FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic-renal failure syndromes have been reported rarely.
Danish: Hepatorenale syndromer har i sjældne tilfælde været rapporteret.
English: Following intravenous administration to healthy adults, the volume of distribution (Vdss) of nevirapine was 1.21  0.09 l/kg, suggesting that nevirapine is widely distributed in humans.
Danish: Efter intravenøs administration hos raske voksne er fordelingsvolumen (Vdss) af nevirapin 1,21±0,09 l/kg, hvilket indikerer, at nevirapin fordeler sig bredt hos mennesket.
English: - B - Non-B
Danish: - Ikke-B
English: ** Includes lost to follow-up, consent withdrawn, noncompliance, lack of efficacy, pregnancy, and other.
Danish: ** Omfatter patienter tabt for opfølgning, som har trukket deres samtykke tilbage, som ikke er compliant, som har mangel på effekt, som er gravide og andet.
English: The geometric mean nevirapine Cmin,ss was 2,770 ng/ml.
Danish: Den geometriske middelværdi for nevirapin Cmin,ss var 2.770 ng/ml.
English: Asymptomatic elevations of GGT levels are the most frequent.
Danish: Asymptomatisk forhøjet GGT-niveau er hyppigst.
English: In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: I tilfælde af samtidig antiviral behandling for hepatitis B eller C vær venlig også at se efter i den relevante produktinformation for disse lægemidler.
English: During the first 18 weeks of treatment with Viramune it is very important that you and your doctor watch out for signs of liver or skin reactions.
Danish: I de første 18 uger, hvor du er i behandling med Viramune, er det meget vigtigt, at du og din læge holder øje med, om der er tegn på leverskader eller hududslæt.
English: It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving nevirapine.
Danish: Det anbefales, at hiv-smittede mødre ikke ammer deres børn for at undgå risiko for postnatal overførsel af hiv og at mødre bør afbryde amningen, hvis de behandles med nevirapin.
English: Decreased blood phosphorus and increased blood pressure were observed in clinical studies with coadministration of tenofovir/emtricitabine.
Danish: Nedsat phosphat i blodet og forhøjet blodtryk blev observeret i de kliniske studier med coadministration af tenofovir/emtricitabin.
English: In study 1100.1526 (TRANxITION) no Grade 3 or 4 clinical hepatic events were observed in either treatment group.
Danish: I studie 1100.1526 (TRANxITION) blev der ikke set kliniske hepatiske hændelser af grad 3 eller 4 i nogen af de to behandlingsgrupper.
English: Total cholesterol/HDL
Danish: Total kolesterol/HDL
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jirovecii-pneumoni.
English: If your doctor has told you that you (or your child) have an intolerance to some sugars or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Danish: Hvis din læge har fortalt dig, at du (eller dit barn) ikke tåler visse sukkerarter eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med din læge før du (eller dit barn) tager eller får dette lægemiddel.
English: No clinical data available.
Danish: Ingen kliniske data er tilgængelige.
English: In some cases, hepatic injury has progressed despite discontinuation of treatment.
Danish: I nogle tilfælde er leverbeskadigelse blevet forværret på trods af behandlingsstop.
English: - or have a body surface area above 1.25 square metres.
Danish: - eller har et legemsoverfladeareal på over 1,25 m².
English: Do not take more Viramune than prescribed by your doctor and described in this leaflet.
Danish: Tag ikke mere Viramune, end lægen har foreskrevet, og som er beskrevet i denne indlægsseddel.
English: Hepatic reactions
Danish: Hepatiske reaktioner
English: ANTITHROMBOTICS Warfarin
Danish: ANTITHROMBOTIKA Warfarin
English: The required dose volumes should be measured employing the enclosed dispensing syringe and adapter, as described in steps 1-5 below.
Danish: Den nødvendige dosisvolumen bør afmåles med den medfølgende dispenseringssprøjte og adaptor som beskrevet i trin 1-5 nedenfor.
English: Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
Danish: De patienter i 2NN studiet, som ved studiets afslutning i uge 48 stadig blev behandlet i kliniken og var i aktiv behandling, blev tilbudt at deltage i dette studie.
