FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 Choose a soft food the child likes.
Danish: 3 Vælg en slags blød mad, som barnet kan lide.
English: The virus may then become harder to treat.
Danish: Virus kan så blive vanskeligere at behandle.
English: Gender, race, elderly
Danish: Køn, race, ældre
English: Tell your doctor:
Danish: Fortæl det til Deres læge:
English: Such changes may in part be linked to disease control and life style.
Danish: Sådanne forandringer kan til dels være forbundet med sygdomskontrol og livsstil.
English: These drugs include:
Danish: Disse lægemidler omfatter:
English: Date of latest renewal: 23 April 2014
Danish: Dato for seneste fornyelse af tilladelsen: 23. april 2014
English: Children and adolescents (3 months to 17 years)
Danish: Børn og unge (3 måneder til 17 år)
English: You must check with your doctor first.
Danish: De skal tjekke dette med lægen først.
English: HORMONAL CONTRACEPTIVES Oral:
Danish: HORMONELLE KONTRACEPTIVA Oral:
English: 48 weeks
Danish: 48 uger
English: Component of a multipack, can't be sold separately.
Danish: Del af en multipakke , må ikke sælges separat.
English: For blisters: 2 years.
Danish: For blister: 2 år.
English: Control regimen (n=635)
Danish: Kontrolregime (n=635)
English: SUSTIVA must be taken every day.
Danish: Sustiva skal tages hver dag.
English: The standard doses of NRTIs given every 12 hours were used in each of these studies.
Danish: Standarddoserne af NRTI´ere, givet hver 12. time, blev anvendt i hver af disse studier.
English: SUSTIVA with food and drink
Danish: Brug af SUSTIVA sammen med mad og drikke
English: These are listed under Do not take SUSTIVA, at the start of Section 2.
Danish: Disse er nævnt under Tag ikke SUSTIVA i begyndelsen af punkt 2.
English: Not recommended as the exposure to both PIs is expected to be significantly decreased.
Danish: Anbefales ikke, da eksponering over for begge PI'er forventes at være betydeligt nedsat.
English: Risk to the infant can not be excluded.
Danish: En risiko for spædbørn kan ikke udelukkes.
English: An alternative anticonvulsant should be considered.
Danish: Et alternativt antikonvulsivum bør overvejes.
English: Tell your doctor immediately if you are pregnant or intend to become pregnant.
Danish: Fortæl det straks til Deres læge, hvis De er gravid eller har til hensigt at blive gravid.
English: 2 Wash and dry your hands before and after preparing the capsule sprinkle.
Danish: 2Vask og tør hænderne før og efter håndtering af kapselpulver.
English: Package leaflet: Information for the user
Danish: INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
English: if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
Danish: hvis et familiemedlem (forældre, bedsteforældre, brødre eller søstre) pludseligt er afgået ved døden på grund af et hjerteproblem eller var født med hjerteproblemer.
English: Adults and adolescents over 40 kg
Danish: Voksne og unge over 40 kg
English: These metabolites are essentially inactive against HIV-1.
Danish: Disse metabolitter er stort set inaktive over for hiv-1.
English: Dose (mg)
Danish: Dosis (mg)
English: Keep the medicine container with you so that you can easily describe what you have taken.
Danish: Behold pakningen, så De nemt kan beskrive, hvad De har taget.
English: In controlled trials, the frequency of specific serious psychiatric events were:
Danish: I kontrollerede undersøgelser var hyppigheden af specifikke, alvorlige psykiske bivirkninger:
English: Information regarding post-marketing surveillance
Danish: Oplysninger vedrørende efter-markedsføringsovervågning
English: Contrada Fontana del Ceraso 03012 Anagni (FR) Italy
Danish: Contrada Fontana del Ceraso 03012 Anagni (FR) Italien
English: Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Danish: Nogle patienter haft mere alvorlige symptomer, der kan påvirke humøret eller evnen til at tænke klart.
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Der bør derfor træffes forholdsregler til at forhindre dette i overensstemmelse med nationale vejledninger.
English: If you are pregnant, you should take SUSTIVA only if you and your doctor decide it is clearly needed.
