FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of efavirenz in children below the age of 3 years or weighing less than 13 kg have not yet been established.
Danish: Sikkerhed og virkning af efavirenz hos børn under 3 år, eller børn der vejer under 13 kg, er endnu ikke klarlagt.
English: In these studies the dose of efavirenz was 600 mg once daily; the dose of indinavir was 1,000 mg every 8 hours when used with efavirenz and 800 mg every 8 hours when used without efavirenz.
Danish: I disse undersøgelser var efavirenzdosis 600 mg en gang dagligt; indinavirdosis på 1.000 mg hver 8. time blev anvendt i kombination med efavirenz, og 800 mg hver 8. time blev anvendt uden efavirenz.
English: If you are affected your doctor may suggest that you take Stocrin at bedtime and on an empty stomach.
Danish: Hvis du er påvirket, kan din læge foreslå, at du tager Stocrin ved sengetid og på tom mave.
English: Cmin: ↓ 8 % (↑ 14 to ↓ 25) Norelgestromin (active metabolite):
Danish: Cmin: ↓ 8% (↑ 14 til ↓ 25) Norelgestromin (aktiv metabolit):
English: Psychiatric symptoms
Danish: Psykiske symptomer
English: Since efavirenz is highly protein bound, dialysis is unlikely to remove significant quantities of it from blood.
Danish: Da efavirenz har en høj proteinbindingsgrad, er det usandsynligt at dialyse vil fjerne signifikante mængder af det fra blodet.
English: A similar reduction in indinavir exposures was observed when indinavir 1,000 mg q8h was given with efavirenz 600 mg daily.
Danish: Der sås en lignende reduktion i indinavireksponering, når indinavir 1.000 mg q8h blev givet sammen med efavirenz 600 mg dagligt.
English: In the subset of 6 children aged 3 - 5 who were compliant with their drug regimen, the mean AUC was 147 M·h, which was 23 % lower than expected.
Danish: I en subgruppe med 6 regimen-kompliante børn i aldersgruppen 3 - 5 år, var det gennemsnitlige AUC 147 M·t, hvilket var 23% lavere end forventet.
English: Sufficient data on the tolerability of efavirenz with low-dose ritonavir (100 mg, once or twice daily) are not available.
Danish: Tilstrækkelige data vedrørende tolerans af efavirenz sammen med ritonavir 100 mg i lav dosis (én eller to gange dagligt) er ikke tilgængelige.
English: Diarrhoea occurred in children who took Stocrin oral solution and nelfinavir in combination with other antiretroviral medicines.
Danish: Diarré er set hos børn i behandling med Stocrin oral opløsning og nelfinavir i kombination med anden antiretroviral behandling.
English: To do this, remove the child-resistant cap and the foil seal.
Danish: Dette gøres ved at fjerne det børnesikrede låg og folieforseglingen.
English: There have been seven retrospective reports of findings consistent with neural tube defects, including meningomyelocele, all in mothers exposed to efavirenz-containing regimens (excluding any efavirenz-containing fixed-dose combination tablets) in the first trimester.
Danish: Der har været 7 retrospektive rapporter om fund svarende til neuralrørsdefekter, herunder meningomyelocele, alle hos mødre, der i første trimester havde været eksponeret for efavirenzholdige regimer (eksklusive efavirenzholdige kombinationstabletter i faste doser).
English: Nervous system disorders common cerebellar coordination and balance disturbances
Danish: Cerebellar koordinations- og balanceforstyrrelse
English: In clinical studies, 26 % of patients treated with 600 mg of efavirenz experienced skin rash compared with 17 % of patients treated in control groups.
Danish: I kliniske undersøgelser fik 26% af de patienter, der blev behandlet med 600 mg efavirenz, hududslæt sammenlignet med 17% af de patienter, der blev behandlet i kontrolgrupperne.
English: Two additional cases (1 prospective and 1 retrospective) including events consistent with neural tube defects have been reported with a fixed-dose combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil.
Danish: Der er rapporteret om yderligere to tilfælde (1 prospektivt og 1 retrospektivt), herunder hændelser svarende til neuralrørsdefekter, med en fastdosis-kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxil.
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Danish: I nogle tilfælde kan det være nødvendigt for lægen at justere din dosis eller kontrollere indholdet i blodet.
English: STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
Danish: STOCRIN er indiceret til antiviral kombinationsbehandling af humant immundefekt-virus-1 (hiv-1)-inficerede voksne, unge og børn fra 3 år og opefter.
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
Danish: • Medicin til behandling af bakterielle infektioner, herunder tuberkulose og aids-relateret mycobacterium avium kompleks: clarithromycin, rifabutin, rifampicin.
