FrancophonIA/ELRC3.0 huggingface dataset:
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Danish: Hos hiv-smittede patienter, med svær immundefekt på tidspunktet for introduktionen af den antiretrovirale kombinationsbehandling (CART), kan der opstå en inflammatorisk reaktion over for asymptomatiske eller residuale, opportunistiske infektioner.
English: The following clinical data is derived from analyses of 48-week data from ongoing studies (RESIST-1 and RESIST-2) measuring effects on plasma HIV RNA levels and CD4 cell counts.
Danish: De præsenterede kliniske data er 48 ugers data fra studierne RESIST-1 og RESIST-2, der måler effekt på plasma-hiv-RNA-niveau og CD4 celletal.
English: Aptivusoral solution is indicated for: children from 2 to 12 years of age
Danish: Aptivus oral opløsning anvendes til behandling af: - børn fra 2 - 12 år
English: Aptivus contains the active substance tipranavir.
Danish: Aptivus indeholder det aktive stof tipranavir.
English: You should continue to take Aptivus for as long as your doctor tells you.
Danish: Du skal blive ved med at tage Aptivus, lige så længe, som din læge anbefaler det.
English: In Phase II and III clinical trials, 276 patients with on-treatment genotypes have demonstrated that the predominant emerging mutations with tipranavir treatment are L33F/I/V, V82T/L and I84V.
Danish: I kliniske fase II og III studier viste 276 patienter, at de mest almindelige mutationer ved tipranavir-behandling er L33F/I/V, V82T/L og I84V.
English: Vitamin E polyethylene glycol succinate Purified water
Danish: Vitamin E polyethylene glycol succinate Propylenglycol
English: Amongst the most common adverse reactions reported for Aptivus were gastrointestinal complaints such as diarrhoea and nausea as well as hyperlipidaemia.
Danish: Blandt de almindeligste bivirkninger rapporteret for Aptivus var gastrointestinale gener som diarré og kvalme og hyperlipidæmi.
English: At tipranavir exposures in rats at 0.8-fold human exposure at the clinical dose, foetal toxicity (decreased sternebrae ossification and body weights) was observed.
Danish: Ved behandling af rotter med tipranavir ved 0,8 gange human behandling ved klinisk dosis observeredes føtal toksicitet (nedsat sternebrae ossifikation og kropsvægt).
English: Colchicine is a substrate of CYP3A4 and P-gp (an intestinal efflux transporter).
Danish: Colchicin er CYP3A4 og P-gp substrat (en intestinal efflukstransporter).
English: Alpha 1-adrenoreceptor antagonists Alfuzosin
Danish: α-1-blokkere Alfuzosin
English: Proportion of patients achieving treatment response at Week 48 (confirmed ≥1 log10 copies/ml decrease in viral load compared to baseline), according to tipranavir baseline mutation score and enfuvirtide use in RESIST patients
Danish: Andelen af patienter, der opnår behandlingsrespons ved uge 48 (bekræftet ≥1 log10 kopier/ml fald i virusmængde sammenlignet med baseline) i henhold til tipranavir baseline-mutationsscore og anvendelse af enfuvirtid til RESIST-patienter.
English: If another cause is identified (e.g. acute hepatitis A, B or C virus, gallbladder disease, other medicinal products), then rechallenge with Aptivus may be considered when ASAT/ALAT have returned to the patient's baseline levels.
Danish: Såfremt der identificeres en anden årsag (f.eks. akut hepatitis A, B eller C virus, sygdom i galdeblæren eller anden medicin), kan det overvejes om behandlingen med Aptivus skal genoptages, når patientens ASAT/ALAT værdier er på samme niveau, som før behandlingen startede.
English: The effective mean elimination half-life of tipranavir with ritonavir in healthy volunteers (n = 67) and HIV-infected adult patients (n = 120) was approximately 4.8 and 6.0 hours, respectively, at steady state following a dose of 500 mg/200 mg twice daily with a light meal.
