natgillin/translations-raw huggingface dataset:
Interaktionsdata er angivet som en geometrisk gennemsnitsværdi med et 90% konfidensinterval (90% CI) når disse data er tilgængelige.
The interaction data is presented as geometric mean value with 90% confidence interval (90% CI) whenever these data were available.
Andre nevirapin formuleringer, såsom tabletter eller oral suspension, bør benyttes (se pkt.
Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2).
Viramune kan også fås i flydende form som oral suspension.
Viramune is also available in liquid form as an oral suspension.
Desuden fås til alle aldersgrupper til administration to gange dagligt en oral suspension (se det pågældende produktresumé).
Furthermore, an immediate-release oral suspension dosage form is available for all age groups for a twice daily administration (please refer to the respective Summary of Product Characteristics).
Følgende bivirkninger har været rapporteret, når nevirapin har været brugt i kombination med andre antiretrovirale midler: Pancreatitis, perifer neuropati og trombocytopeni.
The following adverse reactions have also been reported when nevirapine has been used in combination with other anti-retroviral agents: pancreatitis, peripheral neuropathy and thrombocytopaenia.
Viramune er blevet evalueret i både behandlingsnaive og tidligere behandlede patienter.
Viramune has been evaluated in both treatment-naïve and treatment-experienced patients.
Hos børn bør det overvejes at øge dosis af lopinavir/ritonavir til 300/75 mg/m2 gange dagligt sammen med mad når det coadministreres med Viramune, specielt hos patienter, hvor der er mistanke om en reduceret følsomhed for lopinavir/ritonavir.
For children, increase of the dose of lopinavir/ritonavir to 300/75 mg/m twice daily with food should be considered when used in combination with Viramune, particularly for patients in whom reduced susceptibility to lopinavir/ritonavir is suspected.
Vær sikker på, at sprøjten sidder fast.
Make sure that the syringe is tightly inserted.
Samtidig administration af boceprevir og medicin, der inducerer eller hæmmer CYP3A4/5, kan reducere eller øge eksponeringen.
Co-administration of boceprevir with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure.
Viramune depottabletter må kun bruges til børn i alderen tre år og derover.
Viramune prolonged-release tablets are only to be used for children three years of age and above.
Nevirapins og de fem oxidative metabolitters farmakokinetik blev ikke ændret i dette studie.
In this study, the multiple dose pharmacokinetic disposition of nevirapine and the five oxidative metabolites were not altered.
Nevirapin: plasmakoncentrationer:  1,15-1,28 sammenlignet med historiske kontroller.
Nevirapine: plasma levels:  1.151.28 compared to historical controls.
Tabel 1: Optrapningsfase med Viramune med umiddelbar frigivelse
Table 1: Lead-in phase with Viramune immediate-release
Må ikke tygges, deles eller knuses
Swallow whole, do not chew, divide or crush
Interaktionen mellem nevirapin og warfarin er kompleks med potentiale for både stigning og fald i koagulationstiden.
The interaction between nevirapine and the antithrombotic agent warfarin is complex, with the potential for both increases and decreases in coagulation time when used concomitantly.
Disse tilfælde er normalt forbundet med andre antiretrovirale midler og må forventes at opstå, når Viramune tages i kombination med andre midler; det er dog usandsynligt, at disse tilfælde opstår på grund af behandling med Viramune.
These events are commonly associated with other antiretroviral agents and may be expected to occur when Viramune is used in combination with other agents; however, it is unlikely that these events are due to treatment with Viramune.
Derefter vil dit barn skifte til en dosering 2 gange dagligt og lægen vil fastsætte den korrekte dosis baseret på enten barnets vægt eller legemsoverfladeareal.
Thereafter your child will be switched to a twice daily dosing schedule and your child's doctor will decide the right dose based either on your child's weight or body surface area.
Hormonel kontraceptiva, bortset fra depo-medroxyprogesteronacetat (DMPA) bør ikke bruges som eneste antikonception af kvinder, som tager Viramune, da nevirapin kan sænke plasmakoncentrationen af disse lægemidler.
Hormonal methods of birth control other than Depo-medroxyprogesterone acetate (DMPA) should not be used as the sole method of contraception in women taking Viramune, since nevirapine might lower the plasma concentrations of these medicinal products.
