natgillin/translations-raw huggingface dataset:
Dato for første markedsføringstilladelse: 5. februar 1998
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 February 1998
Overfølsomhed (inkl.
Hypersensitivity (incl.
Disse patienter må ikke genstartes på nevirapin.
In these patients nevirapine must not be restarted.
3 (6,3 % versus 1,2 % for mænd med CD4-celletal < 400 celler/mm
3 (6.3 % versus 1.2 % for men with CD4 counts <400 cells/mm
Nevirapin: eksponering: 100% sammenlignet med historiske data, hvor nevirapin blev administreret alene.
Nevirapine: exposure: 100% compared with historical data where nevirapine was administered alone.
Den samlede procentdel af behandlingsrespondenter set i studie 1100.1486 (herunder optrapningsfasen) uanset formulering, er 793/1.068 = 74,3 %.
The overall percentage of treatment responders observed in study 1100.1486 (including lead-in phase), regardless of the formulation is 793/1,068 = 74.3%.
Nevirapin havde ingen antiviral aktivitet i cellekulturer mod isolater fra gruppe O hiv-1 eller hiv-2.
Nevirapine had no antiviral activity in cell culture against group O HIV-1 isolates or HIV-2 isolates.
Triglycerider (mg/dl) * Ændring hos den enkelte patient fra baseline til uge 48-værdier og er ikke blot en simpel forskel mellem henholdsvis de gennemsnitlige baselineværdier og uge 48-værdierne.
Triglycerides (mg/dL) * Percent change is the median of within-patient changes from baseline for patients with both baseline and week 48 values and is not a simple difference of the baseline and week 48 mean values, respectively.
LÆGEMIDDELFORM Oral suspension.
PHARMACEUTICAL FORM Oral suspension
Det primære endepunkt var død, progression af det erhvervede immundefektsyndrom eller en stigning i hiv-1-RNA niveau til 200 kopier eller mere pr. ml.
The primary study endpoint was death, progression to the acquired immunodeficiency syndrome, or an increase in HIV-1 RNA levels to 200 copies or more per millilitre.
SKAL DU STRAKS STOPPE MED AT TAGE VIRAMUNE OG STRAKS KONTAKTE din læge, da sådanne bivirkninger kan være livstruende eller medføre døden.
YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
Når man tager alle doser på det rigtige tidspunkt, - så øger det i høj grad effekten af kombinationsbehandlingen - mindsker det risikoen for at hiv-infektionen bliver resistent over for den antiretrovirale behandling.
Taking all doses at the appropriate times: - greatly increases the effectiveness of your combination antiretroviral medicines - reduces the chances of your HIV infection becoming resistant to your antiretroviral medicines.
Ellers kræver patienter med CLcr ≥ 20 ml/min ikke justering i nevirapindoseringen.
Otherwise patients with CLcr  20 ml/min do not require an adjustment in nevirapine dosing.
3 og 197 celler/mm
3 and 197 cells/mm
Medianalderen var 34 år og omkring 64 % af patienterne var mænd, median CD4-celletallet var 170 og 190 celler pr mm
Median age was 34 years and about 64 % were male patients, median CD4 cell count was 170 and 190 cells per mm
Derfor vil co-administration sandsynligvis resultere i ændrede plasmakoncentrationer af Viramune og cobicistat.
Therefore coadministration would likely result in altered plasma levels of cobicistat and Viramune.
Der er ikke foretaget specifikke undersøgelser af virkningen på evnen til at føre motorkøretøjer og betjene maskiner.
There are no specific studies about the ability to drive vehicles and use machinery.
Som ved symptomer på udslæt, bør du her informere din læge om enhver bivirkning.
As with rash symptoms, please inform your doctor of any side effects.
Fertilitet I reproduktionstoksikologiske studier fandt man evidens for nedsat fertilitet hos rotter.
Fertility In reproductive toxicology studies, evidence of impaired fertility was seen in rats.