English: This is because Viramune can be partly washed out of your blood by dialysis.
Danish: Årsagen er, at Viramune i en vis udstrækning kan fjernes fra blodet under dialysen.
English: The observed mutations at failure were those expected with a nevirapine-based regimen.
Danish: De observerede mutationer var forventelige ved et nevirapin-baseret regime.
English: The usual dose is the same for all adults (20 ml).
Danish: Alle voksne skal have samme dosis (20 ml).
English: Boceprevir is partly metabolized by CYP3A4/5.
Danish: Boceprevir metaboliseres delvist af CYP3A4/5.
English: A plastic measuring syringe is included for measuring the correct dose.
Danish: En afmålingssprøjte af plastik medfølger til afmåling af den korrekte dosis.
English: Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Danish: Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt genotoksicitet.
English: Clear low density polyethylene bottle-syringe adapter.
Danish: Klar low density polyethylen flaskesprøjte adaptor.
English: These may look like whole tablets, but have not been found to affect the efficacy of nevirapine.
Danish: Det kan ligne hele depottabletter, men det anses ikke for at påvirke virkningen af nevirapin.
English: This is especially important within the first 14 days of treatment (see more information in “How to take Viramune”).
Danish: Det er især vigtigt i den første 14 dages periode (se flere informationer under Sådan skal du tage Viramune.)
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som alle andre lægemidler, give bivirkninger, men ikke alle får bivirkninger.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Viramune tablets can be taken by: - children 16 years of age or older - children under 16 years of age who:
Danish: Viramune tabletter kan tages: - af unge på 16 år eller ældre - unge under 16 år, som
English: They should be advised to promptly notify their physician of any rash and avoid delay between the initial symptoms and medical consultation.
Danish: De skal anbefales at informere deres læge straks angående enhver form for udslæt og undgå forsinkelse mellem de første symptomer og lægekonsultation.
English: Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Danish: Cytokrom P450- metabolismen, glucuronide konjugater og den urinære ekskretion af glucuronide metabolitter repræsenterer således den primære rute for nevirapins biotransformation og elimination hos mennesket.
English: The majority of severe rashes occurred within the first 6 weeks of treatment and some required hospitalisation, with one patient requiring surgical intervention (see section 4.4).
Danish: Hovedparten af alvorlige udslæt opstod indenfor de første 6 ugers behandling, hvoraf nogle krævede hospitalsindlæggelse og en enkelt patient krævede kirurgisk intervention (se pkt.
English: White to off-white homogenous suspension.
Danish: Hvid til næsten hvid homogen suspension.
English: Children less than three years old
Danish: Børn under 3 år
English: Frequency is defined using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Hyppighed er defineret i henhold til følgende konvention: Meget almindelig (1/10), Almindelig (1/100 til, <1/10), Ikke almindelig (1/1.000 til, 1/100), Sjælden (1/10.000 til, 1/1.000), Meget sjælden (1/10.000).
English: * Includes 2 patients who were randomised but never received blinded medicinal products.
Danish: * Omfatter 2 randomiserede patienter, som aldrig fik blindet lægemiddel.
English: When rash occurs it is normally mild to moderate.
Danish: Når der kommer et hududslæt, er det normalt mildt til moderat.
English: Delavirdine
Danish: Delavirdin
English: Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
Danish: Patienter med heriditær fructoseintolerans (HFI) bør ikke tage/få dette lægemiddel.
English: CONTRACEPTIVES Depomedroxyprogesterone acetate (DMPA) 150 mg every 3 months
Danish: KONTRACEPTIVA Depomedroxyprogesteron acetat (DMPA) 150 mg hver 3. måned
English: INTEGRASE INHIBITORS Elvitegravir/ cobicistat
Danish: INTEGRASEHÆMMERE Elvitegravir/ cobicistat
English: The ingested dose was 40 times the recommended dose of 2 mg/kg/day.
Danish: Den indtagne dosis var 40 gange større end den anbefalede dosis på 2 mg/kg/dag.
English: Patients should be instructed to seek medical attention promptly if these occur.