Danish: Hvis De er gravid, bør De kun tage SUSTIVA, hvis De og Deres læge beslutter, at det er absolut nødvendigt.
English: One patient experienced involuntary muscle contractions.
Danish: Én patient oplevede ufrivillige muskelkontraktioner.
English: Effect of food
Danish: Virkning af mad
English: Cholesterol levels should be periodically monitored.
Danish: Kolesterolniveauerne bør monitoreres regelmæssigt.
English: Insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
Danish: Antallet af ældre patienter, der er vurderet i kliniske undersøgelser, er ikke tilstrækkeligt til at afgøre, om de responderer anderledes end yngre patienter.
English: Your doctor has prescribed SUSTIVA for you because you have HIV infection.
Danish: Deres læge har ordineret SUSTIVA til Dem, fordi De har en hiv-infektion.
English: Dose reduction or splitting the daily dose has not been shown to provide benefit.
Danish: Dosisreduktion eller deling af daglig dosis er ikke vist at være en fordel.
English: Similar results were found by other investigators, although the MPA plasma levels were more variable in the second study.
Danish: Lignende resultater blev observeret af andre investigatorer, selvom MPA's plasmakoncentration varierede mere i den anden undersøgelse.
English: Patients who cannot swallow
Danish: Patienter, som ikke er i stand til at sluge
English: Frequency is defined using the following convention: 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); or very rare (< 1/10,000).
Danish: Frekvens defineres ved brug af følgende konvention: 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); eller Meget sjælden (< 1/10.000).
English: Study ACTG 364 48 weeks
Danish: Undersøgelse ACTG 364 48 uger
English: ATC code: J05AG03
Danish: ATC kode: J05AG03
English: Caution is warranted since this dose adjustment might be insufficient in some patients.
Danish: Forsigtighed tilrådes, da denne dosisjustering kan være utilstrækkelig hos nogle patienter.
English: This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
Danish: Dette vil styrke Deres immunsystem og reducere risikoen for at udvikle sygdomme, der er forbundet med HIV-infektion.
English: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL United Kingdom
Danish: Aesica Queenborough Limited North Road, Queenborough Kent, ME11 5EL Storbritannien
English: In addition, your doctor may prescribe a higher dose of SUSTIVA.
Danish: Desuden vil lægen måske ordinere en højere dosis SUSTIVA.
English: The mechanism of tumour formation and the potential relevance for humans are not known.
Danish: Hverken mekanismen for tumordannelse eller den potentielle relevans for mennesker er kendt.
English: Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Danish: Øgning af bupropiondosis bør baseres på klinisk respons, men den maksimale anbefalede bupropiondosis bør ikke overskrides.
English: (inhibition of CYP-mediated oxidative metabolism)
Danish: (hæmning af CYP-medieret oxidativ metabolisme).
English: 9 If the daily dose consists of more than one capsule, follow steps 5-8 for each capsule.
Danish: 9 Hvis den daglige dosis kræver mere end én kapsel, gentages punkt 5-8 for hver kapsel.
English: This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Danish: Dette er meget vigtigt, da mængden af virus kan begynde at stige, hvis medicineringen standses-selv i kort tid.
English: Make sure the child eats the full amount of the mixture of food and capsule contents.
Danish: Sørg for, at barnet spiser hele blandingen af føde og kapselindhold.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: De kan stadig overføre hiv, når De tager denne medicin, selv om risikoen er mindsket af den effektive antiretrovirale behandling.
English: if you have severe liver disease.
Danish: hvis De har en alvorlig leversygdom.
English: Efavirenz is highly bound (approximately 99.5 - 99.75%) to human plasma proteins, predominantly albumin.
Danish: Efavirenz har en høj bindingsgrad (cirka 99,5 - 99,75%) til humane plasmaproteiner, fortrinsvis albumin.
English: any signs of inflammation or infection.
Danish: alle tegn på betændelse eller infektion.
English: There is no experience in patients with severe renal failure and close safety monitoring is recommended in this population.
Danish: Der er ingen erfaring med patienter med svær nyreinsufficiens, og der anbefales omhyggelig sikkerhedsmonitoring i denne population.
English: Rash was more common in children than in adults treated with SUSTIVA.