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1 % of patients treated with efavirenz.
Danish: Der er rapporteret svært udslæt, ledsaget af blæredannelse, fugtig afskalning eller ulceration hos færre end 1% af de patienter, der er behandlet med efavirenz.
English: Thirteen isolates previously characterised as efavirenz-resistant were also resistant to nevirapine and delavirdine.
Danish: Tretten isolater, der tidligere var beskrevet som efavirenzresistente, var også resistente over for nevirapin og delavirdin.
English: In HIV-1 infected patients (n = 9) who received efavirenz 200 to 600 mg once daily for at least one month, cerebrospinal fluid concentrations ranged from 0.26 to 1.19 % (mean 0.69 %) of the corresponding plasma concentration.
Danish: Hos hiv-1-inficerede patienter (n = 9), som fik efavirenz 200 - 600 mg 1 gang dagligt i mindst 1 måned, lå koncentrationerne i cerebrospinalvæsken mellem 0,26 til 1,19% (gennemsnit 0,69%) af den tilsvarende plasmakoncentration.
English: It is recommended that STOCRIN be taken on an empty stomach.
Danish: Det anbefales, at STOCRIN tages på tom mave.
English: The mean CD4 cell counts were increased by 63  34.5 cells/mm
Danish: Middel CD4 celletallene øgedes med 63  34,5 celler/mm fra baseline.
English: In a subset of 1,008 adult patients who received 600 mg efavirenz daily in combination with PIs and/or NRTIs in controlled clinical studies, the most frequently reported adverse reactions of at least moderate severity reported in at least 5 % of patients were rash (11.6 %), dizziness (8.5 %), nausea (8.0 %), headache (5.7 %) and fatigue (5.5 %).
Danish: Hos en undergruppe på 1.008 patienter, som fik 600 mg efavirenz dagligt i kombination med PI'ere og/eller NRTI'ere i kontrollerede kliniske undersøgelser, var de hyppigst rapporterede bivirkninger af mindst moderat sværhedsgrad, rapporteret hos mindst 5% af patienterne: Udslæt (11,6%), svimmelhed (8,5%), kvalme (8,0%), hovedpine (5,7%) og træthed (5,5%).
English: See section Description of selected adverse reactions for more details.
Danish: Beskrivelse af udvalgte bivirkninger for yderligere information.
English: The AUC and Cmax of a single 240 mg dose of efavirenz oral solution in uninfected adult volunteers was increased by 30 % and 43 % respectively, when given with a high-fat meal, relative to fasted conditions.
Danish: AUC og Cmax 240 mg efavirenz oral opløsning hos ikke-inficerede voksne frivillige blev forøget med henholdsvis 30% og 43%, når dosen blev givet sammen med henholdsvis et måltid med stort fedtindhold og under faste.
English: Efavirenz has not been evaluated in children below 3 years of age or who weigh less than 13 kg.
Danish: Efavirenz er ikke vurderet hos børn under 3 år eller børn, som vejer mindre end 13 kg.
English: • The dose for Stocrin may need to be increased or decreased if you are also taking certain medicines (see Other medicines and Stocrin).
Danish: • Det kan blive nødvendigt at øge eller nedsætte Stocrin dosis, hvis du også tager anden medicin
English: Symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported adverse reactions in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).
Danish: Symptomer, der inkluderer, men ikke er begrænsede til, svimmelhed, søvnløshed, søvnighed, nedsat koncentrationsevne og abnorme drømme er hyppigt indberettede bivirkninger hos patienter i kliniske undersøgelser i behandling med efavirenz 600 mg dagligt (se pkt.
English: Medicines used to treat malaria: artemether/lumefantrine: Stocrin may reduce the amount of artemether/lumefantrine in your blood.
Danish: • Medicin til behandling af malaria: artemether/lumefantrin: Stocrin kan nedsætte mængden af artemether/lumefantrin i blodet.
English: Two controlled studies (006 and ACTG 364) of approximately one year duration with efavirenz in combination with NRTIs and/or PIs, have demonstrated reduction of viral load below the limit of quantification of the assay and increased CD4 lymphocytes in antiretroviral therapy-naïve and NRTI-experienced HIV-infected patients.
Danish: To kontrollerede undersøgelser (006 og ACTG 364) af ca. 1 års varighed med efavirenz i kombination med NRTI'ere og/eller PI'ere har vist en reduktion i mængden af virus i blodet til under detektionsgrænsen i assayet og stigning i CD4 lymfocytter hos antiretroviral behandlingsnaive og NRTI-behandlede hiv-inficerede patienter.
