FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Million Women Study, taking 5 years of HRT tibolone resulted in 1 extra case per 2500 users (see Section 4.4).
Danish: I Million Women-studiet resulterede 5 års HRT tibolon-behandling i 1 yderligere tilfælde pr. 2.500 brugere (se pkt.
English: This study showed that the relative risk for ovarian cancer with tibolone was similar to the risk with other types of HRT.
Danish: I henhold til dette studie svarer den relative risiko for ovariecancer ved brug af tibolon til den risiko, der er forbundet med brug af andre typer HRT.
English: Package Leaflet 2.
Danish: Produktresumé, pkt.
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Danish: Epidemiologisk evidens fra en omfattende meta-analyse tyder på, at risikoen er let forhøjet hos kvinder, der tager HRT med østrogen alene eller med kombineret østrogen og gestagen.
English: It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4).
Danish: Det er vigtigt at være opmærksom på, at adhæsion kan forekomme, hvis det tilstødende væv ikke rengøres omhyggeligt (se pkt.
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8).
Danish: Langvarig brug (mindst 5-10 år) af HRT-produkter med østrogen alene er blevet forbundet med en let forhøjet risiko for ovariecancer (se pkt.
English: With use of X, the increased risk of ovarian cancer is similar to other types of HRT.
Danish: Den forhøjede risiko for kræft i æggestokkene ved brug af X svarer til risikoen ved brug af andre typer HRT.
English: For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21,000 users (i.e. about up to 1 extra case).
Danish: Blandt kvinder, som har taget HRT i 5 år, vil der være mellem 2 og ca. 3 tilfælde pr. 21.000 brugere (dvs. ca. op til 1 yderligere tilfælde).
English: Some other studies, including the Women's Health Initiative (WHI) trial, suggest that the longterm use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Danish: Visse andre studier, herunder Women's Health Initiative-studiet (WHI-studiet), tyder på, at langvarig brug af kombinerede HRT-præparater kan give være forbundet med en tilsvarende eller lidt mindre risiko (se pkt.
English: Bowel obstruction and pain following abdominal surgeries can also occur.
Danish: Der kan også forekomme smerter og blokering af tarmene efter et operativt indgreb i maveregionen.
English: In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Danish: I Million Women-studiet resulterede 5 års HRT-behandling i 1 yderligere tilfælde pr. 2 500 brugere.
English: In the Million Women Study For women aged 50 to 54 years taking 5 years of HRT, this resultsed in about 1 extra case per 2,5000 users.
Danish: I Million Women-studiet For kvinder i alderen 50-54 år, der har taget resulterede HRT i 5 år, svarer det til ca. 1 yderligere tilfælde pr. 2 5000 brugere.
English: Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).
Danish: Visse andre studier, herunder WHI-studiet, tyder på, at brug af kombinerede HRT-præparater kan være forbundet med en tilsvarende eller lidt mindre risiko (se pkt.
English: For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21000 users (i.e. up to about 1 extra case).
Danish: Blandt kvinder, som har taget HRT i 5 år, vil der være mellem 2-ca. 3 tilfælde for hver 2.000 brugere (dvs. op til ca. 1 yderligere tilfælde).
English: Gastrointestinal disorders:
Danish: Mave-tarm-kanalen:
English: Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Danish: Epidemiologisk evidens fra en omfattende meta-analyse tyder på, at risikoen er let forhøjet hos kvinder, der tager HRT med østrogen alene.
English: Some other studies, including the WHI trial, suggest that the long-term use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Danish: Visse andre studier, herunder WHI-studiet, tyder på, at langvarig brug af kombinerede HRTpræparater kan give være forbundet med en lignende eller lidt mindre risiko (se pkt.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Danish: For kvinder i alderen 50-54 år, der har taget HRT i 5 år, svarer det til ca. 1 yderligere tilfælde pr. 2.000 brugere.
English: The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.
Danish: HRT-behandling med østrogen alene eller med kombineret østrogen og gestagen er blevet forbundet med en let øget risiko for kræft i æggestokkene.
English: Cleanse surgical instruments, or gloves and adjacent tissues, if necessary.
