FrancophonIA/ELRC3.0 huggingface dataset:
English: It is therefore very important that you read the package leaflets that are provided with these medicines, too.
Danish: Derfor er det yderst vigtigt, at du også læser de indlægssedler, som udleveres sammen med disse lægemidler.
English: Patients Co-infected with HIV-1
Danish: Patienter co-inficeret med hiv-1
English: Telaprevir is approximately 59% to 76% bound to plasma proteins.
Danish: Omtrent 59% til 76% af telaprevir er bundet til plasmaproteiner.
English: The recommended total duration of treatment for patients who have received a liver transplant is 48 weeks.
Danish: Den anbefalede samlede behandlingsvarighed for patienter, som har gennemgået en levertransplantation, er 48 uger.
English: - to check for changes in some values of your blood cells or chemistry.
Danish: - for at kontrollere, om der er forandringer i visse blodværdier eller blodets kemiske sammensætning.
English: Replicon variants generated from patient-derived sequences showed similar results.
Danish: Replicon-varianter genereret fra sekvenser der stammede fra patienterne viste lignende resultater.
English: Via C. Janssen IT-04100 Borgo San Michele Latina, Italy
Danish: Via C. Janssen IT-04100 Borgo San Michele Latina, Italien
English: It may appear at any time after start of treatment, although the majority of cases appeared between six and ten weeks after the start of treatment with INCIVO.
Danish: Det kan opstå når som helst efter behandlingens start, omend de fleste tilfælde opstod seks til ti uger efter indledning
English: Usually the rash is mild or moderate, but the rash may be, or may become, severe and/or life-threatening.
Danish: Sædvanligvis er udslættet mildt til moderat, men det kan også være eller blive alvorligt og/eller livstruende.
English: Transfusion rates over the whole study period were 4.6% and 1.6%, respectively.
Danish: I løbet af hele studieperioden fik henholdsvis 4,6% og 1,6% transfusion.
English: Telaprevir may be less effective due to decreased concentrations.
Danish: Telaprevir kan blive mindre virksomt på grund af de nedsatte koncentrationer.
English: The time dependency indicates that inhibition of CYP3A4 may be intensified during the first 2 weeks of treatment.
Danish: Tidsafhængigheden indikerer, at hæmning af CYP3A4 kan blive forstærket i løbet af de første 2 ugers behandling.
English: In rats (but not in dogs), telaprevir caused degenerative changes in testes which were reversible and did not affect fertility.
Danish: I studier med rotter (men ikke hunde) medførte telaprevir degenerative forandringer i testes, som var reversible og ikke påvirkede fertiliteten.
English: Following administration of a single oral dose of 750 mg
Danish: Efter indgift af en enkelt oral dosis på 750 mg
English: Telaprevir has not been tested for its carcinogenic potential.
Danish: Telaprevir er ikke undersøgt for potentiel karcinogenicitet.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use INCIVO are provided with a healthcare professional educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at ordinere eller anvende INCIVO, forsynes med en uddannelsespakke for sundhedsprofessionelle med følgende
English: You must not reduce your dose of INCIVO.
Danish: Du må ikke nedsætte din dosis af INCIVO.
English: Prior non-responders includes prior partial responders and prior null responders.
Danish: Tidligere non-responders omfatter tidligere partial responders og tidligere null responders.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten efter EXP. Udløbsdatoen er den sidste
English: Always take the tablets with food.
Danish: Tag altid tabletterne i forbindelse med et måltid.
English: HCV sequencing data were not available for 16 (7%) patients.
Danish: HCV-sekventeringsdata forelå ikke for 16 patienter (7%).
English: The frequency rate of the side effects associated with INCIVO is given below.
Danish: Hyppigheden af de bivirkninger, som forbindes med INCIVO, er opstillet nedenfor.
English: Some patients may experience fainting or problems with vision during INCIVO treatment.
Danish: Nogle patienter kan opleve besvimelser eller problemer med synet i løbet af INCIVO-behandling.
English: Syncope and retinopathy have been reported in some patients taking INCIVO and should be considered when assessing a patient's ability to drive or operate machines.
Danish: Der er rapporteret synkope og retinopati hos nogle patienter, der fik INCIVO, og det bør tages i betragtning ved vurdering af en patients evne til at føre motorkøretøj eller betjene maskiner.
English: Subgroup
Danish: Undergruppe
English: The total dose is 6 tablets per day.
