natgillin/translations-raw huggingface dataset:
6.6 Regler for bortskaffelse og anden håndtering Vejledning for administration: 
6.6 Special precautions for disposal and other handling Instructions for administration:
Fik seponeret lægemidlet før uge 48 
Discontinued medicinal product prior to week 48
Køn - Mænd - Kvinder 
Gender - Male - Female
Lactose (som monohydrat) 
Lactose (as monohydrate)
Overfølsomhedsreaktioner (allergiske) kan forekomme. 
Hypersensitivity (allergic) reactions can occur.
Interferoner (pegyleret interferon alfa 2a og alfa 2b) 
Interferons (pegylated interferons alfa 2a and alfa 2b)
Det er derfor en vigtig periode, hvor det kræves, at du følges nøje af din læge. 
This is therefore an important period which requires close monitoring by your doctor.
Viramune oral suspension kan tages af børn i alle aldre. 
Viramune oral suspension can be taken by children of all age groups.
Hidtil har tilgængelige data ikke vist, at dette påvirker det terapeutiske respons. 
Based on the data available so far, this has not been shown to affect the therapeutic response.
Sådanne reaktioner kan blive alvorlige og endog livstruende. 
These can become severe and even life threatening.
Kontakt din læge, hvis du opdager ændringer i kropsfedt (se under punkt 4 ”Bivirkninger”). 
Contact your doctor if you notice changes in body fat (see section 4 “Possible side effects”).
Hvis der er bevis for forværring af leversygdom hos disse patienter bør afbrydelse af eller ophør med behandlingen overvejes. 
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Interaktion er ikke undersøgt. 
Interaction has not been studied.
Utallige studier er udført for at undersøge brugen af Viramune i forhold til perinatal transmission, især HIVNET 012. 
Numerous studies have been performed examining the use of Viramune in regards to perinatal transmission, most notably HIVNET 012.
Omhyggelig monitorering af pædiatriske patienter er specielt berettiget, særligt i de første 18 uger af behandlingen, da disse patienter formodentlig i mindre grad end voksne bemærker eller rapporterer hudreaktioner. 
Careful monitoring of paediatric patients is especially warranted, particularly in the first 18 weeks of treatment, since these patients may be less likely than adults to notice, or report, skin reactions.
Vend flasken på hovedet og udtag forsigtigt den nødvendige mængde Viramune oral suspension. 
Turn the bottle upside down and gently draw out the required amount of Viramune oral suspension.
Der er på nuværende tidspunkt kun få oplysninger om virkningerne af Viramune ved overdosering. 
There is at present little information on the effects of Viramune overdose.
ANTIVIRALE MIDLER TIL KRONISK HEPATITIS B OG C Adefovir 
ANTIVIRALS FOR CHRONIC HEPATITIS B AND C Adefovir
Mere end 80 % af radioaktiviteten i urinen består af glucuronid konjugater af hydroxylerede metabolitter. 
Greater than 80 % of the radioactivity in urine was made up of glucuronide conjugates of hydroxylated metabolites.
Der var ingen signifikante forskelle i demografiske og baseline karakteristika mellem behandlingsgrupperne. 
There were no significant differences in demographic and baseline characteristics between the treatment groups.
Det er vigtigt, at hele den opmålte mængde Viramune oral suspension indtages. 
It is important that the entire measured dose of Viramune oral suspension is administered.
Desuden var begge doseringsregimer effektive til at nedsætte det viral belastning. 
Also, both dosing regimens were effective in reducing the viral load.
Brugen af Viramune er ikke blevet evalueret ved et specifikt studie på PEP, specielt med henblik på behandlingsvarighed, og frarådes derfor kraftigt. 
The use of Viramune has not been evaluated within a specific study on PEP, especially in term of treatment duration and therefore, is strongly discouraged.
De kvindelige patienter viste en 13,8 % lavere clearance af nevirapin end de mandlige patienter. 
Female patients showed a 13.8 % lower clearance of nevirapine than did male patients.
Den kliniske relevans af disse data i den europæiske population er ikke klarlagt. 
The clinical relevance of these data in European populations has not been established.
Interferoner har ingen kendt effekt på CYP3A4 eller 2B6. 
Interferons have no known effect on CYP 3A4 or 2B6.
Lægemidler efter terapeutiske områder 
Medicinal products by therapeutic areas
Den anbefalede orale dosis til pædiatriske patienter baseret på deres vægt fremgår af tabellen nedenfor. 
The recommended oral doses for paediatric patients based upon their weight are described in the table below.
