FrancophonIA/ELRC3.0 huggingface dataset:
English: Total rifabutin and
Danish: Total rifabutin og
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Danish: Tal med lægen om, hvilke forholdsregler, der er nødvendige for at undgå at smitte andre personer.
English: Some people will need special care before or while taking EVOTAZ.
Danish: Visse mennesker har behov for særlige hensyn, før eller mens de tager EVOTAZ.
English: Wait and take the next dose at the usual time.
Danish: Vent og tag den næste dosis til sædvanlig tid.
English: The lowest dose of digoxin should initially be prescribed.
Danish: Den lavest mulige dosis af digoxin bør indledningsvist ordineres.
English: Alternative antibiotics should be considered.
Danish: Andre typer antibiotika bør overvejes.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 July 2015
Danish: Dato for første markedsføringstilladelse: 13. juli 2015
English: A dose reduction of buprenorphine may be considered.
Danish: Reduktion af buprenorphin-dosis kan overvejes.
English: Consideration should be given to official guidance on the appropriate treatment of tuberculosis in HIV infected patients.
Danish: Der bør tages hensyn til de officielle retningslinjer for korrekt behandling af tuberkulose hos hiv-inficerede patienter.
English: Treatment should consist of general supportive measures including monitoring of vital signs and ECG as well as observation of the patient's clinical status.
Danish: Behandlingen bør bestå af generelt understøttende tiltag, inklusive monitorering af vitale tegn og ekg samt observation af patientens kliniske status.
English: Some patients required hospitalisation for additional management and some had complications.
Danish: Hos nogle patienter krævede dette hospitalsindlæggelse med yderligere behandling, og nogle patienter havde komplikationer.
English: An initial dose reduction of diltiazem by 50% should be considered, and electrocardiogram monitoring is recommended.
Danish: En initial dosisreduktion af diltiazem med 50% bør overvejes, og elektrokardiografisk monitorering anbefales.
English: Electrocardiogram monitoring is recommended.
Danish: Elektrokardiografisk monitorering anbefales.
English: If available, 90% confidence intervals (CI) are shown in parentheses.
Danish: Hvis tilgængelige angives 90% konfidensinterval (KI) i parentes.
English: Table 1: Interactions between EVOTAZ and other medicinal products Medicinal products by therapeutic area
Danish: Tabel 1: Interaktioner mellem EVOTAZ og andre lægemidler Lægemidler efter terapeutisk område
English: The use of EVOTAZ should only be considered during pregnancy if the potential benefit justifies the potential risk.
Danish: Brug af EVOTAZ bør kun overvejes i graviditetsperioden, hvis den potentielle gavnlige effekt opvejer den potentielle risiko.
English: Subsequent 9 month oral toxicity studies in dogs showed no drug-related electrocardiographic changes.
Danish: Efterfølgende 9 måneders orale toksicitetsstudier i hunde viste ingen lægemiddelrelaterede elektrokardiografiske forandringer.
English: When treating HIV infection, it is not always easy to identify what side effects are caused by EVOTAZ, by the other medicines you are taking, or by the HIV infection itself.
Danish: Ved behandling af hiv-infektion er det ikke altid let at sige, hvilke bivirkninger der skyldes EVOTAZ, anden medicin du tager eller selve hiv-infektionen.
English: The studies presented in Table 1 were conducted in healthy subjects unless otherwise noted.
Danish: Studierne, der refereres til i Tabel 1, er udført med raske frivillige, medmindre andet er angivet.
English: The mechanism of interaction is unknown.
Danish: Interaktionsmekanismen er ukendt.
English: LOC. FONTANA DEL CERASO, ANAGNI, 03012, Italy
Danish: LOC. FONTANA DEL CERASO, ANAGNI, 03012, Italien
English: If you stop taking EVOTAZ Do not stop taking EVOTAZ before talking to your doctor.
Danish: Hvis du holder op med at tage EVOTAZ Du må ikke holde op med at tage EVOTAZ uden at have talt med lægen.
English: b See section Description of selected adverse reactions for more details.
Danish: b Se afsnittet Beskrivelse af udvalgte bivirkninger for flere oplysninger.
English: These medicines control human immunodeficiency virus (HIV) infection by stopping production of a protein that HIV needs for its multiplication.
Danish: Denne slags medicin kontrollerer infektion med human immundefektvirus (hiv) ved at stoppe produktionen af et protein, som hiv har brug for til at mangfoldiggøre sig.