Patienterne bør underrettes om, at leverreaktioner er en alvorlig toksicitet ved nevirapin som kræver en tæt monitorering i de første 18 uger.
Patients should be informed that hepatic reactions are a major toxicity of nevirapine requiring a close monitoring during the first 18 weeks.
Viramune tabletter og oral suspension har sammenlignelig biotilgængelighed, og skift mellem de to formuleringer kan foregå i doser op til 200 mg.
Viramune tablets and oral suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg.
Ved administration sammen med Viramune bør justering af telaprevirdosis overvejes.
If co-administered with Viramune, an adjustment in the telaprevir dose should be considered.
Fulminant hepatitis (som kan være letal)
Rare hepatitis fulminant (which may be fatal)
Samlet set var eksponeringen hos børn den samme som hos voksne, der fik Viramune i depotform i henhold til studie 1100.1486.
Overall, the exposure in children was similar to that observed in adults receiving Viramune prolonged-release in study 1100.1486.
I dette studie sås i Viramune-gruppen en signifikant reduktion i transmission efter en enkelt dosis nevirapin (13,1 % (n = 310), versus 25,1 % (n = 308) i den ultra-korte zidovudin-gruppe (p = 0,00063)).
This study demonstrated a significant reduction in transmission using single dose nevirapine (13.1 % (n = 310) in the Viramune group, versus 25.1 % (n = 308) in the ultra-short zidovudine group (p = 0.00063)).
Viramune 100 mg depottabletter er gule, runde og bikonvekse.
Viramune 100 mg prolonged-release tablets are yellow, round and biconvex.
Meget almindelig (kan forekomme hos mere end 1 ud af 10 patienter): - udslæt
Very common (may affect more than 1 in 10 people): - rash
Du skal tage Viramune sammen med andre antiretrovirale hiv-lægemidler.
You must take Viramune together with other antiretroviral medicines.
Dog, kan nogle patienter på grund af stor interpatient-variation opleve store stigninger i rifabutineksponeringen og kan derfor have øget risiko for rifabutintoksicitet.
However, due to the high interpatient variability some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity.
Hvis du har glemt at tage Viramune
If you forget to take Viramune
Der er rapporteret letale tilfælde af SJS, TEN og lægemiddelreaktion med eosinifili og systemiske symptomer.
Fatal cases of SJS, TEN and drug reaction with eosinophilia and systemic symptoms have been reported.
Udslættet bør overvåges nøje (se pkt.
The isolated rash should be closely monitored (see section 4.4).
Ingen forandringer af lamivudin tilsyneladende clearance og fordelingsvolumen, hvilket tyder på, at nevirapin ikke inducerer lamivudin clearance.
No changes to lamivudine apparent clearance and volume of distribution, suggesting no induction effect of nevirapine on lamivudine clearance.
Nedsat nyrefunktion (let, moderat og svær) resulterede ikke i en signifikant ændring i nevirapins farmakokinetik.
Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Din læge vil nøje kontrollere virkningen af Viramune og den nævnte medicin ovenfor, hvis du bliver behandlet med flere slags medicin på samme tid.
Your doctor will carefully monitor the effect of Viramune and any of these medicines if you are taking them together.
Nevirapins relative biotilgængelighed, ved indgift af én 400 mg Viramune depottablet i forhold til to Viramune 200 mg tabletter, var på ca. 75 %.
The relative bioavailability of nevirapine when dosed as one 400 mg Viramune prolonged-release tablet, relative to two 200 mg Viramune immediaterelease tablets, was approximately 75 %.
Depottabletter er ikke egnede til 14-dages lead-in perioden for patienter, der starter i nevirapinbehandling.
Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine.
Plasmakoncentrationen af clarithromycin var signifikant reduceret, og plasmakoncentrationen af 14-OH metabolit var øget.
Clarithromycin exposure was significantly decreased, 14-OH metabolite exposure increased.
I uge 48 blev der observeret en markant forbedring i CD4+-celle-procenten hos begge doseringsgrupper.
A marked improvement in the CD4+ cell percent was observed through Week 48 for both dose groups.
In vitro studier med humane levermikrosomer indikerer, at oxidativ metabolisme af nevirapin er medieret primært af cytokrom P450 isozymer fra CYP3A-familien, selvom andre isozymer kan have en sekundær rolle.
