FrancophonIA/ELRC3.0 huggingface dataset:
English: Leflunomide Teva is used to treat adults with active rheumatoid arthritis (an immune system disease
Danish: Leflunomide Teva anvendes til behandling af voksne patienter med aktiv reumatoid artrit (en sygdom i immunsystemet, der medfører betændelse i leddene).
English: Why has Leflunomide Teva been approved?
Danish: Hvorfor blev Leflunomide Teva godkendt?
English: Other information about Leflunomide Teva
Danish: Andre oplysninger om Leflunomide Teva:
English: How has Leflunomide Teva been studied?
Danish: Hvordan blev Leflunomide Teva undersøgt?
English: The Committee recommended that Leflunomide Teva
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Leflunomide Teva.
English: How does Leflunomide Teva work?
Danish: Hvordan virker Leflunomide Teva?
English: It is therefore important that you know about these medicines too.
Danish: Det er derfor vigtigt, at du også har kendskab til disse lægemidler.
English: * AIDS defining illness
Danish: * aids defineret sygdom
English: Practical recommendations deriving from this study are displayed below.
Danish: De praktiske anbefalinger på baggrund af dette studie angives nedenfor.
English: A total of 10% of patients had previously used enfuvirtide.
Danish: I alt 10% af patienterne havde tidligere anvendt enfuvirtid.
English: The following observations were made:
Danish: Følgende blev observeret:
English: These changes may be seen on an ECG (electrocardiogram).
Danish: Disse ændringer vil kunne ses på et elektrokardiogram (ekg).
English: In some patients additional Factor VIII was given.
Danish: Hos nogle patienter blev der givet faktor VIII.
English: This medicine contains sorbitol.
Danish: Denne medicin indeholder sorbitol.
English: Number of TPV Score Mutations**
Danish: Antal af TPV Score mutationer**
English: Effects of food on oral absorption
Danish: Virkningen af føde på oral absorption
English: Median # previous
Danish: Median # tidligere
English: Potential interactions with renal transporters cannot be fully excluded.
Danish: Potentielle interaktioner med renale transportere kan ikke udelukkes.
English: Number of Patients Age-Median (years) Gender
Danish: Antal patienter Alder-median (år) Køn
English: % White % Black % Asian
Danish: % Hvid % Sort % Asiatisk
English: The effects were reversible with termination of treatment.
Danish: Påvirkningerne var reversible ved afslutningen af behandlingen.
English: There may be other particles at the bottom of the bottle.
Danish: Der kan forekomme andre partikler på bunden af flasken.
English: Elimination Administration of
Danish: Elimination Administration af
English: - if you have moderate to severe liver problems.
Danish: - hvis du har moderate til alvorlige leverproblemer.
English: 1184 cells/mm
Danish: 1184 celler/mm
English: ECG evaluation
Danish: Ekg-evaluering
English: Increased ALAT/ASAT monitoring should be considered in these patients.
Danish: Det skal overvejes at øge monitoreringen af ALAT/ASAT hos disse patienter.
English: In addition the majority of participants had mutations associated with both NRTI and NNRTI resistance.
Danish: Desuden havde størstedelen af deltagerne mutationer i tilknytning til både NRTI- og NNRTI-resistens.
English: No specific signs and symptoms of overdose are known.
Danish: Der er ikke kendskab til specifikke tegn og symptomer på overdosering.
English: Further dosage reduction may be necessary.
Danish: Yderligere dosisreduktion kan blive nødvendig.
English: This may be in the skin or joints.
Danish: Disse kan være i huden eller i leddene.
English: In the majority of these patients the bleeding may have had other causes.
Danish: Hos størstedelen af de patienter kunne der være andre årsager til blødningen.
English: Previous ADI*
Danish: Tidligere ADI*
English: Mechanism unknown
Danish: Ukendt mekanisme
English: Tipranavir is extensively bound to plasma proteins (>99.9%).
Danish: Tipranavir er i høj grad bundet til plasmaproteiner (>99,9%).
English: Oral contraceptives and oestrogens
Danish: Oral antikonception og østrogener
English: In addition, most radioactivity (56%) was excreted between 24 and 96 hours after dosing.
Danish: Størstedelen af radioaktiviteten (56%) blev udskilt mellem 24 og 96 timer efter dosering.
English: The combination is not recommended.
Danish: Kombinationen anbefales ikke.
English: Consistent with the recommendation that HIV-infected mothers should not breast-feed their infants under any circumstances to avoid risking postnatal transmission of HIV, mothers should discontinue breast-feeding if they are receiving Aptivus.