English: EU/1/15/1025/001 30 film-coated tablets EU/1/15/1025/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/15/1025/001 30 filmovertrukne tabletter EU/1/15/1025/002 90 (3 beholdere á 30) filmovertrukne tabletter
English: The use of EVOTAZ in children and adolescents has not yet been studied.
Danish: Anvendelse af EVOTAZ til børn og unge er ikke undersøgt endnu.
English: Swallow the tablet whole; do not crush or chew the tablets.
Danish: Synk tabletten hel; du må ikke knuse eller tygge tabletterne.
English: You can still pass on HIV to other people when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: Du kan stadig smitte andre mennesker med hiv, selvom du tager dette lægemiddel, selvom risikoen er nedsat ved effektiv antiretroviral terapi.
English: Grade 3 or 4 elevation of total bilirubin was noted in 37% (6% Grade 4).
Danish: Grad 3 eller 4 forhøjelse af total-bilirubin blev noteret hos 37% (6% grad 4).
English: CCR5 Antagonists
Danish: CCR5-antagonister
English: Study conducted in HIV infected patients
Danish: Studie udført med hiv-inficerede patienter
English: Adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to 1/1,000).
Danish: Bivirkninger er opført efter systemorganklase og hyppighed: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100) og sjælden (≥1/10.000 til 1/1.000).
English: In this way atazanavir reduces the risk of developing illnesses linked to HIV infection.
Danish: På denne måde nedsætter atazanavir risikoen for at udvikle sygdomme forbundet med hiv-infektion.
English: It is normally used in combination with other anti-HIV medicines to help control your HIV infection.
Danish: Det anvendes normalt i kombination med anden medicin mod hiv og medvirker til at kontrollere din hiv-infektion.
English: In treatment-naïve HIV-1 infected patients
Danish: Behandlingsnaive hiv-1-inficerede patienter
English: It should be kept in mind that the twice weekly dosage of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifamycin resistance and a treatment failure.
Danish: Det bør erindres, at 2 ugentlige doser på 150 mg muligvis ikke giver en optimal eksponering for rifabutin med deraf følgende risiko for rifamycin resistens og behandlingssvigt.
English: GASTROINTESTINAL MOTILITY AGENTS Cisapride
Danish: GASTROINTESTINALE MOTILITETSMIDLER Cisaprid
English: EVOTAZ is not a cure for HIV infection.
Danish: EVOTAZ er ikke en kur mod hiv-infektion.
English: PULMONARY ARTERIAL HYPERTENSION
Danish: PULMONAL ARTERIEL HYPERTENSION
English: The film-coated tablet should be swallowed whole and must not be chewed, broken, cut or crushed.
Danish: Den filmovertrukne tablet synkes hel og må ikke tygges, brækkes over, skæres over eller knuses.
English: An increase from baseline in serum creatinine solely due to cobicistat's inhibitory effect generally does not exceed 0.4 mg/dl.
Danish: Stigning fra baseline i serum-kreatinin på grund af cobicistat alene overstiger generelt ikke 0,4 mg/dl.
English: Make sure your doctor knows: if you have liver problems if you develop signs or symptoms of gall stones (pain in your right side).
Danish: Vær sikker på, at din læge ved det: hvis du har leverproblemer hvis du får tegn eller symptomer på galdesten (smerter i højre side).
English: Caution should be exercised.
Danish: Der bør udvises forsigtighed.
English: Quetiapine Lurasidone
Danish: Quetiapin Lurasidon
English: d Includes patients who discontinued due to adverse event (AE) or death at any time point from day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Danish: d Omfatter patienter, som afbrød behandlingen som følge af en bivirkning eller død på et tidspunkt fra dag 1 og i løbet af tidsvinduet, hvis dette ikke resulterede i virologiske data om behandlingen i løbet af det specificerede tidsvindue.
English: The median age of subjects was 36 years (range: 19-70).
Danish: Forsøgspersonernes medianalder var 36 år (19-70).
English: EVOTAZ should be administered 2 hours before or 1 hour after antacids or buffered medicinal products.
Danish: EVOTAZ bør administreres 2 timer før eller 1 time efter antacida eller lægemidler med buffer.
English: Cobicistat has no antiviral activity.
Danish: Cobicistat har ingen antiviral aktivitet.
English: If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: In the majority of cases, jaundice was reported within a few days to a few months after the initiation of treatment (see section 4.4).
