FrancophonIA/ELRC3.0 huggingface dataset:
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Danish: Som det kunne forventes, forekom ASAT- og ALATforhøjelser imidlertid hyppigere hos denne patientpopulation end hos den generelle hiv-inficerede population.
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: Your doctor will carefully consider whether to treat you with medicines containing tenofovir and didanosine.
Danish: Din læge vil nøje overveje, om det er nødvendigt at behandle dig med medicin, der indeholder tenofovir og didanosin.
English: Patients must not have experienced failure of a previous HIV therapy.
Danish: Patienterne må ikke have oplevet, at en tidligere hiv-behandling ikke har virket.
English: In addition, your doctor may consider giving you an additional dose of efavirenz to treat your HIV infection.
Danish: Desuden kan lægen overveje at give dig en højere dosis efavirenz til behandling af din hiv-infektion.
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 din læge, hvis du føler dig deprimeret, har selvmordstanker eller mærkelige tanker (se punkt 4, Bivirkninger).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du bidrage til at tilvejebringe mere information om sikkerheden af dette lægemiddel.
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Danish: Hvis du har en hepatitis B-infektion, vil din læge nøje overveje, hvilken behandling, der er den bedste for dig.
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Danish: - Hvis du tidligere har haft en psykisk sygdom, herunder depression, eller stof- eller alkoholmisbrug.
English: - if you have a history of liver disease, including chronic active hepatitis.
Danish: - Hvis du tidligere har haft en leversygdom, herunder kronisk aktiv hepatitis.
English: The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births.
Danish: Forekomsten af neuralrørsdefekt i befolkningen generelt er 0,51 tilfælde pr. 1.000 levende fødsler.
English: Poly(vinyl alcohol) Macrogol 3350
Danish: Polyvinylalkohol Macrogol 3350
English: Efavirenz does not bind to cannabinoid receptors.
Danish: Efavirenz binder ikke til cannabinoid-receptorer.
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 efavirenz-holdige regimer i første trimester, og som resulterede i 766 levende fødsler.
English: The predominant circulating metabolite of sofosbuvir.
Danish: Den primære cirkulerende metabolit af sofosbuvir.
English: It is important to tell your doctor or pharmacist if you are taking any of the following:
Danish: Det er vigtigt, at du fortæller det til din læge eller apotekspersonalet, hvis du tager et eller flere af følgende:
English: Efavirenz resistance K103N
Danish: Efavirenz-resistens K103N
English: itchy rash to the skin caused by a reaction to sunlight
Danish: Kløende udslæt på huden fremkaldt af en reaktion på sollys
English: No virus analysed contained the K65R or K70E mutation.
Danish: Ingen analyseret virus indeholdt K65R eller K70E mutationen.
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Danish: Op til 30% af emtricitabin-dosis og ca. 10% af tenofovir-dosis kan fjernes ved hæmodialyse.
English: Rash developed in 46% of uninfected volunteers receiving efavirenz and clarithromycin.
Danish: Udslæt udvikledes hos 46% af de ikkeinficerede frivillige, der fik efavirenz og clarithromycin.
English: Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Danish: Anæmi var almindelig og misfarvning af huden (øget pigmentering) meget almindelig, når emtricitabin blev administreret til pædiatriske patienter.
English: Genotypic resistance to efavirenz, predominantly the K103N mutation, developed in virus from
Danish: Genotypisk resistens over for efavirenz, overvejende K103N-mutationen, udviklede sig i virus fra
English: Rosuvastatin is largely excreted unchanged via the faeces, therefore interaction with efavirenz is not expected.
Danish: Rosuvastatin udskilles hovedsageligt uændret via fæces, hvorfor interaktion med efavirenz ikke forventes.
English: If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Danish: Genoptagelse af hepatitis B-behandling kan være nødvendig.
English: Administration to patients with: a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
Danish: Administration til patienter med: - En familieanamnese med pludseligt dødsfald eller med kongenit forlængelse af QTc-intervallet på elektrokardiogrammer eller med andre kliniske tilstande, som vides at forlænge QTcintervallet.
English: No effect (↔) equals a decrease in mean ratio estimate of ≤ 20% or increase in mean ratio estimate of ≤ 25%.
Danish: Ingen virkning (↔) er lig en reduktion i den estimerede gennemsnitlige ratio på ≤ 20% eller en stigning i den estimerede gennemsnitlige ratio på ≤ 25%.
English: C12h: ↑ 3%
Danish: C12t: ↑ 3%
English: There have also been post-marketing reports of severe depression, death by suicide, delusions psychosis-like behaviour, and catatonia.
Danish: Efter markedsføring har der ligeledes været indberetninger vedrørende svær depression, selvmord, vrangforestillinger, psykose-lignende adfærd og katatoni.
