FrancophonIA/ELRC3.0 huggingface dataset:
English: % with Category C 29.2% Treatment history % with any ARV 96.6% Median # previous
Danish: % med katagori C 29,2% Behandlingshistorik % med ARV
English: First-dose tipranavir/r Digoxin Cmax ↔ Digoxin AUC ↔
Danish: Første-dosis tipranavir/r: Digoxin Cmax ↔ Digoxin AUC ↔
English: In a
Danish: C
English: Common: may affect up to 1 in 10 people - Vomiting - Abdominal pain (tummy pain) - Flatulence (breaking wind more often) - Tiredness - Headache - Mild rashes e.g. with hives or with flat or raised small red spots - Increases in blood lipid (fat) levels - Dyspepsia
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter): - opkastning - mavesmerter - luft i maven - træthed - hovedpine - milde udslæt, f.eks. nældefeber eller fladt eller hævet udslæt med røde prikker - stigning i blodets lipid (fedt) niveauer - fordøjelsesbesvær (dyspepsi)
English: - If you have any further questions, please ask your child's doctor or pharmacist.
Danish: Er du i tvivl, så spørg dit barns læge eller apotekspersonalet.
English: The clinical relevance of this reduction in didanosine concentrations has not been established.
Danish: Den kliniske relevans ved reduktionen af didanosinkoncentrationen er ikke fastlagt.
English: No tipranavir with ritonavir dose adjustment is required.
Danish: Dosisjustering af tipranavir med ritonavir er ikke nødvendig.
English: Antimalarial Halofantrine Lumefantrine No interaction study performed
Danish: Antimalaria Halofantrin Lumefantrin Der er ikke udført interaktionsstudier.
English: Simvastatin Lovastatin No interaction study performed
Danish: Simvastatin Lovastatin Der er ikke udført interaktionsstudier.
English: Hepatic impairment
Danish: Mavesmerter Feber
English: Immunosupressants Cyclosporin Tacrolimus Sirolimus
Danish: Immunsuppressiva Ciclosporin Tacrolimus Sirolimus Der er ikke udført interaktionsstudier
English: Amber glass bottle, with two-piece plastic child-resistant closure (outer shell high density polyethylene (HDPE), inner shell polypropylene resin with a foamed laminated polyethylene liner.. Each pack contains 1 bottle of 95 ml oral solution and is supplied with a clear polypropylene 5 ml oral syringe, HDPE syringe tip cap and clear LDPE bottle-syringe adapter.
Danish: Hver pakning indeholder 1 flaske med 95 ml oral opløsning samt en 5 ml oral sprøjte af klar polypropylen, en HDPE-sprøjtespids og en flaske-sprøjte adaptor af klar LDPE.
English: Aptivus capsules should be taken with food.
Danish: Aptivus kaspler skal tages sammen med mad.
English: No interaction study performed
Danish: Der er ikke udført interaktionsstudier
English: Aptivustreatment is therefore appropriate for your child.
Danish: Opbevares utilgængeligt for børn.
English: The concomitant use of Aptivus, coadministered with low dose ritonavir, with abacavir is not recommended unless there are no other available NRTIs suitable for patient management.
Danish: Abacavir anbefales ikke samtidig med Aptivus plus lavdosis ritonavir med medmindre, der ikke er andre tilgængelige NRTI'er, som egner sig til patientbehandlingen.
English: Capsule contents
Danish: Kapslen
English: - 500 mg (two 250 mg capsules) Aptivus together with - 200 mg (two 100 mg capsules) ritonavir twice per day with food.
Danish: Den anbefalede daglige dosis for voksne eller unge fra 12 år er: - 500 mg (2 kapsler a 250 mg) Aptivus taget sammen med - 200 mg (2 kapsler a 100 mg) ritonavir 2 gange dagligt sammen med mad.
English: Since levels of ethinyl oestradiol are decreased, the co-administration of Aptivus co-administered with low dose ritonavir is not recommended.
