FrancophonIA/ELRC3.0 huggingface dataset:
English: The double non-nucleoside study 2 NN was a randomised, open-label, multicentre prospective study comparing the NNRTIs nevirapine, efavirenz and both medicinal products given together.
Danish: Det dobbelte non-nukleosid studie 2NN var et randomiseret, åbent, multicenter prospektivt studie, der sammenlignede NNRT-hæmmerne nevirapin og efavirenz hver for sig og i kombination.
English: If ASAT or ALAT > 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
Danish: Hvis ASAT eller ALAT > 2,5 ULN før eller under behandling må levertests monitorers oftere ved regelmæssige kontrolbesøg.
English: PHARMACEUTICAL FORM AND CONTENTS Treatment initiation pack containing 14 tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Startpakning indeholdende 14 tabletter
English: EXP To be used within 6 months after opening the bottle
Danish: EXP Bør anvendes inden 6 måneder efter flasken er åbnet
English: Your child's doctor will inform you of the correct dose for your child.
Danish: Dit barns læge vil oplyse dig om den korrekte dosis.
English: In single dose, parallel group bioavailability studies (studies 1100.1517 and 1100.1531), the Viramune 50 and 100 mg prolonged-release tablets exhibited extended release characteristics of prolonged absorption and lower maximal concentrations, similar to the findings when a 400 mg prolongedrelease tablet was compared to the Viramune immediate-release 200 mg tablet.
Danish: Enkeltdosis-, parallelgruppe-, biotilgængelighedsstudier (studie1100.1517 og 1100.1531) viste, at Viramune 50 mg og 100 mg depottabletter havde depotkarakteristika for forlænget absorptionstid og lavere maksimalkoncentrationer i lighed med, hvad der blev fundet ved sammenligning mellem 400 mg depottabletten og Viramune 200 mg tabletten.
English: Clinical studies with prolonged-release tablets
Danish: Kliniske studier med depottabletter
English: - Latin America
Danish: - Latinamerika
English: Nevirapine plasma levels were not altered by co-administration of tenofovir.
Danish: Nevirapins plasmakoncentrationer blev ikke ændret ved samtidig coadministration af tenofovir.
English: If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately.
Danish: Hvis du får udslæt og du føler dig syg, så skal du stoppe behandlingen og konsultere din læge omgående.
English: The prolongedrelease tablet should not be divided.
Danish: Depottabletten bør ikke deles.
English: Cases of Viramune overdose at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Danish: Tilfælde af Viramuneoverdosering efter indtagelse af doser mellem 800-6.000 mg/dag i op til 15 dage har været rapporteret.
English: Your doctor might need to monitor whether your other medicines are still working and adjust doses.
Danish: Begrundelsen er, at lægen muligvis bliver nødt til at kontrollere, at den anden medicin stadig virker, som den skal, og evt. ændre på doseringen.
English: Do not chew your tablets.
Danish: Tabletterne må ikke tygges.
English: What Viramune contains
Danish: Viramune indeholder:
English: Methadone-maintained patients beginning Viramune therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.
Danish: Methadonbehandlede patienter, som skal begynde Viramune behandling, bør monitoreres for abstinenssymptomer og efterfølgende have methadondosis justeret afhængigt af disse.
English: The following patients are at increased risk of developing liver problems: - women - infected with hepatitis B or C - abnormal liver function tests
Danish: Følgende patientgrupper har en forhøjet risiko for at udvikle leverskader: - kvinder - patienter, der er smittet med hepatitis B eller hepatitis C - patienter med unormale leverfunktionsværdier
English: Time to emergence of nevirapine resistance in cell culture was not altered when selection included nevirapine in combination with several other NNRTIs.
Danish: Tiden for udvikling af resistens over for nevirapin i cellekulturer blev ikke ændret, når selektionen omfattede nevirapin i kombination med adskillige andre NNRTIlægemidler.
English: What you need to know before you take Viramune
Danish: Det skal du vide, før du begynder at tage Viramune
English: Readministration to patients who previously had ASAT or ALAT > 5 ULN during nevirapine therapy and had recurrence of liver function abnormalities upon readministration of nevirapine (see section
Danish: Genadministration til patienter, som tidligere havde ASAT eller ALAT >5 ULN under nevirapinbehandling og havde tilbagevenden af leverfunktionsabnormaliteter efter genadministration af nevirapin (se pkt.