Danish: Patienterne skal søge lægehjælp omgående, hvis ovenstående opstår.
English: Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.
Danish: De data der er tilgængelige for gravide tyder ikke på misdannelser eller føtal/neonatal toksicitet.
English: In clinical studies, Viramune has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio.
Danish: I kliniske studier er Viramune blevet forbundet med en stigning i HDL-kolesterol og en overordnet forbedring af forholdet mellem total-kolesterol og HDL-kolesterol.
English: Inform your doctor if you find tablet pieces in your faeces.
Danish: Fortæl alligevel din læge, hvis du finder rester af depottabletter i din afføring.
English: Patients with hepatic impairment should be monitored carefully for evidence of medicinal product induced toxicity.
Danish: Patienter med hepatisk dysfunktion bør monitoreres nøje med henblik på lægemiddel induceret toksicitet.
English: Viramune is also available as smaller prolonged-release tablets (for children 3 years of age and above after the lead-in period) or as an oral suspension (for all age groups).
Danish: Viramune fås også som depottabletter i lavere styrker (til børn på 3 år og derover efter optrapningsperioden) eller som en oral suspension (til alle aldersgrupper).
English: There is no known antidote for nevirapine overdose.
Danish: Der findes ingen kendt antidot i tilfælde af overdosering af nevirapin.
English: Where other antiretroviral medicines are accessible, the single dose Viramune regimen should be combined with additional effective antiretroviral medicines (as recommended in internationally recognized guidelines).
Danish: Hvor andre antiretrovirale lægemidler er tilgængelige, bør enkeltdosis-Viramune-regime kombineres med supplerende effektive antiretrovirale lægemidler (som anbefalet i internationalt anerkendte retningslinjer).
English: Liver test monitoring should be performed if the patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity.
Danish: Levertestmonitorering foretages, hvis patienten oplever tegn eller symptomer, der tyder på hepatitis og/eller hypersensitivitet.
English: For this reason, and to reduce the risk of HIV transmission, barrier contraception (e.g., condoms) is recommended.
Danish: Af denne grund og for at reducere risikoen for hiv-smitte så bør barrierekontraception (f.eks. kondom) anbefales.
English: Pharmacokinetic data on 33 patients (age range 0.77 - 13.7 years) in the intensive sampling group demonstrated that clearance of nevirapine increased with increasing age in a manner consistent with increasing body surface area.
Danish: Farmakokinetiske data fra 33 patienter (aldersfordeling 0,77-13,7 år) i den intensive prøvegruppe viste, at nevirapins clearance øgedes ved stigende alder i overensstemmelse med større legemsoverfladeareal.
English: - weigh 50 kg or more
Danish: - vejer 50 kg eller mere
English: Similar EC50 values are obtained when the antiviral activity of nevirapine is measured in peripheral blood mononuclear cells, monocyte derived macrophages or lymphoblastoid cell line.
Danish: Tilsvarende EC50-værdier er opnået, når den antivirale aktivitet af nevirapin bliver målt i perifere mononukleære blodceller, monocytderiverede makrofager eller lymfoblastoide cellerækker.
English: If an alternative measuring device is used (e.g. a dispensing cup or teaspoon for larger doses) it is important that the device is rinsed to ensure complete removal of residual oral suspension.
Danish: Hvis en alternativ afmålingsanordning (f.eks. et målebæger eller en måleske til større doser) bruges, er det vigtigt, at måleredskabet skylles, for at sikre at der ikke er tiloversbleven oral suspension.
English: If patients report such an event, reassurance should be obtained on the lack of impact on therapeutic response.
Danish: Hvis patienter rapporterer om en sådan forekomst, bør det sikres, at det terapeutiske respons ikke er påvirket.
English: NEFA study
Danish: NEFA-studiet
English: The most that you can withdraw is 5 ml at a time.
Danish: Det største volumen, som kan udtages på en gang, er 5 ml.
English: Gender and elderly
Danish: Køn og ældre
English: Monotherapy with Viramune has been associated with the development of NNRTI resistance.
Danish: Monoterapi med Viramune er blevet forbundet med udvikling af NNRTI-resistens.