Hver flaske indeholder 240 ml oral suspension.
Each bottle contains 240 ml of oral suspension.
Nevirapin er ca. 60 % bundet til plasmaproteiner i plasmakoncentrationsområdet 1-10 g/ml.
Nevirapine is about 60 % bound to plasma proteins in the plasma concentration range of 1-10 µg/ml.
Nevirapinfarmakokinetikken hos hiv-1 smittede voksne synes ikke at ændre sig med alderen (indenfor 19-68 år) eller race (farvede, latinamerikanere eller hvide).
Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
Den observerede farmakokinetiske forskel mellem Viramune depottabletterne på henholdsvis 50 mg og 100 mg er ikke klinisk relevant, og 50-mg-depottabletten kan anvendes, som et alternativ til den lidt større 100 mg tablet.
The observed pharmacokinetic difference between the 50 mg and 100 mg Viramune prolonged-release tablets is not clinically relevant, and the 50 mg prolonged-release tablet can be used as an alternative to the slightly larger 100 mg tablet.
Hud og subkutant væv
Skin and subcutaneous tissues
Krydsresistens mellem nevirapin og enten hiv-proteasehæmmere, hivintegrasehæmmere eller hiv-entryhæmmere er usandsynlig, fordi de involverede enzymmål er forskellige.
Cross-resistance between nevirapine and either HIV protease inhibitors, HIV integrase inhibitors or HIV entry inhibitors is unlikely because the enzyme targets involved are different.
Telaprevir metaboliseres i leveren af CYP3A og er et P-glykoprotein substrat.
Telaprevir is metabolised in the liver by CYP3A and is a P-glycoprotein substrate.
Viramune dosering skal muligvis justeres.
The dose of Viramune may need adjusting.
Optrapningsperioden er ikke nødvendig, hvis patienten allerede er i kronisk behandling med Viramune 200 mg tabletter eller Viramune oral suspension to gange dagligt.
The lead-in period is not required if the patient is already on chronic Viramune 200 mg tablets or Viramune oral suspension twice daily treatment.
Fortæl lægen om al anden medicin, du tager, før du begynder at tage Viramune.
Inform your doctor about all other medicines you are taking before you start taking Viramune.
Du kan blive træt, når du tager Viramune.
You may experience fatigue when taking Viramune.
De første 18 uger af behandlingen er en kritisk periode, som kræver nøje overvågning.
The first 18 weeks of treatment is a critical period which requires close monitoring.
For lipider er der i visse tilfælde fundet evidens for en behandlingsrelateret effekt, mens der ikke er tydelig evidens for relation mellem vægtøgning og en specifik behandling.
For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Viramune oral suspension bør bruges inden 6 måneder efter åbning af flasken.
Viramune oral suspension should be used within 6 months after first opening of the bottle.
Hvid high density polyethylene (HDPE) flaske med todelt børnesikringslåg (ydre skal hvid high density polyethylene, inderskal naturel polypropylen) med low density polyethylene (LDPE) skumforing.
White high density polyethylene (HDPE) bottle with two piece child-resistant closure (outer shell white high density polyethylene, inner shell natural polypropylene) with a low density polyethylene (LDPE) foam liner.
Nevirapins farmakokinetik hos hiv-1-inficerede voksne synes ikke at ændres med alderen (i intervallet 18-68 år).
Nevirapine pharmacokinetics in HIV-1 infected adults does not appear to change with age (range 1868 years).
Sikkerhedsdata omfattede alle patientbesøg indtil det tidspunkt, hvor den sidste patient fuldførte 144 uger i studiet.
Safety data included all the patient visits up to the point in time when the last patient completed 144 weeks in the trial.
5 ml indeholder 50 mg af det aktive stof nevirapin (som hemihydrate).
Each 5 ml contains 50 mg of the active substance nevirapine (as hemihydrate).