English: At 12 months, the Kaplan-Meier estimates of the likelihood of reaching the endpoint were 10 % in the Viramune group, 6 % in the efavirenz group, and 13 percent in the abacavir group (P=0.10 according to an intention-to-treat analysis).
Danish: Baseret på Kaplan-Meier-estimater var sandsynligheden for efter 12 måneder at opnå endepunktet 10 % i Viramune-gruppen, 6 % i efavirenzgruppen og 13% i abacavirgruppen (P=0,10 i henhold til intention-to-treat-analyse.
English: You should continue to take Viramune for as long as instructed by your doctor.
Danish: Du skal fortsætte behandlingen med Viramune så længe, som din læge har foreskrevet.
English: Geometric mean steady-state plasma Viramune prolonged-release pre-dose trough concentrations were 3,880 ng/ml, 3,310 ng/ml and 5,350 ng/ml in age groups 3 to <6 years, 6 to <12 years, and 12 to <18 years of age, respectively.
Danish: Geometriske middelværdier for trough-dosiskoncentrationer af Viramune i depotform ved steady state i plasma var henholdsvis 3.880 ng/ml, 3.310 ng/ml og 5.350 ng/ml i aldersgrupperne 3 til < 6 år, 6 til < 12 år og 12 til < 18 år.
English: If you stop taking Viramune
Danish: Hvis du holder op med at tage Viramune
English: Clear polypropylene 5 ml dispensing syringe with silicone rubber piston seal.
Danish: Klar polypropylen 5 ml dispenseringssprøjte med silikonegummi stempelpakning.
English: Common headache
Danish: Hovedpine
English: Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
Danish: Viramune oral suspension forhandles i plastflasker med 240 ml oral suspension pr. flaske.
English: White, oval, biconvex tablets.
Danish: Hvide, ovale, bikonvekse tabletter.
English: Autoinduction also results in a corresponding decrease in the terminal phase half-life of nevirapine in plasma from approximately 45 hours (single dose) to approximately 25-30 hours following multiple dosing with 200-400 mg/day.
Danish: Autoinduktion resulterer tillige i et tilsvarende fald i terminal fase halveringstiden af nevirapin i plasma fra ca. 45 timer (enkeltdosis) til ca. 25-30 timers efter en dosering på 200-400 mg/dag fordelt på flere doser.
English: If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Viramune.
Danish: Hvis du er i dialysebehandling, vil din læge muligvis justere dosis af Viramune.
English: The absorption of nevirapine is not affected by food, antacids or medicinal products which are formulated with an alkaline buffering agent.
Danish: Absorptionen af nevirapine er ikke påvirket af fødeindtagelse, antacida eller lægemidler, der indeholder en basisk buffer.
English: If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.
Danish: Hvis du bruger post-menopausal hormonbehandling, skal du spørge din læge til råds, før du tager Viramune.
English: Children three years and older and adolescents
Danish: Børn på tre år og derover samt unge
English: The safety and efficacy of Viramune has not been established in patients with significant underlying liver disorders.
Danish: Sikkerheden og virkningen af Viramune hos patienter med betydende underliggende leversygdomme er ikke klarlagt.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som er i behandling med antiretroviral kombinationsbehandling, er i en højere risiko for alvorlige og potentielle letale hepatiske bivirkninger.
English: anaphylactic reaction, angioedema, urticaria), drug reaction with eosinophilia and systemic symptoms, anaphylactic reaction
Danish: anafylaktisk reaktion, angioødem, urticaria), lægemiddelreaktion med eosinofili og systemiske symptomer, anafylaktisk reaktion
English: Fit the plastic adapter onto the open bottle neck by first pressing and then screwing the adapter.
Danish: Påsæt plastikadaptoren ved først at presse og derefter skrue den på den åbne flaskehals.
English: Total * Includes patients who received at least one dose of blinded medicinal product after randomisation.
Danish: Total * Omfatter patienter, der efter randomisering fik mindst én dosis blindet lægemiddel.
English: The proportion of patients with at least one grade 3 or 4 liver-associated laboratory toxicity was 8.3 % for nevirapine twice daily and 4.5 % for efavirenz.
Danish: Andelen af patienter med mindst én grad 3 eller 4 leverrelateret laboratorietoksicitet var 8,3 % for nevirapin 2 gange daglig og 4,5 % for efivarenz.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to nevirapine in randomised controlled clinical studies (n=2,718).
Danish: Hyppigheden er estimeret statistisk ud fra det antal patienter, som fik nevirapin behandling i randomiserede, kontrollerede kliniske studier (n = 2.718).
