natgillin/translations-raw huggingface dataset:
Disse tidligere kraftigt behandlede patienter viste en signifikant forbedring af triple behandlingsgruppe over den dobbelt behandlede gruppe med hensyn til både viral RNA og CD4+ celletælling efter 1 års behandling.
These heavily experienced patients demonstrated a significant improvement of the triple therapy group over the double therapy group for one year in both viral RNA and CD4+ cell counts.
17 Et varigt respons i mindst 1 år blev dokumenteret i et forsøg (INCAS) for triple behandlingsarm med VIRAMUNE, zidovudin og didanosin sammenlignet med zidovidin + didanosin eller VIRAMUNE + zidovudin hos 151 HIV- 1 smittede, hos naive patienter med CD4+ celletælling på 200- 600 celler/ mm3 (gennemsnitlig 376 celler/ mm3) og gennemsnitlig udgangsværdi HIV- 1 RNA koncentration i plasma på 4, 41 log10 kopier/ ml (25. 704 kopier/ ml).
A durable response for at least one year was documented in a trial (INCAS) for the triple therapy arm with VIRAMUNE, zidovudine and didanosine compared to zidovudine + didanosine or VIRAMUNE + zidovudine in 151 HIV-1 infected, treatment naive patients with CD4+ cell counts of 200- 600 cells/ mm3 (mean 376 cells/ mm3) and a mean baseline plasma HIV-1 RNA concentration of 4.41 log10 copies/ ml (25,704 copies/ ml).
Behandlingsdosis for VIRAMUNE var 200 mg daglig i 2 uger, efterfulgt af 200 mg 2 gange daglig, eller placebo; zidovudin 200 mg 3 gange daglig; didanosin, 125 eller 200 mg 2 gange daglig (afhængig af vægten).
Treatment doses were VIRAMUNE, 200 mg daily for two weeks, followed by 200 mg twice daily, or placebo; zidovudine, 200 mg three times daily; didanosine, 125 or 200 mg twice daily (depending on the weight).
Perinatal transmission To studier evaluerede effekten af VIRAMUNE til forebyggelse af vertikal transmission af HIV- 1 infektion.
Two studies evaluated the efficacy of VIRAMUNE to prevent vertical transmission of HIV-1 infection.
Mødrene modtog kun studie antiretroviral behandling i disse forsøg.
Mothers received only study antiretroviral therapy during these trials.
I HIVNET 012 studiet i Kampala (Uganda) blev mor- barn parrene randomiseret til at modtage oral VIRAMUNE (moder:
In the HIVNET 012 study in Kampala (Uganda) mother-infant pairs were randomised to receive oral VIRAMUNE (mother:
200 mg ved starten af fødslen; barn:
200 mg at the onset of labour; infant:
2 mg/ kg t indenfor 72 timer efter fødslen), eller en ultrakort oral zidovudine kur (moder:
2 mg/ kg within 72 hours of birth), or an ultra-short oral zidovudine regimen (mother:
600 mg ved starten af fødslen og 300 mg hver 3. time indtil selve fødslen; barn:
600 mg at the onset of labour and 300 mg every 3 hours until delivery; infant:
4 mg/ kg 2 gange daglig i 7 dage).
4 mg/ kg twice daily for 7 days).
Det kumulative HIV- 1 børneinfektionstal i 14- 16 uger var 13, 1% (n=310) i VIRAMUNEgruppen, versus 25, 1% (n=308) i den ultrakorte zidovudinegruppe (p=0, 00063).
The cumulative HIV-1 infant infection rate at 14-16 weeks was 13.1% (n = 310) in the VIRAMUNE group, versus 25.1% (n = 308 in the ultra-short zidovudine group (p = 0.00063).