English: Cmax: ↓ 24 % (↓ 18 to ↓ 30) These changes are not considered clinically significant.
Danish: Cmax: ↓ 24% (↓ 18 til ↓ 30) Disse ændringer anses ikke for at være klinisk signifikante.
English: Medicines used to treat fungal infections (antifungals): voriconazole.
Danish: • Medicin til behandling af svampeinfektioner (antimykotika): voriconazol.
English: Efavirenz tablets must only be administered to children who are able to reliably swallow tablets.
Danish: Efavirenz tabletter må kun gives til børn, der med sikkerhed er i stand til at synke tabletter.
English: Each carton contains 1 bottle of 90 film-coated tablets.
Danish: Hver æske indeholder 1 flaske med 90 filmovertrukne tabletter.
English: Patients taking drugs that are known to prolong the QTc interval (proarrhythmic).
Danish: Patienter der tager lægemidler, som vides at forlænge QTc-intervallet (proarytmisk).
English: If you are affected your doctor may suggest that you take Stocrin at bedtime.
Danish: Hvis du er påvirket, kan din læge foreslå, at du tager Stocrin ved sengetid.
English: The daily dose of rifabutin should be increased by 50 % when administered with efavirenz.
Danish: Den daglige dosis rifabutin bør øges med 50 %, når det administreres sammen med efavirenz.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism which may be clinically relevant in some patients.
Danish: Det er påvist, at efavirenz inducerer CYP3A4 og CYP2B6, hvilket medfører induktion af dets egen metabolisering, hvilket kan være klinisk relevant hos nogle patienter.
English: Carbamazepine may make Stocrin less likely to work.
Danish: Carbamazepin kan bevirke, at Stocrin virker dårligere.
English: OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK
Danish: YDRE PAKNING OG ETIKETTEKST PÅ FLASKE
English: STOCRIN oral solution is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older, who are unable to swallow the film-coated tablets.
Danish: STOCRIN oral opløsning er indiceret til antiviral kombinationsbehandling af humant immundefektvirus-1 (hiv-1)-inficerede voksne, unge og børn fra 3 år og opefter, som ikke er i stand til at synke de filmovertrukne tabletter.
English: False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV-infected subjects receiving efavirenz.
Danish: Med nogle scrennings-analyser er der blevet rapporteret falsk-positive resultater for cannabinoid i urinprøver hos ikke-inficerede og hiv-inficerede personer, som fik efavirenz.
English: In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms (see section 4.8).
Danish: For at forbedre tolerabiliteten af bivirkninger fra nervesystemet anbefales dosering ved sengetid i de første 2 - 4 uger af behandlingen samt til patienter, som fortsat oplever disse symptomer (se pkt.
English: Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm
Danish: Efavirenz er ikke undersøgt i kontrollerede undersøgelser med patienter med fremskreden hiv-sygdom, det vil sige CD4 tal  50 celler/mm
English: The dose of Stocrin oral solution must be measured using the oral syringe supplied in the carton.
Danish: Dosis for Stocrin oral opløsning skal afmåles ved brug af den orale sprøjte, der følger med kartonen.
English: The AUC and Cmax of a single 600 mg dose of efavirenz film-coated tablets in uninfected volunteers was increased by 28 % (90 % CI: 22 - 33 %) and 79 % (90 % CI:58 - 102 %), respectively, when given with a high fat meal relative to when given under fasted conditions (see section 4.4).
Danish: AUC og Cmax af en enkeldosis på 600 mg efavirenz filmovertrukne tabletter hos ikke-inficerede frivillige blev forøget med henholdsvis 28% (90% CI: 22 - 33%) og 79% (90% CI: 58 - 102%), når dosen blev givet henholdsvis med et måltid med stort fedtindhold og under faste (se pkt.
English: Efavirenz oral solution may be taken with or without food (see section 5.2).
Danish: Efavirenz oral opløsning kan tages med eller uden mad (se pkt.
English: You should not breast feed your baby if you are taking Stocrin.
Danish: Du må ikke amme dit barn, hvis du tager Stocrin.
English: Amylase: in the clinical trial subset of 1,008 patients, asymptomatic increases in serum amylase levels greater than 1.5 times the upper limit of normal were seen in 10 % of patients treated with efavirenz and 6 % of patients treated with control regimens.
Danish: Amylase: I en undergruppe på 1.008 patienter i en klinisk undersøgelse, blev der set asymptomatiske stigninger i serumamylase niveauet, til mere end 1,5 gange den øvre normalgrænse hos 10% af de patienter, der blev behandlet med efavirenz og 6% af de patienter, der blev behandlet med kontrolregimer.