Danish: Den samlede dosis er 6 tabletter dagligt.
English: SVR rates for patient subgroups: Study 108
Danish: SVR-rater i patientundergrupper: Studie 108
English: Make sure that you check the following points and tell your doctor treating your hepatitis C virus (HCV) if any of these apply to you.
Danish: Sørg for at undersøge følgende punkter, og fortæl det til den læge, der behandler dig for hepatitis C (HCV), hvis et eller flere af punkterne passer på dig.
English: Therefore, you and your partner must use two other birth control methods during the time you are taking INCIVO and for 2 months after stopping this medicine.
Danish: Derfor skal du og din partner anvende to andre former for sikker prævention i den tid, hvor du tager INCIVO, og i 2 måneder efter, at du stopper med dette lægemiddel.
English: No specific antidote is available for overdose with INCIVO.
Danish: Der findes intet specifikt antidot mod overdosering med INCIVO.
English: The NS3-4A protease inhibitor reduces the amount of hepatitis C virus in your body.
Danish: NS3-4A-proteasehæmmeren nedsætter mængden af hepatitis C virus i kroppen.
English: Your doctor will do blood tests before starting treatment and regularly during your treatment: - to see how much virus is in your blood and to determine if you have the type of virus (genotype 1) that can be treated with INCIVO.
Danish: Før behandlingens start og løbende under behandlingen vil lægen tage nogle blodprøver: - for at se, hvor meget virus du har i blodet, og bestemme, om du har den type virus (genotype 1), som kan behandles med INCIVO.
English: There are no data from the use of INCIVO in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af INCIVO til gravide kvinder.
English: Prior relapsers
Danish: SVR Tidligere relapsers
English: Maraviroc 150 mg twice daily when co-administered with telaprevir.
Danish: Maraviroc 150 mg to gange dagligt ved co-administration med telaprevir.
English: Unless your doctor tells you to stop, continue taking INCIVO in order to ensure that your medicine continues to work against the virus.
Danish: Med mindre lægen anbefaler, at du stopper, skal du fortsætte med at tage INCIVO for at sikre, at medicinen bliver ved med bekæmpe virussen.
English: The lower limit of the 95% CI (-4.9%) was greater than the pre-determined noninferiority margin of -11% and therefore the non inferiority of T12(b.i.d.
Danish: Den nedre grænse af 95% CI (-4,9%) var højere end den på forhånd fastsatte margen for non-inferioritet på -11%, hvilket således påviste non-inferioritet af T12(b.i.d.
English: Co-administration of fluticasone or budesonide and telaprevir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
Danish: Co-administration af fluticason eller budesonid og telaprevir anbefales ikke, medmindre den potentielle fordel for patienten opvejer risikoen for systemiske bivirkninger af kortikosteroid.
English: In a fertility and early embryonic development study in rats, an increase in non-viable conceptuses was observed.
Danish: I et studie af fertilitet og tidlig embryonal udvikling hos rotter sås en stigning i ikke-levedygtige fostre.
English: Caution should be used and dose reduction for amlodipine should be considered.
Danish: Forsigtighed tilrådes, og dosisreduktion for amlodipin bør overvejes.
English: Do not use INCIVO in combination with any of the following medicines as they may increase the risk of severe side effects, and/or affect the way INCIVO or the other medicine works:
Danish: Brug ikke INCIVO i kombination med et af følgende lægemidler, da de kan øge risikoen for alvorlige bivirkninger og/eller påvirke virkningen af INCIVO eller de andre midler:
English: The safety and efficacy of INCIVO in children aged < 18 years have not yet been established.
Danish: Sikkerhed og virkning af INCIVO hos børn i alderen < 18 år er endnu ikke klarlagt.
English: Therefore, telaprevir should be taken with food.
Danish: Telaprevir bør derfor indtages i forbindelse med et måltid.
English: The primary objective was to demonstrate the noninferiority of T12(b.i.d.
Danish: Det primære formål var at påvise non-inferioritet af T12(b.i.d.
English: Rat offspring exposed to telaprevir in utero showed normal body weight at birth.
Danish: Rotteunger, der blev eksponeret for telaprevir in utero, havde normal legemsvægt ved fødslen.
English: Prior partial responders
Danish: Tidligere partial responders
English: amlodipine, diltiazem, felodipine, nicardipine,
Danish: amlodipin, diltiazem, felodipin, nicardipin,
English: Simvastatin is contraindicated due to the predicted marked increase in exposure caused by multiple mechanisms.
