FrancophonIA/ELRC3.0 huggingface dataset:
English: Rarely these muscle disorders have been serious, involving breakdown of muscle tissue (rhabdomyolysis).
Danish: I sjældne tilfælde har disse muskelsygdomme været alvorlige, hvor nedbrydning af muskelvæv har fundet sted (rabdomyolyse).
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Tegn på knoglenekrose er stivhed, ømhed og smerter i ledene (især hofte, knæ og skulder) samt bevægelsesbesvær.
English: Check that the oral solution is clear (see below).
Danish: Tjek om den orale opløsning er en klar opløsning (se nedenfor) 2.
English: Aptivus/ritonavir should not be administered concomitantly with cobicistat or cobicistat-containing products.
Danish: Aptivus/ritonavir bør ikke administreres samtidig med cobicistat eller præparater indeholdende cobicistat.
English: Based on data from the cocktail study where caffeine (CYP1A2 substrate) AUC was reduced by 43%, tipranavir with ritonavir is expected to decrease theophylline concentrations.
Danish: På baggrund af cocktail-studiet, hvor caffein-AUC (CYP1A2substrat) blev reduceret med 43%, kan det forventes, at tipranavir med ritonavir vil nedsætte theophyllinkoncentrationen.
English: The paediatric dose should not exceed the 500 mg/200 mg dose.
Danish: Børnedoseringen bør ikke overskride 500 mg/200mg dosen.
English: Aptivus soft capsules contain alcohol (7% ethanol, ie 100 mg per capsule or up to 200 mg per dose) which can produce disulfiram-like reactions when co-administered with disulfiram or other medicinal products which produce this reaction (e.g. metronidazole).
Danish: Aptivus bløde kapsler indeholder alkohol (7% ethanol, dvs. 100 mg pr. kapsel eller op til 200 mg pr. dosis), som kan give anledning til disulfiram-lignende reaktioner, når det gives sammen med disulfiram eller andre lægemidler, som kan give denne reaktion (f.eks. metronidazol).
English: At steady state, there was a significant induction of CYP 1A2 and a slight induction on CYP 2C9.
Danish: Ved steady state var der en signifikant induktion af CYP1A2 og en svag induktion af CYP2C9.
English: In patients with a body surface area of less than 1.33 m2 appropriate dose adjustments cannot be achieved with the capsule formulation.
Danish: Hos patienter med en kropsoverflade på mindre end 1.33 m kan en korrekt dosisjustering ikke opnås med kapselformuleringen.
English: This medicinal product contains 7 vol % ethanol (alcohol), i.e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or less than 4 ml of wine.
Danish: Denne medicin indeholder 7 vol% ethanol (alkohol), dvs. op til 400 mg pr. dagsdosis, svarende til 8 ml øl, eller mindre end 4 ml vin.
English: If you notice more than a thin layer of crystals at the bottom of the bottle you should: - give the next dose - return the bottle to the pharmacist or doctor as soon as possible for a fresh supply.
Danish: Hvis du opdager, at der er mere end et tyndt lag af krystaller på bunden af flasken bør du: - alligevel give den næste dosis - returner flasken til apoteket snarest muligt for ombytning.
English: If a rash occurs, it is usually mild to moderate.
Danish: Et sådant udslæt vil normalt være af mild til moderat karakter.
English: Potent inhibition of CYP 2D6 and both hepatic and intestinal CYP 3A4 activities were observed.
Danish: Samtidig så man en kraftig inhibition af CYP2D6 og af såvel hepatisk som intestinal CYP3A4-aktivitet.
English: Protein binding studies have shown that the antiviral activity of tipranavir decreases on average 3.75fold in conditions where human serum is present.
Danish: Proteinbindingsstudier har vist, at den antivirale aktivitet af tipranavir falder gennemsnitligt 3,75 gange ved tilstedeværelse af humant serum.
English: 3 in the comparator PI/ritonavir (N=727) arm.
Danish: 3 i komparator-proteasehæmmer/ritonavir-gruppen (N=727).
English: Aptivus may be less effective due to decreased tipranavir plasma concentrations in patients taking these agents concomitantly.
Danish: Aptivus kan have mindre virkning, som følge af lavere tipranavir-plasmakoncentrationer hos patienter, som tager disse lægemidler samtidig.
English: Patients with mild hepatic impairment (Child-Pugh Class A) should be closely monitored.
Danish: Patienter med mild leverinsufficiens (Child-Pugh A) bør monitoreres nøje.
English: Since tipranavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicine.