Danish: Udslæt er mere almindeligt hos børn end hos voksne, der er behandlet med SUSTIVA.
English: Sími: +354 535 7000
Danish: Simí: +354 535 7000
English: Medicinal product by therapeutic areas (dose)
Danish: Lægemidler i henhold til terapeutisk område (dosis)
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Det antages, at disse symptomer skyldes en forbedring i kroppens immunforsvar, som så gør kroppen i stand til at bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English: Pharmacokinetic studies have not been performed in the elderly.
Danish: Der er ikke udført farmakokinetiske undersøgelser hos ældre.
English: Always notify your doctor immediately if you have these symptoms or any side effects while taking SUSTIVA.
Danish: De skal altid straks underrette Deres læge, hvis De har disse symptomer eller andre bivirkninger, mens De tager SUSTIVA.
English: This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
Danish: Dette fald i atazanavirs Cmin kan have negativ indflydelse på effekten af atazanavir.
English: Steps 11-14 must be completed within 30 minutes of mixing: 11 Give the mixture of food and capsule contents to the child, making sure he or she eats the full amount (illustration f).
Danish: Punkt 11-14 skal gennemføres inden for 30 minutter efter sammenblanding: 11 Giv blandingen af mad og kapselindhold til barnet og sørg for, at han/hun spiser det hele (illustration f).
English: Efavirenz has been studied in over 9,000 patients.
Danish: Efavirenz er undersøgt hos mere end 9.000 patienter.
English: This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Danish: Dette kan få nogle bivirkninger (for eksempel svimmelhed, døsighed) til at virke mindre generende.
English: Injection:
Danish: Injektion:
English: 14 Have the child eat the full amount again (illustration f).
Danish: 14 Sørg for, at barnet igen spiser hele mængden (illustration f).
English: Clinical experience in controlled studies with combinations including didanosine or zalcitabine is limited.
Danish: Klinisk erfaring i kontrollerede undersøgelser med kombinationer, der inkluderer didanosin eller zalcitabin er begrænset.
English: Therefore, efavirenz should not be given to children less than 3 months of age.
Danish: Derfor bør efavirenz ikke gives til børn under 3 måneder.
English: Grapefuit juice should be avoided when taking SUSTIVA.
Danish: Grapefrugtjuice bør undgås, når der tages SUSTIVA.
English: If SUSTIVA is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
Danish: Hvis SUSTIVA påbegyndes, fordi Deres nuværende behandling ikke har forhindret virus i at formere sig, skal et andet lægemiddel, som De ikke har taget før, påbegyndes samtidig.
English: Dosing at bedtime seems to improve the tolerability of these symptoms and can be recommended during the first weeks of therapy and in patients who continue to experience these symptoms (see section 4.2).
Danish: Dosering ved sengetid synes at forbedre tolerabiliteten af disse symptomer og kan anbefales i de første uger af behandlingen samt hos patienter, der fortsat får disse symptomer (se pkt.
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
Danish: Ved behandling af hiv-infektion er det ikke altid muligt at sige, hvilke af de uønskede virkninger, der er forårsaget af SUSTIVA eller af de andre lægemidler, De tager samtidigt, eller af selve hiv-infektionen.
English: 42 x 1 hard capsules: blister
Danish: 42 x 1 hårde kapsler: Blister
English: Study 020 showed similar activity in NRTI-experienced patients over 24 weeks.
Danish: Undersøgelse 020 viste lignende aktivitet hos NRTIbehandlede patienter i 24 uger.
English: Administration of activated charcoal may be used to aid removal of unabsorbed efavirenz.
Danish: Administration af aktivt kul kan anvendes for at understøtte fjernelse af ikke-absorberet efavirenz.
English: Other interactions: efavirenz does not bind to cannabinoid receptors.
Danish: Andre interaktioner: Efavirenz binder ikke til cannabinoidreceptorer.
English: Eighty-seven percent of patients had received prior antiretroviral therapy.
Danish: 87% a patienterne havde tidligere modtaget antiretroviral behandling.
English: Antiviral activity
Danish: Antiviral aktivitet
English: If you are affected, do not drive and do not use any tools or machines.
