FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Atazanavir Krka are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Atazanavir Krka vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: This means that Atazanavir Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Reyataz.
Danish: Det betyder, at Atazanavir Krka indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i EU, og som hedder Reyataz.
English: For more information about using Atazanavir Krka, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Atazanavir Krka, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: What measures are being taken to ensure the safe and effective use of Atazanavir Krka?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Atazanavir Krka?
English: Atazanavir Krka is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Danish: Atazanavir Krka er et lægemiddel til behandling af patienter, der er smittet med humant immundefektvirus type 1 (hiv-1), som er årsag til erhvervet immundefektsyndrom (aids).
English: Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection.
Danish: Når enzymet blokeres, kan virusset ikke formere sig, og dermed forsinkes spredningen af infektionen.
English: Atazanavir Krka is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Danish: Atazanavir Krka gives normalt sammen med ritonavir for at forstærke dets virkning, men lægerne kan overveje at stoppe behandlingen med ritonavir hos voksne i visse tilfælde.
English: Atazanavir Krka, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Danish: Når Atazanavir Krka tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet og holdes på et lavt niveau.
English: Atazanavir Krka contains the active substance atazanavir and is a ‘generic medicine'.
Danish: Atazanavir Krka indeholder det aktive stof atazanavir og er et "generisk lægemiddel".
English: As for all medicines, data on the use of Atazanavir Krka are continuously monitored.
Danish: Som for alle lægemidler er data vedrørende brug af Atazanavir Krka løbende overvåget.
English: Because Atazanavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Atazanavir Krka er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: An overview of Atazanavir Krka and why it is authorised in the EU
Danish: Oversigt over Atazanavir Krka, og hvorfor det er godkendt i EU
English: Ritonavir slows down the break-down of atazanavir, increasing the levels of atazanavir in the blood.
Danish: Ritonavir forsinker nedbrydningen af atazanavir, og dermed øges koncentrationen af atazanavir i blodet.
English: Therefore, the Agency's view was that, as for Reyataz, the benefit of Atazanavir Krka outweighs the identified risk and it can be authorised for use in the EU.
Danish: Det var derfor agenturets opfattelse, at fordelene af Atazanavir Krka opvejer de identificerede risici, som for Reyataz, og at det kan godkendes til anvendelse i EU.
English: Doctors should prescribe Atazanavir Krka only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Krka.
Danish: Inden Atazanavir Krka ordineres til en patient, bør lægen først undersøge, hvilke lægemidler patienten i øvrigt har taget, og foretage test for at fastslå, om det er sandsynligt, at virusset vil respondere på Atazanavir Krka.
English: Other information about Atazanavir Krka
Danish: Andre oplysninger om Atazanavir Krka
English: The active substance in Atazanavir Krka, atazanavir, is a protease inhibitor.
Danish: Det aktive stof i Atazanavir Krka, atazanavir, er en proteasehæmmer.
English: What are the benefits and risks of Atazanavir Krka?
Danish: Hvilken fordel og risiko er der forbundet med Atazanavir Krka?
English: Why is Atazanavir Krka authorised in the EU?
Danish: Hvorfor blev Atazanavir Krka godkendt i EU?
English: What is Atazanavir Krka and what is it used for?
Danish: Hvad er Atazanavir Krka, og hvad anvendes det til?
English: In younger patients, the dose of Atazanavir Krka depends on body weight.
Danish: Atazanavir Krka-dosen til yngre patienter afhænger af deres kropsvægt.
English: Atazanavir Krka does not cure HIV infection or AIDS but, when used in combination with other antivirals, it holds off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Det helbreder ikke hivinfektion eller aids, men sinker den skade på immunsystemet og udviklingen af de infektioner og sygdomme, der er forbundet med aids, når det anvendes i kombination med andre antivirale lægemidler.
English: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Krka 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 Atazanavir Krka.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Danish: Atazanavir Krka udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hivinfektion.
English: How is Atazanavir Krka used?
Danish: Hvordan anvendes Atazanavir Krka?
English: How has Atazanavir Krka been studied?
Danish: Hvordan blev Atazanavir Krka undersøgt?
English: How does Atazanavir Krka work?
Danish: Hvordan virker Atazanavir Krka?
English: The medicine should be taken around the same time every day and the need for the oncea-day dosing should be assessed regularly.
Danish: Lægemidlet bør indtages på cirka samme tid hver dag, og behovet for daglig dosering bør vurderes jævnligt.
English: The dose may be increased to 20 mg if the 10 mg dose is not effective.
Danish: Dosen kan øges til 20 mg, hvis 10 mg-dosen ikke er effektiv.
English: Six of the studies included 1,328 patients who took the medicine before sexual activity.
Danish: I seks af undersøgelserne deltog der 1 328 patienter, som tog lægemidlet før seksuel aktivitet.