English: Cmax: ↑ 64% (mechanism of interaction unknown)
Danish: Cmax: ↑ 64% (interaktionsmekanismen er ukendt)
English: Osteomalacia (manifested as bone pain and infrequently contributing to fractures)
Danish: Osteomalaci (manifesteret som knoglesmerter og i sjældne tilfælde medvirkende årsag til frakturer)
English: severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
Danish: - Svær forstyrrelse i elektrolytbalancen, f.eks. hypokaliæmi eller hypomagnesiæmi.
English: elevated serum AST and/or elevated serum ALT, hyperbilirubinaemia
Danish: Forhøjet serum ASAT og/eller forhøjet serum ALAT, hyperbilirubinæmi
English: In other studies (prospective and crosssectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor.
Danish: I andre studier (prospektive studier og tværsnitsstudier) sås de mest udtalte reduktioner i BMD hos patienter, der blev behandlet med tenofovirdisoproxil som del af et regime indeholdende en boostet proteasehæmmer.
English: These immunosuppressants are not anticipated to impact exposure of efavirenz.
Danish: Disse immunsuppressiva forventes ikke at påvirke efavirenz-eksponeringen.
English: Substantial decrease in lopinavir exposure, necessitating dosage adjustment of lopinavir/ritonavir.
Danish: Væsentligt fald i lopinavir-eksponeringen, hvilket nødvendiggør justering af lopinavir/ritonavirdosis.
English: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: Prækliniske data for emtricitabin viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
Danish: Læger bør holde sig til de aktuelle hiv-behandlingsretningslinjer for optimal håndtering af hivinfektion hos patienter med samtidig infektion med HBV.
English: → If you think that you may have any of these serious side effects, talk to your doctor.
Danish: → Hvis du tror, at du kan have en af disse alvorlige bivirkninger, skal du tale med lægen.
English: This may stop your medicines from working properly, or may make any side effects worse.
Danish: Dette kan bevirke, at den medicin, du tager, ikke virker ordentligt, eller at bivirkninger forværres.
English: Cross resistance profiles for efavirenz, nevirapine and delavirdine in vitro demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Danish: Krydsresistensprofilerne for efavirenz, neviparin og delavirdin in vitro har vist, at K103Nsubstitutionen medfører et tab af følsomhed over for alle tre NNRTIer.
English: Studies in humans and in vitro studies using human liver microsomes have demonstrated that efavirenz is principally metabolised by the CYP system to hydroxylated metabolites with subsequent glucuronidation of these hydroxylated metabolites.
Danish: Humane studier og in vitro studier med anvendelse af humane levermikrosomer har vist, at efavirenz hovedsageligt metaboliseres til hydroxylerede metabolitter af CYP-systemet med efterfølgende glukuronidering af disse hydroxylerede metabolitter.
English: Only a limited number of patients were co-infected with HBV (n = 13) or HCV (n = 26) in study GS01-934.
Danish: Det var kun et begrænset antal patienter, som samtidigt var inficerede med HBV (n=13) eller HCV (n=26) i studie GS01934.
English: Bupropion, a medicine used to treat depression or to help you stop smoking, as your doctor may need to change your dose of bupropion.
Danish: Bupropion, medicin til behandling af depression eller til at hjælpe dig med at holde op med at ryge, fordi din læge kan finde det nødvendigt at ændre din bupropion-dosis.
English: Since fluoxetine shares a similar metabolic profile with paroxetine, i.e. a strong CYP2D6 inhibitory effect, a similar lack of interaction would be expected for fluoxetine.
Danish: Da fluoxetin har samme metaboliske profil som paroxetin, dvs. en stærk CYP2D6hæmmende virkning, kan en lignende mangel på interaktion forventes for fluoxetin.
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Danish: Tenofovir udskilles primært af nyrerne ved både filtrering og et aktivt tubulært transportsystem, hvor ca. 70-80% af dosen udskilles uomdannet i urinen efter intravenøs indgivelse.
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg q.d.
Danish: En lignende reduktion i indinavir eksponering blev observeret når indinavir 1000 mg q8h blev givet sammen med efavirenz 600 mg q.d.
English: The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Danish: Øgningen af efavirenz' farmakokinetiske parametre anses ikke for klinisk signifikant.
English: (CYP3A4 induction
Danish: (CYP3A4induktion)
English: Parameters
Danish: Parameter
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: - på anmodning fra Det Europæiske Lægemiddelagentur - når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia or with congestive cardiac failure accompanied by reduced left ventricle ejection fraction.
Danish: - En anamnese med symptomatiske hjertearytmier eller med klinisk relevant bradykardi eller med kongestiv hjerteinsufficiens ledsaget af nedsat venstre ventrikel uddrivningsfraktion.