Danish: Da niveauerne af ethinylestradiol falder anbefales det, ikke at give kombinationen af Aptivus med ritonavir samtidig.
English: Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving ritonavir and inhaled or intranasally administered fluticasone propionate; this could also occur with other corticosteroids metabolised via the P450 3A pathway e.g. budesonide.
Danish: Der er rapporteret systemiske kortikosteriod-effekter, herunder Cushings syndrom og adrenal suppression, hos patienter, der har fået ritonavir og inhaleret eller intranasalt administreret fluticasonproprionat.
English: When Aptivus/ritonavir is co-administered with telaprevir, a decrease or an increase of telaprevir exposure
Danish: Når Aptivus/ritonavir administreres sammen med telaprevir, kan der
English: Tipranavir is metabolised by the hepatic system.
Danish: Tipranavir metaboliseres i leveren.
English: Based on theoretical considerations tipranavir, co-administered with low dose ritonavir, is expected to increase itraconazole or ketoconazole concentrations.
Danish: Teoretisk forventes tipranavir plus lavdosis ritonavir at øge itraconazol- eller ketoconazolkoncentrationer.
English: How to take Aptivus
Danish: Sådan skal du tage Aptivus
English: Therefore, the concomitant use of zidovudine or abacavir with Aptivus, co-administered with low dose ritonavir, is not-recommended unless there are no other available NRTIs suitable for patient management (see section 4.5).
Danish: Derfor kan samtidig behandling med zidovudin eller abavir og Aptivus givet med lavdosis ritonavir ikke anbefales, med mindre der ikke er andre NRTIs tilgængelige for patienten (se pkt.
English: Meperidine No interaction study performed
Danish: Meperidin Der er ikke udført interaktionsstudier
English: emtricitabine: If your child is taking emtricitabine your child's kidney function should be checked before initiation of Aptivus.
Danish: timer før eller efter du tager Aptivus - emtricitabin: Hvis dit barn tager emtricitabin, bør dit barns leverfunktion blive undersøgt før påbegyndelse af Aptivus.
English: Diarrhoea
Danish: Leversygdom
English: All patients * Includes patients who did not receive ENF and those who were previously treated with and continued ENF ** Mutations in HIV protease at positions L10V, I13V, K20M/R/V, L33F, E35G, M36I, K43T, M46L, I47V, I54A/M/V, 58E, H69K, T74P, V82L/T, N83D or I84V ENF Enfuvirtide; TPV/r Tipranavir with ritonavir
Danish: Alle patienter * Omfatter patienter, som ikke har modtaget ENF, samt de patienter, som tidligere er blevet behandlet med og har fortsat ENF **Mutationer i hiv-protease ved positionerne L10V, I13V, K20M/R/V, L33F, E35G, M36I, K43T, M46L, I47V, I54A/M/V, 58E, H69K, T74P, V82L/T, N83D or I84V ENF: Enfuvirtid; TPV/r: Tipranavir med ritonavir
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with alfuzosin is contraindicated.
Danish: Samtidig administration af Aptivus plus lavdosis ritonavir og alfuzosin er kontraindiceret.
English: You should talk to your doctor as you may need to temporarily stop taking either Aptivus or your oral contraceptives or HRT - carbamazepine, phenobarbital and phenytoin (used to treat epilepsy).
Danish: Du skal tale med din læge, da det kan være nødvendigt midlertidigt at stoppe med at tage enten Aptivus eller den anden medicin, der indeholder østrogen eller andre kvindelige kønshormoner.
English: Combination of rifampicin with Aptivus with concomitant low dose ritonavir is contraindicated (see section 4.5).
Danish: Kombination af rifampicin og Aptivus med lavdosis ritonavir er kontraindiceret (se pkt.
English: You should talk to your child's doctor as they may need to temporarily stop taking either Aptivus or their oral contraceptives or HRT - carbamazepine, phenobarbital and phenytoin (used to treat epilepsy).
