FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are taking medicines containing any of the following:
Danish: • Hvis De tager lægemidler, der indeholder nogle af følgende:
English: The use of Tybost in children and adolescents has not yet been studied.
Danish: Anvendelsen af Tybost til børn og unge er ikke undersøgt endnu.
English: Contact your doctor or nearest emergency department immediately for advice.
Danish: Kontakt straks lægen eller den nærmeste skadestue for at få råd.
English: This medicine does not directly treat your HIV infection.
Danish: Denne medicin behandler ikke direkte Deres hiv-infektion.
English: Percentage of subjects with viral load
Danish: Procentdel af personer med viral load
English: In some cases, your doctor may need to adjust your dose or check the levels of medicine in your blood.
Danish: I nogle tilfælde kan det være nødvendigt, at lægen justerer Deres dosis eller kontrollerer niveauet af medicin i Deres blod.
English: The amounts of these medicines in your blood may decrease during pregnancy, which may stop them from working properly.
Danish: Mængden af disse lægemidler i Deres blod kan falde under graviditet, hvilket kan forhindre dem i at virke korrekt.
English: Median age, years (min-max)
Danish: Medianalder, år (min-max)
English: Virologic success
Danish: Virologisk succes
English: Amlodipine Diltiazem Felodipine Nicardipine Nifedipine Verapamil
Danish: Amlodipin Diltiazem Felodipin Nicardipin Nifedipin Verapamil
English: Talk to your doctor if you are taking
Danish: Tal med Deres læge, hvis De tager
English: These are mentioned above under the heading “Do not take Tybost-If you are taking medicines containing any one of the following”.
Danish: De er nævnt ovenfor under overskriften “Tag ikke Tybost - Hvis De tager lægemidler, der indeholder nogle af følgende”.
English: Discuss with your doctor the precautions needed to avoid infecting other people.
Danish: Tal med Deres læge om, hvilke forholdsregler der skal træffes, for at undgå at smitte andre mennesker.
English: Medicines used in treating HIV infection:
Danish: Lægemidler anvendt til behandling af hiv-infektion:
English: The lowest dose of digoxin should initially be prescribed.
Danish: Den laveste dosis digoxin skal først ordineres.
English: Table 2: Interactions between cobicistat and other medicinal products
Danish: Tabel 2: Interaktioner mellem cobicistat og andre lægemidler
English: Your doctor will carefully consider whether to treat you with Tybost.
Danish: Deres læge vil nøje overveje, om De skal behandles med Tybost.
English: Always keep enough Tybost so you don't run out.
Danish: Opbevar altid nok Tybost, så du ikke løber tør.
English: NC = not calculated
Danish: NC = Ikke beregnet
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (frequency cannot be estimated from the available data).
Danish: Frekvens er defineret som meget almindelig(≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: As a result, the amounts of Tybost or other medicines in your blood may be affected.
Danish: Som et resultat heraf kan mængden af Tybost eller anden medicin i Deres blod påvirkes.
English: Cobicistat levels decrease and may not provide sufficient boosting.
Danish: Cobicistatniveauer falder og giver måske ikke tilstrækkeligt boost.
English: Further dose reduction of rifabutin has not been studied.
Danish: En yderligere dosisreduktion af rifabutin er ikke undersøgt.
English: You should not take Tybost with other medicines containing:
Danish: De må ikke tage Tybost med andre lægemidler, der indeholder:
English: • oral or implanted hormonal contraceptives used to prevent pregnancy
Danish: • orale eller implanterede hormonale præventionsmidler, der anvendes til at forebygge graviditet
English: Black or African Heritage Asian
Danish: Sort/afroamerikaner Asiatisk
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 adverse event (AE) 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: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Tybost or by other medicines that you are taking at the same time, or by the HIV disease itself.
Danish: Når hiv-infektion behandles, er det ikke altid muligt at afgøre, om nogle af de uønskede virkninger er forårsaget af Tybost eller af anden medicin, som De tager samtidigt, eller af selve hiv-sygdommen.
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Danish: De kan stadig overføre hiv, mens De tager denne medicin, selvom risikoen er formindsket med effektiv antiretroviral terapi.
English: • If you are allergic to cobicistat or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Danish: • Hvis De er allergisk over for cobicistat eller et af de øvrige indholdsstoffer i denne medicin (angivet i punkt 6 i denne indlægsseddel).