Danish: I overensstemmelse med anbefalingen om, at hiv-smittede mødre ikke bør amme deres børn under nogen omstændigheder for at undgå risikoen for postnatal transmission af hiv, bør mødre standse amningen, hvis de får Aptivus.
English: For this reason it is very important that you tell your doctor about any changes in your health.
Danish: Det er derfor meget vigtigt, at du fortæller din læge om enhver ændring i dit helbred.
English: Tipranavir has been used in limited number of patients 65 years or older.
Danish: Tipranavir har været brugt i begrænset omfang til patienter på 65 år og ældre.
English: Administration of activated charcoal may also be used to aid in removal of unabsorbed substance.
Danish: Administration af aktivt kul kan også være til hjælp ved fjernelse af uabsorberet lægemiddel.
English: New ENF No New ENF*
Danish: Ny ENF Ingen ny ENF*
English: Alternate antimycobacterial agents such as rifabutin should be considered.
Danish: Alternative antimycobakterielle lægemidler såsom rifabutin bør overvejes.
English: In both studies, a total of 67% patient viruses were resistant and 22% were possibly resistant to the pre-selected comparator PIs.
Danish: I begge studier var i alt 67% patientvira resistente, og 22% var muligvis resistente over for på forhånd udvalgte komparator-proteasehæmmere.
English: You should therefore remain in regular contact with your doctor.
Danish: Du skal derfor fortsat være i regelmæssig kontakt med lægen.
English: 3, respectively, (ranges 1-1893 and 1
Danish: 3 (interval 1-1893 og 1
English: Halofantrine, lumefantrine
Danish: Halofantrin, lumefantrin
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune lidelser kan forekomme mange måneder efter påbegyndelse af behandling.
English: Aptivus contains very small amounts of alcohol (see Aptivus capsules contain ethanol).
Danish: Aptivus indeholder meget små mængder alkohol (se Aptivus kapsler indeholder ethanol).
English: It is believed that these symptoms are due to an improvement in the body's immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Danish: Man mener, at disse symptomer skyldes en forbedring af kroppens immunforsvar, der får den til at bekæmpe infektioner, som har været til stede uden tydelige symptomer.
English: The dose for children, aged 2 to 12 years, will be calculated by the doctor.
Danish: Den daglige dosis for børn i alderen 2 - 12 år beregnes af lægen.
English: The limited data available from a phase IIa study in HIV-infected patients suggest that no significant interaction is expected between nevirapine and TPV/r.
Danish: De begrænsede data fra et fase IIa studie af hiv-smittede patienter antyder, at der ikke kan forventes signifikant interaktion mellem nevirapin og TPV/r.
English: Do not refrigerate or freeze.
Danish: Må ikke komme i køleskab eller fryses.
English: UNIQUE IDENTIFIER --- HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: Tipranavir Cmin ↓ 61% (compared to historical data)
Danish: Tipranavir Cmin ↓ 61 % (sammenlignet med historiske data)
English: rilpivirine: If you are taking rilpivirine, your doctor will monitor you closely.
Danish: - rilpivirin: Hvis du tager rilpivirin vil din læge nøje overvåge dig.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 October 2005
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE / FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 25. oktober 2005 Dato for seneste fornyelse: 19. juni 2015
English: In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued.
Danish: I mere end halvdelen af de rapporterede tilfælde fortsatte behandlingen med proteasehæmmere eller blev påbegyndt igen, hvis den havde været seponeret.
English: Although data available at this stage are currently limited to allow a definitive analysis, they suggest that the pharmacokinetic profile is unchanged in older people and comparable between races.
Danish: Selvom de foreliggende data på nuværende tidspunkt er for begrænsede til at tillade en definitiv analyse, tyder de på, at den farmakokinetiske profil er uændret hos ældre og sammenlignelig mellem racer.
English: The combination should be used with caution and a lower dose of trazodone should be considered.
Danish: Kombinationen bør anvendes med forsigtighed, og en lavere trazodondosis bør overvejes.
English: Women using oestrogens may have an increased risk of non serious rash.
Danish: Kvinder, der tager østrogener, kan have en øget risiko for ikke alvorligt udslæt.
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk blevet observeret i løbet af de første få uger eller måneder efter initiering af antiretroviral kombinationsbehandling.
English: The mechanisms and potential mechanisms contributing to the interaction profile of tipranavir are described (see section 4.5).
Danish: Mekanismerne samt de potentielle mekanismer, der bidrager til interaktionsprofilen for tipranavir, er beskrevet (se pkt 4.5).