English: As mentioned in 'Warnings and precautions', above, the most important side effects of Viramune are severe and life threatening skin reactions and serious liver damage.
Danish: Som nævnt i ”Advarsler og forsigtighedsregler” så er de mest alvorlige bivirkninger ved Viramune alvorlige og livstruende hudreaktioner og alvorlige leverskader.
English: An increase in the dose of lopinavir/ritonavir to 533/133 mg (4 capsules) or 500/125 mg (5 tablets with 100/25 mg each) twice daily with food is recommended in combination with Viramune.
Danish: En dosisøgning af lopinavir/ritonavir til 533/133 mg (4 kapsler) 2 gange daglig eller 500/125 mg (5 tabletter á 100/25 mg) 2 gange daglig i kombination med Viramune indtaget sammen med mad anbefales.
English: Similarly the potential for cross-resistance between nevirapine and NRTIs is low because the molecules have different binding sites on the reverse transcriptase.
Danish: På samme måde er potentialet for krydsresistens mellem nevirapin og NRT-hæmmere lille, idet molekylerne har forskellige bindingssteder for revers transskriptase.
English: Abnormal liver functioning has been reported with the use of Viramune.
Danish: Unormal leverfunktion har været rapporteret ved behandling med Viramune.
English: If you have a renal or hepatic dysfunction of any degree please use only Viramune 200 mg tablets or Viramune 50 mg/5 ml oral suspension.
Danish: Hvis du har nedsat nyre- eller leverfunktion, bør du kun behandles med Viramune 200 mg tabletter eller Viramune 50mg/5 ml oral suspension.
English: Other medicines and Viramune
Danish: Brug af anden medicin sammen med Viramune
English: For patients less than 3 years and for all other age groups, an immediate-release oral suspension dosage form is available (please refer to the respective Summary of Product Characteristics).
Danish: For patienter under 3 år og for alle andre aldersgrupper findes en oral suspension med umiddelbar udløsning (se det pågældende produktresumé).
English: Table 2: Outcomes at week 48 in study 1100.1486*
Danish: Tabel 2: Resultater i uge 48 i studie 1100.1486*
English: Viramune contains lactose and sodium
Danish: Viramune indeholder lactose og natrium
English: Furthermore, combining the following compounds with Viramune is not recommended: efavirenz, ketoconazole, delavirdine, etravirine, rilpivirine, elvitegravir (in combination with cobicistat), atazanavir (in combination with ritonavir), boceprevir; fosamprenavir (if not co-administered with low dose ritonavir) (see section 4.5).
Danish: Desuden anbefales det ikke at tage Viramune i kombination med følgende stoffer: efavirenz, ketoconazol, delavirdin, etravirin, rilpivirin, elvitegravir (i kombination med cobicistat), atazanavir (i kombination med ritonavir), boceprevir og fosamprenavir (hvis det ikke administreres samtidig med lav-dosis ritonavir) (se pkt.
English: Twenty per cent of patients assigned to nevirapine twice daily and 18% of patients assigned to efavirenz had at least one grade 3 or 4 clinical adverse event.
Danish: 20 % af patienterne i behandling med nevirapin 2 gange daglig og 18 % af patienterne i behandling med efavirenz havde mindst én grad 3 eller 4 klinisk bivirkning.
English: Concomitant use of etravirine with nevirapine may cause a significant decrease in the plasma concentrations of etravirine and loss of therapeutic effect of etravirine.
Danish: Samtidig brug af etravirin og nevirapin kan medføre et signifikant fald i plasmakoncentrationen og tab af tereapeutisk effekt af etravirin.
English: ANTIFUNGALS Fluconazole
Danish: SVAMPEMIDLER Fluconazol
English: Viramune administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Danish: Administration af Viramune i højere doser end anbefalet kan forøge frekvensen og alvorligheden af hudreaktioner, såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
English: Use caution when engaging in activities such as driving, using any tools or machines.
Danish: Vær forsigtig, når du udøver aktiviteter såsom at køre, arbejde med værktøj eller betjene maskiner.
English: Nevirapine readily crosses the placenta and is found in breast milk.
Danish: Nevirapin passerer hurtigt placenta og spores i modermælk.
English: ENTRY INHIBITORS Enfuvirtide
Danish: FUSIONSHÆMMERE Enfuvirtid
English: Viramune prolonged-release tablets or parts of tablets may occasionally be passed and seen in the stool (faeces).