English: In vitro studies have shown that both emtricitabine and tenofovir can be fully phosphorylated when combined together in cells.
Danish: Studier in vitro har vist, at både emtricitabin og tenofovir kan phosphoryleres fuldstændigt, når de kombineres i celler.
English: Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
Danish: Din læge vil kontrollere kolesterolindholdet og overveje at ændre din statindosis, hvis det er nødvendigt.
English: Hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, as reported post-marketing, were sometimes characterised by a fulminant course, progressing in some cases to transplantation or death.
Danish: Leversvigt, herunder tilfælde hos patienter uden præeksisterende leversygdom eller andre identificerede risikofaktorer, blev i indberetninger efter markedsføringen nogle gange karakteriseret ved et fulminant forløb, som i nogle tilfælde progredierede til transplantation eller død.
English: Genotoxicity and repeated-dose toxicity studies of one month or less with the combination of these two components found no exacerbation of toxicological effects compared to studies with the separate components.
Danish: I studier af en måneds varighed eller derunder af genotoksicitet og af toksicitet efter gentagne doser med en kombination af disse to indholdsstoffer blev der ikke fundet nogen forværring af toksikologiske virkninger, sammenlignet med studier med de separate indholdsstoffer.
English: Interactions between efavirenz/emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, twice daily as “b.i.d.”, once daily as “q.d.” and once every 8 hours as “q8h”).
Danish: Interaktioner mellem efavirenz/emtricitabin/tenofovirdisoproxil eller dets individuelle komponent(er) og andre lægemidler ses i tabel 1 nedenfor (stigning er angivet som „↑“, fald som „↓“, ingen ændring som „↔“, to gange dagligt som „b.i.d.“, en gang dagligt som „q.d.“ og en gang hver 8. time som „q8t“).
English: Cmax: ↑ 38% (competitive inhibition of oxidative metabolism)
Danish: Cmax: ↑ 38% (kompetitiv hæmning af oxidativ metabolisme)
English: Findings in repeated-dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use include renal and bone toxicity and a decrease in serum phosphate concentration.
Danish: Resultater fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber ved eksponeringsniveauer højere end eller lig med kliniske eksponeringsniveauer og med mulig relevans for klinisk anvendelse omfatter nyre- og knogletoksicitet og et fald i serum-phosphat-koncentrationen.
English: Medicines used to prevent organ transplant rejection (also called immunosuppressants), such as cyclosporine, sirolimus or tacrolimus.
Danish: Medicin, der anvendes til at forhindre afstødning af transplanterede organer (også kaldet immunsuppresiva), såsom ciclosporin, sirolimus eller tacrolimus.
English: Also, emtricitabine did not inhibit uridine 5' diphosphoglucuronyl transferase, the enzyme responsible for glucuronidation.
Danish: Heller ikke emtricitabin hæmmede uridin 5'-diphosphoglukuronyltransferase, det enzym der er ansvarligt for glukuronidering.
English: AUC0-last (ng∙h/ml) 125,623.6
Danish: AUC0-last (ng∙t/ml) 125.623,6
English: Thymidine analogue associated mutations included D67N (n=1) and K70R (n=1).
Danish: Thymidin-analogassocierede mutationer omfattede D67N (n=1) og K70R (n=1).
English: M=Excluded
Danish: M=Ekskludere de
English: Psychiatric disorders: Common depression (severe in 3, anxiety 3, abnormal dreams 3, insomnia abnormal dreams, insomnia
Danish: Depression (svær hos 3, angst 3, abnorme drømme 3, søvnløshed
English: - if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
Danish: - Hvis De har en hjertelidelse, såsom et unormalt elektrisk signal kaldet forlænget QTinterval.
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: Din læge vil måske tage blodprøver for at kontrollere, hvordan din lever fungerer, eller kan skifte dig til anden medicin.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige natrium-fri.
English: Verapamil, Felodipine, Nifedipine and
Danish: Verapamil, felodipin, nifedipin og nicardipin
English: The clinical implications of such an association are unknown; however, the potential for an increased frequency and severity of efavirenz-associated adverse events cannot be excluded.
Danish: De kliniske implikationer af en sådan forbindelse er ukendte; muligheden for øget hyppighed af efavirenz-associerede bivirkninger kan dog ikke udelukkes, ligesom sværhedsgraden af disse ikke er kendt.
English: In HIV infected patients, peak efavirenz plasma concentrations were attained by 5 hours and steadystate concentrations reached in 6 to 7 days.
Danish: De højeste efavirenz-plasmakoncentrationer hos hiv-inficerede patienter blev opnået efter 5 timer og steady-state-koncentrationerne blev nået på 6-7 dage.