I SAINT studiet udført i Sydafrika blev mor- barn parrene randomiseret til oral VIRAMUNE (moder:
In the SAINT study conducted in South Africa, mother-infant pairs were randomised to receive oral VIRAMUNE (mother:
200 mg under fødslen og 200 mg 24 - 48 timer efter fødslen; barn:
200 mg during labor and 200 mg 24 to 48 hours postdelivery; infant:
6 mg 24 - 48 timer efter fødslen); eller en kort oral zidovudin plus lamivudin kur (moder: zidovudin 600 mg, derefter 300 mg hver 3. time under fødslen, efterfulgt af 300 mg 2 gange dagligt i 7 dage efter fødslen plus lamivudin 150 mg 2 gange dagligt under fødslen og i 7 dage efter fødslen; barn: zidovudin 12 mg hver 12. time plus lamivudin 6 mg2 gange dagligt i 7 dage [hvis barnets vægt er < 2 kg: zidovudin 4 mg/ kg 2 gange dagligt plus lamivudin 2 mg/ kg 2 gange dagligt i 7 dage]).
6 mg 24 to 48 hours postdelivery); or a short oral zidovudine plus lamivudine regimen (mother: zidovudine 600 mg, then 300 mg every 3 hours during labour, followed by 300 mg b. i. d. for 7 days postdelivery plus lamivudine 150 mg b. i. d. during labour and for 7 days postdelivery; infant: zidovudine 12 mg b. i. d. plus lamivudine 6 mg b. i. d. for 7 days [if infant weight < 2 kg, zidovudine 4 mg/ kg b. i. d. plus lamivudine 2 mg/ kg b. i. d. for 7 days]).
Der var ingen signifikant forskel i HIV- 1 transmission fødselstallene efter 6 - 8 uger mellem VIRAMUNE gruppen (5, 7%, n = 652) og zidovudin - plus lamivudingruppen (3, 6%, n = 649).
There was no significant difference in HIV-1 transmission rates through 6 to 8 weeks between the VIRAMUNE group (5.7%, n = 652) and the zidovudine plus lamivudine group (3.6%, n = 649).
Der var en større risiko for HIV- 1 transmission til babyer, hvis mødre fik deres VIRAMUNE eller deres zidovudin plus lamivudin doser mindre end 2 timer før fødslen.
There was greater risk of HIV-1 transmission to babies whose mothers received their VIRAMUNE or their zidovudine plus lamivudine doses less than 2 hours before delivery.
I SAINT studiet havde 68% af de nevirapin- eksponerede mødre resistente stammer cirka 4 uger efter fødslen.
In the SAINT study 68% of nevirapine-exposed mothers had resistant strains at
Den kliniske relevans af disse data i europæiske befolkningsgrupper er ikke klarlagt.
The clinical relevance of these data in European populations has not been established.
Desuden kan risikoen for hepatotoksicitet hos mor og barn ikke udelukkes i de tilfælde, hvor VIRAMUNE bliver brugt som enkeltdosis for at forhindre vertikal transmission af HIV- 1 infektion.
Furthermore, in the case VIRAMUNE is used as single dose to prevent vertical transmission of HIV-1 infection, the risk of hepatotoxicity in mother and child cannot be excluded.
Et blindet randomiseret klinisk forsøg hos kvinder allerede i antiretroviral behandling gennem hele graviditeten (PACTG 316) viste ingen yderligere reduktion af vertikal HIV- 1 transmission, når moderen og barnet fik en enkelt VIRAMUNE dosis under veerne og efter fødslen.
A blinded randomized clinical trial in women already taking antiretroviral therapy throughout pregnancy (PACTG 316) demonstrated no further reduction of vertical HIV-1 transmission when the mother and the child received a single VIRAMUNE dose during labour and after birth respectively.
HIV- 1 transmissionshyppigheden var ens lav i begge behandlingsgrupper (1, 3% i VIRAMUNE gruppen, 1, 4% i placebogruppen).
HIV-1 transmission rates were similarly low in both treatment groups (1.3% in the VIRAMUNE group, 1.4% in the placebo group).
Den vertikale transmission aftog hverken hos kvinder med HIV- 1 RNA under grænsen for kvantificering eller hos kvinder med HIV- 1 RNA over grænsen for kvantificering før fødslen.
The vertical transmission decreased neither in women with HIV-1 RNA below the limit of quantification nor in women with HIV-1 RNA above the limit of quantification prior to partus.