Danish: Du bør tale med dit barns læge, da det kan være nødvendigt midlertidigt at stoppe med at tage enten Aptivus eller den anden medicin, der indeholder østrogen eller andre kvindelige hormoner.
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase amiodarone, bepridil and quinidine concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger plasmakoncentrationerne af amiodaron, bepridil og quinidin.
English: Before starting treatment, your child's doctor will have taken blood samples to test the resistance of your child's HIV.
Danish: Dit barns læge tager derfor blodprøver før behandlingen startes for at teste, om hiv i dit barns blod er resistent, og at Aptivus er egnet til behandling af dit barn.
English: Musculoskeletal and connective tissue disorders uncommon myalgia, muscle spasms
Danish: Knogler, led, muskler og bindevæv Ikke almindelig myalgi, muskelspasmer
English: The concomitant use of Aptivus, coadministered with low dose ritonavir with zidovudine is not recommended unless there are no other available NRTIs suitable for patient management.
Danish: Zidovudin anbefales ikke samtidig med Aptivus plus lavdosis ritonavir, medmindre der ikke er andre tilgængelige NRTI'er, som egner sig til patientbehandlingen.
English: Dosing by means of the measuring device remains accurate even when crystals are observed.
Danish: Selvom der skulle forekomme krystaller, bliver dosering ved hjælp af målesprøjten korrekt.
English: The clinical relevance of this reduction in saquinavir concentrations has not been established.
Danish: Den kliniske relevans ved reduktionen af saquinavirkoncentrationen er ikke fastlagt.
English: CYP 3A4 inhibition by tipranavir/r and P-gp (an intestinal efflux transporter) inhibition by clarithromycin.
Danish: Tipranavir/r hæmmer CYP3A4, og clarithromycin hæmmer P-gp (Pglykoprotein, en intestinal efflukstransporter).
English: Therefore patients should not be switched from Aptivus capsules to Aptivus oral solution (see sections 5.1 and 5.2).
Danish: Patienter bør ikke skifte behandling fra Aptivus kapsler til Aptivus oral opløsning (se pkt.
English: Zidovudine Cmax ↓ 49% Zidovudine AUC ↓ 36%
Danish: Zidovudin Cmax ↓ 49% Zidovudin AUC ↓ 36%
English: Rash consists of one or more of the preferred terms of rash, drug eruption, rash macular, rash papular, erythema, rash maculo-papular, rash pruritic, and urticaria
Danish: Udslæt består af en eller flere former for udslæt, medikamentelt udslæt, makulært udslæt, papuløst udslæt, erytem, makulopapulært udslæt, kløende udslæt og urticaria.
English: Uncommon: may affect up to 1 in 100 people - Reduction in red and white blood cells - Reduction in blood platelets - Allergic (hypersensitivity) reactions - Decreased appetite - Diabetes - Increased blood sugar - Increased blood levels of cholesterol - Sleeplessness and other sleep disorders
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - et fald i antallet af røde og hvide blodlegemer - et fald i antallet af blodplader - allergiske reaktioner - nedsat appetit - diabetes - forhøjet blodsukker - forhøjet kolesterol i blodet - søvnløshed og andre søvnforstyrrelser - søvnighed - svimmelhed - følelsesløshed og/eller prikken og/eller smerte i fødder eller hænder - åndedrætsbesvær - halsbrand - betændelse i bugspytkirtlen - betændelse i huden - kløe - muskelkramper - muskelsmerter
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase pimozide, sertindole, quetiapine and lurasidone concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger plasmakoncentrationerne af pimozid, sertindol, quetiapin og lurasidon.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each soft capsule contains 250 mg tipranavir
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 blød kapsel indeholder 250 mg tipranavir.
English: Dyspepsia
Danish: Dyspnø
English: Proton pump inhibitors (PPIs) Omeprazole 40 mg QD Omeprazole Cmax ↓ 73%
Danish: Protonpumpehæmmere (PPI) Omeprazol 40 mg x 1
English: This can lead to death - Increased blood levels of bilirubin (a breakdown product of haemoglobin) You should inform your child's doctor if they experience: - Loss of appetite - Nausea (upset stomach) - Vomiting and/or jaundice which may be symptoms of abnormal liver function - Bleeding - * Bleeding in the brain.