Danish: Simvastatin er kontraindiceret, da det forventes at øge eksponeringen markant på grund af en række forskellige mekanismer.
English: Patients should be instructed to swallow the tablets whole (e.g. patients should not chew, break or
Danish: Patienterne bør vejledes om, at tabletterne skal synkes hele (de må f.eks. ikke tygges, deles eller
English: In INCIVO clinical experience, less than 0.1% of patients had Stevens-Johnson Syndrome (SJS).
Danish: I forbindelse med klinisk brug af INCIVO fik færre end 0,1% af patienterne Stevens-Johnsons syndrom (SJS).
English: If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Danish: Hvis det er indikeret, kan elimination af ikke-absorberet aktivt stof opnås med emese eller ventrikelskylning.
English: These recommendations are based on either drug interaction studies (indicated with *) or predicted interactions due to the expected magnitude of interaction and potential for serious adverse reactions or loss of efficacy.
Danish: Disse rekommandationer er baseret på enten lægemiddelinteraktionsstudier (mærket med *) eller forventede interaktioner pga. det forventede omfang af interaktioner og potentialet for alvorlige bivirkninger eller nedsat effekt.
English: Treatment of overdose with INCIVO consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
Danish: Behandling af overdosering med INCIVO består af generel understøttende behandling, der omfatter overvågning af de vitale funktioner og observation af patientens kliniske tilstand.
English: 168 film-coated tablets (4 bottles containing 42 tablets each) The bottles are not to be distributed individually.
Danish: 168 filmovertrukne tabletter (4 beholdere indeholder hver 42 tabletter) Beholderne må ikke distribueres enkeltvist.
English: Telaprevir readily crosses the placenta in both rat and mouse giving a foetal: maternal exposure of 19 - 50%.
Danish: Telaprevir passerer let placenta hos både rotter og mus, hvilket giver en føtal:maternel eksponering på 19-50%.
English: INCIVO has only been used in a limited number of patients of 65 years or older.
Danish: INCIVO har kun været anvendt til et begrænset antal patienter over 65 år.
English: Table 9 shows response rates.
Danish: I tabel 9 vises responsraterne.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: The SVR rate for Black patients was 62% (45/73).
Danish: For sorte patienter var SVR-raten 62% (45/73).
English: Some patients may require higher doses of tacrolimus or cyclosporine A than at the initiation of treatment.
Danish: Nogle patienter kan have brug for en højere dosis af tacrolimus eller ciclosporin end ved indledning af behandlingen.
English: Prior null responders
Danish: Tidligere null responders
English: ADRs are listed by system organ class (SOC) 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: Bivirkningerne er opstillet efter systemorganklasse 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: Pharmacotherapeutic group: Direct-acting antiviral, ATC code: J05AE11.
Danish: Farmakoterapeutisk klassifikation: Direkte virkende antiviralt middel, ATC-kode: J05AE11.
English: The total daily dose is 6 tablets (2,250 mg).
Danish: Den totale døgndosis er 6 tabletter (2.250 mg).
English: Close monitoring of metformin efficacy and safety is recommended when starting or stopping INCIVO in patients receiving metformin.
Danish: Tæt monitorering af metformins virkning og sikkerhed anbefales ved start eller stop af behandling med INCIVO hos patienter, der får metformin.
English: The most marked effects are expected on oral, nasal and buccal/sublingual fentanyl formulations.
Danish: De mest markante virkninger forventes at være med orale, nasale og bukkale/ sublinguale formuleringer af fentanyl.
English: The Physician Leaflet should contain the following key elements:
Danish: Brochuren med information til læger skal indeholde følgende centrale punkter:
English: A decrease in haemoglobin levels occurs during the first 4 weeks of treatment, with lowest values reached at the end of INCIVO dosing.
Danish: Der opstår et fald i hæmoglobinniveauet under de første 4 uger af behandlingen, hvor de laveste værdier nås ved slutningen af INCIVO-behandlingen.
English: Your doctor may stop your treatment.
Danish: Din læge kan afbryde behandlingen.
English: Data in the paediatric population are currently not available.
Danish: Aktuelt foreligger der ingen data om den pædiatriske population.
English: The total treatment duration was determined based on the patients' individual on-treatment viral response.
Danish: Varigheden af den samlede behandling blev fastsat ud fra den enkelte patients virologiske respons under behandlingen.
English: At week 12, INCIVO dosing ended and patients continued on standard therapy only.