Danish: Da tipranavir er stærkt proteinbundet, er det usandsynligt, at dialyse i væsentlig grad kan hjælpe.
English: Reactivation of herpes simplex and herpes zoster virus infections were observed in the RESIST trials.
Danish: Reaktivering af herpes simplex og herpes zostervirusinfektioner blev observeret i RESIST-studierne.
English: A pharmacodynamic interaction study in healthy volunteers demonstrated that administration of loperamide and Aptivus, coadministered with low dose ritonavir, does not cause any clinically relevant change in the respiratory response to carbon dioxide.
Danish: Et farmakodynamisk interaktionsstudie med raske frivillige viste, at administration af loperamid og Aptivus plus lavdosis ritonavir ikke forårsager klinisk relevant ændring i det respiratoriske respons på kuldioxid.
English: Higher doses of carbamazepine (> 200 mg) may result in even larger decreases in tipranavir plasma concentrations (see section 4.4).
Danish: Højere doser af carbamazepin (> 200 mg) kan resultere i et endnu større fald af tipranavirs plasmakoncentrationer (se pkt.
English: For patients with renal impairment dose reduction of clarithromycin should be considered (see clarithromycin and ritonavir product information).
Danish: Hos patienter med nedsat nyrefunktion bør dosisjustering overvejes (se produktinformationen for clarithromycin og ritonavir).
English: Value
Danish: Værdi
English: These drug-drug interactions may reduce the effectiveness of HIV protease inhibitors and/or boceprevir when co-administered.
Danish: Disse lægemiddelinteraktioner kan reducere effekten af hivproteasehæmmere og/eller boceprevir ved samtidig administration.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Tilfælde af osteonekrose er rapporteret, især hos patienter med generelt anerkendte risikofaktorer, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
English: You should write the date of opening the bottle on the label and/or outer carton.
Danish: Du bør skrive datoen for åbningen af beholderen på etiketten og/eller emballagen.
English: Based on the metabolic profiles of tipranavir/r and the proton pump inhibitors, an interaction can be expected.
Danish: På baggrund af de metaboliske profiler af tipranavir/r og protonpumpehæmmerne kan der forventes en interaktion.
English: Therefore, routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus.
Danish: Derfor er rutinemæssige målinger af koagulationsparametre ikke indiceret i behandlingen af patienter med Aptivus.
English: Volume Aptivus (ml)
Danish: Volumen Aptivus (ml)
English: There have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors.
Danish: Der har været rapporteret øget blødning, herunder spontane hudhæmatomer og hæmartrose hos patienter med hæmofili type A og B, behandlet med proteasehæmmere.
English: Keep the container in the outer carton.
Danish: Opbevar flasken i den ydre karton.
English: Since Aptivus capsules and oral solution are not bioequivalent, results obtained with the oral solution cannot be extrapolated to the capsules (see also section 5.2).
Danish: Da Aptivus kapsler og oral opløsning ikke er bioækvivalente, kan resultaterne fra den orale opløsning ikke overføres til kapslerne (se pkt.
English: However, in some cases the role of Aptivus cannot be excluded.
Danish: Imidlertid kan man i visse tilfælde ikke udelukke Aptivus' rolle.
English: A reduced virological response was observed in patients with viral strains harbouring two or more mutations at HIV protease codons 33, 82, 84 or 90, and not receiving new enfuvirtide.
Danish: Der blev observeret nedsat virologisk respons hos patienter med virusstrenge, som havde to eller flere mutationer ved hiv-proteasekodon 33, 82, 84 eller 90, og som ikke havde modtaget ny enfuvirtid.
English: 3 in patients receiving tipranavir with ritonavir
Danish: 3 hos patienter, der fik tipranavir med ritonavir
English: If you have liver disease or hepatitis, your doctor will decide if you need additional testing.
Danish: Hvis du har en leversygdom eller hepatitis, vil din læge vurdere, om du har brug for ekstra studier.
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: Med hensyn til monitorering af lipider og glucose i blodet refereres til eksisterende guidelines for hiv-behandling.
English: UNIQUE IDENTIFIER --- 2D BARCODE
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: The potential net effect of tipranavir with ritonavir on CYP 2D6 is inhibition, because ritonavir is also a CYP 2D6 inhibitor.
Danish: Den potentielle nettoeffekt af tipranavir med ritonavir på CYP2D6 er hæmning, fordi ritonavir også er en CYP2D6-hæmmer.
English: Therefore, it is important that your child continues taking Aptivus correctly, as described above.
Danish: Det er derfor vigtigt, at dit barn tager Aptivus, som anført ovenfor.