Danish: Den effektive gennemsnitlige eliminationshalveringstid for tipranavir med ritonavir hos raske frivillige (n=67) og hiv-inficerede voksne patienter (n=120) var hhv. ca. 4,8 og 6,0 timer ved steady state efter en dosis på 500 mg/200 mg to gange daglig indtaget med et let måltid.
English: Therefore, it is important that you continue taking Aptivus correctly, as described above.
Danish: Det er derfor vigtigt, at du tager Aptivus, som anført ovenfor.
English: Based on similarities in the elimination between pravastatin and rosuvastatin, TPV/r could increase the plasma levels of pravastatin.
Danish: På baggrund af lighederne i eliminationen mellem pravastatin og rosuvastatin, kan TPV/r øge plasmakoncentrationen af pravastatin.
English: Analyses of tipranavir resistance in treatment experienced patients Tipranavir with ritonavir response rates in the RESIST studies were assessed by baseline tipranavir genotype and phenotype.
Danish: Analyse af tipranavir-resistens hos tidligere behandlede patienter Responsrater for tipranavir med ritonavir i RESIST-studierne blev vurderet ud fra baseline tipranavir genotype og fænotype.
English: Children Aptivus soft capsules should not be used by children under 12 years of age.
Danish: Børn Aptivus kapsler bør ikke bruges til børn under 12 år.
English: These have generally occurred in patients with advanced HIV disease taking multiple concomitant medicinal products.
Danish: Disse tilfælde er generelt forekommet hos patienter med fremskreden hiv-sygdom og i multi-medicinsk behandling.
English: Frequencies of marked clinical laboratory abnormalities (Grade 3 or 4) reported in at least 2% of patients in the tipranavir with ritonavir arms in the phase III clinical studies (RESIST-1 and RESIST2) after 48-weeks were increased ASAT (6.1%), increased ALAT (9.7%), increased amylase (6.0%), increased cholesterol (4.2%), increased triglycerides (24.9%), and decreased white blood cell count
Danish: Frekvensen af væsentlige kliniske laboratoriemæssige abnormiteter (niveau 3 eller 4) rapporteret hos mindst 2% af patienterne i tipranavir med ritonavir armen i fase III kliniske studier (RESIST-1 og RESIST-2) efter 48 uger var forhøjet ASAT (6,1%), forhøjet ALAT (9,7%), forhøjet amylase (6,0%), forhøjet kolesterol (4,2%), forhøjet triglycerider (24,9%) og fald i hvide blodlegemer (5,7%).
English: In faeces, unchanged tipranavir represented the majority of faecal radioactivity (79.9% of faecal radioactivity).
Danish: I fæces var uforandret tipranavir hovedparten af radioaktiviteten (79,9% af radioaktiviteten i fæces).
English: Preclinical studies performed with tipranavir showed no adverse effect on fertility (see section 5.3).
Danish: De præ-kliniske studier med tipranavir viste ingen uønsket virkning på fertiliteten (se pkt.
English: Patients should be advised of the need to take Aptivus and ritonavir every day as prescribed.
Danish: Patienter bør informeres om nødvendigheden af dagligt at tage den ordinerede dosis Aptivus og ritonavir.
English: Doses of ritonavir lower than 200 mg twice daily should not be used as they might alter the efficacy profile of the combination.
Danish: Der bør ikke ordineres ritonavir i doser på mindre end 200 mg to gange daglig, da det kan ændre virkningsprofilen ved kombinationsbehandlingen.
English: The maximum volume which can be withdrawn at one time is 5 ml (equivalent to 500 mg tipranavir), which is the maximum single dose for a child with BSA > 1.33 m
Danish: Der kan maksimalt udtrækkes 5 ml ad gangen (svarende til 500 mg tiparanavir), hvilket er den maksimale dosis til et barn med BSA > 1,33 m 5.
English: Aptivus/ritonavir dose (375 mg/m2 Aptivus + 150 mg/m2 ritonavir)
Danish: Aptivus/ritonavir dosis (375 mg/m2 Aptivus + 150 mg/m2 ritonavir)
English: In studies where tipranavir coadministered with low-dose ritonavir was used with or without enfuvirtide, it has been observed that the steady-state plasma tipranavir trough concentration of patients receiving enfuvirtide were 45% higher as compared to patients not receiving enfuvirtide.