Nevirapin: Co-administration af ritonavir giver ingen klinisk relevante ændringer i plasmakoncentrationen af nevirapin.
Nevirapine: Co-administration of ritonavir does not lead to any clinically relevant change in nevirapine plasma levels.
Viramune kan også fås som 200 mg tabletter til ældre børn og voksne.
Viramune is also supplied as 200 mg tablets for older children and adults.
- Europa
- Europe
Både det primære endepunkt (procent af patienter med behandlingssvigt) og det sekundære endepunkt såvel som grundbehandlingen var de samme, som i det oprindelige 2NN studie.
Primary study endpoints (percentage of patients with treatment failures) and secondary study endpoints as well as backbone therapy were similar to the original 2NN study.
Formålet med markeringslinjen er ikke at kunne brække tabletten over.
The score line is not intended for breaking the tablet.
Asymptomatiske GGT- elevationer er ikke en kontraindikation for fortsættelse af behandling.
Asymptomatic GGT elevations are not a contraindication to continue therapy.
Ændring i procentpoint n = 419
Percent change n=419
Nevirapinkoncentrationen i human cerebrospinalvæske (n=6) er 45 % (±5 %) af koncentrationen i plasma; denne ratio er tilnærmelsesvis lig med fraktionen, som ikke er bundet til plasmaprotein.
Nevirapine concentrations in human cerebrospinal fluid (n = 6) were 45 % ( 5 %) of the concentrations in plasma; this ratio is approximately equal to the fraction not bound to plasma protein.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 240 ml oral suspension
PHARMACEUTICAL FORM AND CONTENTS 240 ml oral suspension
Der sås en klinisk ikke relevant stigning i clearance af nevirapin (med 9%) sammenlignet med historiske farmakokinetiske data.
A clinically not relevant increase in the apparent clearance of nevirapine (by 9%) compared to historical data was reported.
Til børn
For children
Nevirapin er ikke specifikt blevet undersøgt hos patienter over 65 år.
Nevirapine has not been specifically investigated in patients over the age of 65.
Seks tilfælde af Stevens-Johnsons syndrom blev indberettet; alle, undtagen ét, indtraf inden for de første 30 dage af nevirapinbehandlingen.
Six cases of Stevens-Johnson Syndrome were reported in the study; all but one occurred within the first 30 days of nevirapine treatment.
Patienter udgået af behandlingen under optrapningsperioden, er ikke inkluderet.
Patients who discontinued treatment during the lead-in period are excluded.
Randomiseringen var stratificeret efter niveauet af hiv-1-rna ved screening (≤ 100.000 kopier/ml og > 100.000 kopier/ml).
Randomisation was stratified by screening HIV-1 RNA level (<100,000 copies/ml and >100,000 copies/ml).
De estimerede frekvenser er baseret på poolede data fra de kliniske studier og omfatter hændelser, der er vurderet til at være relateret til Viramune behandling.
The frequencies estimated are based on pooled clinical study data for adverse reactions considered related to Viramune treatment.
Den kliniske betydning af denne observerede reduktion af troughkoncentrationen af boceprevir er ikke blevet direkte vurderet.
The clinical outcome of this observed reduction of boceprevir trough concentrations has not been directly assessed.
Asymptomatiske elevationer af leverenzymer beskrives ofte og er ikke en nødvendigvis en kontraindikation ved brugen af nevirapin.
Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a contraindication to use nevirapine.
Følg altid den anvisning, som barnets læge har givet.
Always follow the exact instructions given by your child's doctor.
Den almindeligste kliniske toksicitet ved nevirapin er udslæt.
The most common clinical toxicity of nevirapine is rash.
Æsker indeholdende 2 blisterark (14 tabletter).
Cartons containing 2 blister cards (14 tablets).
Ændring i procentpoint n = 406
Percent change n=406
Dosisjustering for Viramune er ikke påkrævet når der coadministreres med lopinavir.