English: Peak efavirenz plasma concentrations of 1.6 - 9.1 M were attained by 5 hours following single oral doses of 100 mg to 1,600 mg administered to uninfected volunteers.
Danish: De højeste efavirenz-plasmakoncentrationer på 1,6 - 9,1 M blev nået senest 5 timer efter orale enkeltdoser på 100 - 1.600 mg, der blev indgivet til ikke-inficerede frivillige.
English: Cross resistance profiles for efavirenz, nevirapine and delavirdine in cell culture demonstrated that the K103N substitution confers loss of susceptibility to all three NNRTIs.
Danish: Ved cellekultur viste krydsresistensprofiler for efavirenz, nevirapin og delavirdin, at K103N-substitutionen giver tab af følsomhed over for alle tre NNRTI'ere.
English: The free concentration of efavirenz required for 90 to 95 % inhibition of wild type or zidovudine-resistant laboratory and clinical isolates in vitro ranged from 0.46 to 6.8 nM in lymphoblastoid cell lines, peripheral blood mononuclear cells (PBMCs) and macrophage/monocyte cultures.
Danish: Den frie koncentration af efavirenz, der er nødvendig for 90 - 95% hæmning af vildtype- eller zidovudinresistente laboratorieisolater og kliniske isolater in vitro var fra 0,46 til 6,8 nM i lymfoblastoide cellelinier, perifere mononukleare blodlegemer (PBMCer) og makrofag/monocytkulturer.
English: Five of these NNRTI-resistant isolates were found to have K103N or a valine-to-isoleucine substitution at position 108 (V108I) in RT. Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Danish: Man fandt, at 5 af disse NNRTI-resistente isolaterhavde K103N- eller en valin-til-isoleucin-substitution på position 108 (V108I) i RT. Tre af de testede efavirenz-behandlingssvigtisolater forblev følsomme over for efavirenz ved cellekultur og var også følsomme over for nevirapin og delavirdin.
English: Isolated elevations of GGT in patients receiving efavirenz may reflect enzyme induction.
Danish: Isolerede forhøjelser af GGT hos patienter, som får efavirenz, kan vise enzyminduktion.
English: Stocrin may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of Stocrin in your blood.
Danish: Stocrin kan mindske mængden af voriconazol i blodet, og voriconazol kan øge mængden af Stocrin i blodet.
English: The potential for cross resistance between efavirenz and PIs is low because of the different enzyme targets involved.
Danish: Potentialet for krydsresistens mellem efavirenz og PI'ere er lille på grund af de forskellige enzymmål, der er involverede.
English: Exposures of raltegravir (a UGT1A1 substrate) are reduced in the presence of efavirenz (see section 4.5, table 2).
Danish: Eksponeringen for raltegravir (et UGT1A1-substrat) reduceres ved tilstedeværelse af efavirenz (se pkt.
English: The bottle adapter, which is already fixed to the nozzle of the syringe, can then be fitted into the neck of the bottle and pressed firmly down.
Danish: Sprøjten sidder allerede i flaskeadapteren, som nu kan sættes i flaskens hals og presses hårdt ned.
English: Skin rash was considered treatment related in 18 % of patients treated with efavirenz.
Danish: Hududslæt blev betragtet som behandlingsrelateret hos 18% af de patienter, der blev behandlet med efavirenz.
English: What you need to know before you take Stocrin
Danish: Det skal du vide, før du begynder at tage Stocrin
English: Individuals with these conditions may take efavirenz oral solution, which is free from lactose.
Danish: Personer med disse sygdomme kan tage efavirenz oral opløsning, som er lactosefri.
English: Elevations of GGT to greater than five times ULN were observed in 4 % of all patients treated with 600 mg of efavirenz and 1.5 - 2 % of patients treated with control regimens (7 % of efavirenz-treated patients and 3 % of control-treated patients after long-term treatment).
Danish: Der sås forhøjelser af GGT til mere end fem gange ULN hos 4% af alle patienter, der blev behandlet med 600 mg efavirenz og hos 1,5-2% af de patienter, der blev behandlet med kontrolregimerne (7% af de efavirenzbehandlede patienter og 3% patienter i kontrolgruppen efter langtidsbehandling).
English: Each carton contains 1 bottle of 30 film-coated tablets.
Danish: Hver æske indeholder 1 flaske med 30 filmovertrukne tabletter.
English: Stocrin taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Danish: Stocrin taget sammen med anden antiretroviral behandling reducerer mængden af virus i blodet.