Danish: I studier, hvor kombinationen tipranavir og lavdosis ritonavir blev anvendt med eller uden enfuvirtide, blev det observeret, at steady state dalværdi-koncentrationen (minimumsværdien) af tipranavir var 45% højere hos patienter, som fik enfuvirtid, end hos de patienter, som ikke fik enfuvirtid.
English: Genotypic or phenotypic testing (when available) and treatment history should guide the use of Aptivus.
Danish: Genotype- eller fænotype-studier (når det er muligt) og tidligere behandlinger skal tages i betragtning ved behandling med Aptivus.
English: However, since the renal clearance of tipranavir is negligible, a decrease in total body clearance is not expected in patients with renal impairment.
Danish: Men da renal clearance af tipranavir er negligeabel, forventes ikke et fald i total clearance hos patienter med nyreinsufficiens.
English: Data are not available to indicate whether tipranavir inhibits or induces glucuronosyl transferases.
Danish: Der foreligger ingen data til indikation af, om tipranavir hæmmer eller inducerer glucuronosyl transferaser.
English: RESIST participants receiving Aptivus with ritonavir tended to have an increased risk of bleeding; at 24 weeks the relative risk was 1.98 (95% CI=1.03, 3.80).
Danish: RESIST deltagere der blev behandlet med Aptivus med ritonavir tenderede til at have en øget risiko for blødning; efter 24 uger var den relative risiko 1,98 (95% CI=1,03; 3,80).
English: Dose Aptivus (mg)
Danish: Dosis Aptivus (mg)
English: The most abundant faecal metabolite, at 4.9% of faecal radioactivity (3.2% of dose), was a hydroxyl metabolite of tipranavir.
Danish: 4,9% af radioaktiviteten (3,2% af dosis) var en hydroxylmetabolit fra tipranavir.
English: The maximum volume you can withdraw at one time is 5 ml (equivalent to 500 mg tipranavir), which is the maximum single dose for a child with BSA (Calculated body surface area) > 1.33 m
Danish: Der kan maksimalt udtrækkes 5 ml ad gangen (svarende til 500 mg tiparanavir), hvilket er den maksimale dosis til et barn med et beregnet kropsoverflade areal (BSA) > 1,33 m 5.
English: This will depend on, for example: which other medicines your child has already taken for HIV which medicines your child's HIV is resistant to.
Danish: Dette vil være afhængigt af f.eks.: - Hvilken anden medicin dit barn tidligere har fået mod hiv.
English: Due to multiple CYP isoenzyme systems involved in voriconazole metabolism, it is difficult to predict the interaction with tipranavir, coadministered with low-dose ritonavir.
Danish: Da der indgår flere enzymsystemer i metabolismen af voriconazol, er det vanskeligt at forudsige interaktionen med tipranavir plus lavdosis ritonavir.
English: It has not been shown that tipranavir is superior to these boosted comparator protease inhibitors in patients harbouring strains susceptible to these protease inhibitors.
Danish: Det er ikke vist, at tipranavir er overlegen til disse boostede komparator protease-inhibitor hos patienter, der har stammer, som er modtagelige over for disse proteasehæmmere.
English: Concomitant use of Aptivus, co-administered with low dose ritonavir, with the protease inhibitors amprenavir, lopinavir or saquinavir (each co-administered with low dose ritonavir) in a dual-boosted regimen, results in significant decreases in plasma concentrations of these protease inhibitors.
Danish: Samtidig anvendelse af Aptivus plus lavdosis ritonavir og proteasehæmmerne amprenavir, lopinavir eller saquinavir (hver især indgivet med lavdosis ritonavir) i en dobbelt boostet behandling resulterer i signifikante fald i plasmakoncentrationerne af disse proteasehæmmere.
English: The most frequently reported moderate or severe adverse reactions in the 48 week analyses are noted below.