English: Carbamazepine-10,11-epoxide:
Danish: Carbamazepin-10,11-epoxid:
English: This increase is not considered to be clinically relevant and does not necessitate dose adjustment of tenofovir disoproxil.
Danish: Denne stigning betragtes ikke som klinisk relevant og nødvendiggør ikke dosisjustering af tenofovirdisoproxil.
English: If you are a woman with HIV it is recommended that you do not breast-feed to avoid passing the virus to the baby through your breast milk.
Danish: Hvis De er en kvinde med hiv, anbefales det, at De ikke ammer for at undgå at overføre virus til barnet via Deres brystmælk.
English: • alpha 1-adrenoreceptor antagonists: alfuzosin
Danish: • alpha 1-adrenoreceptorantagonister: alfuzosin
English: Voriconazole should not be used unless the possible benefit is considered to outweigh the risks associated with the unpredictable effect on plasma concentrations.
Danish: Voriconazol bør ikke anvendes, medmindre den mulige fordel anses for at opveje risici forbundet med den uforudsigelige virkning på plasmakoncentrationerne.
English: • yellowing of the skin and/or eyes (jaundice)
Danish: • gulfarvning af hud og/eller øjne (gulsot)
English: In treatment-naïve HIV-1 infected patients
Danish: Hos behandlingsnaive, hiv-1-inficerede patienter
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 pakningen efter (EXP).
English: Tybost is used in adults aged 18 years and over who are infected with HIV, the virus that causes acquired immunodeficiency syndrome (AIDS).
Danish: Tybost anvendes hos voksne i alderen 18 år og derover, der er smittet med hiv, som er den virus, der forårsager erhvervet immundefekt syndrom (aids).
English: In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Danish: For at undgå overførsel af hiv til spædbørn anbefales det, at hiv-inficerede kvinder under ingen omstændigheder ammer deres børn.
English: Pregnant women should not take Tybost with darunavir.
Danish: Gravide kvinder bør ikke tage Tybost sammen med darunavir.
English: This may stop your medicines from working properly, or may make any side effects worse.
Danish: Dette kan forhindre, at Deres medicin virker korrekt, eller det kan gøre bivirkninger værre.
English: Dose reductions of colchicine may be required.
Danish: Dosisreduktioner af colchicin kan være nødvendigt.
English: > 100,000 copies/ml
Danish: > 100.000 kopier/ml
English: For these sedatives/hypnotics, dose reduction may be necessary and concentration monitoring is recommended.
Danish: For disse sedativa/hypnotika kan en dosisreduktion være nødvendig, og det anbefales at overvåge koncentrationen.
English: ND = not determined
Danish: ND = Ikke klarlagt
English: Cobicistat has not been studied in patients receiving dialysis, and, therefore, no recommendation can be made for these patients.
Danish: Cobicistat er ikke blevet undersøgt hos patienter, der gennemgår dialyse, og der kan derfor ikke gives sikker anbefaling for disse patienter.
English: It is not known if the active substance in this medicine can pass into human breast milk.
Danish: Det er ukendt, om det aktive stof i dette lægemiddel kan udskilles i mælken hos mennesker.
English: Pharmacotherapeutic group: All other therapeutic products, ATC code: V03AX03
Danish: Farmakoterapeutisk klassifikation: Alle andre terapeutiske produkter, ATC-kode: V03AX03
English: Table 1: Dosing regimens Dose of Tybost
Danish: Tabel 1: Doseringsplan Dosis af Tybost
English: The median terminal plasma half-life of cobicistat following administration of Tybost is approximately 3-4 hours.
Danish: Den mediane terminale halveringstid i plasma for efter administration af Tybost er ca. 3-4 timer.
English: If you are taking Tybost with atazanavir your doctor will discuss the potential benefits and risks of taking Tybost to you and your child.
Danish: Hvis De tager Tybost med atazanavir, vil Deres læge drøfte de potentielle fordele og risici ved at tage Tybost for Dem og Deres barn.
English: The serum digoxin concentrations should be monitored and used for titration of digoxin dose to obtain the desired clinical effects.
Danish: Serum-digoxinkoncentrationer skal overvåges og anvendes til titrering af digoxindosis for at opnå de ønskede, kliniske virkninger.