Danish: I størstedelen af tilfældene blev gulsot rapporteret inden for få dage til få måneder efter opstart af behandlingen (se pkt.
English: Electrocardiographic changes (sinus bradycardia, prolongation of PR interval, prolongation of QT interval, and prolongation of QRS complex) were observed only in an initial 2 week oral toxicity study performed in dogs.
Danish: Elektrokardiografiske forandringer (sinusbradykardi, forlængelse af PR-interval, forlængelse af QT-interval og forlængelse af QRS-kompleks) blev kun observeret i et indledende 2-ugers oral toksicitetsstudie udført i hunde.
English: The 24-hour atazanavir concentration following a high-fat meal was increased approximately 23% due to delayed absorption; the median Tmax increased from 2.0 to 3.5 hours.
Danish: 24-timers koncentrationen af atazanavir efter et fedtrigt måltid steg med ca. 23% som følge af forsinket absorption; median Tmax steg fra 2,0 til 3,5 timer.
English: rifampicin (an antibiotic used to treat tuberculosis)
Danish: rifampicin (et antibiotikum, der bruges til at behandle tuberkulose).
English: EVOTAZ and dolutegravir can be used without dose adjustments.
Danish: EVOTAZ og dolutegravir kan anvendes uden dosisjusteringer.
English: EVOTAZ should not be used in children less than 3 months of age because of safety concerns especially taking into account the potential risk of kernicterus associated with the atazanavir component.
Danish: EVOTAZ bør ikke anvendes til børn under 3 måneder på grund af problemstillinger vedrørende sikkerhed, især på grund af den potentielle risiko for kernicterus, som er forbundet med indholdet af atazanavir.
English: EVOTAZ has no or negligible influence on the ability to drive or use machines.
Danish: EVOTAZ påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The signs may be a mild yellowing of the skin or eyes.
Danish: Symptomerne kan være svag gulfarvning af hud og øjne.
English: It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.
Danish: Kvinder, som er smittede med hiv bør ikke amme, da virusset kan overføres gennem modermælken.
English: The median terminal plasma half-life of cobicistat following administration of cobicistat is approximately 3-4 hours.
Danish: Den mediane terminale halveringstid i plasma efter administration af cobicistat er ca. 3-4 timer.
English: Atorvastatin 10 mg single dose
Danish: Atorvastatin 10 mg enkeltdosis
English: No virologic data in week 48 or week 144 window Discontinued study drug due to AE or deathd
Danish: Ingen virologiske data i uge 48 eller uge 144-vinduet Seponeret studielægemiddel som følge af bivirkning eller dødd
English: Complex or unknown mechanisms of drug interaction preclude extrapolation of ritonavir drug interactions to certain cobicistat drug interactions.
Danish: Komplekse eller ukendte mekanismer ved lægemiddelinteraktion udelukker ekstrapolering af ritonavir lægemiddelinteraktioner med visse cobicistat lægemiddelinteraktioner.
English: Cobicistat, does not directly treat your HIV, but boosts the levels of atazanavir in the blood.
Danish: Cobicistat behandler ikke hiv direkte, men forhøjer niveauerne af atazanavir i blodet.
English: If the patient has developed SJS or DRESS associated with the use of EVOTAZ, EVOTAZ may not be restarted.
Danish: Hvis patienten har udviklet SJS eller DRESS under behandling med EVOTAZ, bør EVOTAZ-behandling ikke genoptages.
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 ved hepatitis B eller C, henvises der også til de relevante produktresuméer for disse lægemidler.
English: Atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Danish: Atazanavir udviser anti-hiv-1 (herunder alle testede undergrupper) og anti-hiv-2 aktivitet i cellekulturer.
English: Data are not available to make recommendations regarding the use of EVOTAZ with other oral contraceptives.
Danish: Der foreligger ingen data til at fremsætte anbefalinger for brugen af EVOTAZ med andre orale kontraceptiva.
English: There is no specific antidote for overdose with EVOTAZ.
Danish: Der findes ingen specifik antidot for overdosering med EVOTAZ.
English: If trazodone is co-administered with EVOTAZ, the combination should be used with caution and a lower dose of trazodone should be considered.
Danish: Hvis trazodon administreres samtidig med EVOTAZ, bør kombinationen anvendes med forsigtighed og en lavere dosis af trazodon bør overvejes.
English: Calcium channel blockers
Danish: Calciumkanalblokkere
English: A coagulation test helps to identify patients with an increased bleeding risk due to increased dabigatran exposure.