English: The full EPAR for Tadalafil Lilly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Tadalafil Lilly findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The side effects seen with the medicine are considered manageable.
Danish: De bivirkninger, der er observeret ved dette lægemiddel, vurderes til at være håndterbare.
English: This is a summary of the European public assessment report (EPAR) for Tadalafil Lilly.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Tadalafil Lilly.
English: For erectile dysfunction, the usual dose is 10 mg at least 30 minutes before sexual activity.
Danish: Den sædvanlige dosis til behandling af erektil dysfunktion er 10 mg, som indtages mindst 30 minutter inden seksuel aktivitet.
English: Tadalafil Lilly contains the active substance tadalafil and is the same as Cialis, which is already authorised in the European Union (EU).
Danish: Tadalafil Lilly indeholder det aktive stof tadalafil og er det samme som Cialis, der allerede er godkendt i Den Europæiske Union (EU).
English: The other three studies included 853 patients taking Tadalafil Lilly once a day at doses of 2.5 or 5 mg.
Danish: De andre tre undersøgelser omfattede 853 patienter, der tog Tadalafil Lilly én gang dagligt ved en dosis på 2,5 mg eller 5 mg.
English: The company that makes Cialis has agreed that its scientific data can be used for Tadalafil Lilly (‘informed consent').
Danish: Den virksomhed, som fremstiller Cialis, har indvilget i, at dens videnskabelige oplysninger må anvendes for Tadalafil Lilly (informeret samtykke).
English: It must also not be taken by patients who have ever had loss of vision in one eye because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy, NAION).
Danish: Det må heller ikke tages af patienter, som tidligere har oplevet synstab i et øje forårsaget af et problem med blodtilførslen til nerven i øjet (non-arteritis anterior iskæmisk opticusneuropati (NAION)).
English: Results for one of the questionnaires, in which men rated their condition on a scale of 0 (indicating severe erectile dysfunction) to 30 (no erectile dysfunction), showed that patients improved from about 15 before treatment, to 23 and 25 after treatment with Tadalafil Lilly 10 and 20 mg, respectively.
Danish: Resultaterne for ét af spørgeskemaerne, hvor mændene bedømte deres tilstand på en skala fra 0 (svær grad af erektil dysfunktion) til 30 (ingen erektil dysfunktion), viste, at patienterne oplevede en forbedring fra ca. 15 før behandling til henholdsvis 23 og 25 efter behandling med Tadalafil Lilly 10 mg og 20 mg.
English: Men who intend to use Tadalafil Lilly frequently (twice a week or more) can take a lower dose (5 or 2.5 mg) once a day, based on the doctor's judgement.
Danish: Mænd, der ønsker at bruge Tadalafil Lilly ofte (to eller flere gange om ugen), kan tage en lavere dosis (5 mg eller 2,5 mg) én gang dagligt, afhængigt af lægens skøn.
English: All the studies compared Tadalafil Lilly with placebo (a dummy treatment) and measured improvements using questionnaires completed before and after treatment.
Danish: I alle undersøgelserne blev Tadalafil Lilly sammenlignet med placebo (en uvirksom behandling), og forbedringer blev målt ved hjælp af spørgeskemaer, der blev udfyldt før og efter behandling.
English: In four main studies involving 1,500 patients, some of whom also had erectile dysfunction, patients taking Tadalafil Lilly at a dose of 5 mg had greater reductions in IPSS (4.8 to 6.3 points) after 12 weeks than those taking placebo (2.2 to 4.4 points).
Danish: I fire hovedundersøgelser med 1 500 patienter, hvoraf nogle også havde erektil dysfunktion, oplevede de patienter, der fik en dosis på 5 mg Tadalafil Lilly, større reduktioner på IPSS-skalaen (4,8-6,3 point) efter 12 ugers behandling end dem, der fik placebo (2,2-4,4 point).
English: What measures are being taken to ensure the safe and effective use of Tadalafil Lilly?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Tadalafil Lilly?
English: Tadalafil Lilly must not be taken with nitrates (a type of medicine used for angina) or medicines of the class ‘guanylate cyclase stimulators' such as riociguat (a medicine for high blood pressure in the vessels supplying the lungs, known as pulmonary hypertension).
Danish: Tadalafil Lilly må ikke tages sammen med nitrater (en gruppe af lægemidler, der anvendes til behandling af angina) eller lægemidler i klassen "guanylatcyklasestimulatorer", såsom riociguat (et lægemiddel til behandling af højt blodtryk i de kar, der forsyner lungerne, kendt som pulmonal hypertension).
English: The active substance of Tadalafil Lilly, tadalafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive stof i Tadalafil Lilly tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5 (PDE5)-hæmmere.