English: When
Danish: Når
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Tegnene på osteonekrose omfatter: stivhed, ømhed og smerter i led (især hofte, knæ og skuldre) samt bevægelsesbesvær.
English: Efavirenz significantly decreases voriconazole plasma concentrations while voriconazole also significantly increases efavirenz plasma concentrations.
Danish: Efavirenz reducerer plasmakoncentrationen af voriconazol signifikant, mens voriconazol også øger plasmakoncentrationen af efavirenz signifikant.
English: if you have a heart condition, such as an abnormal electrical signal called prolongation of the QT interval that puts you at high risk for severe heart rhythm problems (Torsade de Pointes).
Danish: hvis De har en hjertelidelse, såsom et unormalt elektrisk signal kaldet forlænget QTinterval, som giver høj risiko for alvorlige problemer med hjerterytmen (Torsade de Pointes).
English: AUCinf (ng∙h/ml) 146,074.9
Danish: AUCinf (ng∙t/ml) 146.074,9
English: Your doctor may also order blood tests during treatment to monitor your kidneys.
Danish: Lægen kan også bede om blodprøver under behandlingen for at kontrollere dine nyrer.
English: Since no dose recommendation can be made for itraconazole
Danish: Da der ikke kan gives nogen doseringsanbefaling for itraconazol, når det anvendes sammen med
English: → Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Danish: → Bemærker du nogle nye eller usædvanlige symptomer efter behandlingens ophør, skal du omgående oplyse din læge herom, især hvis det drejer sig om symptomer, som du forbinder med hepatitis B-infektion.
English: - Independent of a history of liver disease, your doctor will consider regular blood tests to check how your liver is working.
Danish: - Uanset om du tidligere har haft en leversygdom, vil din læge overveje at tage regelmæssige blodprøver for at kontrollere, hvordan din lever fungerer.
English: Common cerebellar coordination and balance disturbances somnolence (2.0%) headache (5.7%) disturbance in attention
Danish: Cerebellære koordinationsog balanceforstyrrelser døsighed (2,0%)
English: If you are pregnant, you should take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka only if you and your doctor decide it is clearly needed.
Danish: Hvis du er gravid, må du kun tage Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, hvis du og din læge beslutter, at det er klart nødvendigt.
English: Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Danish: Sertralin, medicin til behandling af depression, fordi din læge kan finde det nødvendigt at ændre din sertralin-dosis.
English: EU/1/17/1263/001 30 film-coated tablets EU/1/17/1263/002 90 (3 x 30) film-coated tablets
Danish: EU/1/17/1263/001 30 filmovertrukne tabletter EU/1/17/1263/002 90 (3 x 30) filmovertrukne tabletter
English: A similar trend was observed in a sub-group analysis of treatment-experienced patients with baseline HIV-1 RNA < 75 copies/ml from a retrospective cohort study (data collected over 20 months, see Table 5).
Danish: En lignende tendens blev observeret i en undergruppeanalyse af behandlingserfarne patienter med hiv1 RNA < 75 kopier/ml ved baseline fra et retrospektivt kohorte-studie (data indsamlet i løbet af 20 måneder, se tabel 5).
English: Side effects to the liver: If you are also infected with hepatitis B virus, you may experience a worsening of hepatitis after discontinuation of treatment (see section 3).
Danish: Bivirkninger, som påvirker leveren: Hvis du også har en hepatitis B-virusinfektion, kan du komme ud for en forværring af din hepatitis efter behandlingsophør (se punkt 3).
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
Danish: Hos nogle patienter med fremskreden leversygdom eller cirrose bør behandlingen ikke ophøre, fordi det kan medføre en forværring af din hepatitis, hvilket kan være livstruende.
English: Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in every 1,000 patients) but serious side effect that can be fatal.
Danish: Laktatacidose (overskud af mælkesyre i blodet) er en sjælden (kan påvirke op til 1 ud af hver 1.000 patienter), men alvorlig bivirkning, som kan være livstruende.
English: IMMUNOSUPPRESSANTS Immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, sirolimus)/Efavirenz
Danish: IMMUNSUPPRIMERENDE MIDLER Immunsuppressiva, som metaboliseres via CYP3A4 (f.eks. ciclosporin, tacrolimus, sirolimus)/efavirenz
English: Medicines used to treat malaria: Atovaquone/proguanil or artemether/lumefantrine.
Danish: Medicin til behandling af malaria: Atovaquon/proguanil eller artemether/lumefantrin.
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin.
Danish: Medicin til behandling af bakterieinfektioner, herunder tuberkulose og AIDS-relaterede mykobakterier: Clarithromycin, rifabutin, rifampicin.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Indenfor hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: patients with HIV-1 RNA < 50 copies/ml
Danish: Patienter med hiv-1 RNA < 50 kopier/ml