Danish: Rengør de kirurgiske instrumenter, og handskerne og det tilstødende væv, hvis det er nødvendigt, da TachoSil kan klæbe til disse, hvis de er dækket af blod.
English: SmPC section 4.4: Special warnings and precautions for use Ovarian cancer
Danish: 4.8: Bivirkninger Ovariecancer
English: Long-term uUse of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Danish: Langvarig bHRT-behandling med østrogen alene er blevet associeret med en let øget risiko for at få ovariecancer (se pkt.
English: For example, in women aged 50 to 5469 who are not taking HRT, on average about 2 women in 21,000 will be diagnosed with ovarian cancer over a 5year period.
Danish: Eksempel: Blandt Kkvinder i alderen 50-5469 år, som ikke tager HRT, diagnosticeres i gennemsnit kræft i æggestokkene hos ca. 2 ud af 2.000 kvinder i løbet af en periode på 5 år.
English: In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Danish: Blandt kvinder i alderen 50-54 år, som ikke tager HRT, diagnosticeres ovariecancer hos ca. 2 ud af 2.000 kvinder i løbet af en periode på 5 år.
English: Long-term uUse of oestrogen-only and or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Danish: Langvarig bHRT-behandling med østrogen alene og eller med kombineret østrogen og gestagen har været associeret med en let forhøjet risiko for at få ovariecancer (se pkt.
English: For example, in Wwomen aged 50 to 5469 who are not taking HRT, on average about 2 women in 21000 will be diagnosed with ovarian cancer over a 5year period.
Danish: Sammenlign med kvinder i alderen 50-5469 år, som ikke tager HRT, diagnosticeres kræft i æggestokkene hos ca. 2 ud af 2.000 kvinder i løbet af en periode på 5 år.
English: Inactivated Rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ≥70% cELISA40* (*) ≥=70% of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Danish: --1 Inaktiveret kanin hæmoragisk lidelse type 2 virus (RHDV2), stamme V-1037: ≥70% cELISA40* (*) ≥70 % af de vaccinerede kaniner skal opnå en cELISA-antistoftiter på mindst 40.
English: Vial (glass) 0.5 ml (1 dose)
Danish: 0,5 ml (1 dosis)
English: 10 vials Zero days
Danish: 0 dage
English: Target species
Danish: Hætteglas
English: • if they drink alcohol
Danish: • hvis man drikker alkohol
English: Then continue your treatment as before.
Danish: Fortsæt herefter behandlingen som før.
English: The mechanism for the decrease is unknown.
Danish: Mekanismen bag denne reduktion er ukendt.
English: • if they are overweight.
Danish: • hvis man er overvægtig.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk observeret inden for de første få uger eller måneder efter indledning af CART.
English: • if they have been taking combination therapy for a long time
Danish: • hvis man har fået kombinationsbehandling i lang tid
English: → Tell your doctor immediately.
Danish:  Gå til lægen straks.
English: 50 to <200 200 to <350
Danish: 50 til < 200 200 til < 350
English: People may be more likely to get this condition:
Danish: Man har større risiko for at få denne tilstand:
English: Keep the bottle tightly closed.
Danish: Hold beholderen tæt lukket.
English: Symptoms usually include fever, plus some of the following:
Danish: Symptomer involverer som regel feber, samt nogle af følgende:
English: → Don't drive or operate machinery unless you are sure you're not affected.
Danish:  Du må ikke føre motorkøretøjer eller betjene maskiner, medmindre du er sikker på, at du ikke er påvirket.
English: Such infections may have been “silent” and not detected by the weak immune system before treatment was started.
Danish: Sådanne infektioner kan have været 'stille' og ikke opdaget af det svage immunsystem inden behandlingen blev startet.
English: OSS=0 OSS=1 OSS=2 OSS>2 Total
Danish: OSS = 0 OSS = 1 OSS = 2 OSS > 2 Samlet Samlet
English: There were no new target organs identified in juveniles compared to adults.
Danish: Der blev ikke identificeret nye målorganer hos unge sammenlignet med voksne.
English: **see below under Description of selected adverse reactions.
Danish: **Se nedenfor under 'Beskrivelse af udvalgte bivirkninger'.