Danish: Viramune depottabletter eller dele af depottabletten kan sommetider passere gennem mave-tarmsystemet og ses i afføringen.
English: Maintenance packs:
Danish: Vedligeholdelsespakning:
English: They should be informed that occurrence of symptoms suggestive of hepatitis should lead them to discontinue nevirapine and immediately seek medical evaluation, which should include liver function tests.
Danish: De skal informeres om, at hvis de oplever symptomer, der tyder på hepatitis, skal de straks stoppe med nevirapin og omgående søge lægehjælp, som bør omfatte leverfunktionstest.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv infektion (aids), som tidligere har haft opportunistisk infektion (sygdom, der tyder på aids), kan tegn og symptomer på betændelse fra tidligere infektioner forekomme kort efter, at anti-hiv behandlingen er startet.
English: In addition, the observed trough nevirapine concentrations were comparable between the two methods.
Danish: Desuden var de observerede nevirapin-trough-koncentrationer sammenlignelige med de to metoder til beregning af dosis.
English: Peak plasma nevirapine concentrations of 2  0.4 µg/ml (7.5 µM) were attained by 4 hours following a single 200 mg dose.
Danish: Peakplasmakoncentration for nevirapin på 2±0,4 g/ml (7,5 M) opnås efter 4 timer efter en enkelt dosis på 200 mg.
English: Nevirapine AUC  1.26
Danish: Nevirapin AUC  1,26
English: By weight the recommended oral dose for paediatric patients up to 8 years of age is 4 mg/kg once daily for two weeks followed by 7 mg/kg twice daily thereafter.
Danish: Den anbefalede orale dosis til pædiatriske patienter på op til 8 år efter kropsvægt er 4 mg/kg en gang dagligt i 2 uger, hvorefter dosis øges til 7 mg/kg to gange dagligt.
English: This is due to induction of medicinal product metabolism enzymes and/or transport proteins by St. John's Wort.
Danish: Det skyldes, at perikon inducerer lægemiddelmetaboliserende enzymer og/eller transportproteiner.
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code J05AG01.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, non-nukleosid revers transkriptasehæmmere, ATC-kode J05AG01.
English: Based on clinical study experience of 361 paediatric patients the majority of which received combination treatment with ZDV or/and ddI, the most frequently reported adverse events related to nevirapine were similar to those observed in adults.
Danish: På baggrund af erfaring fra kliniske studier med 361 pædiatriske patienter, hvor hovedparten fik kombinationsbehandling med ZDV og/eller ddl, er de bivirkninger, som hyppigst er relateret til nevirapin tilsvarende dem, som er observeret hos voksne.
English: Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction.
Danish: Kontakt straks lægen, hvis du får udslæt og en af de nævnte overfølsomhedsreaktioner (allergiske reaktioner).
English: All paediatric patients should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
Danish: Alle pædiatriske patienter skal regelmæssigt kontrolvejes eller have kontrolleret deres legemsoverfladeareal for at vurdere, om dosisjustering er nødvendig.
English: If you are taking oral contraceptives (e.g. „pill“) or other hormonal methods of birth control during treatment with Viramune, you should use a barrier contraception (e.g. condoms) in addition to prevent pregnancy and further HIV transmission.
Danish: Hvis du bruger p-piller eller andre hormonelle præventionsmetoder under behandling med Viramune, bør du samtidig bruge kondom for at beskytte mod graviditet og overførsel af smitte.
English: Physicians and patients should be vigilant for prodromal signs or findings of hepatitis, such as anorexia, nausea, jaundice, bilirubinuria, acholic stools, hepatomegaly or liver tenderness.
Danish: Læger og patienter skal være vagtsomme over for prodromale tegn eller fund, der antyder hepatitis, såsom anoreksi, kvalme, gulsot, bilirubinuri, akolisk fæces, hepatomegali eller leverømhed.
English: Viramune is also available as an oral suspension, tablets or as prolonged-release tablets with lower strength.
Danish: Viramune kan også fås som oral suspension, tabletter eller depottabletter i lavere styrke.
English: The side effects described below have been experienced by patients given Viramune:
Danish: Følgende bivirkninger er set hos patienter, der er behandlet med Viramune:
English: The total daily dose at any time during treatment should not exceed 400 mg for any patient.
Danish: Overvejelser i forbindelse med fastsættelse af dosis Den samlede daglige dosis på et hvilket som helst tidspunkt under behandlingen må ikke overstige 400 mg for nogen af patienterne.