Revers transkriptase er et enzym, som hiv har brug for for at kunne formere sig. 
Reverse transcriptase is an enzyme that HIV needs in order to multiply.
Den anbefalede vægtbaserede pædiatriske dosis afhænger af patientens alder, idet de anbefalede doser til børn fra 3 til < 8 år og børn på 8 år eller derover er forskellige. 
The recommended weight-based paediatric dose is dependent upon the patient's age, with different recommended doses for children from 3 to < 8 years of age and children 8 years or older.
Samlet set var incidensen af symptomatiske hepatiske hændelser blandt mænd og kvinder, der var inkluderet i VERxVE, ens. 
Overall, there was a comparable incidence of symptomatic hepatic events among men and women enrolled in VERxVE.
Der var også akkumulering af nevirapin-hydroxy-metabolitter i plasma. 
There was also accumulation of nevirapine hydroxy-metabolites in plasma.
Ændringer af fordelingen af kropsfedt kan forekomme hos patienter, som modtager antiretroviral kombinationsbehandling. 
Changes of body fat may occur in patients receiving combination antiretroviral therapy.
Da Viramune altid skal tages sammen med andre hiv-antiretrovirale lægemidler, bør du nøje følge instruktionerne for de andre lægemidler. 
As Viramune must always be taken together with other HIV antiretroviral medicines, you should follow the instructions for your other medicines carefully.
• har et legemsoverfladeareal på 1,17 m2 eller højere i henhold til Mosteller-formlen 
• have a body surface area of 1.17 m2 or above according to the Mosteller formula.
Inkluderet i 1.068 er 55 patienter, der stoppede behandlingen i optrapningsfasen, og to randomiserede patienter, som aldrig blev behandlet med randomiseringsdosen. 
The denominator 1,068 includes 55 patients who stopped treatment during the lead in phase and two patients randomized but never treated with randomized dose.
Vær sikker på, at adaptoren sidder godt fast. 
Make sure that the adapter is fitted tightly.
Sæt sprøjten i adaptoren. 
Insert the syringe into the adapter.
Natriumhydroxid ( til pH justering) Renset vand 
Sodium hydroxide (for pH-adjustment) Purified water
Maksimum volumen, som kan afmåles med dispenseringssprøjten, er 5 ml og derfor skal trin 3-5 gentages ved dosisvolumen på mere end 5 ml. 
The maximum volume which can be measured with the dispensing syringe is 5 ml and therefore steps 3-5 must be repeated for dose volumes greater than 5 ml.
Da regimet med nevirapin og efavirenz ikke viste yderligere effekt og forårsagede flere bivirkninger end hvert lægemiddel for sig, kan dette regime ikke anbefales. 
As the regimen of nevirapine plus efavirenz did not have additional efficacy and caused more adverse events than each medicinal product separately, this regimen is not recommended.
Lipider, ændring i forhold til baseline Ændringer i fastende lipider i forhold til baseline, er vist i tabel 4. 
Lipids, Change from baseline Changes from baseline in fasting lipids are shown in Table 4.
ANALGETIKA/OPIOIDER Methadon individuel dosering 
ANALGESICS/OPIOIDS Methadone Individual Patient Dosing
Af disse 50 patienter udviklede 28 resistens over for efavirenz, og 39 udviklede resistens over for etravirin (den hyppigst opståede resistensmutation var Y181C). 
Of these 50 patients, 28 developed resistance to efavirenz and 39 developed resistance to etravirine (the most frequently emergent resistance mutation being Y181C).
Plasmakoncentrationen af nevirapin var inden for det område, som er set hos voksne og den resterende pædiatriske population, men var mere variable i mellem patienterne, især dem på to måneder. 
The plasma nevirapine concentrations observed were within the range observed in adults and the remainder of the paediatric population, but were more variable between patients, particularly in the second month of age.
Hepatorenale syndromer har i sjældne tilfælde været rapporteret. 
Hepatic-renal failure syndromes have been reported rarely.
Efter intravenøs administration hos raske voksne er fordelingsvolumen (Vdss) af nevirapin 1,21±0,09 l/kg, hvilket indikerer, at nevirapin fordeler sig bredt hos mennesket. 
Following intravenous administration to healthy adults, the volume of distribution (Vdss) of nevirapine was 1.21  0.09 l/kg, suggesting that nevirapine is widely distributed in humans.
- Ikke-B 
- B - Non-B
** Omfatter patienter tabt for opfølgning, som har trukket deres samtykke tilbage, som ikke er compliant, som har mangel på effekt, som er gravide og andet. 
