FrancophonIA/ELRC3.0 huggingface dataset:
English: Two of the studies compared adding Azopt, dorzolamide or placebo (a dummy treatment) to timolol, and the final two studies compared Azopt used twice a day with timolol, when they were used as an add-on to travoprost (a prostaglandin analogue).
Danish: I de sidste to undersøgelser sammenlignedes Azopt anvendt to gange dagligt i kombination med timolol som tillægsbehandling til travoprost (en prostaglandinanalog).
English: By blocking the production of bicarbonate in the eye, Azopt slows down the production of aqueous humour, reducing the pressure inside the eye.
Danish: Ved at hæmme bikarbonatproduktionen bremser Azopt produktionen af kammervæske.
English: In three of the studies, Azopt, used on its own two or three times a day, was compared with timolol (a beta-blocker) and with dorzolamide (another carbonic anhydrase inhibitor).
Danish: Det blev her sammenlignet med timolol (en betablokker) og dorzolamid (en anden carboanhydrasehæmmer).
English: Azopt was as effective as dorzolamide when used on its own or as an add-on to timolol, with decreases in pressure of between 3.4 and 5.7 mmHg.
Danish: Azopt var lige så effektivt som dorzolamid, når det blev anvendt alene eller som tillægsbehandling til timolol.
English: How does Azopt work?
Danish: Hvordan virker Azopt?
English: - if you are over 65.
Danish: - Hvis De er over 65 år.
English: Insufficient safety data are available for children below 18 years of age.
Danish: Der foreligger ikke tilstrækkelige sikkerhedsdata for børn under 18 år.
English: Component of a multipack cannot be sold separately.
Danish: En del af en multipakning må ikke sælges separat.
English: <for carton only> Open date:
Danish: <kun til kartonen> Åbningsdato:
English: (mechanism)
Danish: (mekanisme)
English: *lower than recommended dose
Danish: * Lavere end anbefalede dosis
English: Wait and take the next dose at the regular time.
Danish: Vent, og tag den næste dosis på det normale tidspunkt.
English: Based on the different elimination pathways, no interaction is expected.
Danish: Baseret på forskellige elimineringsveje forventes ingen interaktion.
English: - any signs of inflammation or infection.
Danish: - Tegn på betændelse eller infektion.
English: Values for Test and Reference are mean (% coefficient of variation).
Danish: Værdierne for Test og Reference er gennemsnitlige (% variationskoefficient).
English: Tenofovir concentrations not measured, no effect is expected.
Danish: Koncentrationen af tenofovir er ikke målt, ingen virkning forventes.
English: Lopinavir concentrations: ↓ 30
Danish: Lopinavir-koncentrationer: ↓ 30
English: If bone abnormalities are suspected then appropriate consultation should be obtained.
Danish: Hvis der er mistanke om knogleabnormiteter, skal der foretages relevant konsultation.
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: 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: - bone problems.
Danish: - Knogleproblemer.
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 bupropion-dosis skal styres af klinisk respons, men den maksimalt anbefalede bupropiondosis må ikke overskrides.
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: Selvom effektiv viral suppression med antiretroviral behandling har vist sig at nedsætte risikoen væsentligt for seksuel overførsel, kan en residualrisiko ikke udelukkes.
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 med en reduktion i den estimerede gennemsnitlige ratio på ≤ 20% eller en stigning i den estimerede gennemsnitlige ratio på ≤ 25%.
English: An alternative anticonvulsant should be considered.
Danish: Et alternativt krampestillende lægemiddel skal overvejes.
English: • liver failure, in some cases leading to death or liver transplant.
Danish: • leversvigt, som i nogle tilfælde medfører død eller levertransplantation.
English: - if you have or have had kidney disease, or if tests have shown problems with your kidneys.
Danish: - Hvis De har eller har haft en nyresygdom, eller hvis prøver har vist, at der er problemer med Deres nyrer.
English: Thirteen percent of the emtricitabine dose was recovered in urine as three metabolites.
Danish: 13% af emtricitabin-dosen blev genfundet i urinen som tre metabolitter.