English: For more information about treatment with Tadalafil Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Tadalafil Lilly, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What is Tadalafil Lilly and what is it used for?
Danish: Hvad er Tadalafil Lilly, og hvad anvendes det til?
English: The most common side effects with Tadalafil Lilly are headache, indigestion, back pain and muscle pain, which are more common at higher doses.
Danish: De hyppigste bivirkninger ved Tadalafil Lilly er hovedpine, fordøjelsesbesvær, rygsmerter og muskelsmerter, som er mere almindelige ved højere doser.
English: Tadalafil Lilly is available as tablets (2.5, 5, 10 and 20 mg) to be taken by mouth.
Danish: Tadalafil Lilly fås som kapsler (2,5 mg, 5 mg, 10 mg og 20 mg), der tages gennem munden.
English: Tadalafil Lilly has also been shown to improve the symptoms of benign prostatic hyperplasia as measured using the international prostate symptom score (IPSS), which ranges from 0 (no symptoms) to 35 (severe symptoms).
Danish: Det er også påvist, at Tadalafil Lilly forbedrer symptomerne på godartet forstørret blærehalskirtel som bedømt ved brug af den internationale prostatasymptomscore (IPSS), der går fra 0 (ingen symptomer) til 35 (svære symptomer).
English: This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.
Danish: Dette kan reducere problemer med urinstrømmen, som er symptomer på godartet forstørret blærehalskirtel.
English: Results also reported improved erections with Tadalafil Lilly compared with those taking placebo.
Danish: Resultaterne heraf viste også forbedring af erektionerne ved brug af Tadalafil Lilly sammenholdt med placebo.
English: Tadalafil Lilly must not be used in men with certain cardiovascular (heart and blood vessel) conditions or when sexual activity is inadvisable.
Danish: Tadalafil Lilly må ikke anvendes af mænd, der har visse hjerte-kar-problemer, eller når seksuel aktivitet ikke er tilrådeligt.
English: In men with benign prostatic hyperplasia, or both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.
Danish: Hos mænd med godartet forstørret blærehalskirtel eller med både godartet forstørret blærehalskirtel og erektil dysfunktion er den anbefalede dosis 5 mg én gang dagligt.
English: It is not intended to provide practical advice on how to use Tadalafil Lilly.
Danish: Det er ikke en praktisk vejledning i, hvordan Tadalafil Lilly bør anvendes.
English: Tadalafil Lilly is a medicine used to treat men with erectile dysfunction (sometimes called impotence).
Danish: Tadalafil Lilly er et lægemiddel, der anvendes til at behandle erektil dysfunktion (dvs. impotens) hos mænd.
English: Other information about Tadalafil Lilly
Danish: Andre oplysninger om Tadalafil Lilly
English: therefore concluded that Tadalafil Lilly's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Tadalafil Lilly opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: For practical information about using Tadalafil Lilly, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Tadalafil Lilly, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: By blocking the breakdown of cGMP, Tadalafil Lilly restores erectile function during sexual stimulation and also improves the blood flow to, and relaxes the muscles of, the prostate and bladder.
Danish: Ved at blokere nedbrydningen af cGMP gendanner Tadalafil Lilly den erektile funktion under seksuel stimulering og forbedrer endvidere blodstrømningen til blærehalskirtlen og blæren og får musklerne heri til at slappe af.
English: Why is Tadalafil Lilly approved?
Danish: Hvorfor blev Tadalafil Lilly godkendt?
English: What are the risks associated with Tadalafil Lilly?
Danish: Hvilke risici er der forbundet med Tadalafil Lilly?
English: For the full list of all side effects with Tadalafil Lilly, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Tadalafil Lilly fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tadalafil Lilly 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 Tadalafil Lilly.
English: As shown in studies, Tadalafil Lilly is effective at improving the ability to get and maintain erections and at relieving the symptoms of benign prostatic hyperplasia.
Danish: Som vist i undersøgelserne forbedrer Tadalafil Lilly evnen til at få og fastholde en erektion, og det lindrer symptomerne på godartet forstørret blærehalskirtel.
English: How is Tadalafil Lilly used?
Danish: Hvordan anvendes Tadalafil Lilly?
English: It can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged prostate gland that is not cancerous, which leads to problems with the flow of urine).
Danish: Tadalafil Lilly kan også anvendes til behandling af tegn og symptomer på godartet forstørret blærehalskirtel (benign prostatahyperplasi), som giver problemer med urinstrømmen.
English: Tadalafil Lilly has been shown to improve the ability to get and maintain an erection in nine main studies involving over 2,000 men with erectile dysfunction.
Danish: Det er i ni hovedundersøgelser med over 2 000 mænd med erektil dysfunktion blevet påvist, at Tadalafil Lilly forbedrer evnen til at få og fastholde en erektion.