In vitro studies with human liver microsomes suggest that oxidative metabolism of nevirapine is mediated primarily by cytochrome P450 isozymes from the CYP3A family, although other isozymes may have a secondary role.
Hvis du tager eller får ordineret rifampicin til behandling af tuberkulose, skal du tale med din læge, før du tager Viramune.
If you are taking or are prescribed rifampicin to treat tuberculosis please inform your doctor before taking this medicine with Viramune.
Risikoen fortsætter dog udover denne periode og overvågning med hyppige intervaller bør fortsættes under behandlingen.
However the risk continues past this period and monitoring should continue at frequent intervals throughout treatment.
Det primære endepunkt, behandlingssvigt, var defineret som mindre end 1 log10 fald i plasma hiv1-RNA i de første 12 uger eller mere end 50 kopier/ml i to på hinanden følgende målinger efter uge 24, eller sygdomsprogression.
The primary endpoint, treatment failure, was defined as less than 1 log10 decline in plasma HIV-1 RNA in the first 12 weeks, or two consecutive measurements of more than 50 copies/ ml from week 24 onwards, or disease progression.
Under hiv-behandling kan der forekomme vægtstigning samt forhøjede koncentrationer af lipider og glukose i blodet.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Konsulter lægen, hvis du har taget mere Viramune end du skal.
Consult your doctor if you have taken more Viramune than you should.
Methyl- og propylparahydroxybenzoater: Viramune oral suspension indeholder methyl- og propylparahydroxybenzoat, der kan give allergiske reaktioner (muligvis forsinket).
Methyl and propyl parahydroxybenzoates: Viramune oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reaction (possibly delayed).
Hjælpestoffer, som behandleren skal være opmærksom på En ml oral suspension indeholder 150 mg saccharose, 162 mg sorbitol, 1,8 mg methylparahydroxybenzoat og 0,24 mg propylparahydroxybenzoat.
Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate.
I beregningen indgår dit barns alder, legemsvægt eller legemsoverfladeareal.
The calculation will include your child's age and body weight, or body surface area.
- Aktivt stof: Nevirapin.
- The active substance is nevirapine.
Saquinavir/ritonavir De begrænsede data, der er tilgængelige for saquinavir soft gel kapslen boosted med ritonavir, indikerer, at der ikke skulle være klinisk signifikante interaktioner mellem saquinavir boosted med ritonavir og nevirapin.
Saquinavir/ritonavir The limited data available with saquinavir soft gel capsule boosted with ritonavir do not suggest any clinically relevant interaction between saquinavir boosted with ritonavir and nevirapine.
Troughplasmakoncentrationen af boceprevir blev reduceret, når det blev coadministreret med en NNRTI med en lignende metaboliseringsvej som nevirapin.
Plasma trough concentrations of boceprevir were decreased when administered with an NNRTI with a similar metabolic pathway as nevirapine.
Den samlede analyse af Paediatric aids Clinical Trials Group (PACTG)'s protokoller 245, 356, 366, 377 og 403 tillod evaluering at pædiatriske patienter yngre end 3 måneder (n=17) i disse PACTGstudier.
The consolidated analysis of Paediatric AIDS Clinical Trials Group (PACTG) protocols 245, 356, 366, 377, and 403 allowed for the evaluation of paediatric patients less than 3 months of age (n=17) enrolled in these PACTG studies.
Der bør udvises forsigtighed ved co-administration af telaprevir og nevirapin.
Caution should be exercised when co-administering telaprevir with nevirapine.
Uge 48 (gennemsnit) n = 407
Week 48 (mean) n=407
Efter uge 48 var den gennemsnitlige ændring i CD4-celletallet i forhold til baseline, på henholdsvis 184 celler/mm
At week 48, mean change from baseline in CD4 cell count was 184 cells/mm
Monitorering af levertests bør foretages hver anden uge i løbet af de første 2 måneder af behandlingen, efter 3 måneders behandling og derefter regelmæssigt.
Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3
Disse fund er højst sandsynligt relateret til, at nevirapin er en stærk inducer af leverenzymer, og ikke tegn på genotoksicitet.
These findings are most likely related to nevirapine being a strong inducer of liver enzymes, and not due to a genotoxic mode of action.
Der blev ikke rapporteret nogle livstruende (grad 4) udslæt relateret til Viramune under randomiseringsfasen.