** Includes lost to follow-up, consent withdrawn, noncompliance, lack of efficacy, pregnancy, and other.
Den geometriske middelværdi for nevirapin Cmin,ss var 2.770 ng/ml. 
The geometric mean nevirapine Cmin,ss was 2,770 ng/ml.
Asymptomatisk forhøjet GGT-niveau er hyppigst. 
Asymptomatic elevations of GGT levels are the most frequent.
I tilfælde af samtidig antiviral behandling for hepatitis B eller C vær venlig også at se efter i den relevante produktinformation for disse lægemidler. 
In the case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
I de første 18 uger, hvor du er i behandling med Viramune, er det meget vigtigt, at du og din læge holder øje med, om der er tegn på leverskader eller hududslæt. 
During the first 18 weeks of treatment with Viramune it is very important that you and your doctor watch out for signs of liver or skin reactions.
Det anbefales, at hiv-smittede mødre ikke ammer deres børn for at undgå risiko for postnatal overførsel af hiv og at mødre bør afbryde amningen, hvis de behandles med nevirapin. 
It is recommended that HIV-infected mothers do not breast-feed their infants to avoid risking postnatal transmission of HIV and that mothers should discontinue breast-feeding if they are receiving nevirapine.
Nedsat phosphat i blodet og forhøjet blodtryk blev observeret i de kliniske studier med coadministration af tenofovir/emtricitabin. 
Decreased blood phosphorus and increased blood pressure were observed in clinical studies with coadministration of tenofovir/emtricitabine.
I studie 1100.1526 (TRANxITION) blev der ikke set kliniske hepatiske hændelser af grad 3 eller 4 i nogen af de to behandlingsgrupper. 
In study 1100.1526 (TRANxITION) no Grade 3 or 4 clinical hepatic events were observed in either treatment group.
Total kolesterol/HDL 
Total cholesterol/HDL
Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jirovecii-pneumoni. 
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Hvis din læge har fortalt dig, at du (eller dit barn) ikke tåler visse sukkerarter eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med din læge før du (eller dit barn) tager eller får dette lægemiddel. 
If your doctor has told you that you (or your child) have an intolerance to some sugars or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Ingen kliniske data er tilgængelige. 
No clinical data available.
I nogle tilfælde er leverbeskadigelse blevet forværret på trods af behandlingsstop. 
In some cases, hepatic injury has progressed despite discontinuation of treatment.
- eller har et legemsoverfladeareal på over 1,25 m². 
- or have a body surface area above 1.25 square metres.
Tag ikke mere Viramune, end lægen har foreskrevet, og som er beskrevet i denne indlægsseddel. 
Do not take more Viramune than prescribed by your doctor and described in this leaflet.
Hepatiske reaktioner 
Hepatic reactions
ANTITHROMBOTIKA Warfarin 
ANTITHROMBOTICS Warfarin
Den nødvendige dosisvolumen bør afmåles med den medfølgende dispenseringssprøjte og adaptor som beskrevet i trin 1-5 nedenfor. 
The required dose volumes should be measured employing the enclosed dispensing syringe and adapter, as described in steps 1-5 below.
De patienter i 2NN studiet, som ved studiets afslutning i uge 48 stadig blev behandlet i kliniken og var i aktiv behandling, blev tilbudt at deltage i dette studie. 
Patients who participated in the 2NN study and were still under active follow-up at week 48 when the study closed and were still being treated at the study clinic, were asked to participate in this study.
Årsagen er, at Viramune i en vis udstrækning kan fjernes fra blodet under dialysen. 
This is because Viramune can be partly washed out of your blood by dialysis.
De observerede mutationer var forventelige ved et nevirapin-baseret regime. 
The observed mutations at failure were those expected with a nevirapine-based regimen.
Alle voksne skal have samme dosis (20 ml). 
The usual dose is the same for all adults (20 ml).
Boceprevir metaboliseres delvist af CYP3A4/5. 
Boceprevir is partly metabolized by CYP3A4/5.
En afmålingssprøjte af plastik medfølger til afmåling af den korrekte dosis. 
A plastic measuring syringe is included for measuring the correct dose.
Non-kliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser samt genotoksicitet. 
Non-clinical data reveal no special hazard for humans other than those observed in clinical studies based on conventional studies of safety, pharmacology, repeated dose toxicity, and genotoxicity.
Klar low density polyethylen flaskesprøjte adaptor. 