English: Propafenone Metoprolol (given in heart failure)
Danish: Metoprolol (anvendt ved hjertesvigt)
English: Result
Danish: Resultat
English: An increased risk of ICH has previously been observed in patients with advanced HIV disease/AIDS such as those treated in the Aptivus clinical trials.
Danish: Man har tidligere observeret øget risiko for ICH hos patienter med fremskreden hiv/aids svarende til hvad der er set i de kliniske afprøvninger af Aptivus.
English: In pre- and post-natal development studies with tipranavir in rats, growth inhibition of pups was observed at maternally toxic doses approximating 0.8-fold human exposure.
Danish: I prenatale og postnatale udviklingsstudier med tipranavir hos rotter observeredes væksthæmning hos unger ved maternelle toksiciske doser på ca. 0,8 gange human eksponering.
English: The interaction profile of Aptivus, co-administered with low dose ritonavir, is complex and requires special attention in particular in combination with other antiretroviral agents.
Danish: Interaktionsprofilen for Aptivus plus lavdosis ritonavir er kompleks og kræver særlig opmærksomhed, især i kombination med andre antiretrovirale midler.
English: Bone problems: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Knogleproblemer: Nogle af de patienter, der får en kombination af antiretrovirale lægemidler, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: Aptivus therapy should be discontinued in patients experiencing ASAT or ALAT elevations greater than 10X ULN, or developing signs or symptoms of clinical hepatitis during therapy.
Danish: Behandling med Aptivus bør seponeres hos patienter, der får forhøjede værdier af ASAT eller ALAT på mere end 10 gange ULN, eller som udvikler tegn eller symptomer på klinisk hepatitis under behandlingen.
English: It may be difficult to tell the difference between: - side effects caused by Aptivus - side effects caused by the other medicines you are also taking - complications of HIV infection.
Danish: Det kan være vanskeligt at skelne mellem: - bivirkninger fra Aptivus - bivirkninger fra den anden medicin du tager - eller fra komplikationer i forbindelse med hiv-infektionen.
English: In the tipranavir and comparator arms median baseline CD4 cell counts were 158 and 166 cells/mm
Danish: I grupperne med tipranavir og komparator var median baseline CD4 celletal hhv. 158 og 166 celler/mm
English: In a study conducted in rats with tipranavir at systemic exposure levels (AUC) equivalent to human exposure at the recommended clinical dose, no adverse effects on mating or fertility were observed.
Danish: I et studie udført på rotter med tipranavir ved systemiske eksponeringsniveauer (AUC) svarende til human eksponering ved anbefalet klinisk dosis, observeredes ingen bivirkninger på parring eller fertilitet.
English: Crystals may be seen as a paper-thin layer at the bottom of the bottle when it is stored upright.
Danish: Krystaller kan forekomme som et papirtyndt lag på bunden af flasken, når den står opret.
English: There is no known antidote for tipranavir overdose.
Danish: Der findes ingen kendt antidot i tilfælde af overdosering med tipranavir.
English: The metabolism of tipranavir in the presence of low dose ritonavir is minimal.
Danish: Metabolismen af tipranavir ved tilstedeværelsen af lavdosis ritonavir er minimal.
English: Telaprevir is metabolized in the liver by CYP3A and is a Pglycoprotein (P-gp) substrate, but other enzymes may be involved in the metabolism.
Danish: Telaprevir metaboliseres i leveren af CYP3A og er et P-glykoprotein(P-gp) substrat, men andre enzymer kan også være involveret i metaboliseringen.
English: No dosage adjustments are recommended.
Danish: Der anbefales ingen dosisjusteringer.
English: Psychiatric disorders uncommon insomnia, sleep disorder
Danish: Psykiske forstyrrelser Ikke almindelig søvnløshed, søvnforstyrrelser
English: Warnings and precautions Talk to your child's doctor or pharmacist before giving Aptivus to your child.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du giver dit barn Aptivus.
English: No data are available for H2receptor antagonists in combination with tipranavir and low dose ritonavir.
Danish: Der foreligger ingen data med H2receptor antagonister i kombination med tipranavir og lavdosis ritonavir.
English: Therefore, Aptivus should be used with caution, and with increased monitoring frequency, in patients with mild hepatic impairment (ChildPugh Class A).
Danish: Aptivus bør derfor anvendes med forsigtighed og med øget monitoreringsfrekvens hos patienter med mild leverinsufficiens (Child-Pugh A).
English: This indication is based on the results of two phase III studies, performed in highly pre-treated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.