No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.
Ribavirin hæmmer ikke CYP-enzymer, og fra toksicitetesstudier er der ingen tegn på, at ribavirin inducerer leverenzymer.
Ribavirin does not inhibit cytochrome P450 enzymes, and there is no evidence from toxicity studies that ribavirin induces liver enzymes.
Til pædiatriske patienter kan Viramune doseres enten efter legemsoverfladeareal eller efter legemsvægt som følger: Ved legemsoverfladearealet beregnet efter Mostellerformlen er den anbefalede orale dosis til pædiatriske patienter i alle aldre 150 mg/m² en gang dagligt i to uger efterfulgt af 150 mg/m² to gange dagligt.
Viramune may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows: By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m2 once daily for two weeks followed by 150 mg/m2 twice daily thereafter.
Viramune bør ikke anvendes som eneste aktive antiretrovirale behandling, da det er påvist, at monoterapi med antiretrovirale stoffer resulterer i viral resistens.
Viramune should not be used as the sole active antiretroviral, as monotherapy with any antiretroviral has shown to result in viral resistance.
Hovedparten af udslæt i forbindelse med nevirapin opstår inden for de første 6 uger efter behandlingsstart.
The majority of rashes associated with nevirapine occur within the first 6 weeks of initiation of therapy.
Du bør nøje læse indlægssedlerne for de andre typer hiv-medicin, som du skal tage i kombination med Viramune.
Carefully read the package leaflet of all other HIV medicines you are taking in combination with Viramune.
Alle disse hændelser fortog sig efter ophør af nevirapin.
All of these effects subsided following discontinuation of nevirapine.
Én-gang dagligt vedligeholdelsesdosis med Viramune depottabletter (efter optrapnings perioden): Dosis til pædiatriske patienter udregnet efter deres legemsoverfladeareal fremgår af tabellen nedenfor.
Once daily maintenance dosing with Viramune prolonged-release tablets (after the lead-in): The recommended oral doses for paediatric patients based upon their BSA are described in the table below.
Uge 48 (gennemsnit) n = 419
Week 48 (mean) n=419
I carcinogenicitetsstudier, øger nevirapin hepatiske tumorer i rotter og mus.
In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
Efter 14 dage, er dosis 20 ml (200 mg) 2 gange daglig.
After 14 days, the usual dose is 20 ml (200 mg) twice a day.
Overholdelse af dosis er obligat, specielt i den 14 dages optrapningsperiode (se pkt.
The dose must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Prednison bør ikke anvendes til behandling af udslæt forårsaget af Viramune.
Prednisone should not be used to treat a rash related to Viramune.
Depottabletterne skal tages med væske og må ikke knuses eller tygges.
The prolonged-release tablets shall be taken with liquid, and should not be broken or chewed.
Den præcise dosis afmåles ved hjælp af den medfølgende sprøjte og adaptor.
Measure the exact dose using the measuring syringe and adapter supplied as follows:
Det er derfor vigtigt, at du regelmæssigt kommer til kontrol hos din læge.
You should therefore remain in regular contact with your doctor.
Vægtinterval (kg) for patienter  8 år
Weight Range (kg) for patients  8 years of age
Viramune 400 mg depottabletter kan, som anført for pædiatrisk dosisrecommendation, også tages af børn efter doseringsplanen for voksne, hvis de:
According to paediatric dose recommendations Viramune 400 mg prolonged-release tablets can be also taken by children, following the adult dosing schedule, if they
Hos børn og unge kan endvidere ses følgende bivirkninger Den reduktion i antallet af hvide blodlegemer (granulocytopeni), der kan forekomme, ses oftere hos børn.
Additional side effects in children and adolescents A reduction in white blood cells (granulocytopenia) can occur, which is more common in children.
For patienter på 8 år og derover er den anbefalede dosis 4 mg/kg en gang dagligt i 2 uger, hvorefter dosis på 4 mg/kg gives to gange dagligt.
For patients 8 years and older the recommended dose is 4 mg/kg once daily for two weeks followed by 4 mg/kg twice daily thereafter.
Patienter, som udvikler tegn eller symptomer på hepatitis, svært hududslæt eller overfølsomhedsreaktioner, skal stoppe nevirapin-behandling og søge lægehjælp omgående.
Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediately.
Hovedparten af erfaringen med Viramune er i kombinationen med nukleosid reverse transkriptasehæmmere.
Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
Forsigtighed tilrådes derfor ved færdsel i trafikken eller ved betjening af maskiner.
Therefore, caution should be recommended when driving a car or operating machinery.
Signifikant færre patienter i abacavirgruppen stoppede behandlingen på grund af uønskede hændelser (9 patienter, eller 6 %) end i nevirapingruppen (26 patienter, eller 17 %) og i efavirenzgruppen (27 patienter, eller 17 %).
Significantly fewer patients in the abacavir group (9 patients, or 6 %) than in the nevirapine group (26 patients, or 17 %) or the efavirenz group (27 patients, or 17 %) discontinued the medicinal product because of adverse events.
Viramune kan også fås som oral suspension, tabletter eller depottabletter med højere styrke.
Viramune is also available as an oral suspension, tablets or as prolonged-release tablets with higher strength.
Hvis du får nevirapin og zidovudin samtidigt, kan det blive aktuelt, at lægen kontrollerer dine hvide blodlegemer.
If you are taking nevirapine and zidovudine concomitantly please inform your doctor since he might need to check your white blood cells.
Isolerede tilfælde af Stevens-Johnsons syndrom eller Stevens-Johnsons/toksisk epidermal nekrolyse overgangssyndrom er blevet rapporteret hos denne befolkningsgruppe.
Isolated cases of Stevens-Johnson syndrome or Stevens-Johnson/toxic epidermal necrolysis transition syndrome have been reported in this population.
Viramune 50 mg/5 ml oral suspension og Viramune 400 mg og 100 mg depottabletter
Viramune 50 mg/5 ml Oral suspension and Viramune 400 mg and 100 mg prolonged-release tablets
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.
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.
Hvis ASAT eller ALAT > 2,5 ULN før eller under behandling må levertests monitorers oftere ved regelmæssige kontrolbesøg.
If ASAT or ALAT > 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Startpakning indeholdende 14 tabletter
PHARMACEUTICAL FORM AND CONTENTS Treatment initiation pack containing 14 tablets
EXP Bør anvendes inden 6 måneder efter flasken er åbnet
EXP To be used within 6 months after opening the bottle
Dit barns læge vil oplyse dig om den korrekte dosis.
Your child's doctor will inform you of the correct dose for your child.
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.
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.
Kliniske studier med depottabletter
Clinical studies with prolonged-release tablets
- Latinamerika
- Latin America
Nevirapins plasmakoncentrationer blev ikke ændret ved samtidig coadministration af tenofovir.
Nevirapine plasma levels were not altered by co-administration of tenofovir.
Hvis du får udslæt og du føler dig syg, så skal du stoppe behandlingen og konsultere din læge omgående.
If rash occurs and you also feel sick, you must stop treatment and visit your doctor immediately.
Depottabletten bør ikke deles.
The prolongedrelease tablet should not be divided.
Tilfælde af Viramuneoverdosering efter indtagelse af doser mellem 800-6.000 mg/dag i op til 15 dage har været rapporteret.
Cases of Viramune overdose at doses ranging from 800 to 6,000 mg per day for up to 15 days have been reported.
Begrundelsen er, at lægen muligvis bliver nødt til at kontrollere, at den anden medicin stadig virker, som den skal, og evt. ændre på doseringen.
Your doctor might need to monitor whether your other medicines are still working and adjust doses.
Tabletterne må ikke tygges.
Do not chew your tablets.
Viramune indeholder:
What Viramune contains
Methadonbehandlede patienter, som skal begynde Viramune behandling, bør monitoreres for abstinenssymptomer og efterfølgende have methadondosis justeret afhængigt af disse.
Methadone-maintained patients beginning Viramune therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly.
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
The following patients are at increased risk of developing liver problems: - women - infected with hepatitis B or C - abnormal liver function tests
Tiden for udvikling af resistens over for nevirapin i cellekulturer blev ikke ændret, når selektionen omfattede nevirapin i kombination med adskillige andre NNRTIlægemidler.
Time to emergence of nevirapine resistance in cell culture was not altered when selection included nevirapine in combination with several other NNRTIs.
Det skal du vide, før du begynder at tage Viramune
What you need to know before you take Viramune