Clear low density polyethylene bottle-syringe adapter.
Det kan ligne hele depottabletter, men det anses ikke for at påvirke virkningen af nevirapin. 
These may look like whole tablets, but have not been found to affect the efficacy of nevirapine.
Det er især vigtigt i den første 14 dages periode (se flere informationer under Sådan skal du tage Viramune.) 
This is especially important within the first 14 days of treatment (see more information in “How to take Viramune”).
Dette lægemiddel kan som alle andre lægemidler, give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP. 
The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing authorisation and any agreed subsequent updates of the RMP.
Viramune tabletter kan tages: - af unge på 16 år eller ældre - unge under 16 år, som 
Viramune tablets can be taken by: - children 16 years of age or older - children under 16 years of age who:
De skal anbefales at informere deres læge straks angående enhver form for udslæt og undgå forsinkelse mellem de første symptomer og lægekonsultation. 
They should be advised to promptly notify their physician of any rash and avoid delay between the initial symptoms and medical consultation.
Cytokrom P450- metabolismen, glucuronide konjugater og den urinære ekskretion af glucuronide metabolitter repræsenterer således den primære rute for nevirapins biotransformation og elimination hos mennesket. 
Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans.
Hovedparten af alvorlige udslæt opstod indenfor de første 6 ugers behandling, hvoraf nogle krævede hospitalsindlæggelse og en enkelt patient krævede kirurgisk intervention (se pkt. 
The majority of severe rashes occurred within the first 6 weeks of treatment and some required hospitalisation, with one patient requiring surgical intervention (see section 4.4).
Hvid til næsten hvid homogen suspension. 
White to off-white homogenous suspension.
Børn under 3 år 
Children less than three years old
Hyppighed er defineret i henhold til følgende konvention: Meget almindelig (1/10), Almindelig (1/100 til, <1/10), Ikke almindelig (1/1.000 til, 1/100), Sjælden (1/10.000 til, 1/1.000), Meget sjælden (1/10.000). 
Frequency is defined using the following convention: very common (1/10); common (1/100 to <1/10); uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000).
* Omfatter 2 randomiserede patienter, som aldrig fik blindet lægemiddel. 
* Includes 2 patients who were randomised but never received blinded medicinal products.
Når der kommer et hududslæt, er det normalt mildt til moderat. 
When rash occurs it is normally mild to moderate.
Patienter med heriditær fructoseintolerans (HFI) bør ikke tage/få dette lægemiddel. 
Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.
KONTRACEPTIVA Depomedroxyprogesteron acetat (DMPA) 150 mg hver 3. måned 
CONTRACEPTIVES Depomedroxyprogesterone acetate (DMPA) 150 mg every 3 months
INTEGRASEHÆMMERE Elvitegravir/ cobicistat 
INTEGRASE INHIBITORS Elvitegravir/ cobicistat
Den indtagne dosis var 40 gange større end den anbefalede dosis på 2 mg/kg/dag. 
The ingested dose was 40 times the recommended dose of 2 mg/kg/day.
Patienterne skal søge lægehjælp omgående, hvis ovenstående opstår. 
Patients should be instructed to seek medical attention promptly if these occur.
De data der er tilgængelige for gravide tyder ikke på misdannelser eller føtal/neonatal toksicitet. 
Currently available data on pregnant women indicate no malformative or foeto/ neonatal toxicity.
I kliniske studier er Viramune blevet forbundet med en stigning i HDL-kolesterol og en overordnet forbedring af forholdet mellem total-kolesterol og HDL-kolesterol. 
In clinical studies, Viramune has been associated with an increase in HDL- cholesterol and an overall improvement in the total to HDL-cholesterol ratio.
Fortæl alligevel din læge, hvis du finder rester af depottabletter i din afføring. 
Inform your doctor if you find tablet pieces in your faeces.
Patienter med hepatisk dysfunktion bør monitoreres nøje med henblik på lægemiddel induceret toksicitet. 
Patients with hepatic impairment should be monitored carefully for evidence of medicinal product induced toxicity.
Viramune fås også som depottabletter i lavere styrker (til børn på 3 år og derover efter optrapningsperioden) eller som en oral suspension (til alle aldersgrupper). 
Viramune is also available as smaller prolonged-release tablets (for children 3 years of age and above after the lead-in period) or as an oral suspension (for all age groups).
Der findes ingen kendt antidot i tilfælde af overdosering af nevirapin. 
There is no known antidote for nevirapine overdose.