English: Peak plasma concentrations are reached within 1 to 5 hours after dose administration depending upon the dosage used.
Danish: Peak-plasmakoncentrationer nås i løbet af 1-5 timer efter administration afhængig af den anvendte dosis.
English: Data on the 29 patients who switched to capsules during the first 48 weeks are presented.
Danish: Data for de 29 patienter, som ændrede behandling til kapsler i løbet af de første 48 uger, er nævnt.
English: The study was prematurely stopped after 60 weeks.
Danish: Dette studie blev derfor stoppet tidligere end planlagt, efter 60 uger.
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Danish: Ethvert symptom på inflammation bør evalueres og behandling igangsættes hvis nødvendigt.
English: Despite an almost half reduction of C12, previous clinical studies with this combination did not evidence an impaired outcome.
Danish: På trods af en halvering af C12 viste kliniske studier med denne kombination ikke en nedsat virkning,
English: Antiarrhythmics Amiodarone Bepridil
Danish: Antiarytmika Amiodaron Bepridil
English: One patient in the tipranavir arm had four mutations.
Danish: En patient i tipranavir-gruppen havde fire mutationer.
English: The development of resistance to tipranavir in vitro is slow and complex.
Danish: Udviklingen af resistens over for tipranavir in vitro er langsom og kompleks.
English: Absorption of tipranavir in humans is limited, though no absolute quantification of absorption is available.
Danish: Absorptionen af tipranavir hos mennesker er begrænset, selvom der ikke findes nogen absolut absorptionskvantifikation.
English: Paediatric population The oral solution has been shown to have greater bioavailability than the soft capsule formulation.
Danish: Pædiatrisk population Det er påvist, at den orale opløsning har en større biotilgængelighed end den bløde kapselformulering.
English: There are no adequate data from the use of tipranavir in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af tipranavir hos gravide kvinder.
English: The increase in carbamazepine total PK parameters is not expected to have clinical consequences.
Danish: Stigningen af PK parametre af carbamazepin total forventes ikke at have kliniske konsekvenser.
English: Only a few metabolites were found in plasma, and all were at trace levels (0.2% or less of the plasma radioactivity).
Danish: Der blev kun fundet nogle få metabolitter i plasma, og alle var på sporniveau (0,2% eller mindre af plasmaens radioaktivitet).
English: Itraconazole or ketoconazole should be used with caution (doses 200 mg/day are not recommended).
Danish: Itraconazol eller ketoconazol bør anvendes med forsigtighed (doser >200 mg/dag anbefales ikke).
English: Tipranavir should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Tipranavir bør kun anvendes under graviditet, hvis de forventede fordele retfærdiggør den potentielle risiko for fosteret.
English: No information is available for the parameters AUC and Cmax.
Danish: Der er ingen data for værdierne af AUC og Cmax.
English: Aptivus should be prescribed by physicians who are experienced in the treatment of HIV-1 infection.
Danish: Aptivus bør ordineres af læger, der har erfaring med behandling af hiv-1-infektion.
English: The increase of tipranavir Cmin may be clinically relevant.
Danish: Stigningen af tipranavir Cmin kan være klinisk relevant.
English: Median (Min - Max) % with VL > 100,000 copies/ml
Danish: Median (Min - Max) % med VL > 100,000 kopier/ml
English: Therefore, an alternative, effective, safe method of contraception should be used during treatment (see section 4.5).
Danish: Derfor, bør der anvendes en effektiv og sikker alternativ antikonceptionsmetode i behandlingsperioden (se pkt.
English: Monitoring of digoxin serum concentrations is recommended until steady state has been obtained.
Danish: Det anbefales at monitorere koncentrationen af serumdigoxin, indtil steady state er opnået.
English: However, in some cases the role of tipranavir cannot be excluded.
Danish: Imidlertid kan man i visse tilfælde ikke udelukke tipranavir's rolle.
English: Gastrointestinal motility agents Cisapride
Danish: Gastrointestinale motilitetsmidler Cisaprid
English: Combination of all three of these is usually required for reduced susceptibility.
Danish: Det er normalt nødvendigt med tilstedeværelsen af alle disse tre før der ses nedsat følsomhed.
English: Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.
Danish: I tilfælde af ophør af glukokortikoider kan det desuden være nødvendigt at gennemføre progressiv dosisreduktion over længere tid.
English: The significance of this finding is being further monitored.
Danish: Betydningen af disse resultater overvåges nærmere.