Danish: Du skal kontakte dit barns læge, hvis barnet oplever: - nedsat appetit - kvalme - opkastning og/eller gulsot (gulfarvning af huden og i øjnene) da det kan være tegn på unormal leverfunktion - Blødninger - *blødninger i hjernen.
English: % with Category C 48.4% Treatment history % with any ARV 96.8% Median # previous
Danish: Behandlingshistorik % med ARV Median # tidligere
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 mg tipranavir
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 ml indeholder 100 mg tipranavir.
English: Patients with moderate or severe (Child-Pugh B or C) hepatic impairment.
Danish: Patienter med moderat til svær leverinsufficiens (Child-Pugh B eller C).
English: Nevirapine No interaction study performed
Danish: Nevirapin Der er ikke udført interaktionsstudier.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Risikofaktorer for udvikling af denne sygdom er blandt andre: Tidsperioden for kombinationsbehandlingen med flere antiretrovirale lægemidler, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar, samt (over-)vægt (højere Body Mass Index (BMI)).
English: This is due to induction of drug metabolising enzymes by St John's wort.
Danish: Dette skyldes at perikon inducerer metaboliserende enzymer.
English: Aptivus oral solution co-administered with low dose oral solution ritonavir should be taken with food (see section 5.2).
Danish: Aptivus oral opløsning plus lavdosis oral opløsning af ritonavir bør tages sammen med mad (se pkt.
English: Transient inhibition of P-gp by tipranavir/r, followed by induction of P-gp by tipranavir/r at steadystate
Danish: Tipranavir/r hæmmer P-gp forbigående efterfulgt af induktion ved steady-state.
English: The concomitant administration with Aptivus, co-administered with low dose ritonavir, is not recommended.
Danish: Administration sammen med Aptivus og lavdosis ritonavir anbefales ikke.
English: You should inform your doctor as soon as possible if you notice the signs or symptoms of hepatitis: - fever - malaise (feeling generally unwell) - nausea (upset stomach) - vomiting - abdominal pain - tiredness
Danish: Får du nogle af nedenstående tegn eller symptomer på hepatitis, skal du hurtigst muligt kontakte din læge: - feber - utilpashed - kvalme - opkastning - smerte i maveregionen - træthed - gulsot (gulfarvning af huden og i øjnene).
English: The combined use of Aptivus, coadministered with low dose ritonavir, with proton pump inhibitors is not recommended (see section 4.4).
Danish: Kombinationen af Aptivus plus lavdosis ritonavir med protonpumpehæmmere kan ikke anbefales (se pkt.
English: Coadministration of boceprevir with Aptivus/ritonavir is not recommended.
Danish: Samtidig administration af boceprevir og Aptivus/ritonavir anbefales ikke.
English: Theophylline No interaction study performed
Danish: Theophyllin Der er ikke udført interaktionsstudier.
English: Desipramine No interaction study performed
Danish: Desipramin Der er ikke udført interaktionsstudier.
English: These occur particularly when Aptivus or other protease inhibitors are taken together with nucleoside analogues.
Danish: Der er rapporter om smerter eller ømhed i musklerne eller muskelsvækkelse efter især antiretroviral kombinationsbehandling med proteasehæmmere og nukleosid-analoger.
English: Fatal and non-fatal intracranial haemorrhages (ICH) have been reported in patients receiving Aptivus, many of whom had other medical conditions or were receiving concomitant medicinal products that may have caused or contributed to these events.
Danish: Mange af disse patienter havde andre sygdomme eller fik samtidigt anden medicin, der kunne have forårsaget eller medvirket til disse hændelser.
English: Grade 3 or 4 elevations of triglycerides occurred more frequently in the tipranavir with ritonavir arm compared with the comparator arm. At 48 weeks these rates were 25.2% of patients in the tipranavir with ritonavir arm and 15.6% in the comparator arm.