English: insomnia, abnormal dreams
Danish: insomni, unormale drømme
English: It should be kept in mind that a twice weekly dose of 150 mg may not provide an optimal exposure to rifabutin thus leading to a risk of rifabutin resistance and a treatment failure.
Danish: Det bør overvejes, at en dosis på 150 mg to gange ugentligt måske ikke giver en optimal eksponering over for rifabutin, hvilket i så fald fører til en risiko for resistens over for rifabutin og behandlingssvigt.
English: CCR5 Antagonists Maraviroc
Danish: CCR5-antagonister Maraviroc
English: Tybost may interact with other substances.
Danish: Tybost kan påvirke andre stoffer.
English: Treatment of overdose with cobicistat consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Danish: Behandling af overdosering med cobicistat består af en støttende standardbehandling, herunder overvågning af vitale tegn samt observation af patientens kliniske status.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen skal påbegyndes af en læge med erfaring i behandlingen af hiv-infektion.
English: Contraception requirements
Danish: Krav til kontraception
English: Do not stop taking Tybost Do not stop taking Tybost without talking to your doctor.
Danish: Hold ikke op med at tage Tybost Hold ikke op med at tage Tybost uden at tale med Deres læge.
English: Tybost must be taken orally, once daily with food.
Danish: Tybost skal tages oralt, én gang dagligt, sammen med mad.
English: ANTIRETROVIRALS
Danish: ANTIRETROVIRALER
English: Buprenorphine/Naloxone
Danish: Buprenorphin/Naloxon
English: A food effect study was not conducted for Tybost.
Danish: Der blev ikke udført et studie af virkningen af mad for Tybost.
English: These interactions are based on either drug interaction studies or predicted interactions due to the expected magnitude of interaction and potential for serious and/or life-threatening events or loss of efficacy.
Danish: Disse interaktioner er enten baseret på lægemiddelinteraktionsstudier eller forventede interaktioner på grund af det forventede omfang af interaktion og risikoen for alvorlige og/eller livstruende hændelser eller svigtende virkning.
English:  If any of these applies to you, you should not take Tybost and you should tell your doctor immediately.
Danish:  Hvis noget af dette gælder for Dem, må De ikke tage Tybost og De skal omgående fortælle Deres læge det.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: • Tell your doctor immediately if you are pregnant, think you may be pregnant or are planning to have a baby.
Danish: • Fortæl det straks til lægen, hvis De er gravid, har mistanke om, at De er gravid, eller planlægger at blive gravid.
English: Effects on the liver
Danish: Virkninger på leveren
English: Tybost has no or negligible influence on the ability to drive and use machines.
Danish: Tybost påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
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: • HMG Co-A reductase inhibitors: lovastatin, simvastatin
Danish: • HMG Co-A-reduktasehæmmere: lovastatin, simvastatin
English: There are some medicines that should never be taken with Tybost.
Danish: Visse lægemidler må aldrig tages sammen med Tybost.
English: The film-coated tablet should not be chewed or crushed.
Danish: Den filmovertrukne tablet må ikke tygges eller knuses.
English: • 12 hours or more after the time you usually take Tybost, then do not take the missed dose.
Danish: • 12 timer eller længere efter det tidspunkt, De normalt tager Tybost på, skal De ikke tage den glemte dosis.
English: Tybost does not directly treat your HIV, but boosts the levels of atazanavir and darunavir in the blood.
Danish: Tybost behandler ikke Deres hiv direkte, men forhøjer niveauer af atazanavir og darunavir i blodet.
English: Concomitant use contraindicated
Danish: Samtidig brug kontraindiceret
English: Among the 21 patients, 3 developed the emtricitabine-associated resistance substitution M184V.
Danish: Blandt de 21 patienter udviklede 3 emtricitabin-associeret resistenssubstitution M184V.
English: DOAC = direct oral anticoagulant 1 Study was conducted with tenofovir disoproxil fumarate
Danish: DOAK = direkte oral antikoagulant 1 Studiet blev udført med tenofovirdisoproxilfumarat
English: • within 12 hours of the time you usually take Tybost, you must take the tablet as soon as possible.
Danish: • inden 12 timer efter det tidspunkt, De normalt tager Tybost på, skal De tage tabletten så hurtigt som muligt.
English: Pharmacokinetics of cobicistat have not been fully evaluated in the elderly (65 years of age and older).