English: Diarrhoea occurred in six of nineteen (32 %) children, aged 3 - 8 years, who took efavirenz oral solution in combination with nelfinavir (20 - 30 mg/kg given three times a day) and one or more NRTIs.
Danish: Diarré sås hos 19 (32%) børn i alderen 3 - 8 years, som fik efavirenz oral opløsning sammen med nelfinavir (20 - 30 mg/kg 3 gange om dagen) og en eller flere NRTIere.
English: Stocrin may interact with other medicines, including herbal preparations such as Ginkgo biloba extracts.
Danish: Stocrin kan påvirke eller påvirkes af anden medicin herunder naturlægemidler som Ginkgo biloba.
English: If you could get pregnant while receiving Stocrin, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Danish: Hvis du kan blive gravid, mens du tager Stocrin, er det nødvendigt at bruge en pålidelig form for barriereprævention (fx kondom) sammen med andre præventionsmetoder, herunder p-piller eller andre hormonale præventionsmidler (fx implantat, indsprøjtning).
English: EFV, efavirenz; ZDV, zidovudine; 3TC, lamivudine; IDV, indinavir; NRTI, nucleoside reverse transcriptase inhibitor; NFV, nelfinavir.
Danish: EFT, efavirenz; ZDV, zidovudin; 3TC, lamivudin; IDV, indinavir; NRTI, nucleoside reverse transkriptasehæmmer; NFV, nelfinavir
English: STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm
Danish: STOCRIN er ikke tilstrækkeligt undersøgt hos patienter med fremskreden hiv-sygdom, det vil sige patienter med CD4 tal  50 celler/mm
English: EXP Use the oral solution within one month after first opening the bottle.
Danish: EXP Den orale opløsning bør anvendes inden for en måned efter åbning.
English: Rash was reported in 26 of 57 children (46 %) treated with efavirenz during a 48-week period and was severe in three patients.
Danish: Udslæt er indberettet hos 26 ud af 57 børn (46%), der er blevet behandlet med efavirenz i løbet af en periode på 48 uger; udslættet var alvorligt hos tre patienter.
English: This effect is due to an induction of CYP3A4 or P-gp by efavirenz and is expected to result in the loss of virologic response of elbasvir/grazoprevir.
Danish: Denne effekt skyldes en CYP3A4eller P-gp-induktion forårsaget af efavirenz og forventes at medføre tab af virologisk respons på elbasvir/grazoprevir.
English: In clinical studies 2 % of patients treated with efavirenz discontinued therapy due to such symptoms.
Danish: I kliniske undersøgelser ophørte 2% af de patienter, der blev behandlet med efavirenz med behandlingen på grund af sådanne symptomer.
English: Efavirenz film-coated tablets must only be administered to children who are able to reliably swallow tablets.
Danish: Efavirenz filmovertrukne tabletter må kun gives til børn, der med sikkerhed er i stand til at synke tabletter.
English: Individuals with these conditions may take Stocrin oral solution, which is free from lactose.
Danish: Personer med disse sygdomme kan tage Stocrin oral opløsning, som er lactosefri.
English: If air bubbles appear in the syringe, keep the bottle upside down and slowly push in the plunger and pull it back again.
Danish: Hvis der kommer luftbobler i sprøjten, skubbes stemplet langsomt ned og trækkes derefter tilbage igen, idet flasken fortsat er vendt på hovedet.
English: When your Stocrin supply starts to run low, get more from your doctor or pharmacist.
Danish: Når din Stocrin er ved at slippe op, skal du hente mere hos din læge eller på apoteket.
English: 3 - < 5 years
Danish: Børn 3- < 5 år
English: The most notable unwanted effects reported with Stocrin in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
Danish: De mest fremtrædende uønskede virkninger, der er rapporteret for Stocrin i kombination med andre anti-hiv-lægemidler, er udslæt og symptomer fra nervesystemet.
English: Long-term results at 168 weeks of study 006 (160 patients completed study on treatment with EFV +IDV, 196 patients with EFV + ZDV + 3TC and 127 patients with IDV + ZDV + 3TC, respectively), suggest durability of response in terms of proportions of patients with HIV RNA < 400 copies/ml, HIV RNA < 50 copies/ml and in terms of mean change from baseline CD4 cell count.
Danish: Langtidsresultater efter 168 uger i Undersøgelse 006 (160 patienter fuldførte undersøgelsen med EFV+IDV, 196 med EFV+ZDV+3TC og 127 patienter med IDV+ZDV+3TC) tyder på varigt respons med hensyn til mængden af patienter med hiv RNA < 400 kopier/ml, hiv RNA < 50 kopier/ml og med hensyn til middelændring fra baseline af CD4 celletal.