Danish: I uge 12 afsluttedes indgift af INCIVO, og patienterne fortsatte med standardbehandling alene.
English: CYP3A4 is partly responsible for the metabolism of telaprevir.
Danish: CYP3A4 er delvist ansvarlig for telaprevirs metabolisme.
English: Do not take INCIVO if you are allergic to telaprevir or any of the other ingredients of this medicine
Danish: Tag ikke INCIVO, hvis du er allergisk over for telaprevir eller et af de øvrige indholdsstoffer i
English: Patients experiencing mild to moderate rash should be monitored for signs of progression; however, progression was infrequent (less than 10%).
Danish: Patienter, der får let til moderat udslæt, bør kontrolleres for tegn på progression, men det forekom dog ikke hyppigt (hos færre end 10%).
English: - 3 tablets of INCIVO twice daily (morning and evening) with food.
Danish: - 3 tabletter INCIVO to gange dagligt (morgen og aften) i forbindelse med et måltid.
English: Population pharmacokinetic analysis of INCIVO in HCV-infected subjects indicated that the exposure to telaprevir was similar in Blacks/African-Americans and Caucasians.
Danish: Populationsfarmakokinetisk analyse af INCIVO hos HCV-inficerede forsøgspersoner indikerede, at eksponeringen for telaprevir var sammenlignelig hos sorte/afroamerikanere og kaukasere.
English: Dose reduction for parenterally administered midazolam should be considered, especially if more than a single dose of midazolam is administered.
Danish: Dosisreduktion ved parenteral anvendelse af midazolam bør overvejes - især hvis der anvendes mere end en enkelt dosis midazolam.
English: The effect of subject gender on telaprevir pharmacokinetics was evaluated using population pharmacokinetics of data from Phase 2 and 3 studies of INCIVO.
Danish: Effekten af forsøgspersonernes køn på telaprevirs farmakokinetik blev evalueret ved hjælp af populationsfarmakokinetiske data fra fase 2- og 3-studier af INCIVO.
English: This difference is likely due to the higher genetic barrier for the V36M and R155K substitutions for genotype 1b than genotype 1a.
Danish: Denne forskel skyldes formentlig den højere genetiske barriere for V36M- og R155K-substitutioner for genotype 1b end for genotype 1a.
English: Two months after completion of INCIVO treatment, hormonal contraceptives are again appropriate as one of the two required effective methods of birth control.
Danish: To måneder efter gennemførelse af INCIVO-behandlingen kan hormonale kontraceptiva atter anvendes som den ene af de to krævede sikre kontraceptionsmetoder.
English: Voriconazole should not be administered to patients receiving telaprevir unless an assessment of the benefit/risk ratio justifies its use.
Danish: Voriconazol bør ikke anvendes til patienter, der er i behandling med telaprevir, med mindre en vurdering af benefit/risk-forholdet berettiger dette.
English: Telaprevir is extensively metabolised in the liver, involving hydrolysis, oxidation, and reduction.
Danish: Telaprevir metaboliseres i udstrakt grad i leveren ved hjælp af hydrolyse, oxidation og reduktion.
English: Table 2: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Danish: Tabel 2: INTERAKTIONER OG DOSISREKOMMANDATIONER I FORBINDELSE MED ANDRE LÆGEMIDLER
English: Increased plasma concentrations of quetiapine may lead to coma.
Danish: En øget koncentration af quetiapin kan føre til koma.
English: The Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events (DAIDS, version 1.0, December 2004) was used in the pooled laboratory datasets.
Danish: DAIDS-tabellen fra Division of AIDS til inddeling af uønskede hændelser hos voksne og børn (DAIDS, version 1.0, december 2004) blev anvendt til de poolede laboratoriedatasæt.
English: Erythropoisis-stimulating agents (ESAs) were generally not permitted and used in only 1% of patients in the Phase 2 and 3 clinical trials.
Danish: Erytropoisestimulerende stoffer (ESA) var generelt ikke tilladt og blev kun anvendt hos 1% af patienterne i de kliniske fase 2- og 3-studier.
English: These are recommended baseline values for initiation of INCIVO combination treatment: - Haemoglobin: ≥ 12 g/dl (females); ≥ 13 g/dl (males)
Danish: Anbefalede baselineværdier for indledning af INCIVO-kombinationsbehandling: - Hæmoglobin: ≥ 12 g/dl (kvinder); ≥ 13 g/dl (mænd)
English: Atazanavir/ritonavir: this combination is associated with a high frequency of hyperbilirubinaemia/icterus.