Dose adjustment of Viramune is not required when co-administered with lopinavir.
Viramune oral suspension er en hvid til råhvid homogen suspension.
Viramune oral suspension is a white to off-white homogenous suspension.
Hvis Viramune er ordineret til dit barn, så bemærk, at denne information er beregnet til dit barn, og du skal erstatte ”du” med ”dit barn”.
If Viramune has been prescribed for your child, please note that all information in this leaflet is addressed to your child (please read “your child” instead of “you”).
Viramune kan også fås som oral suspension
Viramune is also available as an oral suspension.
ANTI-INFEKTIVA ANTIVIRALE LÆGEMIDLER NRTIs
ANTI-INFECTIVES ANTIRETROVIRALS NRTIs
Patienter skal monitoreres tæt, hvis et isoleret tilfælde af udslæt opstår.
Patients should be closely monitored if an isolated rash occurs.
Kvinder synes at have en større risiko end mænd for udvikling af udslæt, hvad enten de får behandling indeholdende nevirapin eller ej.
Women appear to be at higher risk than men of developing rash, whether receiving nevirapine or nonnevirapine containing therapy.
I dette 48-ugers studie var der ingen uventede bivirkninger i nogen af doseringsgrupperne.
In this 48week study no unexpected safety findings were observed in either dosing group.
Unormale leverfunktionstests har været rapporteret med nevirapin, nogle i de første få uger af behandlingen.
Abnormal liver function tests have been reported with nevirapine, some in the first few weeks of therapy.
Følgende bivirkninger er blevet identificeret i andre nevirapin undersøgelser eller ved postmarketing overvågning, men er ikke observeret i det randomiserede, kontrollerede kliniske studie 1100.1486.
The following adverse reactions were identified in other nevirapine studies or by post-marketing surveillance but not observed in the randomised, controlled clinical study 1100.1486.
Nogle patienter har rapporteret om, at der i fæces kan forekomme rester, der ligner hele tabletter.
Some patients have reported the occurrence of remnants in faeces which may resemble intact tablets.
På grund af risikoen for forøget eksponering af Viramune, bør der udvises forsigtighed, hvis produkterne gives samtidigt, og patienterne bør monitoreres nøje.
Because of the risk of increased exposure to Viramune, caution should be exercised if the medicinal products are given concomitantly and patients should be monitored closely.
Cimetidin: Ingen signifikant virkning på cimetidin PK parametre er observeret.
Cimetidine: no significant effect on cimetidine PK parameters is seen.
Afhængig af resultater fra resistenstestning kan et regime med bl.a. etravirine formenligt anvendes.
Depending on resistance testing results, an etravirine-containing regimen may be used subsequently.
De fleste tilfælde af både alvorligt hududslæt og mildt/moderat hududslæt opstår i de første 6 uger af behandlingen.
Most of the cases of both severe rash and mild/moderate rash occur in the first six weeks of treatment.
LISTE OVER HJÆLPESTOFFER Hjælpestoffer: Indeholder lactose (se indlægssedlen for mere information)
LIST OF EXCIPIENTS Excipients: includes lactose (see leaflet for further information)
Alle patienter fik desuden tenofovir + emtricitabin.
All patients received tenofovir + emtricitabine as background therapy.
Pædiatrisk population Børn på tre år og derover samt unge
Paediatric population Children three years and older and adolescents
En flaske indeholder 2,4 g nevirapin (som hemihydrat) i 240 ml Viramune oral suspension.
Each bottle contains 2.4 g of nevirapine (as hemihydrate) in 240 ml of Viramune oral suspension.
Undgå at springe en dosis over.
Try not to miss a dose.
Den modsatte side er markeret med firmalogo.
The opposite side is marked with the company symbol.
Nevirapin: Sammenlignet med historiske kontroller, var plasmakoncentrationen tilsyneladende uændret.
