natgillin/translations-raw huggingface dataset:
Genadministration til patienter, som tidligere havde ASAT eller ALAT >5 ULN under nevirapinbehandling og havde tilbagevenden af leverfunktionsabnormaliteter efter genadministration af nevirapin (se pkt.
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
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.
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).
Du skal fortsætte behandlingen med Viramune så længe, som din læge har foreskrevet.
You should continue to take Viramune for as long as instructed by your doctor.
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.
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.
Hvis du holder op med at tage Viramune
If you stop taking Viramune
Klar polypropylen 5 ml dispenseringssprøjte med silikonegummi stempelpakning.
Clear polypropylene 5 ml dispensing syringe with silicone rubber piston seal.
Hovedpine
Common headache
Viramune oral suspension forhandles i plastflasker med 240 ml oral suspension pr. flaske.
Viramune oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
Hvide, ovale, bikonvekse tabletter.
White, oval, biconvex tablets.
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.
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.
Hvis du er i dialysebehandling, vil din læge muligvis justere dosis af Viramune.
If you are undergoing kidney dialysis, your doctor may consider a dose adjustment of Viramune.
Absorptionen af nevirapine er ikke påvirket af fødeindtagelse, antacida eller lægemidler, der indeholder en basisk buffer.
The absorption of nevirapine is not affected by food, antacids or medicinal products which are formulated with an alkaline buffering agent.
Hvis du bruger post-menopausal hormonbehandling, skal du spørge din læge til råds, før du tager Viramune.
If you are receiving post-menopausal hormone therapy, ask your doctor for advice before taking this medicine.
Børn på tre år og derover samt unge
Children three years and older and adolescents
Sikkerheden og virkningen af Viramune hos patienter med betydende underliggende leversygdomme er ikke klarlagt.
The safety and efficacy of Viramune has not been established in patients with significant underlying liver disorders.
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.
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.
anafylaktisk reaktion, angioødem, urticaria), lægemiddelreaktion med eosinofili og systemiske symptomer, anafylaktisk reaktion
anaphylactic reaction, angioedema, urticaria), drug reaction with eosinophilia and systemic symptoms, anaphylactic reaction
Påsæt plastikadaptoren ved først at presse og derefter skrue den på den åbne flaskehals.
Fit the plastic adapter onto the open bottle neck by first pressing and then screwing the adapter.
Total * Omfatter patienter, der efter randomisering fik mindst én dosis blindet lægemiddel.
Total * Includes patients who received at least one dose of blinded medicinal product after randomisation.
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.
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.
Hyppigheden er estimeret statistisk ud fra det antal patienter, som fik nevirapin behandling i randomiserede, kontrollerede kliniske studier (n = 2.718).
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).
Som nævnt i ”Advarsler og forsigtighedsregler” så er de mest alvorlige bivirkninger ved Viramune alvorlige og livstruende hudreaktioner og alvorlige leverskader.
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.
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.
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.
På samme måde er potentialet for krydsresistens mellem nevirapin og NRT-hæmmere lille, idet molekylerne har forskellige bindingssteder for revers transskriptase.
Similarly the potential for cross-resistance between nevirapine and NRTIs is low because the molecules have different binding sites on the reverse transcriptase.
Unormal leverfunktion har været rapporteret ved behandling med Viramune.
Abnormal liver functioning has been reported with the use of Viramune.
Hvis du har nedsat nyre- eller leverfunktion, bør du kun behandles med Viramune 200 mg tabletter eller Viramune 50mg/5 ml oral suspension.
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.
Brug af anden medicin sammen med Viramune
Other medicines and Viramune
For patienter under 3 år og for alle andre aldersgrupper findes en oral suspension med umiddelbar udløsning (se det pågældende produktresumé).
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).
Tabel 2: Resultater i uge 48 i studie 1100.1486*
Table 2: Outcomes at week 48 in study 1100.1486*
Viramune indeholder lactose og natrium
Viramune contains lactose and sodium
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.
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).
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.
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.
Samtidig brug af etravirin og nevirapin kan medføre et signifikant fald i plasmakoncentrationen og tab af tereapeutisk effekt af etravirin.
Concomitant use of etravirine with nevirapine may cause a significant decrease in the plasma concentrations of etravirine and loss of therapeutic effect of etravirine.
SVAMPEMIDLER Fluconazol
ANTIFUNGALS Fluconazole
Administration af Viramune i højere doser end anbefalet kan forøge frekvensen og alvorligheden af hudreaktioner, såsom Stevens-Johnsons syndrom og toksisk epidermal nekrolyse.
Viramune administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Vær forsigtig, når du udøver aktiviteter såsom at køre, arbejde med værktøj eller betjene maskiner.
Use caution when engaging in activities such as driving, using any tools or machines.
Nevirapin passerer hurtigt placenta og spores i modermælk.
Nevirapine readily crosses the placenta and is found in breast milk.
FUSIONSHÆMMERE Enfuvirtid
ENTRY INHIBITORS Enfuvirtide
Viramune depottabletter eller dele af depottabletten kan sommetider passere gennem mave-tarmsystemet og ses i afføringen.