English: This also includes safety data for patient visits in the post-week 144 open label extension (which patients in either treatment group who completed the 144 week blinded phase could enter).
Danish: Dette omfatter også sikkerhedsdata for patientbesøg efter uge 144 i open-label forlængelsen (hvor patienter fra begge behandlingsgrupper, der gennemførte den 144 uger blindede fase, kunne deltage).
English: If ASAT or ALAT increase to > 5 ULN during treatment, nevirapine should be immediately stopped.
Danish: Hvis ASAT eller ALAT stiger til > 5 ULN under behandling, bør nevirapin straks seponeres.
English: Anaphylactic reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical studies.
Danish: Anafylaktisk reaktion er blevet identificeret gennem postmarketing overvågning, men er ikke observeret i de randomiserede, kontrollerede kliniske studier.
English: Granulocytopenia was more frequently observed in children.
Danish: Granulocytopeni sås oftere hos børn.
English: If liver function abnormalities recur, nevirapine should be permanently discontinued.
Danish: Hvis abnormaliteter i leverfunktionen genopstår, bør nevirapin seponeres permanent.
English: Viramune is also available as tablets.
Danish: Viramune kan også fås som tabletter.
English: The simultaneous use of nevirapine (400 mg) plus efavirenz (800 mg) was associated with the highest frequency of clinical adverse events and with the highest rate of treatment failure (53.1 %).
Danish: Samtidig brug af nevirapin (400 mg) og efavirenz (800 mg) var forbundet med den højeste forekomst af kliniske bivirkninger og med den højeste forekomst af behandlingssvigt (53,1 %).
English: Paediatric patients:
Danish: Pædiatriske patienter:
English: Patients should be advised of the need to take Viramune every day as prescribed.
Danish: Patienterne skal have at vide, at det er nødvendigt at tage Viramune hver dag som ordineret.
English: Your doctor will recommend the best medicines for you.
Danish: Din læge vil ordinere de lægemidler, som er bedst for dig.
English: This is particularly suitable if: - you have problems swallowing tablets - or you are a child weighing less than 50 kg - or you are a child having a body surface area less than 1.25 square metres (your doctor will work out your surface area).
Danish: Denne formulering er særligt egnet: - hvis du har besvær med at sluge tabletter - eller du er et barn, der vejer mindre end 50 kg - eller du er et barn med et legemsoverfladeareal på mindre end 1,25 m² (din læge kan beregne dit legemsoverfladeareal).
English: Since neither body weight nor Body Mass Index (BMI) had influence on the clearance of nevirapine, the effect of gender cannot be explained by body size.
Danish: Eftersom hverken legemsvægt eller body mass index (BMI) havde indflydelse på clearance af nevirapine, kan forskellen mellem kønnene ikke forklares med kropsstørrelse.
English: Adefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renally.
Danish: Adefovir påvirkede ingen af de almindelige CYP-isoformer, som er involveret i human lægemiddelmetabolisering, og bliver udskilt via nyrerne.
English: Nevirapine metabolites: Studies using human liver microsomes indicated that the formation of nevirapine hydroxylated metabolites was not affected by the presence of dapsone, rifabutin, rifampicin, and trimethoprim/sulfamethoxazole.
Danish: Nevirapin metabolitter: Studier med humane levermikrosomer indikerede, at dannelsen af hydroxylerede metabolitter af nevirapin ikke var påvirket af tilstedeværelsen af dapson, rifabutin, rifampicin, og trimethoprim/sulfamethoxazol.
English: In this study, no Grade 3 or 4 rash was observed in either treatment group.
Danish: I dette studie blev der ikke set udslæt af grad 3 eller 4 i nogen af de to behandlingsgrupper.
English: The best predictor of a serious hepatic event was elevated baseline liver function tests.
Danish: Den bedste forudsigelse for et alvorligt levertilfælde var forhøjet leverfunktionstest ved baseline.
English: Absorption: Nevirapine is readily absorbed (> 90 %) after oral administration in healthy volunteers and in adults with HIV-1 infection.