Danish: Hvis De er påvirket af medicinen, må De ikke køre bil eller betjene værktøj eller maskiner.
English: The steady-state AUC, Cmax and Cmin of the active carbamazepine epoxide metabolite remained unchanged.
Danish: Steady-state AUC, Cmax og Cmin for den aktive carbamazepinepoxid-metabolit forblev uændret.
English: Efavirenz should not be used during pregnancy, unless the patient's clinical condition requires such treatment.
Danish: Efavirenz bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver denne behandling.
English: If you have severe liver disease, do not take SUSTIVA (see section 2, Do not take SUSTIVA).
Danish: Hvis De har alvorlig leversygdom, må De ikke tage SUSTIVA (se punkt 2 Tag ikke SUSTIVA).
English: This proportion is approximately 3-fold higher than the nonprotein-bound (free) fraction of efavirenz in plasma.
Danish: Denne procentdel er ca. 3 gange højere end den ikkeproteinbundne (frie) fraktion af efavirenz i plasma.
English: Physicians were allowed to change their patient's NRTI regimen upon entry into the study.
Danish: Lægen kunne skifte patienternes NRTI regime ved indgangen til studiet.
English: Undesirable effects in children were generally similar to those of adult patients.
Danish: Hos børn var bivirkningerne generelt de samme som hos voksne patienter.
English: unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly suicide
Danish: Uforklarede følelser af bekymring, der ikke er forbundet med hallucinationer, men det kan være svært at tænke klart og fornuftigt
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selv om en effektiv viral hæmning med antiretrovitral behandling har vist sig at reducere risikoen for seksuel overføring væsentligt, kan en rest-risiko ikke udelukkes.
English: Consider doubling the rifabutin dose in regimens where rifabutin is given 2 or 3 times a week in combination with efavirenz.
Danish: Overvej fordobling af rifabutindosis i regimer, hvor rifabutin gives 2 eller 3 gange om ugen sammen med efavirenz.
English: Close monitoring of immunosuppressant concentrations for at least 2 weeks (until stable concentrations are reached) is recommended when starting or stopping treatment with efavirenz.
Danish: Tæt monitorering af de immunsuppressive koncentrationer anbefales i mindst 2 uger (indtil stabil koncentration er nået), når behandling med efavirenz igangsættes eller seponeres.
English: Tell your doctor if you notice any of the following side effects:
Danish: Fortæl det til lægen, hvis De bemærker en eller flere af følgende bivirkninger:
English: Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Danish: Lignende forhøjelser blev set hos patienter, der blev behandlet med kontrolregimer (5% efter langtidsbehandling).
English: Instructions for capsule sprinkle method:
Danish: Instruktioner for kapselpulvermetoden:
English: Although limited data suggest that females as well as Asian and Pacific Island patients may have higher exposure to efavirenz, they do not appear to be less tolerant of efavirenz.
Danish: Selvom begrænsede data tyder på, at kvinder samt patienter fra Asien og Stillehavsøerne har højere påvirkningsgrad af efavirenz, synes deres tolerabilitet af efavirenz ikke at være mindre.
English: Time to peak plasma concentrations (3 - 5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 6 - 7 days.
Danish: Tiden indtil peak plasmakoncentrationer (3 - 5 timer) ændredes ikke efter multiple doseringer, og steady-state plasmakoncentrationerne blev nået på 6 - 7 dage.
English: If available, 90% or 95% confidence intervals are shown in parentheses.
Danish: Hvis muligt vises 90% eller 95% konfidensinterval i parentes.
English: Most cases occurred in patients who already had liver disease, but there have been a few reports in patients without any existing liver disease.
Danish: I de fleste tilfælde opstod det hos patienter, som allerede havde leversygdom, men der har kun været få indberetninger hos patienter uden eksisterende leversygdom.
English: If you are affected your doctor may suggest that you take SUSTIVA at bedtime and on an empty stomach.
Danish: Hvis De er påvirket, kan Deres læge foreslå, at De tager SUSTIVA ved sengetid og på tom mave.
English: b 95% confidence intervals.
Danish: b95% konfidensinterval.