Danish: Denne indikation er baseret på resultater fra to fase III-studier, udført i kraftigt forbehandlede voksne patienter (median:12 antiretrovirale lægemiddelstoffer) med virus resistent overfor protease hæmmere og et fase II-studie, hvor farmakokinetik, sikkerhed og virkning af Aptivus hos hovedsagligt behandlingserfarne unge patienter fra 12 til 18 år blev undersøgt.
English: Due to this and to the high vitamin E content of the oral solution, the risk of adverse reactions (type, frequency and/or severity) may be higher than with the capsule formulation.
Danish: Derfor, og grundet det høje indhold af vitamin E i den orale opløsning, kan det forventes, at risikoen for bivirkninger (type, frekvens og/eller alvorlighed) er højere end for kapslerne.
English: Buprenorphine/Naloxone Buprenorphine ↔ Norbuprenorphine AUC  79% Norbuprenorphine Cmax  80% Norbuprenorphine Cmin  80%
Danish: Buprenorphin/naloxon Buprenorphin ↔ Norbuprenorphin AUC  79% Norbuprenorphin Cmax  80% Norbuprenorphin Cmin  80%
English: Endothelin receptor antagonists Bosentan
Danish: Endothelinreceptoragonister Bosentan
English: Date of first opening:
Danish: Dato for anbrud:
English: Some patients who developed rash also had: - joint pain or stiffness - throat tightness - generalized itching
Danish: Nogle patienter, som udviklede udslæt, havde også: - ledsmerter eller -stivhed - sammensnævring i halsen - generel kløe.
English: The net effect will vary depending on the relative affinity of the co-administered substance for CYP3A and P-gp, and the extent of intestinal first-pass metabolism/efflux.
Danish: Nettoeffekten vil variere afhængigt af den relative affinitet af de samtidigt indgivne lægemidler på CYP3A og P-gp og omfanget af first-pass metabolisme/efflux i tarmen.
English: Do not take Aptivus - if you are allergic to tipranavir or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Aptivus - hvis du er allergisk over for tipranavir eller et af de øvrige indholdsstoffer i Aptivus (angivet i afsnit 6).
English: Due to Aptivus containing small amounts of sorbitol, patients with rare hereditary problems of fructose intolerance should not take this medicine.
Danish: Advarsler i forbindelse med nogle af indholdsstofferne Idet Aptivus indeholder en lille mængde sorbitol, bør patienter med hereditær fructoseintolerans ikke anvende denne medicin.
English: Very common: may affect more than 1 in 10 people - Diarrhoea - Nausea (upset stomach)
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter): - diarré - kvalme
English: In a pharmacokinetic study of healthy volunteers, boceprevir decreased the exposure of ritonavir, and some ritonavir-boosted protease inhibitors.
Danish: I et farmakokinetisk studie med raske frivillige nedsatte boceprevir eksponeringen af ritonavir og nogle ritonavir-forstærkede proteasehæmmere.
English: Inhaled beta agonists Salmeterol
Danish: Beta-agonister til inhalation Salmeterol
English: In patients less than 12 years of age, however, the oral solution is the only available option for treatment with tipranavir, as no data are available on the efficacy and safety of Aptivus capsules in children less than 12 years of age.
Danish: For børn under 12 år er det kun Aptivus oral opløsning, som kan bruges ved behandling med tipranavir, da der ikke foreligger data for sikkerhed og virkning for Aptivus kapsler hos børn yngre end 12 år.
English: Most patients were able to continue treatment with tipranavir with ritonavir.
Danish: De fleste patienter var i stand til at fortsætte behandlingen med tipranavir med ritonavir.
English: You should know that you may continue to develop infections and other illnesses associated with HIV disease.
Danish: Du vil fortsat kunne få infektioner og andre sygdomme i relation til hiv-sygdommen.
English: Data suggest that, although ritonavir is a P-gp inhibitor, the net effect of Aptivus, coadministered with low dose ritonavir, at the proposed dose regimen at steady-state, is P-gp induction.
Danish: Data tyder på, at selvom ritonavir er en P-gp-hæmmer, er nettopåvirkningen af Aptivus plus lavdosis ritonavir ved det foreslåede dosisregime ved steady state P-gp-induktion.
English: Theophylline plasma concentrations should be monitored during the first two weeks of co-administration with Aptivus, co-administered with low dose ritonavir, and the theophylline dose should be increased as needed.
Danish: Plasmakoncentrationen for theophyllin bør monitoreres de første 2 uger, når Aptivus gives sammen med lavdosis ritonavir, og theophyllindosis bør om nødvendigt øges.