Viramune prolonged-release tablets or parts of tablets may occasionally be passed and seen in the stool (faeces).
Vedligeholdelsespakning:
Maintenance packs:
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.
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.
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.
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.
Desuden var de observerede nevirapin-trough-koncentrationer sammenlignelige med de to metoder til beregning af dosis.
In addition, the observed trough nevirapine concentrations were comparable between the two methods.
Peakplasmakoncentration for nevirapin på 2±0,4 g/ml (7,5 M) opnås efter 4 timer efter en enkelt dosis på 200 mg.
Peak plasma nevirapine concentrations of 2  0.4 µg/ml (7.5 µM) were attained by 4 hours following a single 200 mg dose.
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.
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.
Det skyldes, at perikon inducerer lægemiddelmetaboliserende enzymer og/eller transportproteiner.
This is due to induction of medicinal product metabolism enzymes and/or transport proteins by St. John's Wort.
Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, non-nukleosid revers transkriptasehæmmere, ATC-kode J05AG01.
Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code J05AG01.
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.
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.
Kontakt straks lægen, hvis du får udslæt og en af de nævnte overfølsomhedsreaktioner (allergiske reaktioner).
Tell your doctor immediately if you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction.
Alle pædiatriske patienter skal regelmæssigt kontrolvejes eller have kontrolleret deres legemsoverfladeareal for at vurdere, om dosisjustering er nødvendig.
All paediatric patients should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
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.
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.
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.
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.
Viramune kan også fås som oral suspension, tabletter eller depottabletter i lavere styrke.
Viramune is also available as an oral suspension, tablets or as prolonged-release tablets with lower strength.
Følgende bivirkninger er set hos patienter, der er behandlet med Viramune:
The side effects described below have been experienced by patients given Viramune:
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.
The total daily dose at any time during treatment should not exceed 400 mg for any patient.
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.
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.
I et åbent, klinisk studie (ACTG 180) blev granulocytopeni vurderet som lægemiddelrelateret hos 5/37 (13,5 %) af patienterne.
In an open-label clinical study (ACTG 180) granulocytopenia assessed as medicinal product-related occurred in 5/37 (13.5 %) of patients.
Co-administration af Viramune og elvitegravir i kombination med cobicistat kan ikke anbefales (se pkt.
Coadministration of Viramune with elvitegravir in combination with cobicistat is not recommended (see section 4.4).
Udslæt er ofte lette til moderate, makulopapuløse, erytematøse hududslæt med eller uden kløe, lokaliseret til truncus, ansigt og ekstremiteterne.
Rashes are usually mild to moderate, maculopapular erythematous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities.
EXP Anvendes inden 2 måneder efter anbrud.
EXP Use within 2 months after 1
Især hos patienter med generelt anerkendte risikofaktorer er der rapporteret om tilfælde af osteonekrose, fremskreden hiv-sygdom eller langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
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).
Hvis du får nogen form for udslæt i denne periode, må du ikke øge dosis, men skal kontakte din læge i stedet.
If you have any rash during this period, do not increase the dose but consult your doctor.
Patienter, der allerede får 200 mg tabletter eller oral suspension, kan skifte til depottabletter uden en optrapningsperiode.
Patients who are already on immediate-release tablets or oral suspension can switch to prolongedrelease tablets without lead-in period.
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.
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.
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.
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.
Viramune depottabletters sikkerhed og effekt hos børn under tre år er ikke klarlagt.
The safety and efficacy of Viramune prolonged-release tablets in children aged less than 3 years has not been established.
INFORMATION I BRAILLESKRIFT Viramune 50 mg/5 ml
INFORMATION IN BRAILLE Viramune 50 mg/5 ml
Viramune oral suspension indeholder methylparahydroxybenzoat og propylparahydroxybenzoat.
Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Den kliniske betydning heraf er dog ukendt, da der ikke er udført specifikke studier.
However, in the absence of specific studies, the clinical impact of these findings is not known.
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.
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.
En ml oral suspension indeholder 10 mg nevirapin (som hemihydrat).
Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate).
Disse resultater omfatter alle patienter randomiseret efter 14 dages optrapningsperiode med Viramune 200 mg tabletter, og som fik mindst én dosis blindet lægemiddel.
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.
Maraviroc AUC  1,01 (0,6 -1,55) Maraviroc Cmin ND Maraviroc Cmax  1,54 (0,94-2,52) Sammenlignet med historiske kontroller
Maraviroc AUC  1.01 (0.6 -1.55) Maraviroc Cmin ND Maraviroc Cmax  1.54 (0.94-2.52) compared to historical controls
Viramune depottabletter bør doseres ud fra patientens vægt eller legemsoverfladeareal.
Viramune prolonged-release tablets may be dosed based on a patient's weight or body surface area (BSA).
Det er vigtigt, at du fortsætter med at tage Viramune korrekt, som anført ovenfor, medmindre din læge anbefaler dig at stoppe.