Danish: Ved 48 uger var tallene 25,2% for patienterne i tipranavir med ritonavir-gruppen og 15,6% i komparatorgruppen.
English: If a dose is missed by less than 5 hours, the patient should be instructed to take the missed dose immediately, and then to take the next dose of Aptivus and ritonavir at the regularly scheduled time.
Danish: Overskrides doseringstidspunktet med mindre end 5 timer, skal patienten instrueres i at tage den glemte dosis med det samme og tage den næste Aptivus- og ritonavirdosis som planlagt.
English: You should check with your doctor if you do wish to continue taking oral contraceptives or HRT.
Danish: Tal med din læge om det, hvis du fortsat ønsker at tage p-piller eller kvindelige kønshormoner.
English: Tenofovir 300 mg QD (TPV/r 750/200 mg BID)
Danish: Tenofovir 300 mg x 1 (TPV/r 750/200 mg x 2)
English: - Sleepiness - Dizziness - Numbness and/or tingling and/or pain in the feet or hands - Breathing difficulties - Heartburn - Inflammation of the pancreas - Skin inflammation - Itching - Muscle cramp - Muscle pain - Kidney disease - Flu like symptoms (feeling unwell) - Fever - Weight loss - Increased blood levels of the pancreas enzyme amylase - Increases in liver enzyme activity - Hepatitis with liver cell damage due to influence of a toxin
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter): - et fald i antallet af røde og hvide blodlegemer - et fald i antallet af blodplader - allergiske reaktioner - nedsat appetit - diabetes - forhøjet blodsukker - forhøjet kolesterol i blodet - søvnløshed og andre søvnforstyrrelser - søvnighed - svimmelhed - følelsesløshed og/eller prikken og/eller smerte i fødder eller hænder - åndedrætsbesvær - halsbrand - betændelse i bugspytkirtlen - betændelse i huden - kløe - muskelkramper - muskelsmerter - nyrefunktionsfejl - influenza-lignende symptomer (generel sygdomsfølelse) - feber - vægttab - forhøjet indhold af bugspytkirtel-enzymet amylase i blodet - stigning i aktiviteten af leverenzymer - leverbetændelse med levercelleskade grundet udskillelse af et toksin (et giftstof)
English: propylene glycol, mono/diglycerides of caprylic/capric acid, sucralose, ascorbic acid, Butter
Danish: - Øvrige indholdsstoffer: Macrogol, vitamin E, propylenglykol, renset vand, mono/diglycerider af caprylsyre/caprinsyre, sukralose, butter mint (aroma), Butter toffee (aroma), ascorbinsyre
English: First-dose tipranavir/r Midazolam Cmax ↑ 5.0 fold Midazolam AUC ↑ 27 fold
Danish: Første-dosis tipranavir/r: Midazolam Cmax ↔ Midazolam AUC ↑ 5,1 gange
English: When Aptivus/ritonavir is co-administered with telaprevir, a decrease or an increase of telaprevir exposure could be expected.
Danish: sammen med telaprevir, kan der forventes et fald eller en stigning i eksponeringen af telaprevir.
English: Renal and urinary disorders uncommon renal failure
Danish: Nyrer og urinveje Ikke almindelig nyresvigt
English: If the combination is nevertheless considered necessary, a monitoring of the plasma levels of saquinavir is strongly encouraged (see section
Danish: Hvis kombinationen alligevel anses for nødvendig, anbefales det kraftigt at monitorere plasmakoncentrationerne for saquinavir (se pkt.
English: Coadministration of telaprevir with Aptivus/ritonavir is not recommended.
Danish: Samtidig administration af telaprevir og Aptivus/ritonavir anbefales ikke.
English: Tipranavir AUC over a 12 hour dosing interval averaged 851 ± 309 µM•h (CL=1.15 l/h) for female patients and 710 ± 207 µM•h (CL=1.27 l/h) for male patients.