Danish: Nevirapin absorberes hurtigt (>90 %) efter oral administration hos raske forsøgspersoner og hos voksne hiv-1 smittede.
English: In such patients haematological parameters should be carefully monitored.
Danish: Hæmatologiske parametre skal monitoreres nøje hos disse patienter.
English: The NEFA study is a controlled prospective randomised study which evaluated treatment options for patients who switch from protease inhibitor (PI) based regimen with undetectable load to either Viramune, efavirenz or abacavir.
Danish: NEFA-studiet er et kontrolleret, prospektiv, randomiseret studie, der evaluerede behandlingsmuligheder for patienter, som skiftede fra proteasehæmmer(PI)-baseret behandlingsregime med et ikke-detekterbar load til enten Viramune, efavirenz eller abacavir.
English: No specific drug-drug interaction study has been performed.
Danish: Der er ikke udført specifikke lægemiddel interaktionsstudier.
English: This includes some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis), and liver failure, which can be both fatal.
Danish: Dette inkluderer tilfælde af leverbetændelse (hepatitis), som kan opstå pludseligt og kraftigt (fulminant leverbetændelse) eller leversvigt, som begge kan være dødelige.
English: Shake gently before use
Danish: Omrystes let før brug
English: Viramune should be administered by physicians who are experienced in the treatment of HIV infection.
Danish: Viramune bør ordineres af læger med erfaring i behandling af hiv-infektion.
English: Therefore, patients should be monitored carefully for the appearance of rash during this period.
Danish: Derfor skal patienterne monitoreres omhyggeligt for opståen af udslæt i denne periode.
English: Dividing a 200 mg total dose into four 50 mg doses rather than two 100 mg doses produced a 7-11 % greater overall absorption, but with comparable medicinal product release rates.
Danish: Ved opsplitning af en dosis på 200 mg på fire doser á 50 mg i stedet for to doser á 100 mg, opnåede man en 7-11 % større samlet absorption, men med sammenlignelig medicinfrigivelse.
English: You must take it with at least two other antiretroviral medicines.
Danish: Du skal tage det med mindst to andre slags antiretrovirale lægemidler.
English: Approximately half of the patients had tenofovir + emtricitabine as their background therapy, with the remaining patients receiving abacavir sulfate + lamivudine or zidovudine + lamivudine.
Danish: Cirka halvdelen af patienterne fik tenofovir + emtricitabin som tillægsbehandling, og resten af patienterne fik abacavir sulfat + lamivudin eller zidovudin + lamivudin.
English: Your doctor might then decide to restart you on a lower dose.
Danish: Beslutningen kan også blive, at du skal genstarte behandlingen med en lavere dosis.
English: Patients 16 years and older
Danish: Patienter på 16 år og derover
English: Selected demographic and baseline disease characteristics are displayed in Table 1.
Danish: Udvalgte karakteristika for demografi og sygdom ved baseline er vist i tabel 1.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR´er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Therefore, caution should be used in concomitant administration.
Danish: Der tilrådes således forsigtighed ved samtidig anvendelse.
English: Long-term efficacy appears to be most likely in patients whose nevirapine trough levels exceed 3.5 µg/ml.
Danish: Langvarig virkning synes at være mere sandsynlig hos patienter, hvis nevirapine through niveauer overstiger 3,5 μg/ml.
English: Viramune co-administration did not alter the ovulation suppression effects of DMPA.
Danish: Viramune co-administration ændrede ikke DMPA's suppression af ovulation.
English: This is a retrospective multicentre study comparing the 3-year antiviral efficacy of Viramune and efavirenz in combination with stavudine and lamivudine in 2NN patients from week 49 to week 144.
Danish: Dette studie er et retrospektivt, multicenter studie, som sammenligner virkningen af 3-års antiviral behandling med Viramune og efivarenz i kombination med stavudin og lamivudin hos 2NN patienter i perioden fra uge 49 til uge 144.
English: 2NN study
Danish: 2NN-studiet
English: Cartons containing 6 or 12 blister cards (60 or 120 tablets).
Danish: Æsker indeholdende 6 eller 12 blisterark (60 eller 120 tabletter).