Ud af de 95 kvinder som fik VIRAMUNE under fødslen udviklede 15% nevirapin resistente mutationer 6 uger efter fødslen.
Of the 95 women who received intrapartum VIRAMUNE, 15% developed nevirapine resistance mutations at 6 weeks post partus.
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.
Nevirapin absorberes hurtigt (> 90%) efter oral administration hos raske forsøgspersoner og hos voksne HIV- 1 smittede.
Nevirapine is readily absorbed (> 90%) after oral administration in healthy volunteers and in adults with HIV-1 infection.
Absolut biotilgængelighed hos 12 raske voksne efter en enkelt dosis var 93±9% (gennemsnitlig SD) efter en 50 mg tablet og 91±8% efter peroral opløsning.
Absolute bioavailability in 12 healthy adults following single-dose administration was 93 ± 9% (mean SD) for a 50 mg tablet and 91 ± 8% for an oral solution.
Peakplasmakoncentration for nevirapin på 2±0, 4 µg/ ml (7, 5 µM) 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.
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.
18 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.
Langvarig virkning synes at være mere sandsynlig hos patienter, hvis nevirapine through niveauer overstiger 3, 5 µg/ ml.
Long-term efficacy appears to be most likely in patients whose nevirapine trough levels exceed 3.5 µg/ ml.
Nevirapin er lipofilt og er essentielt ikke- ioniseret ved fysiologisk pH.
Nevirapine is lipophilic and is essentially nonionized at physiologic pH.
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.
60% bundet til plasmaproteiner i plasmakoncentrationsområdet 1- 10 µg/ ml.
Nevirapine is about 60% bound to plasma proteins in the plasma concentration range of 1-10 µg/ ml.
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.
I humane in- vivo studier og in- vitro studier med humane levermikrosomer har vist, at nevirapin i høj grad biotransformeres via cytokrom P450 (oxidativ) metabolisme til adskillige hydroxylerede metabolitter.
In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 (oxidative) metabolism to several hydroxylated metabolites.
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.
I urinen (81, 3±11, 1%) hvilket repræsenterer den primære ekskretionsvej sammenlignet med fæces (10, 1±1, 5%).
In a mass balance/ excretion study in eight healthy male volunteers dosed to steady state with nevirapine 200 mg given twice daily followed by a single 50 mg dose of 14C-nevirapine, approximately 91.4 ± 10.5% of the radiolabelled dose was recovered, with urine (81.3 ± 11.1%) representing the primary route of excretion compared to faeces (10.1 ± 1.5%).
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.
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.
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 eliminiationen 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.
Nevirapin har vist sig at inducere leverens cytokrome P450- metaboliske enzymer.
The
Farmakokinetikken af autoinduktionen karakteriseres ved en tilnærmelsesvis 1, 5- 2 gange stigning i den åbenbare perorale clearance af nevirapin når en behandling fortsættes fra en enkeltdosis til 2- 4 ugers behandling med 200- 400 mg daglig.
19 pharmacokinetics of autoinduction are characterised by an approximately 1.5 to 2 fold increase in the apparent oral clearance of nevirapine as treatment continues from a single dose to two-to-four weeks of dosing with 200-400 mg/ day.
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.
Enkeltdosis pharmakokinetik af nevirapin er blevet sammenlignet med 23 personer med enten mild (50≤CLcr < 80 ml/ min, moderat (30 ≤ CLcr < 50 ml/ min) eller alvorlig renal dysfunktion (CLcr < 30 ml/ min), renal svækkelse eller end- stage renal sygdom (ESRD) krævende dialyse, og 8 personer med normal renal funktion (CLcr > 80 ml/ min).
The single-dose pharmacokinetics of nevirapine have been compared in 23 subjects with either mild (50 ≤ CLcr < 80 ml/ min), moderate (30 ≤ CLcr < 50 ml/ min) or severe renal dysfunction (CLcr< 30 ml/min), renal impairment or end-stage renal disease (ESRD) requiring dialysis, and 8 subjects with normal renal function (CLcr> 80 ml/ min).