English: How does Tadalafil Lilly work?
Danish: Hvordan virker Tadalafil Lilly?
English: What benefits of Tadalafil Lilly have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Tadalafil Lilly?
English: Missing values were considered a non-response.
Danish: Manglende værdier blev betragtet som non-respons.
English: You can take OCALIVA with or without food.
Danish: Du kan tage OCALIVA med eller uden mad.
English: Final report: 2020
Danish: Endelig rapport: 2020
English: Your doctor will discuss any change of dose with you.
Danish: Lægen vil drøfte en eventuel ændring af dosis med dig.
English: The mean age was 56 years, with the majority of patients less than 65 years old.
Danish: Gennemsnitsalderen var 56 år, og størstedelen af patienterne var under 65 år.
English: The study population was predominantly female (91%) and white (94%).
Danish: Studiepopulationen bestod hovedsageligt af kvinder (91 %) og hvide (94 %).
English: Components of primary endpointe
Danish: Komponenter i det primære endepunkte
English: Mean reduction in ALP
Danish: Gennemsnitlig reduktion i ALP
English: The Fisher's exact test was used to calculate the 95% Confidence Intervals (Cis).
Danish: Fishers eksakte test blev anvendt til at beregne 95 %-konfidensintervallerne (CI).
English: Method of administration The tablet should be taken orally with or without food.
Danish: Administration Tabletten skal tages oralt med eller uden mad.
English: Final report: 2023
Danish: Endelig rapport: 2023
English: Date of latest renewal: 12 December 2018
Danish: Dato for seneste fornyelse: 12. december 2018
English: Very common side effects (may affect more than 1 in 10 people):
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer):
English: For patients experiencing severe intolerability due to pruritus, one or more of the following should be considered:
Danish: Hos patienter, der oplever svær intolerabilitet på grund af pruritus, kan en eller flere af følgende strategier overvejes:
English: Rationale: to investigate the uncertainties related to the lack of data in a population with more advanced liver disease
Danish: Rationale: At undersøge usikkerhedsfaktorerne forbundet med manglende data i en population med mere fremskreden leversygdom
English: Skip the missed dose and take your next dose when you would normally take it. Do not take a double dose to make up for a forgotten tablet.
Danish: Spring den glemte dosis over, og tag den næste dosis på det tidspunkt, hvor du normalt skal tage den. Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: Responders, n (%) Corresponding 95% CI p-valued
Danish: Responders, n (%) Korresponderende 95 % CI p-værdi
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter “EXP”.
English: Limited data exists in elderly patients.
Danish: Der foreligger begrænsede data for ældre patienter.
English: Your doctor will do blood tests to monitor the health of your liver when you start treatment and regularly from there on.
Danish: Din læge vil tage blodprøver for at overvåge, hvordan din lever fungerer, når du starter behandlingen og jævnligt derefter.
English: Depending on your body's response after 6 months your doctor may increase your dose to 10 mg once daily.
Danish: Afhængigt af, hvordan din krop reagerer efter 6 måneder, vil lægen måske øge dosis til 10 mg én gang dagligt.
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) and not known (cannot be estimated from the available data).
Danish: Hyppighederne defineres 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The most commonly reported adverse reactions were pruritus (63%) and fatigue (22%).
Danish: De hyppigst rapporterede bivirkninger var pruritus (63 %) og træthed (22 %).
English: There are limited pharmacokinetic data in elderly patients (≥ 65 years).
Danish: Der foreligger begrænsede farmakokinetiske data fra ældre patienter (≥ 65 år).
English: Approximately 60% of patients had a history of pruritus upon enrollment in the phase III study.
Danish: Cirka 60 % af patienterne havde pruritus i anamnesen ved optagelse i fase III-studiet.
English: ALP and total bilirubin were assessed as categorical variables in the primary composite endpoint, as well as continuous variables over time.
Danish: ALP og total-bilirubin blev evalueret både som kategoriske variabler i det primære sammensatte endepunkt og som kontinuerlige variabler over tid.
English: There is little information about the effects of OCALIVA in pregnancy.
Danish: Der er kun få oplysninger om virkningen af OCALIVA i forbindelse med graviditet.
English: After initiation of therapy, all patients should be monitored for progression of PBC disease with laboratory and clinical assessment to determine whether dosage adjustment is needed.
Danish: Efter påbegyndelse af behandlingen skal alle patienter overvåges for progression af PBC ved hjælp af laboratorietest og kliniske vurderinger for at bestemme, om det er nødvendigt at justere dosis.
English: Frequency of adverse reactions in PBC patients*
Danish: Hyppigheden af bivirkninger hos PBC-patienter*
English: 10 mg twice weekly (at least 3 days apart)
Danish: 10 mg to gange ugentligt (med mindst 3 dages mellemrum)