Danish: AUC for tipranavir var i løbet af et 12-timers doseringsinterval gennemsnitligt 851 +/- 309 µM
English: Co-administration of bosentan and Aptivus with low dose ritonavir is not recommended (see section 4.4).
Danish: Samtidig administration af bosentan og Aptivus plus lavdosis ritonavir anbefales ikke (se pkt.
English: Tabulated summary of adverse reactions
Danish: Resumé af bivirkninger
English: The concomitant use of Aptivus, co-administered with low dose ritonavir, with amiodarone, bepridil or quinidine is contraindicated due to potential serious and/or life threatening events (see section 4.3)
Danish: Samtidig brug af Aptivus plus lavdosis ritonavir med amiodaron, bepridil eller quinidin er kontraindiceret på grund af risiko for alvorlige og/eller livstruende bivirkninger (se pkt.
English: Compared to the oral solution, tipranavir exposure is lower when administering the same dose as capsules.
Danish: Absorptionen af tipranavir er højere fra oral opløsning end når den samme dosis gives, som kapsler.
English: RESIST-1 and RESIST-2 are ongoing, randomised, open-label, multicentre studies in HIV-positive, triple-class experienced patients, evaluating treatment with 500 mg tipranavir co-administered with low dose ritonavir (200 mg; twice daily) plus an optimised background regimen (OBR) individually defined for each patient based on genotypic resistance testing and patient history.
Danish: I disse studier behandles med 500 mg tipranavir plus lavdosis ritonavir 200 mg; to gange daglig plus en optimeret baggrundsbehandling, der defineres individuelt for hver enkelt patient ud fra genotypisk resistenstest og patientens anamnese.
English: Renal impairment No dosage adjustment is required in patients with renal impairment (see sections 4.4 and 5.2).
Danish: Nyreinsufficiens Der kræves ingen dosisjustering til patienter med nyreinsufficiens (se pkt.
English: Lamivudine 150 mg BID (TPV/r 750/100 mg BID)
Danish: Lamivudin 150 mg x 2 (TPV/r 750/100 mg x 2)
English: Based on theoretical considerations, tipranavir, co-administered with low dose ritonavir, is expected to increase flecainide, propafenone and metoprolol concentrations.
Danish: Teoretisk forventes det, at tipranavir plus lavdosis ritonavir øger plasmakoncentrationerne af flecainid, propafenon og metoprolol.
English: Antithrombotics Warfarin 10 mg QD First-dose tipranavir /r: S-warfarin Cmax ↔ S-warfarin AUC ↑ 18%
Danish: Første-dosis tipranavir/r: S-warfarin Cmax ↔ S-warfarin AUC ↑ 18%
English: NNRTIs
Danish: (NNRTI).
English: Abacavir 300 mg BID (TPV/r 750/100 mg BID)
Danish: Abacavir 300 mg x 2 (TPV/r 750/100 mg x 2)
English: Anti-HCV agents Boceprevir No interaction study performed
Danish: Anti-HCV-midler Boceprevir
English: Always take this medicine in combination with other antiretroviral medicines.
Danish: Du skal altid tage dette lægemiddel sammen med andre antiretrovirale lægemidler, og du skal følge vejledningen i de tilhørende indlægssedler.
English: Administer Aptivus oral solution immediately.
Danish: Den udtrukkede Aptivus-dosis skal indtages med det samme.
English: Response rates were higher in tipranavir with ritonavir patients than comparator PI boosted with ritonavir in new enfuvirtide patients, or patients without new enfuvirtide.
Danish: Responsraten var højere hos patienter i tipranavir med ritonavir-behandling end de, der fik komparator proteasehæmmer/ritonavir.
English: It may be difficult to tell the difference between: - side effects caused by Aptivus - side effects caused by the other medicines your child is also taking - complications of HIV infection.
Danish: - bivirkninger fra den anden medicin dit barn tager - eller fra komplikationer i forbindelse med hiv-infektionen.