Renal svækkelse (mild, moderat og alvorlig) resulterede ikke i en signifikant ændring i pharmakokinetikken af nevirapin.
Renal impairment (mild, moderate and severe) resulted in no significant change in the pharmacokinetics of nevirapine.
Hos personer med ESRD, der krævede dialyse, fandt man en 43, 5% reduktion af nevirapin for AUC over en afprøvningsperiode på 1 uge.
However, subjects with ESRD requiring dialysis exhibited a 43.5% reduction in nevirapine AUC over a one-week exposure period.
Der var også akkumulering af nevirapin hydroxy- metabolitter i plasmaet.
There was also accumulation of nevirapine hydroxy-metabolites in plasma.
Resultatet tyder på at supplerende VIRAMUNE terapi med en ekstra dosis på 200 mg dosering VIRAMUNE efterfølgende hver dialyse behandling, vil afhjælpe effekten af dialyse på nevirapin clearance.
The results suggest that supplementing VIRAMUNE therapy with an additional 200 mg dose of VIRAMUNE following each dialysis treatment would help offset the effects of dialysis on nevirapine clearance.
I andre henseender kræver patienter med CLcr ≥ 20 ml/ min ikke en justering i VIRAMUNE doseringen.
Otherwise patients with CLcr ≥ 20 ml/ min do not require an adjustment in VIRAMUNE dosing.
I et steady state studie der sammenlignede 46 patienter med mild (n=17; Ishak Score 1- 2), moderat (n=20; Ishak Score 3- 4), eller alvorlig (n=9; Ishak Score 5- 6, Child- Pugh A i 8 patienter, score for 1 Child- Pugh er ikke tilgængelig) blev hepatisk fibrosis brugt som målestok for hepatisk dysfunktion.
Hepatic dysfunction: A steady state study comparing 46 patients with mild (n=17:
De var som minimum behandlet med 200 mg Viramune 2 gange dagligt i 6
Ishak Score 1-2), moderate (n=20; Ishak Score 3-4), or severe (n=9; Ishak Score 5-6, Child-Pugh A in 8 pts., for 1 Child-Pugh score not applicable) liver fibrosis as a measure of hepatic impairment was conducted.
19 uger inden de farmakokinetiske prøver blev taget.
The patients studied were receiving antiretroviral therapy containing Viramune 200 mg twice daily for at least 6 weeks prior to pharmacokinetic sampling, with a median duration of therapy of 3.4 years.
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 hepatisk dysfunktion bør monitoreres nøje med henblik på lægemiddel induceret toksicitet.
Patients with hepatic impairment should be monitored carefully for evidence of drug induced toxicity.
Dette antyder, at patienter med forværring af den hepatiske funktion og ascites risikerer akkumulering af nevirapine i den systemiske cirkulation.
In a 200 mg nevirapine single dose pharmacokinetic study of HIV-negative patients with mild and moderate hepatic impairment (Child-Pugh A, n=6; Child-Pugh B, n=4), a significant increase in the AUC of nevirapine was observed in one Child-Pugh B patient with ascites suggesting that patients with worsening hepatic function and ascites may be at risk of accumulating nevirapine in the systemic circulation.
4, 4).
Because nevirapine induces its own metabolism with multiple dosing, this single dose study may not reflect the impact of hepatic impairment on multiple dose pharmacokinetics (see section 4.4).
Det multinationale 2NN studie, indeholdt et farmakokinetisk substudie med 1077 patienter, hvoraf de 391 var kvinder.
In the multinational 2NN study, a population pharmacokinetic substudy of 1077 patients was performed that included 391 females.
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.
Eftersom hverken kropsvægt eller body mass index (BMI) havde indflydelse på clearance af nevirapine, kan forskellen mellem kønnene ikke forklares med kropsstørrelse.
Since neither body weight nor Body Mass Index (BMI) had influence on the clearance of nevirapine, the effect of gender cannot be explained by body size.
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 do not appear to change with age (range 19-68 years) or race (Black, Hispanic, or Caucasian).