Hvor andre antiretrovirale lægemidler er tilgængelige, bør enkeltdosis-Viramune-regime kombineres med supplerende effektive antiretrovirale lægemidler (som anbefalet i internationalt anerkendte retningslinjer). 
Where other antiretroviral medicines are accessible, the single dose Viramune regimen should be combined with additional effective antiretroviral medicines (as recommended in internationally recognized guidelines).
Levertestmonitorering foretages, hvis patienten oplever tegn eller symptomer, der tyder på hepatitis og/eller hypersensitivitet. 
Liver test monitoring should be performed if the patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity.
Af denne grund og for at reducere risikoen for hiv-smitte så bør barrierekontraception (f.eks. kondom) anbefales. 
For this reason, and to reduce the risk of HIV transmission, barrier contraception (e.g., condoms) is recommended.
Farmakokinetiske data fra 33 patienter (aldersfordeling 0,77-13,7 år) i den intensive prøvegruppe viste, at nevirapins clearance øgedes ved stigende alder i overensstemmelse med større legemsoverfladeareal. 
Pharmacokinetic data on 33 patients (age range 0.77 - 13.7 years) in the intensive sampling group demonstrated that clearance of nevirapine increased with increasing age in a manner consistent with increasing body surface area.
- vejer 50 kg eller mere 
- weigh 50 kg or more
Tilsvarende EC50-værdier er opnået, når den antivirale aktivitet af nevirapin bliver målt i perifere mononukleære blodceller, monocytderiverede makrofager eller lymfoblastoide cellerækker. 
Similar EC50 values are obtained when the antiviral activity of nevirapine is measured in peripheral blood mononuclear cells, monocyte derived macrophages or lymphoblastoid cell line.
Hvis en alternativ afmålingsanordning (f.eks. et målebæger eller en måleske til større doser) bruges, er det vigtigt, at måleredskabet skylles, for at sikre at der ikke er tiloversbleven oral suspension. 
If an alternative measuring device is used (e.g. a dispensing cup or teaspoon for larger doses) it is important that the device is rinsed to ensure complete removal of residual oral suspension.
Hvis patienter rapporterer om en sådan forekomst, bør det sikres, at det terapeutiske respons ikke er påvirket. 
If patients report such an event, reassurance should be obtained on the lack of impact on therapeutic response.
NEFA-studiet 
NEFA study
Det største volumen, som kan udtages på en gang, er 5 ml. 
The most that you can withdraw is 5 ml at a time.
Køn og ældre 
Gender and elderly
Monoterapi med Viramune er blevet forbundet med udvikling af NNRTI-resistens. 
Monotherapy with Viramune has been associated with the development of NNRTI resistance.
Dette omfatter også sikkerhedsdata for patientbesøg efter uge 144 i open-label forlængelsen (hvor patienter fra begge behandlingsgrupper, der gennemførte den 144 uger blindede fase, kunne deltage). 
This also includes safety data for patient visits in the post-week 144 open label extension (which patients in either treatment group who completed the 144 week blinded phase could enter).
Hvis ASAT eller ALAT stiger til > 5 ULN under behandling, bør nevirapin straks seponeres. 
If ASAT or ALAT increase to > 5 ULN during treatment, nevirapine should be immediately stopped.
Anafylaktisk reaktion er blevet identificeret gennem postmarketing overvågning, men er ikke observeret i de randomiserede, kontrollerede kliniske studier. 
Anaphylactic reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical studies.
Granulocytopeni sås oftere hos børn. 
Granulocytopenia was more frequently observed in children.
Hvis abnormaliteter i leverfunktionen genopstår, bør nevirapin seponeres permanent. 
If liver function abnormalities recur, nevirapine should be permanently discontinued.
Viramune kan også fås som tabletter. 
Viramune is also available as tablets.
Samtidig brug af nevirapin (400 mg) og efavirenz (800 mg) var forbundet med den højeste forekomst af kliniske bivirkninger og med den højeste forekomst af behandlingssvigt (53,1 %). 
The simultaneous use of nevirapine (400 mg) plus efavirenz (800 mg) was associated with the highest frequency of clinical adverse events and with the highest rate of treatment failure (53.1 %).
Pædiatriske patienter: 
Paediatric patients:
Patienterne skal have at vide, at det er nødvendigt at tage Viramune hver dag som ordineret. 
Patients should be advised of the need to take Viramune every day as prescribed.
Din læge vil ordinere de lægemidler, som er bedst for dig. 
Your doctor will recommend the best medicines for you.