English: PVR (KM): Pure virologic response assessed using the Kaplan Meier (KM) method M: Missing
Danish: PVR (KM): Rent virologisk respons vurderet ved hjælp af Kaplan Meier- (KM) metoden: M: Mangler
English: ANTI-INFECTIVES HIV antivirals
Danish: ANTI-INFEKTIVER Hiv-antiviraler
English: Expected: Voxilaprevir:↓
Danish: Forventet: Voxilaprevir:↓
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: De kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem, som fremgår af Appendiks V. Når De indberetter bivirkninger, kan De hjælpe med at tilvejebringe yderligere oplysninger om sikkerheden ved denne medicin.
English: - You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: - De kan stadig smitte andre med hiv, selvom De tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
Danish: Denne reduktion i atazanavir Cmin kan forringe virkningen af atazanavir.
English: Mean percent change in AUC, Cmax, Cmin with 90% confidence intervals if available
Danish: Ændring i gennemsnitprocent i AUC, Cmax, Cmin med 90% konfidensintervaller, hvis det er muligt
English: Alternative treatment regimens should be considered for patients with osteoporosis that are at a high risk for fractures.
Danish: Alternative behandlingsregimener skal overvejes til patienter med osteoporose med høj risiko for frakturer.
English: Excipient with known effect:
Danish: Hjælpestoffer med kendt effekt:
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse.
English: If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Danish: Genoptagelse af antihepatitis b-behandling kan være nødvendig.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale indberetningssystem anført i Appendiks V.
English: See section 2.
Danish: Se punkt 2.
English: Efavirenz is an NNRTI of HIV-1.
Danish: Efavirenz er en NNRTI af hiv-1.
English: Efavirenz has a relatively long terminal half-life of at least 52 hours after single doses (see also data from bioequivalence study described above) and 40 to 55 hours after multiple doses.
Danish: Efavirenz har en forholdsvis lang terminal halveringstid på mindst 52 timer efter enkeltdoser (se også data fra bioækvivalensstudiet beskrevet ovenfor) og 40-55 timer efter multiple doser.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og kartonen efter (EXP).
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Alle inflammatoriske symptomer skal vurderes, og behandling påbegyndes efter behov.
English: • allergic reaction (hypersensitivity) that may cause severe skin reactions (Stevens-Johnson syndrome, erythema multiforme, see section 2)
Danish: • allergisk reaktion (overfølsomhed) som kan medføre alvorlige hudreaktioner (Stevens-Johnsons syndrom, erythema multiforme, se punkt 2)
English: - if you have a history of mental illness, including depression, or of substance or alcohol abuse.
Danish: - Hvis De tidligere har haft en psykisk sygdom, herunder depression, eller stof- eller alkoholmisbrug.
English: Tell your doctor if you are taking other medicines which may damage your kidneys.
Danish: Fortæl det til lægen, hvis De tager anden medicin, som kan skade Deres nyrer.
English: Patients coinfected with HIV and HBV
Danish: Patienter som samtidigt er inficerede med hiv og HBV
English: Patients must not have experienced failure of a previous HIV therapy.
Danish: Patienterne behøver ikke at have være udsat for, at en tidligere hiv-behandling ikke har virket.
English: Carbamazepine plasma levels should be monitored periodically.
Danish: Carbamazepins plasmakoncentrationer skal monitoreres regelmæssigt.
English: - if you have a history of liver disease, including chronic active hepatitis.
Danish: - Hvis De tidligere har haft en leversygdom, herunder kronisk aktiv hepatitis.
English: These immunosuppressants are not anticipated to impact exposure of efavirenz.
Danish: Disse immunsuppressiva forventes ikke at påvirke eksponeringen af efavirenz.
English: It is important to tell your doctor or pharmacist if you are taking any of the following:
Danish: Det er vigtigt, at De fortæller det til Deres læge eller apotekspersonalet, hvis De tager et eller flere af følgende:
English: (ng·h/ml)
Danish: (ng·t/ml)
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 regimener i første trimester, og som resulterede i 766 levendefødsler.
English: Stayed on original treatment regimen (N=97) n/N (%)
Danish: Blev i originalt behandlingsreg imen (N=97) n/N (%)
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Patienter med sjældne, arvelige problemer, som galaktose-intolerans, total laktase-mangel eller malabsorption af glucose-galaktose, må ikke tage denne medicin.