English: Resistance in vivo
Danish: Resistens in vivo
English: Like all medicines, this medicine can cause side effects, but not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Creatinine increases were comparable by various background regimens.
Danish: Stigningerne i kreatininniveau var sammenlignelige med adskillige baggrundsregimer.
English: • weakness beginning in the hands and feet and moving up towards the trunk of the body.
Danish: • svaghed, der starter i hænderne og fødderne og efterfølgende bevæger sig ind mod kropsstammen.
English: Virologic non-response†
Danish: Virologisk non-respons†
English: Baseline parameters
Danish: Baseline parametre
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Danish: Symptomerne på autoimmune forstyrrelser kan udvikle sig mange måneder efter, at du er startet med at tage medicin til behandling af din hiv-infektion.
English: Tivicay can be taken with or without food.
Danish: Tivicay kan tages med eller uden mad.
English: If you miss a dose, take it as soon as you remember.
Danish: Hvis du glemmer en dosis, skal du tage den, så snart du kommer i tanke om det.
English: To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.
Danish: For at kontrollere din hiv-infektion og for at forhindre din sygdom i at blive værre, skal du blive ved med at tage alle dine lægemidler, medmindre lægen foreskriver andet.
English: Gender Male Female Race White African-America/African Heritage/Other Age (years)
Danish: Køn Mand Kvinde Race Hvid Afroamerikansk/afrikansk oprindelse/andre Alder (år)
English: When Tivicay is taken twice a day, your doctor may advise you to take with food.
Danish: Når Tivicay tages 2 gange daglig, kan lægen anbefale dig at tage det med mad.
English: At week 96, results were consistent with those seen at week 48.
Danish: Resultaterne ved uge 96 var konsistente med resultaterne ved uge 48.
English: After the functional monotherapy phase, subjects had the opportunity to re-optimize their background regimen when possible.
Danish: Efter fasen med funktionel monoterapi havde personerne lejlighed til på ny at få optimeret deres baggrundsregime, når det var muligt.
English: • if their immune systems are very weak
Danish: • hvis ens immunforsvar er meget svækket
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR
Danish: Extremadura 3, 09400 Aranda De Duero, Burgos, Spanien Eller
English: This antiviral response was maintained for 3 to 4 days after the last dose in the 50 mg group.
Danish: Denne antivirale respons blev opretholdt i 3-4 dage efter administration af den sidste dosis hos 50 mg-gruppen.
English: → Read the information in Section 4 of this leaflet.
Danish:  Læs oplysningerne under punkt 4 i denne indlægsseddel.
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 2.
Danish: Påviste og teoretiske interaktioner med udvalgte antiretrovirale og ikke-antiretrovirale lægemidler er anført i tabel 2.
English: Resistance in vitro
Danish: Resistens in vitro
English: Table 2: Drug Interactions Medicinal products by therapeutic areas
Danish: Tabel 2: Lægemiddelinteraktioner Lægemidler efter terapeutiske områder
English: Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står efter EXP på kartonen og tabletbeholderen.
English: The R263K mutation was also selected in vitro (see above).
Danish: R263K-mutationen blev også selekteret in vitro (se ovenfor).
English: †Other clades included: Complex (43), F1 (32), A1 (18), BF (14), all others <10.
Danish: †Andre clader omfattede: kompleks (43), F1 (32), A1 (18), BF (14), alle andre < 10.
English: Dolutegravir ↔ (Not studied)
Danish: Dolutegravir  (Ikke undersøgt)
English: • suicide attempt*
Danish: • selvmordsforsøg*
English: Do not discontinue Tivicay without consulting your doctor, as this may harm you and your unborn child.
Danish: Du må ikke ophøre med at tage Tivicay uden først at tale med lægen, da det kan være skadeligt for dig og dit ufødte barn.
English: These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate.
Danish: Disse ændringer anses ikke for at være klinisk relevante, da de ikke afspejler en ændring i den glomerulære filtreringshastighed.
English: ‡ Adjusted mean treatment difference was statistically significant (p<0.001)
Danish: ‡Justeret gennemsnitlig behandlingsforskel var statistisk signifikant (p < 0,001).