English: Monitoring of hepatic tests should be done prior to initiation of therapy, after two, four and then every four weeks until 24 weeks, and then every eight to twelve weeks thereafter.
Danish: Monitorering af leverfunktionen bør ske før initiering af behandling, efter to og fire uger og sidenhen hver fjerde uge indtil 24. uge og derefter hver ottende til tolvte uge.
English: Antipsychotics Pimozide
Danish: Antipsykotika Pimozid
English: Aptivus is supplied in bottles containing 120 capsules.
Danish: Aptivus bliver leveret i beholdere indeholdende 120 kapsler.
English: If patients experience fatigue, dizziness, or somnolence they should avoid potentially hazardous tasks such as driving or operating machinery.
Danish: Hvis patienter oplever træthed, svimmelhed eller døsighed bør de undgå potentielt risikable opgaver såsom bilkørsel og betjening af maskiner.
English: Fluconazole doses 200 mg/day are not recommended.
Danish: Fluconazoldoser >200 mg/dag anbefales ikke.
English: Baseline HIV-1 RNA (log10 copies/ml)
Danish: Baseline hiv-1 RNA (log10 kopier/ml)
English: Tabulated summary of adverse reactions associated with Aptivus based on clinical studies and postmarketing experience:
Danish: Resumé af bivirkninger forbundet med Aptivus baseret på kliniske studier og post-marketing erfaringer:
English: *Carbamazepine total = total of carbamazepine and epoxycarbamazepine (both are pharmacologically active moieties).
Danish: *Carbamazepin total = sum af carbamazepin og epoxycarbamazepin (begge er pharmakologiske aktive).
English: Mutations at position 82 occur via two pathways: one from preexisting mutation 82A selecting to 82T, the other from wild type 82V selecting to 82L.
Danish: Mutationer i position 82 sker via to pathways: en fra allerede eksisterende mutation 82A, der ændrer sig til 82T, og den anden fra vildtype 82V, der ændrer sig til 82L.
English: Aptivus oral solution contains vitamin E. Your child should not take any additional vitamin E supplements.
Danish: Aptivus oral opløsning indeholder vitamin E. Dit barn bør ikke få nogen form for vitamin E-tilskud.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/315/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/315/001
English: Moreover a study with TPV/r and another NNRTI (efavirenz) did not show any clinically relevant interaction (see above).
Danish: Endvidere viser et studie med TPV/r og et andet NNRTI (efavirenz) ikke nogen klinisk relevant interaktion (se ovenfor).
English: Bleeding observed in rats was associated with prolonged prothrombin time (PT), activated partial thromboplastin time (APTT) and a decrease in some vitamin K dependent factors.
Danish: Blødning observeret hos rotter var forbundet med forlænget prothrombintid (PT), aktiveret partiel thromboplastintid (APTT) og et fald i nogle K-vitamin afhængige faktorer.
English: Mutations at protease codons 33, 82, 84 and 90
Danish: - Mutationer ved proteasekodon 33, 82, 84 og 90
English: This will be based on the child's body surface area in metres squared.
Danish: Beregningen er baseret på dit barns kropsoverflade i kvadratmeter.
English: - abacavir and zidovudine.
Danish: Abacavir og zidovudine
English: If the coadministration is judged unavoidable, this should be done under close clinical monitoring.
Danish: Hvis samtidig administration ikke kan undgås, bør det ske under tæt klinisk monitorering.
English: No clinically significant interaction is observed.
Danish: Der er ikke set klinisk signifikant interaktion.
English: A pharmacokinetic interaction is mechanistically unexpected and the interaction has not been confirmed in a controlled interaction study.
Danish: Interaktionen er uventet, vurderet ud fra et farmakokinetisk synspunkt, og interaktionen er ikke blevet bekræftet i et kontrolleret interaktionsstudie.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and pneumocystis pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobaketerielle infektioner og pneumocystis pneumonia.
English: Disulfiram/metronidazole
Danish: Disulfiram/metronidazol
English: Tipranavir demonstrates antiviral activity in vitro against a broad panel of HIV-1 group M non-clade B isolates (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
Danish: Tipranavir viser antiviral aktivitet in vitro mod en bred vifte af hiv-1 gruppe M ikke-indkapslede Bisolater (A, C, D, F, G, H, CRF01 AE, CRF02 AG, CRF12 BF).
English: In vitro, there is an inverse correlation between the degree of resistance to tipranavir and the capacity of viruses to replicate.