English: Anti-infectives
Danish: Antiinfektiva
English: Includes abdominal pain (N=1) and dyspepsia (N=1).
Danish: Omfatter abdominalsmerte (N=1), dyspepsis (N=1).
English: Human experience with tipranavir overdose is very limited.
Danish: Erfaring med overdosering af tipranavir hos mennesker er meget begrænset.
English: The reduction of bupropion plasma levels is likely due to induction of CYP2B6 and UGT activity by RTV
Danish: Reduktion af plasmakoncentrationen af bupropion er sandsynligt på grund af induktionen af CYP2B6 og UGT-aktivitet af RTV.
English: Do not use this medicine after the expiry date which is stated on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: A correlation between the tipranavir mutation score and response to tipranavir with ritonavir therapy at week 48 has been established.
Danish: Man så en sammenhæng mellem mutationsscoren for tipranavir og responsen over for tipranavir med ritonavir-behandling ved uge 48.
English: Aptivus with ritonavir should not be used in treatment-naïve patients.
Danish: Aptivus med ritonavir bør ikke anvendes til behandlingsnaive patienter.
English: - didanosine: If you are taking didanosine enteric coated tablets, you should take them at least two hours before or after Aptivus.
Danish: - didanosin: Hvis du er i behandling med didanosin depottabletter, skal disse tages mindst 2 timer før eller efter Aptivus.
English: Carcinogenicity studies of tipranavir in mice and rats revealed tumourigenic potential specific for these species, which are regarded as of no clinical relevance.
Danish: Karcinogenicitetsstudier af tipranavir i mus og rotter viste potentiel tumorgenicitet, specifikt for disse arter.
English: Pink, oblong soft gelatin capsules imprinted with “TPV 250” in black.
Danish: Pink, aflange bløde gelatine kapsler påtrykt ”TPV 250” i sort.
English: Studies with co-administration of tipranavir and ritonavir did not reveal any additional toxicological effects when compared to those seen in the tipranavir single agent toxicological studies.
Danish: Studier med samtidig indgift af tipranavir og ritonavir viste ingen yderligere toksikologiske virkninger, når man sammenligner med dem, der ses i toksikologiske studier med tipranavir alene.
English: A higher increase of blood lipids were seen with tipranavir/ritonavir than with comparators (other protease inhibitors) in clinical trials.
Danish: Der blev observeret en højere stigning i blodlipider med tipranavir/ritonavir i forhold til komparatorer (andre proteasehæmmere) i kliniske studier.
English: Some of the side effects of Aptivus may affect your ability to drive or operate machinery (e.g. dizziness and sleepiness).
Danish: Nogle af bivirkningerne ved Aptivus kan påvirke evnen til at føre bil eller betjene maskiner (f.eks. svimmelhed og søvnighed).
English: However, children previously treated with Aptivus oral solution and becoming 12 years of age should be switched to capsules, particularly because of the more favourable safety profile of the capsules.
Danish: Børn, der tidligere er blevet behandlet med Aptivus oral opløsning og bliver 12 år, skal skifte til kapsler, primært pga. kapslernes mere fordelagtige sikkerhedsprofil.
English: Aptivus should neither be used by children under 2 years of age nor by adolescents 12 years of age or older.
Danish: Børn og unge Aptivus bør ikke bruges til børn under 2 år eller til unge på 12 år eller derover.
English: PHARMACEUTICAL FORM AND CONTENTS 95 ml oral solution (1 bottle) Oral syringe
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 95 ml oral opløsning (1 flaske)
English: Among all randomised and treated patients, the median change from baseline in CD4+ cell count at the last measurement up to Week 48 was +23 cells/mm
Danish: Blandt alle randomiserede og behandlede patienter, var median-ændringen i CD4+-celletællingen ved baseline ved sidste måling op til uge 48 +23 celler/mm
English: The effects of sildenafil and vardenafil are likely to be increased if you take them with Aptivus.
Danish: Virkningen af sildenafil og vardenafil har en tendes til at blive forøget, hvis de tages sammen med Aptivus.
English: It is difficult to predict the net effect of Aptivus co-administered with low dose ritonavir on oral bioavailability and plasma concentrations of agents that are dual substrates of CYP3A and P-gp.
Danish: Det er vanskeligt at forudse nettoeffekten af Aptivus plus lavdosis ritonavir på oral biotilgængelighed og plasmakoncentrationer af stoffer, som er dobbeltsubstrater af CYP3A og P-gp.
English: Antiretrovirals
Danish: Antiretroviral