FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if you notice any of the following side effects: Very common (affects more than 1 user in 10)
Danish: Fortæl det til lægen, hvis du bemærker en eller flere af følgende bivirkninger: Meget almindelig (berører flere end 1 ud af 10 brugere)
English: Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterpakningen og på æsken efter udløbsdatoen.
English: (CYP3A induction - effect on boceprevir) *0-8 hours
Danish: (CYP3A induktion - effekt på boceprevir) *0-8 timer
English: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands
Danish: Teva BV, Swensweg 5, 2031GA Haarlem, Holland
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 varierde mere i den anden undersøgelse.
English: b C.I., confidence interval.
Danish: b C.I., konfidensinterval.
English: This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
Danish: Det vil styrke dit immunsystem og nedsætte risikoen for at udvikle sygdomme, der er forbundet med hiv-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 sikkerhedsmonitorering i denne population.
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: - Efavirenz Teva must be taken every day.
Danish: - Efavirenz Teva skal tages hver dag.
English: (PLIVA Croatia Ltd.), Prilaz baruna Filipovića 25, 10000 Zagreb, Croatia
Danish: Pliva Croatia Ltd, Prilaz baruna Filipovića 25, 10000 Zagreb, Kroatien
English: If you are pregnant, you should take Efavirenz Teva only if you and your doctor decide it is clearly needed.
Danish: Hvis du er gravid, bør du kun tage Efavirenz Teva, hvis du og din læge beslutter, at det er absolut nødvendigt.
English: c C.I., confidence interval for proportion of patients in response.
Danish: c C.I., konfidensinterval for antal patienter med respons.
English: If you are affected, do not drive and do not use any tools or machines.
Danish: Hvis du er påvirket af medicinen, må du ikke køre bil eller betjene værktøj eller maskiner.
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 din læge har fortalt dig, at du har et højt eller lavt indhold af elektrolytter, såsom kalium eller magnesium, i blodet.
English: - Medicines used to treat malaria:
Danish: - Medicin til behandling af malaria:
English: Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Danish: Nogle patienter, der ved et uheld har taget 600 mg 2 gange daglig, har rapporteret forøgede symptomer fra nervesystemet.
English: - unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly - suicide
Danish: - uforklarlig følelse af bekymring, der ikke er forbundet med hallucinationer, men det kan være svært at tænke klart eller fornuftigt.
English: This proportion is approximately 3-fold higher than the non-protein-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: Substitutions at RT positions 98, 100, 101, 108, 138, 188, 190 or 225 were also observed, but at lower frequencies, and often only in combination with K103N.
Danish: Der blev også observeret substitutioner på RTpositionerne 98, 100, 101, 108, 138, 188, 190 eller 225, men med lavere frekvenser og ofte kun i kombination med K103N.
English: Your doctor has prescribed Efavirenz Teva for you because you have HIV infection.
Danish: Din læge har ordineret Efavirenz Teva til dig, fordi De har en hiv-infektion.
English: - If you are allergic to efavirenz or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for efavirenz eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
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 du vil eventuelt fortsætte med at udvikle infektioner eller andre sygdomme, der er forbundet med hiv-sygdom.
English: Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Danish: Lignende forhøjelser blev set hos patienter behandlet med kontrolregimer (5% efter langtidsbehandling).
English: Efavirenz concentrations not measured, no effect is expected.
Danish: Koncentrationen af efavirenz er ikke målt, ingen effekt forventes.
English: If
Danish: Hvis
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Efavirenz Teva 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 Efavirenz Teva eller af de andre lægemidler, du tager samtidigt, eller af selve hiv-infektionen.
English: Time to peak plasma concentrations (3-5 hours) did not change following multiple dosing and steady-state plasma concentrations were reached in 67 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: 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 minimal risiko ikke udelukkes.
English: Since use of two NNRTIs proved not beneficial in terms of efficacy and safety, co-administration 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: It is important to tell your doctor or pharmacist if you are taking any of the following: - Other medicines used for HIV infection:
Danish: Det er vigtigt, at du fortæller det til lægen eller apotekspersonalet, hvis du tager følgende: - Anden medicin mod hiv-infektion:
English: Efavirenz Teva 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: Efavirenz Teva påbegyndes, fordi din nuværende behandling ikke har forhindret virus i at formere sig, skal et andet lægemiddel, som du ikke har taget før, påbegyndes samtidig.
English: Always notify your doctor immediately if you have these symptoms or any side effects while taking Efavirenz Teva.
Danish: Du skal altid straks underrette din læge, hvis du har disse symptomer eller andre bivirkninger, mens du tager Efavirenz Teva.
