identification, clarity of solution, sulphated ash, water content, strength, related substances, residual solvent, heavy metals, specific surface area and microscopy.
Danish: Specifikationen af det aktive stof er harmoniseret og inkluderer følgende test: beskrivelse, identifikation, klarhed af opløsning, sulfataske, vandindhold, styrke, relaterede stoffer, restsolvent, tungmetaller, specifikt overfladeareal og mikroskopi.
English: In most countries the SPCs contained only a contraindication for the use of anastrazole in pregnancy and lactation with no additional information.
Danish: I de fleste lande indeholder produktresuméet kun en kontraindikation til anvendelse af anastrazol under graviditet og amning og ikke yderligere oplysninger.
English: The drug product specification has been harmonised and includes the following tests: description, average weight, identity, dissolution, content, uniformity of content, water content, degradation products, identification of titanium dioxide and microbial quality.
Danish: Lægemiddelspecifikationen er harmoniseret og inkluderer følgende test: beskrivelse, gennemsnitsvægt, identitet, opløsning, indhold, indholdets ensartethed, vandindhold, nedbrydningsprodukter, identifikation af titandioxid og mikrobiel kvalitet.
English: The CHMP noted that the MAH did not suggest its inclusion as part of the harmonised indication, and agreed to this.
Danish: CHMP bemærkede, at indehaveren af markedsføringstilladelsen ikke foreslog, at den blev inkluderet i den harmoniserede indikation, og erklærede sig enig.
English: Section 4.3 Contraindications
Danish: Punkt 4.3 Kontraindikationer
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Danish: I en klinisk pivotalundersøgelse blev virkningen ikke påvist, og sikkerheden ikke klarlagt (se pkt.