Nevirapine: compared to historical controls, levels appeared to be unchanged.
Forskellen i nevirapins farmakokinetik, når Viramune depottabletter indgives fastende over for ikke-fastende, betragtes ikke som klinisk relevant.
The difference in nevirapine pharmacokinetics observed when Viramune prolonged-release tablets are dosed under fasted or fed conditions is not considered clinically relevant.
Den ene side er præget med koden ”54 193”, med en markeringslinje mellem ”54” og ”193”.
One side is marked with the code “54 193”, with a single bisect separating the “54” and “193”.
En dosisøgning af itraconazol bør overvejes når disse to stoffer anvendes sammen.
A dose increase for itraconazole should be considered when these two agents are administered concomitantly.
I abacavirgruppen var forekomsten af hændelser signifikant lavere (61 patienter, eller 41 %) end i nevirapingruppen (83 patienter, eller 54 %) og i efavirenzgruppen (89 patienter, eller 57 %).
The overall incidence of adverse events was significantly lower (61 patients, or 41 %) in the abacavir group than in the nevirapine group (83 patients, or 54 %) or the efavirenz group (89 patients, or 57 %).
Virologisk responder (hiv-1-rna < 50 kopier/ml)
Virologic responder (HIV-1 RNA <50 copies/ml)
Kontakt lægen eller apotekspersonalet, før du tager Viramune.
Talk to your doctor or pharmacist before taking Viramune.
Udslæt (12,5 %)
Very common rash (12.5 %)
I et panel med 2.923 altovervejende undergruppe B hiv-1 kliniske isolater var den gennemsnitlige EC50værdi 90 nM.
In a panel of 2,923 predominantly subtype B HIV-1 clinical isolates, the mean EC50 value was 90nM.
Hiv-1-isolater med reduceret følsomhed (100-250 gange) over for nevirapin forekommer i cellekultur.
HIV-1 isolates with reduced susceptibility (100-250-fold) to nevirapine emerge in cell culture.
Genotypiske analyser viste mutationer i hiv-1 RT-genet Y181C og/eller i genet V106A afhængigt af virusstammen og af selve cellelinjen.
Genotypic analysis showed mutations in the HIV-1 RT gene Y181C and/or V106A depending upon the virus strain and cell line employed.
Forsigtighed bør udvises ved ordinering af nevirapin til gravide kvinder (se pkt.
Caution should be exercised when prescribing nevirapine to pregnant women (see section 4.4).
Valg af anden behandling efter ophør af Viramune bør baseres på klinisk erfaring og test af resistens (se pkt.
The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Viramune tabletter er i blisterpakninger med 14, 60 eller 120 tabletter i hver æske.
Viramune tablets are supplied in blisters, with 14, 60 or 120 tablets per carton.
Den inducerede virkning kan fortsætte i mindst 2 uger efter ophør af behandling med perikon.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St. John‘s Wort.
Døgndosis bør ikke overskride 400 mg for nogen patient.
The total daily dose should not exceed 400 mg for any patient.
Produktet bør bruges inden 6 måneder efter åbning.
The medicinal product should be used within 6 months of opening.
Nevirapin: Der var ingen signifikant forskel i nevirapins farmakokinetiske parametre.
Nevirapine: there was no significant difference in nevirapine pharmacokinetic parameters.
Prospektivt blev indsamlet data om potentielle symptomer på hepatiske hændelser.
Data on potential symptoms of hepatic events were prospectively collected in this study.
Nevirapin er lipofilt og er essentielt ikke-ioniseret ved fysiologisk pH.
Distribution: Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
Nevirapin inducerer CYP3A og potentielt CYP2B6 med maksimal induktion indenfor 2-4 uger efter flerdosis behandling er startet.
Nevirapine is an inducer of CYP3A and potentially CYP2B6, with maximal induction occurring within 2-4 weeks of initiating multiple-dose therapy.