English: Excipient(s) with known effect:
Danish: Hjælpestof(fer) med kendt effekt:
English: Date of latest renewal: 21 September 2018
Danish: Dato for første markedsføringstilladelse: 20. januar 2014 Dato for seneste fornyelse: 21. september 2018
English: If overdose occurs, the patient should be treated supportively with appropriate monitoring, as necessary.
Danish: Hvis der sker en overdosering, skal patienten have den nødvendige understøttende behandling med relevant monitorering.
English: Based on data from other CYP3A4 inhibitors, a marked increase is not expected.
Danish: På basis af data om andre CYP3A4-hæmmere forventes ikke en markant øgning.
English: Approximately one third of the patients were infected with an HIV non-B subtype; these characteristics were similar between treatment groups.
Danish: Omtrent en tredjedel af patienterne var smittet med en hiv non-Bsubtype; disse karakteristika var ens mellem behandlingsgrupper.
English: OSS: combined genotypic and phenotypic resistance (Monogram Biosciences Net Assessment)
Danish: OSS: kombineret genotypisk og fænotypisk resistens (Monogram Biosciences Net Assessment).
English: If you are pregnant, if you become pregnant, or if you are planning to have a baby:
Danish: Hvis du er gravid, bliver gravid eller planlægger at blive gravid:
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion spredes ved seksuel kontakt med en person, der har infektionen, eller ved overførsel af inficeret blod (f.eks. ved at dele injektionsnåle med andre).
English: Increases in serum creatinine occurred within the first week of treatment with dolutegravir and remained stable through 48 weeks.
Danish: Niveauet af serumkreatinin steg i løbet af den første uge af behandlingen med dolutegravir, og det forblev stabilt igennem 48 uger.
English: • liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
Danish: • leversvigt (tegn kan omfatte gulfarvning af huden og det hvide i øjnene eller usædvanlig mørk urin)
English: Dolutegravir is highly bound (>99%) to human plasma proteins based on in vitro data.
Danish: Dolutegravir er i høj grad bundet (> 99 %) til humane plasmaproteiner baseret på in vitro-data.
English: 1 Historical or phenotypic evidence of INI resistance only.
Danish: 1 Historisk eller fænotypisk påvisning af kun IN-resistens.
English: Recommendations concerning co-administration
Danish: Anbefalinger vedrørende samtidig administration
English: The response was lower when the Q148-mutation was present at baseline, and in particular in the presence of ≥2 secondary mutations, Table 8.
Danish: Responset var lavere, når Q148-mutationen var til stede ved baseline, og særligt ved tilstedeværelsen af ≥ 2 sekundære mutationer, tabel 8.
English: • increase in the level of enzymes produced in the muscles (creatine phosphokinase).
Danish: • øget niveau af enzymer, der dannes i musklerne (kreatinkinase).
English: If you notice any of these symptoms: → Tell your doctor.
Danish: Hvis du bemærker nogen af disse symptomer:  Fortæl det til lægen.
English: Primary mutation other than
Danish: Primær mutation forskellig fra
English: Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Tivicay helbreder ikke hiv-infektion, men det nedsætter mængden af virus i kroppen og holder antallet på et lavt niveau.
English: Median Change from Baseline, cells/mm3
Danish: Median ændring fra baseline, celler/mm3
English: With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
Danish: Denne tilstand medfører, at dele af knoglevævet dør på grund af nedsat blodtilførsel til knoglerne.
English: Children 6 to less than 12 years of age
Danish: Børn fra 6 år op til 12 år
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Danish: Bivirkningernes hyppighed er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000).
English: Due to the potential risk of neural tube defects, dolutegravir should not be used during the first trimester unless there is no alternative.
Danish: På grund af den potentielle risiko for neuralrørsdefekter med dolutegravir, bør dolutegravir ikke anvendes i det første trimester, medmindre der ikke findes andre muligheder.
English: Food increased the extent and slowed the rate of absorption of dolutegravir.
Danish: Mad øgede omfanget og nedsatte hastigheden af absorption af dolutegravir.
English: Total blood and plasma drug-related radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Danish: Forholdet mellem den samlede koncentration af lægemiddelrelateret radioaktivitet i blod og plasma lå i gennemsnit fra 0,441 til 0,535, hvilket tyder på minimal association af radioaktivitet med cellulære blodkomponenter.