Danish: De hyppigste bivirkninger, moderate til alvorlige, der er observeret i perioden på 48 uger, er gengivet nedenunder.
English: Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis, have been reported with protease inhibitors, particularly in combination with nucleoside reverse transcriptase inhibitors.
Danish: Forhøjet kreatinkinase, myalgi, myositis og - i sjældne tilfælde - rabdomyolyse er rapporteret ved behandling med proteasehæmmere, især i kombination med nukleosid reverse transcriptasehæmmere.
English: If you take more Aptivus than you should Inform your doctor as soon as possible if you take more than the prescribed dose of Aptivus.
Danish: Hvis du har taget for meget Aptivus Informér din læge hurtigst muligt, hvis du tager mere Aptivus end foreskrevet.
English: Limited data are currently available for the use of Aptivus, co-administered with low dose ritonavir, in patients co-infected with hepatitis B or C. Aptivus should therefore be used with caution in patients co-infected with hepatitis B or C. 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: Der foreligger på nuværende tidspunkt begrænsede data vedrørende brugen af Aptivus plus lavdosis ritonavir til patienter, der også er smittede med hepatitis B eller C. Aptivus bør derfor anvendes med forsigtighed hos patienter, der også er smittede med hepatitis B eller C. Aptivus bør kun anvendes i denne patientpopulation, hvis den potentielle fordel opvejer den potentielle risiko, og med både øget klinisk monitorering og laboratoriemonitorering.
English: In order to achieve effective tipranavir plasma concentrations and a twice daily dosing regimen, coadministration of tipranavir with low dose ritonavir twice daily is essential (see section 4.2).
Danish: For at opnå effektive plasmakoncentrationer af tipranavir er samtidig administration af tipranavir og lavdosis ritonavir to gange daglig nødvendig (se pkt.
English: After four weeks of Aptivus 500 mg with 200 mg ritonavir (twice daily) the median plasma trough concentration of tipranavir was 43.9 µM for females and 31.1 µM for males.
Danish: Efter 4 uger med 500 mg Aptivus med 200 mg ritonavir; to gange daglig, var middel dalværdien for plasmakoncentrationen af tipranavir 43,9 µM for kvinder og 31,1 µM for mænd.
English: The HMG-CoA reductase inhibitors simvastatin and lovastatin are highly dependent on CYP3A for metabolism.
Danish: HMG-CoA reduktasehæmmerne simvastatin og lovastatin, metaboliseres i høj grad af CYP3A.
English: Treatment response is presented for the overall population (displayed by enfuvirtide use), and detailed by PI strata for the subgroup of patients with genotypically resistant strains in the Table below.
Danish: Behandlingsrespons foreligger for den samlede population (vist ud fra brug af enfuvirtid) og beskrevet ud fra proteasehæmmerstrata for subgruppen af patienter med genotypiske resistente stammer i nedenstående tabel.
English: If affected, your child should not drive or operate machinery.
Danish: Hvis dit barn får disse bivirkninger, må dit barn ikke køre bil eller betjene maskiner.
English: Dosage increase and long-term use of meperidine with Aptivus, coadministered with low dose ritonavir, are not recommended due to the increased concentrations of the metabolite normeperidine which has both analgesic activity and CNS stimulant activity (e.g. seizures).
Danish: Dosisøgninger og langtidsanvendelse af meperidin med Aptivus og lavdosis ritonavir anbefales ikke pga. øgede koncentrationer af metabolitten normeperidin, som har både analgetisk aktivitet og centralnervestimulerende aktivitet (f.eks. kramper).
English: Each ml contains 100 mg tipranavir.
Danish: En ml indeholder 100 mg tipranavir.
English: In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical studies with Aptivus, co-administered with low dose ritonavir.
Danish: Desuden er reaktivering af herpes simplex og herpes zoster påvist i kliniske studier med Aptivus plus lavdosis ritonavir.
English: Studies in human liver microsomes indicated tipranavir is an inhibitor of CYP 1A2, CYP 2C9, CYP 2C19 and CYP 2D6.