English: Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Danish: Patienterne skal informeres om, at disse almindelige bivirkninger sandsynligvis bedres ved fortsat behandling, og at de ikke betyder, at der efterfølgende vil opstå nogle af de mindre hyppige psykiatriske symptomer.
English: The clinical significance of these changes in clarithromycin plasma levels is not known.
Danish: Den kliniske signifikans af disse ændringer i clarithromycins plasmakoncentrationer kendes ikke.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 September 2017
Danish: Dato for første markedsføringstilladelse: 05 September 2017
English: Cholesterol levels should be periodically monitored.
Danish: Kolesterolkoncentrationerne skal monitoreres regelmæssigt.
English: 6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Use within 60 days after first opening.
Danish: Skal bruges inden for 60 dage efter anbrud.
English: Pharmacokinetics in special populations
Danish: Farmakokinetik i særlige populationerAlder
English: Because of interpatient variability in these parameters and concerns regarding development of resistance, HIV treatment guidelines should be consulted, also taking into consideration the reason for discontinuation.
Danish: På grund af den individuelle variabilitet i disse parametre samt risikoen for resistensudvikling skal anbefalingerne for hiv-behandling konsulteres, idet årsagen til seponering også tages med i overvejelserne.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling af hepatitis b eller c henvises der også til de relevante produktresuméer for disse lægemidler.
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: Cmax: ↑ 64% (mechanism of interaction unknown)
Danish: Cmax: ↑ 64% (Interaktionsmekanisme kendes ikke)
English: Individual tolerability and virological response should be considered when making the dose adjustment (see section 5.2).
Danish: Individuel tolerabilitet og virologisk respons skal tages i betragtning, når dosis justeres (se pkt.
English: Monitoring of renal function may be indicated, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Danish: Monitorering af nyrefunktion kan indiceres, især hos patienter med underliggende systemisk eller renal sygdom eller hos patienter, der tager nefrotoksiske lægemidler.
English: It contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og Pneumocystis jirovecii-pneumoni.
English: There were insufficient data to determine whether moderate or severe hepatic impairment (Child-Pugh-Turcotte Class B or C) affects efavirenz pharmacokinetics.
Danish: Der var utilstrækkelige data til at bestemme, om moderat eller svær nedsat leverfunktion (Child-Pugh-Turcotte klasse B eller C) påvirker farmakokinetikken for efavirenz.
English: Refer to the Summary of Product Characteristics for the medicinal product containing maraviroc.
Danish: Se produktresuméet for lægemidlet indeholdende maraviroc.
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 NNRTI'er.
English: This may stop your medicines from working properly, or may make any side effects worse.
Danish: Det kan stoppe den hensigtsmæssige virkning af Deres medicin eller forværre evt. bivirkninger.
English: Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Danish: På trods af reduktionen i eksponering for buprenorphin udviste ingen af patienterne abstinenssymptomer.
English: • disturbances of coordination and balance
Danish: • Allergiske reaktioner • Koordinations- og balanceproblemer
English: In other studies (prospective and cross-sectional), 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 en del af et regimen indeholdende en boostet proteasehæmmer.
English: Open date:
Danish: Åbningsdato:
English: Verapamil, Felodipine, Nifedipine and Nicardipine
Danish: Verapamil, felodipin, Nifedipin og nicardipin
English: Substantial decrease in lopinavir exposure, necessitating dosage adjustment of lopinavir/ritonavir.
Danish: Betydeligt fald i eksponering af lopinavir, der nødvendiggør dosisjustering af lopinavir/ritonavir.
English: 117 Allée Des Parcs, 69 800 Saint-Priest, France
Danish: 117 Allée Des Parcs, 69 800 Saint-Priest, Frankrig
English: Modified LOCF: Post-hoc analysis where patients who failed virologically or discontinued for adverse events were treated as failures; for other drop-outs, the LOCF (last observation carried forward) method was applied
Danish: Modificeret LOCF: Post-hoc-analyse, hvor patienterne med virologisk „failure“ eller som afsluttede pga bivirkninger, blev behandlet som „failures“; for andre „drop-outs“ blev LOCF-metoden (last observation carried forward) brugt.