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Patienter bør underrettes om, at en alvorlig toksicitet ved nevirapin er udslæt.
Patients should be instructed that a major toxicity of nevirapine is rash.
Til pædiatriske patienter på 3 år og ældre fås 100-mg-depottabletter.
For paediatric patients aged 3 years and older, 100 mg prolonged-release tablets are available.
Itraconazol AUC  0,39 Itraconazol Cmin  0,13
Itraconazole AUC  0.39 Itraconazole Cmin  0.13
3, som har detekterbar hiv-1-rna i plasma, medmindre fordelene opvejer risiciene.
3, who have a detectable plasma HIV-1 RNA unless the benefit outweighs the risk.
ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC {nummer} [produktkode]
PC {number} [product code]
Der er størst risiko for sådanne reaktioner i de første 6 uger af behandlingen.
You are at greatest risk of such a reaction during the first 6 weeks of treatment.
Analysen af disse prøver fra patienter, der fik Viramune 200 mg tabletter to gange dagligt eller Viramune depottabletter én gang dagligt i kombination med tenofovir og emtricitabin, viste, at isolater fra 50 patienter indeholdt resistensmutationer forventeligt fra et nevirapin-baseret regime.
The analysis of these samples of patients receiving Viramune immediate-release twice daily or Viramune prolonged-release once daily in combination with tenofovir and emtricitabine showed that isolates from 50 patients contained resistance mutations expected with a nevirapine-based regimen.
Itraconazol Cmax  0,62
Itraconazole Cmax  0.62
Ketoconazol og erytromycin hæmmer signifikant dannelsen af hydroxylerede metabolitter af nevirapin.
Ketoconazole and erythromycin significantly inhibited the formation of nevirapine hydroxylated metabolites.
Generelt anbefales det ikke at amme, da hivinfektionen kan overføres til barnet via brystmælken.
It is in general recommended that you do not breast-feed if you have HIV infection because it is possible that your baby can become infected with HIV through your breast milk.
Kombination af andre antiretrovirale lægemidler med enkelt dosis nevirapin sænker forekomsten af nevirapinresistens.
Combination of other antiretrovirals with single-dose nevirapine attenuates the emergence of nevirapine resistance.
Tag ikke Viramune hvis du er allergisk over for nevirapin eller et af de øvrige indholdsstoffer i Viramune (angivet i punkt 6).
Do not take Viramune - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in section
Viramune oral suspension er en flydende suspension, der skal indtages gennem munden.
Viramune oral suspension is in a liquid suspension form and should only be taken by mouth.
Der blev ikke rapporteret nogle livstruende (grad 4) udslæt relateret til Viramune under randomiseringsfasen.. Seks tilfælde af Stevens-Johnsons syndrom blev indberettet; alle, undtagen ét, indtraf inden for de første 30 dage af nevirapinbehandlingen.
No life-threatening (Grade 4) rash events considered related to Viramune were reported during the randomised phase of this study.Six cases of Stevens-Johnson Syndrome were reported in the study; all but one occurred within the first 30 days of nevirapine treatment.
Det er ikke vist, at Viramune forårsager forstyrrelser i blodglucose.
In addition, Viramune has not been shown to cause glucose disturbances.
En reduktion af røde blodlegemer (anæmi), der kan være relateret til behandling med nevirapin, forekommer også hyppigere hos børn.
A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children.
Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Sorbitol
Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Sorbitol
Sørg for at få klar besked af lægen om, hvilken dosis du skal give dit barn.
Make sure that your child's doctor clearly tells you what dose you must give to your child.
Alle patienter yngre end 16 år, som tager Viramune oral suspension, bør kontrolvejes eller have kontrolleret deres legemsoverfladeareal regelmæssigt for at vurdere om dosisjustering er nødvendig.
All patients less than 16 years of age receiving Viramune oral suspension should have their weight or BSA checked frequently to assess if dose adjustments are necessary.
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.