Danish: Studier med humane levermikrosomer har vist, at tipranavir hæmmer CYP1A2, CYP2C9, CYP2C19 og CYP2D6.
English: Sedatives/hypnotics Midazolam 2 mg QD (iv)
Danish: Sedativa/hypnotika Midazolam 2 mg x 1 (i.v.)
English: Combined 48-week median time to treatment failure for both studies was 115 days in the tipranavir with ritonavir arm and 0 days in the comparator arm (no treatment response was imputed to day 0).
Danish: Kombineret 48 ugers mediantid til behandlingssvigt for begge studier var 115 dage i tipranavir med ritonavir-gruppen og 0 dage i komparatorgruppen (intet behandlingsrespons var tillagt til dag 0).
English: If your child is pregnant or breast-feeding, you think your child may be pregnant or is planning to have a baby, ask your child's doctor or pharmacist for advice before giving this medicine.
Danish: Hvis dit barn er gravid eller ammer, du har mistanke om, at dit barn er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du giver dit barn dette lægemiddel.
English: In deciding to initiate treatment with Aptivus, co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents.
Danish: Når der skal tages stilling til, om behandling med Aptivus med lavdosis ritonavir skal initieres, skal tidligere behandling af den enkelte patient nøje evalueres, herunder mønstrene for mutationer forbundet med forskellige præparater.
English: You should follow the instructions for these medicines within the supplied Package Leaflets.
Danish: Du bør nøje følge vejledningen for de øvrige lægemidler i de tilhørende indlægssedler.
English: Each Aptivus capsule contains 250 mg of the active substance tipranavir.
Danish: Hver Aptivus-kapsel indeholder 250 mg af den aktive substans tipranavir.
English: INFORMATION IN BRAILLE Aptivus 100 mg/ml
Danish: INFORMATION I BRAILLESKRIFT Aptivus 100 mg/ml
English: If Aptivus with ritonavir is administered with parenteral midazolam, close clinical monitoring for respiratory depression and/or prolonged sedation should be instituted and dosage adjustment should be considered.
Danish: Hvis Aptivus med ritonavir administreres samtidig med parenteral midazolam, skal der foretages en tæt klinisk monitorering for respirationsdepression og/eller forlængelse af sederingen.
English: Treatment of overdose should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
Danish: monitorering af vitale parametre og observation af patientens kliniske status.
English: If you stop taking Aptivus
Danish: Hvis du holder op med at tage Aptivus
English: Rash accompanied by joint pain or stiffness, throat tightness, or generalized pruritus has been reported in both men and women receiving Aptivus co-administered with low dose ritonavir.
Danish: Udslæt ledsaget af ledsmerter eller -stivhed, sammensnøring i halsen, eller generel pruritus er rapporteret hos både mænd og kvinder, der har fået Aptivus sammen med lavdosis ritonavir.
English: Your child must not breast-feed the baby because it is possible that the baby can become HIV-infected through the breast milk.
Danish: Dit barn må ikke amme, da det nyfødte barn kan blive smittet med hiv-infektionen via mælken.
English: P-gp activity is significantly inhibited after the first dose, but there was a slight induction at steady state.
Danish: Efter første dosis er P-gp-aktiviteten signifikant hæmmet, men der fandtes en svag induktion ved steady state.
English: If your child takes more Aptivus than he/she should Inform your child's doctor as soon as possible if they take more than the prescribed dose of Aptivus.
Danish: Hvis dit barn har taget for meget Aptivus Informér dit barns læge hurtigst muligt, hvis det har taget mere Aptivus end foreskrevet.
English: The clinical relevance of this reduction has not been established, but may decrease the efficacy of abacavir.
Danish: Den kliniske relevans af reduktionen er ikke fastlagt, men muligvis mindskes effekten af abacavir.