English: Film-coated tablet Yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other
Danish: Filmovertrukket tablet Gul, kapselformet, filmovertrukket tablet præget med ”Teva” på den ene side og ”7541” på den anden.
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Danish: hvis du har en hjertesygdom, såsom unormalt elektrisk signal kaldet forlænget QTinterval.
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses and 40-55 hours after multiple doses.
Danish: Efavirenz har en forholdsvis lang halveringstid på mindst 52 timer efter enkeltdoser og 40 - 55 timer efter multiple doser.
English: Cmax and AUC were seen for doses up to 1,600 mg; the increases were less than proportional suggesting diminished absorption at higher doses.
Danish: Der blev set dosisrelaterede stigninger i Cmax og AUC for doser på op til 1.600 mg. Stigningerne var mindre end proportionale, hvilket tyder på formindsket absorption ved højere doser.
English: Efavirenz: no clinically significant interaction.
Danish: Efavirenz: Ingen klinisk signifikant interaktion.
English: In addition, your doctor may prescribe a higher dose of Efavirenz Teva.
Danish: Desuden vil lægen måske ordinere en højere dosis Efavirenz Teva.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis du af din læge har fået at vide, at der er visse sukkerarter, du ikke kan tåle, bør du kontakte lægen, før du tager dette lægemiddel.
English: While the carcinogenic potential in humans is unknown, these data suggest that the clinical benefit of efavirenz outweighs the potential carcinogenic risk to humans.
Danish: Selvom carcinogenecitetspotentialet hos mennesker ikke er kendt, antyder disse data, at efavirenz' kliniske fordele opvejer den mulige carcinogenecitet hos mennesker.
English: - Medicines used to treat infection with the hepatitis C virus: boceprevir, telaprevir,
Danish: - Medicin til behandling af infektion med hepatitis C-virus: boceprevir, telaprevir,
English: if you have a history of liver disease, including active chronic hepatitis.
Danish: hvis du tidligere har haft leversygdom, herunder aktiv kroniks hepatitis.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, dvs. det er i det væsentlige natrium-frit.
English: Verapamil, felodipine, nifedipine and nicardipine
Danish: Verapamil, felodipin, nifedipin og nicardipin
English: - Efavirenz Teva should never be used alone to treat HIV.
Danish: - Efavirenz Teva må aldrig anvendes alene til behandling af hiv.
English: If you are affected your doctor may suggest that you take Efavirenz Teva at bedtime and on an empty stomach.
Danish: Hvis du er påvirket, kan din læge foreslå, at du tager Efavirenz Teva ved sengetid og på tom mave.
English: Your doctor may conduct blood tests in order to check how well your liver is working or may switch you to another medicine.
Danish: Lægen vil måske tage blodprøver for at kontrollere, hvor godt din lever virker eller måske skifte din til anden medicin.
English: d EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir.
Danish: d EFV, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir.
English: ZDV + 3TC a NC = F, noncompleter = failure.
Danish: ZDV + 3TC a NC = F, non-completer = failure.
English: The net effect of coadministration is not clear
Danish: Nettoeffekten ved samtidig administration er ikke klarlagt.
English: This medicine contains 9.98 mg lactose (as monohydrate) per tablet.
Danish: Dette lægemiddel indeholder 9,98 mg lactose (i form af monohydrat) pr. tablet.
English: Uncommon Flushing†
Danish: Flushing†
English: In a single-dose study, half-life was doubled in the single patient with severe hepatic impairment (Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
Danish: I en undersøgelse med enkeltdosering blev halveringstiden fordoblet hos den enkelte patient med svær leverinsufficiens (Child Pugh klasse C), hvilket indikerer en risiko for en langt større grad af akkumulering.
English: Gender, race, elderly
Danish: Køn, etnicitet, ældre patienter
English: If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Danish: Hvis du kommer til at springe en dosis over, skal du tage den næste dosis så hurtigt som muligt, men du må ikke fordoble den næste dosis.
English: It is an antiretroviral medicine that fights human immunodeficiency virus (HIV-1) infection by reducing the amount of the virus in blood.
Danish: Det er en antiretroviral medicin, som bekæmper humant immundefekt virus (hiv)-infektion ved at reducere mængden af virus i blodet.
English: 95% confidence intervals.
Danish: b 95% konfidensinterval.
English: In the analysis of responder rates (the non-completer equals failure analysis [NC = F]), patients who terminated the study early for any reason, or who had a missing HIV-RNA measurement that was either preceded or followed by a measurement above the limit of assay quantification were considered to have HIV-RNA above 50 or above 400 copies/ml at the missing time points.