English: Five further subjects experienced PDVF between weeks 24 and 48, and 2 of these 5 had treatment emergent mutations.
Danish: Yderligere fem patienter oplevede PDVS mellem uge 24 og 48 og hos to af disse fem opstod der mutationer under behandlingen.
English: These are uncommon in people taking Tivicay.
Danish: Disse er ”ikke almindelige” hos personer, der tager Tivicay.
English: Dolutegravir is present in cerebrospinal fluid (CSF).
Danish: Dolutegravir er til stede i cerebrospinalvæsken (CSF).
English: The day 8 responses in this placebo controlled study were fully in line with those seen in VIKING-3 (not placebo controlled), including by baseline integrase resistance categories.
Danish: De reaktioner, der blev set dag 8 i dette placebokontrollerede studie var fuldt i overensstemmelse med dem set i VIKING-3 (ikke placebokontrolleret), inkluderet pr. baseline integraseresistens-kategorier.
English: Tivicay can also affect how some other medicines work.
Danish: Tivicay kan også påvirke virkningen af andre lægemidler.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release GLAXO WELLCOME, S.A., Avda.
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse GLAXO WELLCOME, S.A., Avda.
English: For the comparator arms, the same lack of treatment emergent resistance was also the case for patients treated with darunavir/r in FLAMINGO.
Danish: I sammenligningsgrupperne var den samme mangel på behandlingsrelateret resistens også tilfældet for patienter behandlet med darunavir/r i FLAMINGO.
English: A mean change from baseline of 9.96 µmol/L was observed after 48 weeks of treatment.
Danish: Der blev observeret en gennemsnitlig ændring i forhold til baseline på 9,96 mol/l efter 48 ugers behandling.
English: Oral contraceptives Ethinyl estradiol (EE) and Norelgestromin (NGMN)
Danish: Orale kontraceptiva Ethinylestradiol (EE) og norgestromin (NGMN)
English: • rifampicin, to treat tuberculosis (TB) and other bacterial infections
Danish: • rifampicin, til behandling af tuberkulose (TB) og andre bakterieinfektioner.
English: Adolescents aged 12 and above
Danish: Unge fra 12 år og derover
English: Dolutegravir is rapidly absorbed following oral administration, with median Tmax at 2 to 3 hours post dose for tablet formulation.
Danish: Dolutegravir absorberes hurtigt efter oral administration, med en median Tmax på 2-3 timer efter dosering for tabletformulering.
English: There is currently limited experience with overdosage in dolutegravir.
Danish: Der er på nuværende tidspunkt begrænset erfaring med overdosering af dolutegravir.
English: The linearity of dolutegravir pharmacokinetics is dependent on dose and formulation.
Danish: Lineariteten af dolutegravirs farmakokinetik afhænger af dosis og formulering.
English: There are limited data available on the use of dolutegravir in patients aged 65 years and over.
Danish: Der er begrænset data om anvendelse af dolutegravir hos patienter på 65 år og derover.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer bør vurderes, og behandling indledes efter behov.
English: Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay.
Danish: Lægen kan beslutte at foretage undersøgelser af din lever, dine nyrer eller dit blod, og vil måske bede dig om at stoppe med at tage Tivicay.
English: Tivicay is always used in combination with other anti-retroviral medicines (combination therapy).
Danish: Tivicay anvendes altid i kombination med andre antiretrovirale lægemidler (kombinationsbehandling).
English: These increases may be clinically relevant in the presence of certain integrase class resistance.
Danish: Disse stigninger kan være klinisk relevante ved tilstedeværelse af resistens over for visse integrasehæmmere.
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Danish: Der er ingen tegn på, at ældre patienter har behov for en anden dosis end yngre voksne patienter (se pkt.
English: Week 48 (N=160)
Danish: Uge 48 (N = 160)
English: Table 9 Virologic (Snapshot algorithm) and Immunologic Activity of Treatment for Subjects 6 Years and Older in P1093
Danish: Tabel 9 Virologisk (snapshot algoritme) og immunologisk aktivitet af behandling af patienter fra 6 år og derover i P1093
English: Iron supplements
Danish: Jerntilskud