English: Dose ritonavir (mg)
Danish: Dosis ritonavir (mg)
English: Aptivus capsules contain ethanol, macrogolglycerol ricinoleate and sorbitol (E420) Aptivus contains 7 % 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: Aptivus kapsler indeholder ethanol, macrogolglycerol ricinolat og sorbitol (E420) Aptivus indeholder 7 % ethanol (alkohol), dvs. op til 400 mg pr. dagsdosis svarende til 8 ml øl eller mindre end 4 ml vin, hvilket er skadeligt for patienter, som er alkoholikere.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral solution contains 100 mg tipranavir.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml oral opløsning indeholder 100 mg tipranavir.
English: Dosing with Aptivus capsules 500 mg twice daily concomitant with 200 mg ritonavir twice daily for 2 to 4 weeks and without meal restriction produced a mean tipranavir peak plasma concentration (Cmax) of 94.8 ± 22.8 µM for female patients (n=14) and 77.6 ± 16.6 µM for male patients (n=106), occurring approximately 3 hours after administration.
Danish: Dosering med Aptivus kapsler a 500 mg 2 gange dagligt samtidig med 200 mg ritonavir 2 gange daglig i 2-4 uger og uden kostbegrænsninger viste en middel-tipranavir-peak-plasmakoncentration (Cmax) på 94,8 +/- 22,8 µM for kvindelige patienter (n=14) og 77,6 +/- 16,6 µM for mandlige patienter (n=106) og sås ca. 3 timer efter administration.
English: Isolates with baseline fold change of >0 to 3 are considered susceptible; isolates with >3 to 10 fold changes have decreased susceptibility; isolates with >10 fold changes are resistant.
Danish: Isolater med ændringer på >3-10 fold har nedsat følsomhed, mens isolater med ændringer på >10 fold er resistente.
English: No data are available on the efficacy and safety of Aptivus capsules in children less than 12 years of age.
Danish: Der foreligger ingen data for sikkerhed og virkning for Aptivus kapsler hos børn yngre end 12 år.
English: In the RESIST trials, the risk of rash was similar between tipranavir with ritonavir and comparator arms (16.3% vs. 12.5%, respectively; see section 4.4).
Danish: I RESIST-studierne var risikoen for udslæt identisk i tipranavir med ritonavir-gruppen og komparatorgruppen (henholdsvis 16,3% imod 12,5%; se pkt.
English: Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Danish: I nedenstående tabel er anført kendte og teoretiske interaktioner over for en række antiretrovirale og non-antiretrovirale lægemidler.
English: Aptivussoft capsules are indicated for: adolescents12 years of age or older adults
Danish: Aptivus bløde kapsler anvendes til behandling af: - unge fra 12 års alderen - voksne
English: Alternative or additional contraceptive measures are to be used when oestrogen based oral contraceptives are coadministered with Aptivus and low dose ritonavir.
Danish: Der skal anvendes alternativ eller supplerende antikonception, når østrogenbaseret oral antikonception anvendes sammen med Aptivus og lavdosis ritonavir.
English: Carbamazepine induces CYP3A4.
Danish: Carbamazepin inducerer CYP3A4.
English: If your child forgets to take Aptivus
Danish: Hvis dit barn har glemt at tage Aptivus
English: Assessment of adverse reactions from HIV-1 clinical study data is based on experience in all Phase II and III trials in adults treated with the 500 mg tipranavir with 200 mg ritonavir dose twice daily (n=1397) and are listed below by system organ class and frequency according to the following categories:
Danish: Vurdering af bivirkninger fra hiv-1 kliniske studier baseret på erfaringer fra alle fase II og III studier hos voksne, som blev behandlet med 500 mg tipranavir plus 200 mg ritonavir to gange dagligt (n=1.397), er anført herunder efter systemorganklasse og frekvens i henhold til følgende kategorier:
English: Paediatric patients who were 12 years or older and received the maximum dose of 500 mg/200 mg twice daily could change to Aptivus capsules from study day 28.
Danish: Pædiatriske patienter på 12 år eller ældre og som fik højeste dosis på 500 mg/200 mg 2 gange daglig, kunne skifte til behandling med Aptivus kapsler fra dag 28 i studiet.