Danish: I analysen af responsraten (non-completer lig med failure analysen [NC = F]), blev patienter, der udgik af studiet tidligt uanset grund, patienter som manglede en hiv-RNA måling, som enten var forudgået eller blev efterfulgt af en måling over assaygrænsen, formodet at have hiv-RNA over 50 eller over 400 kopier/ml på de manglende tidspunkter.
English: Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Danish: Patienter, som får krampestillende lægemidler, der hovedsageligt metaboliseres i leveren, som f.eks. phenytoin, carbamazepin og phenobarbital, kan have brug for periodisk monitorering af plasmaniveauer.
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 4 by weight ranges that correspond to the recommended doses of the capsules.
Danish: De farmakokinetiske parametre for efavirenz ved steady-state hos pædiatriske patienter blev forudsagt af en farmakokinetisk populationsmodel og er sammenfattet i Tabel 4 med vægtintervaller, som svarer til de anbefalede doser af kapslerne.
English: Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Danish: Efavirenz er indiceret til antiviral kombinationsbehandling af humant immundefekt virus-1 (hiv-1)-1-inficerede voksne, unge og børn fra 3 år og opefter.
English: Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking Efavirenz Teva.
Danish: Derfor bør du fortsætte med at bruge prævention som nævnt ovenfor i 12 uger efter, at du er stoppet med at tage Efavirenz Teva.
English: 30 x 1 film-coated tablets.
Danish: 30 x 1 filmovertrukne tabletter.
English: Cmax: ↓ 24% (↓ 18 to ↓ 30) These changes are not considered clinically significant.
Danish: Cmax: ↓ 24% (↓ 18 til ↓ 30) Disse ændringer anses ikke for at være klinisk signifikante.
English: If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking Efavirenz Teva.
Danish: Hvis du får noget af denne medicin, kan det være nødvendigt, at lægen kontrollerer mængden af denne medicin i din blod for at sikre, at denne ikke påvirkes af, at du tager Efavirenz Teva.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Ved samtidig antiviral behandling af Hepatitis B eller C, henvises til det pågældende produktresumé for disse lægemidler.
English: The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept. 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Danish: Hyppigheden "sjælden" blev defineret i henhold til vejledningen "A Guideline on Summary of Product Characteristics (SmPC)" (rev. 2. september 2009) på basis af en estimeret øvre grænse for 95% konfidensintervallet for 0 hændelser på baggrund af det antal forsøgspersoner, der blev behandlet med efavirenz i disse kliniske undersøgelser (n=3.969).
English: Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with Efavirenz Teva.
Danish: Lægen kan bede dig om at tage en graviditetstest for at sikre, at du ikke er gravid, før du starter behandling med Efavirenz Teva.
English: Efavirenz exposure may be increased when given with medicinal products (for example, ritonavir) or food (for example, grapefruit juice), which inhibit CYP3A4 or CYP2B6 activity.
Danish: Efavirenzeksponeringen kan være øget, når det gives sammen med lægemidler (f.eks. ritonavir) eller føde (f.eks. grapefrugtjuice), som hæmmer CYP3A4- eller CYP2B6-aktivitet.
English: Since efavirenz is highly protein-bound, dialysis is unlikely to remove significant quantities of it from blood.
Danish: Da efavirenz har en høj proteinbindingsgrad, er det usandsynligt, at dialyse vil fjerne signifikante mængder af det fra blodet.
English: Pregnancy, breast-feeding and fertility Women should not get pregnant during treatment with Efavirenz Teva and for 12 weeks thereafter.
Danish: Graviditet, amning og fertilitet Kvinder bør ikke blive gravide under behandling med Efavirenz Teva og i 12 uger efter ophørt behandling.
English: - The dose for adults is 600 mg once daily.
Danish: - Dosis til voksne er 600 mg 1 gang dagligt.
English: Interaction not studied
Danish: Interaktion er ikke undersøgt
English: Rash was more common in children than in adults treated with efavirenz.
Danish: Udslæt er mere almindeligt hos børn end hos voksne, der er behandlet med efavirenz.
English: ‡These adverse reactions were identified through post-marketing surveillance but not reported as drug-related events for efavirenz-treated patients in 16 clinical trials.
Danish: ‡Disse bivirkninger blev identificeret efter markedsføring, men blev ikke indberettet som lægemiddelrelaterede hændelser hos efavirenzbehandlede patienter i 16 kliniske undersøgelser.
English: Hepatobiliary disorders common aspartate aminotransferase (AST) increased*, alanine aminotransferase (ALT) increased*, gamma-glutamyltransferase (GGT) increased*
Danish: Almindelig Forhøjet aspartataminotransferase (ASAT)*, forhøjet alaninaminotransferase (ALAT)*, forhøjet gamma-glutamyltransferase (GGT)*
English: If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with Efavirenz Teva.