Danish: In vitro er der en omvendt korrelation mellem graden af resistens over for tipranavir og virus' replikationskapacitet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/315/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/315/002
English: 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)
Danish: Meget almindelig (1/10), almindelig (1/100 til <1/10), ikke almindelig (1/1.000 til 1/100),
English: - with ENF (FAS) - without ENF (FAS)
Danish: - med ENF (FAS) - uden ENF (FAS)
English: % Male
Danish: % Mænd
English: These may decrease the effectiveness of Aptivus.
Danish: Disse midler kan nedsætte virkningen af Aptivus.
English: Additional changes included bleeding in rats at high doses (rodents specific).
Danish: Andre ændringer omfattede blødning hos rotter ved høje doser (gnaverspecifik).
English: Further information on possible side effects related to combination antiretroviral treatment: - Bleeding - Increased bleeding.
Danish: Yderligere information om bivirkninger, der er relateret til antiretroviral kombinationsbehandling: - Blødning - Øget blødningstendens.
English: SPECIAL STORAGE CONDITIONS Do not store below 15°C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer under 15ºC.
English: Dosage of methadone may need to be increased.
Danish: Øgning af metadondosis kan være nødvendig.
English: Treatment response* at week 48 (pooled studies RESIST-1 and RESIST-2 in treatmentexperienced patients)
Danish: Behandlingsrespons* i uge 48 (poolede RESIST-1 og RESIST-2-studie med behandlingserfarne patienter)
English: If you are older than 65 years your doctor will exercise caution when prescribing Aptivus soft capsules to you and will closely monitor your therapy.
Danish: Hvis du er over 65 år, vil din læge udvise særlig forsigtighed ved ordinering af Aptivus bløde kapsler, og din behandling vil blive nøje overvåget af lægen.
English: Dosage reduction and concentration monitoring of desipramine is recommended.
Danish: Dosisreduktion og monitorering af desipraminkoncentrationer anbefales.
English: Phosphodiesterase 5 (PDE5) inhibitors Sildenafil
Danish: Phosphodiesterase-5 (PDE5)-hæmmere Sildenafil
English: This difference in concentrations does not warrant a dose adjustment.
Danish: Denne forskel i koncentrationer indicerer ingen dosisjustering.
English: Be sure your child's doctor clearly informs you what the correct dose for your child should be. You should measure the exact dose using the supplied measuring syringe and adapter, as follows:
Danish: Vær sikker på, at dit barns læge klart oplyser, hvad den korrekte dosis for dit barn er. Du bør afmåle den nøjagtige dosis ved hjælp af doseringssprøjten og adaptoren, som leveres sammen med flasken på følgende måde:
English: No clinically significant change is observed in tipranavir PK parameters.
Danish: Der er ikke set klinisk signifikant ændring i tipranavir PK parametre.
English: Aptivus should be used in this patient population only if the potential benefit outweighs the potential risk, and with increased clinical and laboratory monitoring.
Danish: Aptivus bør kun anvendes til denne patientpopulation, hvis den potentielle fordel opvejer den potentielle risiko, og under øget klinisk og laboratoriemonitorering.
English: Patients should be instructed to observe closely for crystals.
Danish: Patienterne skal informeres om at holde godt øje med krystallerne.
English: No cases of Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis have been reported in the clinical development programme of tipranavir.
Danish: Der er ikke rapporteret tilfælde af Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse i det kliniske udviklingsprogram for tipranavir.
English: (N=740) versus +4 cells/mm
Danish: (N=740) i modsætning til +4 celler/mm
English: The unbound fraction of tipranavir appeared to be independent of total concentration over this concentration range.
Danish: Den ubundne del af tipranavir var uafhængig af den samlede koncentration i dette koncentrationsinterval.
English: Therefore, a modification of Aptivus exposure cannot be ruled out.
Danish: Derfor kan ændring af eksponeringen for Aptivus ikke udelukkes.
English: Baseline phenotypic susceptibility was evaluated in 454 baseline patient samples.
Danish: Baseline fænotypisk følsomhed blev vurderet i 454 patientprøver ved baseline.
English: The trial evaluated pharmacokinetics, safety and tolerability, as well as virologic and immunologic responses through 48 weeks.
Danish: Studiet undersøgte farmakokinetik, sikkerhed og tolerabilitet, såvel som virologiske og immunologiske respons gennem 48 uger.
English: Clinical studies of Aptivus did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects (see section 5.2).
Danish: Kliniske studier med Aptivus omfattede ikke et tilstrækkeligt antal patienter på 65 år eller mere til at kunne vurdere, om de responderer anderledes end yngre patienter (se pkt.