Danish: En koagulationstest kan hjælpe med at identificere patienter med øget blødningsrisiko som følge af øget dabigatran-eksponering.
English: Interactions between EVOTAZ and other medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Danish: Interaktioner mellem EVOTAZ og andre lægemidler angives i Tabel 1 (stigninger er angivet med “↑”, fald med “↓”, ingen ændring med “↔”).
English: In study GS-US-216-0114, decreases in estimated creatinine clearance occurred early in treatment with cobicistat, after which they stabilised.
Danish: I studie GS-US-216-0114 opstod der fald i den estimerede kreatininclearance tidligt i behandlingen med cobicistat, hvorefter den stabiliserede sig.
English: Very common (may affect more than 1 in 10 people) ocular icterus (presence of jaundice in the white part of the eyes, i.e. the eyes become yellow) nausea jaundice (when the skin and/or eyes become yellow)
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer) gulsot i det hvide i øjnene, dvs. øjnene bliver gule (okulær ikterus) kvalme gulsot (når hud og/eller øjne bliver gule)
English: If co-administration is required, the daily dose of ketoconazole or itraconazole should not exceed 200 mg.
Danish: Hvis samtidig administration er nødvendig, bør den daglige dosis af ketoconazol eller itraconazol ikke oversige 200 mg.
English: When co-administration is necessary, do not exceed 10 mg rosuvastatin daily, and clinical monitoring for safety (e.g. myopathy) is recommended.
Danish: Hvis samtidig administration er nødvendig, må dosis ikke overstige 10 mg rosuvastatin dagligt, og klinisk monitorering for sikkerhed (f.eks. myopati) anbefales.
English: This way, you can be sure your medicine is fully effective and you reduce the risk of the HIV-virus developing resistance to the treatment.
Danish: Sådan kan du være sikker på, at medicinen virker bedst muligt, og risikoen for, at hiv-virusset udvikler resistens over for behandlingen, er mindre.
English: EVOTAZ contains two active substances: atazanavir, an antiviral (or antiretroviral) medicine.
Danish: EVOTAZ indeholder to aktive stoffer: atazanavir, en medicin til antiviral (eller antiretroviral) behandling.
English: Your doctor will discuss with you which combination of these medicines with EVOTAZ is best for you.
Danish: Lægen vil tale med dig om, hvilken kombination af anden medicin og EVOTAZ, der er bedst for dig.
English: HORMONAL CONTRACEPTIVES Progestin/estrogen
Danish: HORMONELLE KONTRACEPTIVA Progestin/østrogen
English: In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive embryo-development study.
Danish: Hos drægtige kaniner sås omfattende læsioner i mave og tarm hos døde eller moribunde hunner ved maternelle doser 2 og 4 gange den højeste dosis administreret i det endelige fosterudviklingsstudie.
English: If you forget to take EVOTAZ
Danish: Hvis du har glemt at tage EVOTAZ
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandling bør indledes af en læge, der har erfaring med behandling af hiv-infektion.
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 mykobakterielle infektioner og pneumocystis jirovecii pneumoni.
English: To enhance bioavailability, EVOTAZ is to be taken with food.
Danish: For at øge biotilgængeligheden skal EVOTAZ tages sammen med et måltid.
English: The mechanism of interaction between atazanavir and tenofovir DF is unknown.
Danish: Interaktionsmekanismen mellem atazanavir og tenofovir DF er ukendt.
English: Co-administration of EVOTAZ and rilpivirine can be used without dose adjustments, as the expected increase in rilpivirine concentrations is not considered clinically relevant.
Danish: Samtidig administration af EVOTAZ og rilpivirin kan foretages uden dosisjusteringer, da den forventede stigning i rilpivirin-koncentrationen ikke anses for klinisk relevant.
English: The pharmacokinetics of atazanavir and cobicistat, alone or in combination, have not been evaluated in an elderly population (65 years of age and older).
Danish: Atazanavirs og cobicistats farmakokinetik, hver for sig eller i kombination, er ikke undersøgt hos den ældre population (65 år og derover).
English: Among the 21 subjects, 3 developed the emtricitabine-associated resistance substitution M184V.
Danish: Blandt de 21 forsøgspersoner udviklede 3 den emtricitabin-relaterede resistenssubstitution M184V.