Danish: Cobicistats farmakokinetik er ikke blevet fuldt evalueret hos ældre patienter (65 år og derover).
English: • increased appetite, disturbed sense of taste, dry mouth
Danish: • øget appetit, smagsforstyrrelse, tør mund
English: If you accidentally take more than the recommended dose of Tybost you may be at increased risk of experiencing side effects with this medicine (see section 4 of this leaflet).
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Tybost, kan De have større risiko for at få bivirkninger med denne medicin (se punkt 4 i denne indlægsseddel).
English: Effects on estimated creatinine clearance
Danish: Virkninger på estimeret kreatininclearance
English: EU/1/13/872/001 30 film-coated tablets EU/1/13/872/002 90 (3 bottles of 30) film-coated tablets
Danish: EU/1/13/872/001 30 filmovertrukne tabletter EU/1/13/872/002 90 (3 tabletbeholdere med 30) filmovertrukne tabletter
English:  If any of these applies to you, talk to your doctor before taking Tybost.
Danish:  Hvis noget af dette gælder for Dem, skal De tale med lægen før De tager Tybost.
English: Darunavir/ritonavir may be considered as an alternative.
Danish: Darunavir/ritonavir kan overvejes som et alternativ.
English: In the ritonavir group, genotypic data was available for all 19 virologic failures.
Danish: I ritonavir-gruppen forelå der genotypedata for alle 19 patienter med virologisk svigt.
English: As cobicistat is highly bound to plasma proteins, it is unlikely that it will be significantly removed by hemodialysis or peritoneal dialysis.
Danish: Da cobicistat i høj grad er bundet til plasmaproteiner, er det usandsynligt, at det i signifikant grad vil fjernes ved hæmodialyse eller peritonealdialyse.
English: Interactions of cobicistat and potential co-administered medicinal products are listed in Table 2 below
Danish: Interaktioner mellem cobicistat og mulige samtidigt administrerede lægemidler ses i tabel 2 nedenfor
English: There is no specific antidote for overdose with cobicistat.
Danish: Der er ingen specifik antidot for overdosering med cobicistat.
English: 150 mg once daily
Danish: 150 mg én gang dagligt
English: It is unknown whether cobicistat/metabolites are excreted in human milk.
Danish: Det er ukendt, om cobicistat/metabolitter udskilles i human mælk.
English: You must remain under the care of your doctor while taking Tybost.
Danish: De skal fortsætte med at være under lægens opsyn, mens De tager Tybost.
English: Randomisation was stratified by screening HIV-1 RNA level (≤ 100,000 copies/ml or > 100,000 copies/ml).
Danish: Randomiseringen blev stratificeret ved screening af hiv-1-rna-niveau (≤ 100.000 kopier/ml eller > 100.000 kopier/ml).
English: If you are affected while taking Tybost, do not drive and do not use any tools or machines.
Danish: Hvis De oplever dette, mens De tager Tybost, må De ikke føre motorkøretøj eller betjene værktøjer eller maskiner.
English: Cobicistat is 97-98% bound to human plasma proteins and the mean plasma to blood drug concentration ratio was 2.
Danish: Cobicistat er 97-98 % bundet til humane plasmaproteiner og den gennemsnitlige lægemiddelkoncentration i plasma var 2.
English: Tybost contains the active substance cobicistat.
Danish: Tybost indeholder det aktive stof cobicistat.
English: If you forget to take Tybost
Danish: Hvis De har glemt at tage Tybost
English: No dose adjustment of methadone is required.
Danish: Ingen dosisjustering af methadon er nødvendig.
English: A long term carcinogenicity study in mice did not show any carcinogenic potential.
Danish: Et langvarigt karcinogenicitetsstudie med mus viste ingen karcinogenicitet.
English: Careful patient monitoring and dose adjustment of metformin is recommended in patients who are taking Tybost.
Danish: Nøje overvågning af patienten og dosisjustering af metformin anbefales for patienter, som tager Tybost.
English: Do not stop your treatment without contacting your doctor.
Danish: Afbryd ikke behandlingen uden først at kontakte Deres læge.
English: Norgestimate/Ethinyloestradiol Interaction not studied.
Danish: Norgestimat/Ethinylestradiol Interaktion er ikke undersøgt.
English: Cobicistat and atazanavir should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus and mother.