English: Nevirapine exhibited additive to synergistic anti-HIV-1 activity in combination with the protease inhibitors amprenavir, atazanavir, indinavir, lopinavir, saquinavir and tipranavir, and the NRTIs abacavir, didanosine, emtricitabine, lamivudine, stavudine, tenofovir and zidovudine.
Danish: Nevirapin viste additiv synergistisk anti-hiv-1-aktivitet i kombination med proteasehæmmerne amprenavir, atazanavir, indinavir, lopinavir, saquinavir og tipranavir og NRTIerne abacavir, didanosin, emtricitabin, lamivudin, stavudin, tenofovir og zidovudin.
English: In an open-label clinical study (ACTG 180) granulocytopenia assessed as medicinal product-related occurred in 5/37 (13.5 %) of patients.
Danish: I et åbent, klinisk studie (ACTG 180) blev granulocytopeni vurderet som lægemiddelrelateret hos 5/37 (13,5 %) af patienterne.
English: Coadministration of Viramune with elvitegravir in combination with cobicistat is not recommended (see section 4.4).
Danish: Co-administration af Viramune og elvitegravir i kombination med cobicistat kan ikke anbefales (se pkt.
English: Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities.
Danish: Udslæt er ofte lette til moderate, makulopapuløse, erytematøse hududslæt med eller uden kløe, lokaliseret til truncus, ansigt og ekstremiteterne.
English: EXP Use within 2 months after 1
Danish: EXP Anvendes inden 2 måneder efter anbrud.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Danish: Især hos patienter med generelt anerkendte risikofaktorer er der rapporteret om tilfælde af osteonekrose, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
English: If you have any rash during this period, do not increase the dose but consult your doctor.
Danish: Hvis du får nogen form for udslæt i denne periode, må du ikke øge dosis, men skal kontakte din læge i stedet.
English: Patients who are already on immediate-release tablets or oral suspension can switch to prolongedrelease tablets without lead-in period.
Danish: Patienter, der allerede får 200 mg tabletter eller oral suspension, kan skifte til depottabletter uden en optrapningsperiode.
English: Combination therapy with nevirapine is not a curative treatment of patients infected with HIV-1; patients may continue to experience illnesses associated with advanced HIV-1 infection, including opportunistic infections.
Danish: Kombinationsbehandling med nevirapin er ikke en kurativ behandling af patienter smittet med hiv-1; nogle patienter kan fortsat udvikle sygdom i forbindelse med fremskreden hiv-1-infektion, inkl.
English: Only a small fraction (< 5%) of the radioactivity in urine (representing < 3 % of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound.
Danish: Kun en lille fraktion (< 5 %) af radioaktiviteten i urinen (repræsenterende < 3 % af den totale dosis) består af det oprindelige stof; derfor spiller den renale ekskretion en mindre rolle i eliminationen af det oprindelige stof.
English: The safety and efficacy of Viramune prolonged-release tablets in children aged less than 3 years has not been established.
Danish: Viramune depottabletters sikkerhed og effekt hos børn under tre år er ikke klarlagt.
English: INFORMATION IN BRAILLE Viramune 50 mg/5 ml
Danish: INFORMATION I BRAILLESKRIFT Viramune 50 mg/5 ml
English: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Danish: Viramune oral suspension indeholder methylparahydroxybenzoat og propylparahydroxybenzoat.
English: However, in the absence of specific studies, the clinical impact of these findings is not known.
Danish: Den kliniske betydning heraf er dog ukendt, da der ikke er udført specifikke studier.
English: Two new substitutions on codons previously associated with nevirapine resistance were observed: one patient with Y181I in the Viramune prolonged-release group and one patient with Y188N in the Viramune immediate-release group; resistance to nevirapine was confirmed by phenotype.
Danish: To nye substitutioner baseret på codoner, der tidligere er blevet forbundet med nevirapin-resistens, blev set: én patient med Y181I af dem behandlet med Viramune i depotform, og én patient med Y188N af dem behandled med Viramune 200 mg; ud fra fænotype kunne resistens over for nevirapin bekræftes.
English: Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
Danish: En ml oral suspension indeholder 10 mg nevirapin (som hemihydrat).
English: These outcomes include all patients who were randomised after the 14 day lead-in with Viramune immediate-release and received at least one dose of blinded medicinal product.
Danish: Disse resultater omfatter alle patienter randomiseret efter 14 dages optrapningsperiode med Viramune 200 mg tabletter, og som fik mindst én dosis blindet lægemiddel.