Danish: Atazanavir/ritonavir: Denne kombination er forbundet med en høj forekomst af hyperbilirubinæmi/icterus.
English: A dose adjustment of metformin may be necessary.
Danish: Justering af metformindosis kan være nødvendig.
English: T12/PR All Patients
Danish: T12/PR Alle patienter
English: Co-administration with inducers may lead to lower exposure of telaprevir with risk of lower efficacy.
Danish: Co-administration af induktorer kan føre til lavere eksponering for telaprevir med risiko for nedsat virkning.
English: The food is important to get the right levels of medicine in your body.
Danish: Maden har betydning for, at du får den rigtige koncentration af lægemidlet i kroppen.
English: Do not drive or operate machines if you feel faint or have problems with your vision while taking INCIVO.
Danish: Du skal ikke føre bil eller betjene maskiner hvis du føler dig svag eller har synsforstyrrelser, mens du er i behandling med INCIVO.
English: PDE-5 INHIBITORS sildenafil tadalafil vardenafil
Danish: PDE-5-HÆMMERE sildenafil tadalafil vardenafil
English: When co-administration is required, high doses of itraconazole (> 200 mg/day) or ketoconazole (> 200 mg/day) are not recommended.
Danish: Ved behov for samtidig anvendelse anbefales det ikke at anvende høje doser af itraconazol (> 200 mg/dag) eller ketoconazol (> 200 mg/dag).
English: Co-administration should be done in a setting which ensures clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Samtidig brug bør finde sted under forhold, der muliggør klinisk monitorering og passende medicinsk behandling i tilfælde af respirationsdepression og/eller langvarig sedation.
English: Tell your doctor if you have had or are going to have a liver or other organ transplant as INCIVO might not be right for you in this situation.
Danish: Fortæl det til lægen, hvis du har fået eller skal have en ny lever eller et andet organ transplanteret, da INCIVO måske ikke er den rette medicin for dig i denne situation.
English: If you have both hepatitis C virus infection and human immunodeficiency virus infection, and are taking efavirenz, the recommended dose regimen is 3 tablets of INCIVO every 8 hours with food.
Danish: Hvis du både har hepatitis C-infektion og hiv-infektion og tager efavirenz, er den anbefalede dosis 3 tabletter INCIVO hver 8. time i forbindelse med et måltid.
English: What you need to know before you take INCIVO
Danish: Det skal du vide, før du begynder at tage INCIVO
English: After ending treatment, approximately one week may be needed for the inhibition to completely disappear.
Danish: Efter endt behandling vil der gå omtrent en uge, før hæmningen er aftaget helt.
English: Concomitant administration of INCIVO and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Danish: Samtidig administration af INCIVO og quetiapin er kontraindiceret, da quetiapinrelateret toksicitet derved kan øges.
English: (< 25,000/mm absolute lymphocyte count
Danish: (< 25.000/mm absolut lymfocyttal
English: However, when fed via milk from telaprevir-treated dams, body weight gain of rat pups was lower than normal (likely due to taste aversion).
Danish: Når rotteungerne fik mælk fra telaprevir-behandlede moderdyr, var deres vægtøgning dog lavere end normalt (formentlig på grund af aversion mod smagen).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with INCIVO in one or more subsets of the paediatric population in chronic hepatitis C (see section 4.2 for
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med INCIVO i en eller flere undergrupper af den pædiatriske population med kronisk hepatitis C (se pkt.
English: Gastric lavage should only be performed if this can be done within one hour after ingestion.
Danish: Ventrikelskylning bør kun udføres, hvis den kan finde sted inden for en time efter indtagelse.
English: Medicinal products by therapeutic areas
Danish: Lægemidler inddelt efter terapeutisk område
English: Telaprevir binds primarily to
Danish: Telaprevir bindes primært til
English: Additional methods of non-hormonal contraception should be used when hormonal contraceptives are co-administered with telaprevir.
Danish: Der bør suppleres med andre, ikke-hormonale kontraceptionsmetoder, når hormonale kontraceptiva anvendes sammen med telaprevir.
English: However, clinical monitoring is recommended as the dose of methadone during maintenance therapy may need to be adjusted in some patients.
Danish: Klinisk kontrol anbefales dog, da der kan opstå behov for at justere methadondosen hos nogle patienter under vedligeholdelsesbehandling.