English: The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Danish: Følgende pakningsstørrelser er tilgængelige: Yderkarton med 1 tabletbeholder indeholdende 30 filmovertrukne tabletter og yderkarton med 90 (3 beholdere á 30) filmovertrukne tabletter.
English: The dose of the H2-receptor antagonist should not exceed a dose comparable to famotidine 20 mg twice daily.
Danish: Dosis af H2-receptorantagonisten bør ikke overstige en dosis, der svarer til famotidin 20 mg to gange dagligt.
English: Table 3: Virologic outcome of randomised treatment of study GS-US-216-0114 at weeks 48a and 144b
Danish: Tabel 3: Virologisk resultat af randomiseret behandling i studie GS-US-216-0114 ved uge 48a og 144b
English: If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom)
Danish: Hvis du på nuværende tidspunkt tager p-piller eller anvender p-plastre for at forebygge graviditet, skal du anvende et ekstra eller en anden type præventionsmiddel (f.eks. kondom).
English: If you accidentally take more EVOTAZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Danish: Hvis du ved en fejltagelse har taget mere af EVOTAZ, end lægen har foreskrevet, skal du kontakte din læge eller nærmeste hospital og bede om råd.
English: Treatment outcomes at weeks 48 and 144 for study GS-US-216-0114 are presented in Table 3.
Danish: Behandlingsresultater ved uge 48 og 144 for studie GS-US-216-0114 er anført i Tabel 3.
English: The following statements reflect the preclinical safety results of the individual active substances of EVOTAZ.
Danish: Følgende redegørelser vedrører de præ-kliniske sikkerhedsresultater for de enkelte aktive stoffer i EVOTAZ.
English: When co-administering maraviroc and EVOTAZ, patients should receive maraviroc 150 mg twice daily.
Danish: Ved samtidig administration af maraviroc og EVOTAZ bør patienten få maraviroc 150 mg to gange dagligt.
English: Effects on estimated creatinine clearance
Danish: Effekt på estimeret kreatininclearance
English: For these sedatives/hypnotics, dose reduction may be necessary and concentration monitoring is recommended.
Danish: Dosisreduktion af disse sedativa/hypnotika kan være nødvendig, og monitorering af koncentrationer anbefales.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking EVOTAZ.
Danish: Omhyggelig patientmonitorering og dosisjustering af metformin anbefales hos patienter, der tager EVOTAZ.
English: Patients with previous liver dysfunction or patients with chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med tidligere leverdysfunktion eller patienter med kronisk aktiv hepatitis har en øget forekomst af abnorm leverfunktion under antiretroviral kombinationsbehandling og bør monitoreres i overensstemmelse med standardpraksis.
English: It is unknown if cobicistat/metabolites are excreted in human milk.
Danish: Det er ukendt, om cobicistat/metabolitter udskilles i human mælk.
English: The safety and efficacy of EVOTAZ in children less than 18 years of age have not been established.
Danish: EVOTAZ's sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Cobicistat is 97-98% bound to human plasma proteins and the mean plasma to blood drug concentration ratio was 2.
Danish: Cobicistat bindes med cirka 97-98% til humane plasmaproteiner, og gennemsnitlig ratio for lægemiddelkoncentration i plasma til blod var 2.
English: ANTIDEPRESSANTS Other antidepressants:
Danish: ANTIDEPRESSIVA Andre antidepressiva:
English: You must not take EVOTAZ with certain medicines.
Danish: Du må ikke tage EVOTAZ sammen med visse andre lægemidler.
English: Talk to your doctor or pharmacist before taking EVOTAZ.
Danish: Kontakt lægen eller apotekspersonalet, før du tager EVOTAZ.
English: What EVOTAZ contains
Danish: EVOTAZ indeholder
English: Cobicistat does not select any HIV resistance mutations, due to its lack of antiviral activity.
Danish: Cobicistat selekterer ikke hiv-resistensmutationer pga. dets mangel på antiviral aktivitet.
English: In a 3-month combination oral toxicity study of atazanavir and cobicistat in rats, there were no toxicologic interactions apparent as no additive or synergistic toxicities were observed.
Danish: I et 3 måneders oral toksicitetsstudie med atazanavir og cobicistat i rotter var der ingen synlige toksikologiske interaktioner, eftersom der ikke blev observeret additiv eller synergistisk toksicitet.
English: Alternative forms of contraception (non-hormonal) should be considered (see section 4.5).
Danish: Alternative former for kontraception (ikke-hormonelle) bør overvejes (se pkt.