English: As of July 2013, the Antiretroviral Pregnancy Registry (APR) has received prospective reports of 904 pregnancies with first trimester exposure to efavirenz-containing regimens, resulting in 766 live births.
Danish: Fra juli 2013 har Antiretroviral Pregnancy Registry (APR) modtaget prospektive rapporter om 904 graviditeter, der har været eksponeret for efavirenzholdige regimer i første trimester, og som resulterede i 766 levendefødsler.
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking SUSTIVA.
Danish: Derfor bør De fortsætte med at bruge prævention som nævnt ovenfor i 12 uger efter, at De er stoppet med at tage SUSTIVA.
English: if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
Danish: hvis Deres læge har fortalt Dem, at De har et højt eller lavt indhold af elektrolytter, såsom kalium eller magnesium, i blodet.
English: 30 x 1 TABLETS
Danish: 30 x 1 TABLETTER
English: Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, coadministration of efavirenz and another NNRTI is not recommended.
Danish: Da anvendelse af to af NNRTIerne ikke viste sig at være gunstig med hensyn til effektivitet og sikkerhed, anbefales samtidig administration af efavirenz og en anden NNRTI ikke.
English: This medicine is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV disease.
Danish: Denne medicin helbreder ikke hiv-infektion, og De vil eventuelt fortsætte med at udvikle infektioner eller andre sygdomme, der er forbundet med hiv-sygdom.
English: The doctor may also recommend this method of taking SUSTIVA for adults who cannot swallow capsules.
Danish: Lægen kan også anbefale denne metode til voksne, der ikke kan sluge SUSTIVA-kapsler.
English: The clinical significance of these effects is not known.
Danish: Den kliniske signifikans af disse påvirkninger er ikke kendt.
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with SUSTIVA.
Danish: Lægen kan bede Dem om at tage en graviditetstest for at sikre, at De ikke er gravid, før De starter behandling med SUSTIVA.
English: Alternatives to clarithromycin (e.g. azithromycin) may be considered.
Danish: Alternativer til clarithromycin (fx azithromycin) kan overvejes.
English: Efavirenz regimen (n=1,008)
Danish: Efavirenzregime (n=1.008)
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette er til dels forbundet med forbedret helbredstilstand og med livsstil, og for lipidernes vedkommende sommetider med selve hiv-medicinen.
English: Hard capsule
Danish: Hårde kapsler
English: Responder rates were highest in patients who switched NRTIs.
Danish: Responsraten var højest for de patienter, som skiftede NRTI'ere.
English: 5 SUSTIVA capsules must be opened carefully over the food container, as described in steps 6-7, so that the contents do not spill.
Danish: 5 SUSTIVA-kapsler skal åbnes forsigtigt over skålen, som beskrevet i punkt 6-7, således at indholdet ikke spildes.
English: Very common (affects more than 1 user in 10) skin rash
Danish: Meget almindelige (berører flere end 1 ud af 10 brugere) Hududslæt
English: Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
Danish: Behandling af overdosis med efavirenz bør bestå i almindelige, støttende foranstaltninger inklusive monitorering af objektive symptomer og observation af patientens kliniske tilstand.
English: For the drug-drug interaction with etonogestrel implant, the PRAC noted the available data from 16 case reports and the published literature articles by Vieira et al., 2014 and Chappel et al., 2017.
Danish: Vedrørende lægemiddelinteraktionen med etonogestrel-implantatet har PRAC taget de tilgængelige data fra 16 caserapporter samt artiklerne publiceret af Vieira et al., 2014 og Chappel et al., 2017 i betragtning.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Long-term use of efavirenz in this study was not associated with any new safety concerns.
Danish: I dette studie var langtidsbrug af efavirenz ikke forbundet med nogen nye sikkerhedsproblemer.
English: Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Danish: Fortæl det straks til lægen, hvis De føler Dem nedtrykt, har selvmordstanker eller mærkelige tanker (se punkt 4 Bivirkninger).
English: Carbamazepine plasma levels should be monitored periodically.
Danish: Carbamazepins plasmakoncentration bør monitoreres regelmæssigt.
English: Number of Capsules or Tablets and Strength to Administer kg
Danish: Antal kapsler eller tabletter samt styrke til indgivelse kg