Danish: Hvis du får udslæt, mens du tager en anden NNRTI, kan du have større risiko for at få udslæt med Efavirenz Teva.
English: If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced.
Danish: Hvis du tager disse to lægemidler sammen, skal dosis af voriconazol øges og dosis af efavirenz nedsættes.
English: The single substitutions which led to the highest resistance to efavirenz in cell culture correspond to a leucine-to-isoleucine change at position 100 (L100I, 17 to 22-fold resistance) and a lysine-to-asparagine at position 103 (K103N, 18 to 33-fold resistance).
Danish: De enkelte substitutioner, der resulterede i den største resistens over for efavirenz ved cellekultur, svarer til en leucin-til-isoleucin forandring på position 100 (L100I, 17 til 22 gange så stor resistens) og en lysin-tilasparagin på position 103 (K103N, 18 til 33 gange så stor resistens).
English: Clarithromycin 14-hydroxymetabolite:
Danish: Clarithromycins 14-hydroxymetabolit:
English: - Once you start taking Efavirenz Teva, look out for: signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or abnormal dreaming.
Danish: Når du er startet med Efavirenz Teva, skal du være opmærksom på: tegn på svimmelhed, besvær med at falde i søvn, døsighed, besvær med at koncentrere sig eller unormale drømme.
English: Name and address of the manufacturer responsible for batch release PLIVA Hrvatska d.o.o.
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse Pliva Croatia Ltd.
English: - Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
Danish: - Medicin til at mindske fedt i blodet (også kaldet statiner): atorvastatin, pravastatin,
English: Taking these medicines with Efavirenz Teva could create the potential for serious and/or life-threatening side effects or stop Efavirenz Teva from working properly.
Danish: Hvis du tager disse lægemidler sammen med Efavirenz Teva, kan der opstå alvorlige og/eller livstruende bivirkninger eller Efavirenz Teva kan holde op med at virke på den rigtige måde.
English: Laboratory tests should be performed to evaluate their liver disease at periodic intervals (see section
Danish: Der bør med jævne mellemrum udføres laboratorieundersøgelser med henblik på vurdering af deres leversygdom (se pkt.
English: The potency of efavirenz in cell culture against viral variants with amino acid substitutions at positions 48, 108, 179, 181 or 236 in RT or variants with amino acid substitutions in the protease was similar to that observed against wild-type viral strains.
Danish: Ved cellekultur var potensen af efavirenz over for virusvarianter med aminosyresubstitutioner på positionerne 48, 108, 179, 181 eller 236 i RT eller varianter med aminosyresubstitutioner i proteasen lig den, der sås over for vildtype-virusstammer.
English: With efavirenz, an increase of the lopinavir/ritonavir soft capsule or oral solution doses by 33% should be considered (4 capsules/ ~6.5 ml twice daily instead of 3 capsules/5 ml twice daily).
Danish: Sammen med efavirenz bør en øgning af dosis for lopinavir/ ritonavir blød kapsel eller oral opløsning på 33% overvejes (4 kapsler/~ 6,5 ml to gange dagligt i stedet for 3 kapsler/5 ml to gange dagligt).
English: In uninfected volunteers, multiple doses of 200-400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22-42% lower) and a shorter terminal half-life compared with single dose administration (see below).
Danish: Hos ikke-inficerede frivillige resulterede multiple doser på 200 - 400 mg per dag i 10 dage i en lavere grad af akkumulation (2242% lavere) end forudset samt kortere halveringstid sammenlignet med enkeltdosisadministration (se nedenfor).
English: a 90% confidence intervals unless otherwise noted.
Danish: a 90% konfidensinterval med mindre andet er angivet.
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Danish: For at undgå overførsel af hiv, anbefales det, at hiv-smittede kvinder ikke ammer deres børn under nogen omstændigheder.
English: Uncommon Erythema multiforme, Stevens-Johnson syndrome* Rare
Danish: Erythema multiforme, Stevens-Johnsons syndrom*
English: Efavirenz is not recommended for patients who have had a life-threatening cutaneous reaction (e.g., Stevens-Johnson syndrome) while taking another NNRTI.
Danish: Efavirenz bør ikke gives til patienter, som har haft livstruende kutan reaktion (f.eks. Stevens-Johnsons syndrom), mens de fik en anden NNRTI.
English: The free concentration of efavirenz required for 90 to 95% inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Danish: Den frie koncentration af efavirenz, der er nødvendig for 90 - 95% hæmning af vildtype- eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0,46 til 6,8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag/monocytkulturer.
English: - It is recommended that the tablet be swallowed whole with water.
Danish: Det anbefales at tabletten sluges hel sammen med postevand.