Danish: Cobicistat og atazanavir bør kun anvendes under graviditet, hvis de potentielle fordele opvejer den potentielle risiko for foster og moder.
English: • clarithromycin and rifabutin, medicines used to treat bacterial infections including tuberculosis
Danish: • clarithromycin og rifabutin, lægemidler, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose
English: ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan
Danish: ENDOTHELIN RECEPTORANTAGONISTER Bosentan
English: Alternative forms of contraception should be considered (see section 4.5).
Danish: Alternative former for kontraception skal overvejes (se pkt.
English: However, patients should be informed that dizziness has been reported during treatment with cobicistat-containing regimens.
Danish: Patienter bør dog informeres om, at svimmelhed er blevet indberettet under behandling, der inkluderer cobicistat.
English: • feeling depressed
Danish: • følelse af nedtrykthed
English: It is recommended that Tybost be administered with food.
Danish: Det anbefales, at Tybost administreres sammen med mad.
English: log10 copies/ml
Danish: log10 kopier/ml
English: Cobicistat is not expected to induce CYP3A4 or P-gp (MDR1).
Danish: Cobicistat forventes ikke at inducere CYP3A4 eller P-gp (MDR1).
English: It is taken with atazanavir or darunavir (both protease inhibitors) and acts as a booster (enhancer) to help improve their effect.
Danish: Den tages sammen med atazanavir eller darunavir (begge proteasehæmmere) og virker som en booster (forstærkende stof) for at hjælpe med at forbedre deres virkning.
English: • sedatives/hypnotics: orally administered midazolam, triazolam
Danish: • sedativa/hypnotika: oralt administreret midazolam, triazolam
English: If the combination is needed, the recommended dose of rifabutin is 150 mg 3 times per week on set days (for example MondayWednesday-Friday).
Danish: Hvis kombinationen er nødvendig, er den anbefalede dosis rifabutin 150 mg 3 gange ugentligt på faste dage (for eksempel mandag-onsdag-fredag).
English: Virologic failurec No virologic data in week 48 or 144 window
Danish: Virologisk svigtc Ingen virologiske data i uge 48eller uge 144-vinduet
English: The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Danish: Silicageltørremidlet er i et separat brev eller en separat beholder, og må ikke sluges.
English: Cobicistat has no detectable antiviral activity against HIV-1, HBV or HCV and does not antagonise the antiviral effect of HIV inhibitors.
Danish: Cobicistat har ingen målelig antiviral aktivitet mod hiv-1, HBV eller HCV og antagoniserer ikke den antivirale virkninger af hiv-hæmmere.
English: However, a higher percentage of subjects in the cobicistat-boosted group had increases in total bilirubin > 2 x ULN than those in the ritonavir-boosted group (88.0% versus 80.9%).
Danish: Imidlertid havde en højere procentdel af personerne i den cobicistat-boostede gruppe forhøjelser i total-bilirubin > 2 x ULN end i den ritonavir-boostede gruppe (88,0 % versus 80,9 %).
English: There are limited data from the use of cobicistat and atazanavir in pregnant women.
Danish: Der er begrænsede data fra brugen af cobicistat og atazanavir hos gravide kvinder.
English: Increased plasma concentrations of salmeterol are associated with the potential for serious and/or life-threatening reactions.
Danish: Øgede plasmakoncentrationer af salmeterol forbindes med risiko for alvorlige og/eller livstruende reaktioner.
English: The following side effects may occur when taking Tybost with atazanavir.
Danish: Der kan opstå følgende bivirkninger, når De tager Tybost sammen med atazanavir.
English: In rats, ossification changes in the spinal column and sternebra of foetuses occurred at a dose that produced significant maternal toxicity.
Danish: Hos rotter forekom der ossifikationsændringer i fostres rygsøjle og sternum ved en dosis, der producerede signifikant maternel toksicitet.
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: Tybost comes in bottles of 30 tablets (with a silica gel sachet or canister that must be kept in the bottle to help protect your tablets).
Danish: Tybost leveres i tabletbeholdere, der indeholder 30 tabletter (med et brev eller en beholder med silicagel, der skal opbevares i beholderen for at hjælpe med at beskytte tabletterne).
English: Following oral administration of [14C]cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Danish: Efter oral administration af [14C]cobicistat var 99 % af den cirkulerende radioaktivitet i plasma fra uændret cobicistat.