English: - a history of symptomatic cardiac arryhthmias 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: If you think that you may have any of these serious side effects, talk to your doctor.
Danish: Hvis De tror, at De kan have en af disse alvorlige bivirkninger, skal De tale med lægen.
English: The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Danish: Den kliniske konsekvens af denne observerede reduktion i dal-boceprevirkoncentrationen er ikke blevet vurderet direkte.
English: This medicine is available in plastic bottles containing a desiccant labelled ‘DO NOT EAT' and 30 tablets and in multipacks of 90 tablets comprising 3 bottles, each containing 30 tablets.
Danish: Medicinen fås i tabletbeholdere med tørremiddel mærket "MÅ IKKE SPISES" og 30 tabletter og i multipakninger med 90 tabletter i 3 tabletbeholdere hver med 30 tabletter.
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulphoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Biotransformation af emtricitabin omfatter oxidering af thioldelen til dannelse af 3'-sulphoxiddiastereomerer (ca. 9% af dosis) samt konjugation med glukuronsyre til dannelse af 2'-O-glukuronid (ca. 4% af dosis).
English: K103N was the most frequently observed RT substitution in viral isolates from patients who experienced rebound in viral load during clinical studies of efavirenz.
Danish: K103N var den hyppigst observerede RT-substitution i virale isolater fra patienter, som oplevede reboundviræmi under de kliniske studier med efavirenz.
English: In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Danish: Hos sådanne patienter skal det overvejes at afbryde eller seponere behandlingen (se pkt.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/YYYY}.
English: Physicians should refer to current HIV treatment guidelines for the optimal management of HIV infection in patients co-infected with HBV.
Danish: Læger skal holde sig til de aktuelle hiv-behandlingsretningslinjer for optimal håndtering af hivinfektion hos patienter med samtidig infektion med HBV.
English: Poly(vinyl alcohol)
Danish: Poly(vinylalkohol) Talkum
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Hvor længe den antiretrovirale kombinationsbehandling varer, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar samt højere Body Mass Index (BMI) kan bl.a. være nogle af mange risikofaktorer for at udvikle denne sygdom.
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: One child was reported to have a neural tube defect, and the frequency and pattern of other birth defects were similar to those seen in children exposed to non-efavirenz-containing regimens, as well as those in HIV negative controls.
Danish: Der blev rapporteret om ét barn med neuralrørsdefekt, og frekvensen og mønsteret for andre fødselsdefekter var de samme som hos børn, der havde været eksponeret for regimener uden efavirenz samt hos hiv-negative kontroller.
English: - dry mouth - incoherent speech - increased appetite - libido decreased - myalgia
Danish: Ikke almindelig: - Mundtørhed - Usammenhængende tale - Øget appetit - Nedsat libido - Myalgi
English: Common elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated gammaglutamyltransferase (GGT)
Danish: Forhøjet aspartatamino-transferase (ASAT), forhøjet alaninaminotransferase (ALAT), forhøjet gammaglutamyl-transferase (GGT)
English: In uninfected volunteers, multiple doses of 200 to 400 mg per day for 10 days resulted in a lower than predicted extent of accumulation (22 to 42% lower) and a shorter terminal half-life of 40 to 55 hours (single dose half-life 52 to 76 hours).
Danish: Hos ikke-inficerede frivillige resulterede multiple doser på 200-400 mg pr. dag i 10 dage i en lavere grad af akkumulation (22-42% lavere) end forudset samt kortere terminal halveringstid på 40-55 timer (halveringstid for enkeltdosis 52-76 timer).
English: Rare completed suicide3,4, delusion3,4, neurosis3,4
Danish: Fuldbyrdet selvmord3,4, vrangforestillinger3,4, neuroser3,4
English: Clinically significant interactions are not expected as simeprevir and emtricitabine are eliminated via different pathways.
Danish: Klinisk signifikante interaktioner forventes ikke, da simeprevir og emtricitabin elimineres via forskellige veje.
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: 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-fosfatkoncentrationen.
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: 1 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Danish: Smerter, asteni 1 Anæmi var almindelig og misfarvning af huden (øget pigmentering) meget almindelig, når emtricitabin blev administreret til pædiatriske patienter.