It is important that you continue taking Viramune correctly, as described above, unless your doctor instructs you to stop.
Efter flere doser stiger peakplasmakoncentrationen for nevirapin lineært i dosisområdet 200-400 mg daglig.
Following multiple doses, nevirapine peak concentrations appear to increase linearly in the dose range of 200 to 400 mg/day.
Hos mænd sås der en øget risiko ved detekterbart hiv-1-rna i plasma og CD4-celletal > 400 celler/mm
An increased risk was observed in men with detectable HIV-1 RNA in plasma and CD4 counts > 400 cells/mm
Nevirapin AUC  0,42
Nevirapine AUC  0.42
Dog havde ca. 15 % af patienterne med hepatisk fibrose en nevirapin trough koncentration på over 9,000 ng/ml (dobbelt så meget som den almindelige trough gennemsnitsværdi).
However, approximately 15 % of these patients with hepatic fibrosis had nevirapine trough concentrations above 9,000 ng/ml (2 fold the usual mean trough).
Patienter med før-eksisterende leverfunktionssvigt inklusive kronisk aktiv hepatitis har en højere risiko for leverfunktions abnormaliteter under antiretroviral kombinationsbehandling og bør monitoreres ifølge standard i praksis.
Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
3 i henholdsvis ”Viramune to gange daglig”-gruppen og i efavirenzgruppen.
3 in the Viramune twice daily and efavirenz groups, respectively.
24 uger efter randomisering til TRANxITION-studiet havde 92,6 % og 93,6 % af de patienter, der fik enten Viramune 200 mg to gange dagligt eller Viramune 400 mg i depotform én gang dagligt, fortsat hiv-1-rna < 50 kopier/ml.
At 24 weeks after randomisation in the TRANxITION study, 92.6 % and 93.6 % of patients receiving Viramune 200 mg immediate-release twice daily or Viramune 400 mg prolonged-release once daily, respectively, continued to have HIV-1 RNA < 50 copies/ml.
Viramune 100 mg depottabletter kan anvendes til børn i alderen 3 år og derover.
Viramune 100 mg prolonged-release tablets can be taken by children three years of age and above.
Tabel 1: Karakteristika for demografi og sygdom ved baseline i studie 1100.1486 Viramune
Table 1: Demographic and Baseline Disease Characteristics in study 1100.1486
Interaktionsdata er fra Viramune 200 mg tabletter, men forventes at gælde for alle doseringsformer.
The following data were generated using the Viramune immediate-release tablets but are expected to apply to all dosage forms.
På isolater fra de 86 antiretroviralnaive patienter, der udgik af VERxVE-studiet (1100.1486) på grund af virologisk svigt (rebound, delvist respons), eller en bivirkning, eller forbigående øget virusbelastning i løbet af studiet, blev der foretaget genotypeanalyse.
Genotypic analysis was performed on isolates from 86 antiretroviral naïve patients who discontinued the VERxVE study (1100.1486) after experiencing virologic failure (rebound, partial response) or due to an adverse event or who had transient increase in viral load during the course of the study.
Disse tilfælde omfatter Stevens-Johnsons syndrom toksisk epidermal nekrolyse og overfølsomhedsreaktioner karakteriseret ved udslæt, konstitutionelle symptomer og andre organpåvirkninger.
These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
Tallet 793 er antallet af behandlings-respondenter efter uge 48 (384 fik Viramune 200 mg tabletter, og 409 fik Viramune depottabletter).
The numerator 793 is the number of patients who were treatment responders at 48 weeks (384 from immediate-release and 409 from prolonged-release treatment groups).
Lægen vil beregne barnets dosis.
Your child's doctor will calculate the dose for your child.
Hvis patienter udvikler et udslæt, der kan være forbundet med nevirapin, bør der udføres leverfunktionstests.
If patients present with a suspected nevirapine-associated rash, liver function tests should be performed.
Data der er rapporteret i litteraturen fra 20 hiv-inficerede patienter antyder et Cmax ved steady state på 5,74 μg/ml (5,00-7,44) og Cmin på 3,73 μg/ml (3,20-5,08) med AUC på 109,0 h*μg/ml (96,0-143,5) hos patienter, der indtager 200 mg af nevirapine 2 gange daglig.
Data reported in the literature from 20 HIV-infected patients suggest a steady state Cmax of 5.74 µg/ml (5.00-7.44) and Cmin of 3.73 µg/ml (3.20-5.08) with an AUC of 109.0 h*µg/ml (96.0-143.5) in patients taking 200 mg of nevirapine bid.
I stedet bruges Viramune 400 mg depottabletter efter optrapningsperioden.
Instead Viramune 400 mg prolonged-release tablets should be used after the lead-in period.
Hos patienter med dialysekrævende ESRD, fandt man en 43,5 % reduktion af nevirapins AUC over en afprøvningsperiode på 1 uge.
However, patients with ESRD requiring dialysis exhibited a 43.5 % reduction in nevirapine AUC over a one-week exposure period.