VIRAMUNE er ikke specifikt blevet undersøgt hos patienter over 65 år.
VIRAMUNE has not been specifically investigated in patients over the age of 65.
Dels et 48- ugers pædiatrisk studie i Sydafrika (BI1100. 1368) med 123 HIV- 1 positive, antiretroviralt naive patienter i en alder fra 3 måneder og op til 16 år samt en samlet analyse af fem Paediatric AIDS Clinical Trials Group (PACTG) ’ s protokoller, der omfatter 495 patienter i alderen fra 14 dage op til 19 år.
Data concerning the pharmacokinetics of nevirapine has been derived from two major sources: a 48 week paediatric trial in South Africa (BI 1100.1368) involving 123 HIV-1 positive, antiretroviral naïve patients aged 3 months to 16 years; and a consolidated analysis of five Paediatric AIDS Clinical Trials Group (PACTG) protocols comprising 495 patients aged 14 days to 19 years.
Resultatet af det 48- ugers sydafrikanske studie BI1100. 1368 bekræftede, at for grupperne af patienter doseret med 4/ 7 mg/ kg og 150 mg/ m² nevirapin var dosen samlet veltolerereret og effektiv i behandlingen af antiretrovirale naive, pædiatriske patienter.
20 The results of the 48 week analysis of the South African study BI 1100.1368 confirmed that the 4/ 7 mg/ kg and 150 mg/ m2 nevirapine dose groups were well tolerated and effective in treating antiretroviral naïve paediatric patients.
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.
Desuden var begge doseringer effektive til at nedsætte viral belastning.
Also, both dosing regimens were effective in reducing the viral load.
I dette 48- ugers studie var der ingen uventede sikkerhedsfund i nogen af doseringsgrupperne.
In this 48 week study no unexpected safety findings were observed in either dosing group.
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 legemsoverflade.
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.
Dosering af nevirapin med 150 mg/ m² to gange dagligt (efter en to ugers indkøringsperiode med 150 mg/ m² en gang dagligt) gav geometriske middelværdier eller middelværdi af trough nevirapinkoncentrationer på 4- 6 µg/ ml (som voksendata).
Dosing of nevirapine at 150 mg/ m2 BID (after a two-week lead in at 150 mg/ m2 QD) produced geometric mean or mean trough nevirapine concentrations between 4- 6 µg/ ml (as targeted from adult data).
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 PACTG studier.
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.
Prækliniske data viser ikke nogen speciel risiko for mennesker andre end dem som er observeret i de kliniske studier baseret på konventionelle undersøgelse af sikkerhed, farmakologi, gentagen dosistoksikologi og 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.
Disse
In carcinogenicity studies, nevirapine induces hepatic tumours in rats and mice.
20 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.
Cellulose, mikrokrystallinsk Lactosemonohydrat Povidon K25 Natriumstivelsesglycollat Kolloid silica dioxid Magnesiumstearat
Microcrystalline cellulose Lactose monohydrate Povidone K25 Sodium starch glycolate Colloidal silicon dioxide Magnesium stearate
Startpakning:
Treatment initiation pack:
Blister i polyvinylchlorid (PVC) / aluminiumsfolie (blisterark med 7 tabletter).
Polyvinyl chloride (PVC)/ aluminium foil push-through blister units (blister card of 7 tablets).
Vedligeholdelsespakning:
21 Maintenance packs:
Blister i polyvinylchlorid (PVC) / aluminiumsfolie (blisterark med 10 tabletter).
Polyvinyl chloride (PVC)/ aluminium foil push-through blister units (blister card of 10 tablets).
Boehringer Ingelheim International GmbH Binger Strasse 173 D- 55216 Ingelheim am Rhein, Tyskland
Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein, Germany
EU/ 1/ 97/ 055/ 001 (60 tabletter) EU/ 1/ 97/ 055/ 003 (120 tabletter) EU/ 1/ 97/ 055/ 004 (14 tabletter)
EU/ 1/ 97/ 055/ 001 (60 tablets) EU/ 1/ 97/ 055/ 003 (120 tablets) EU/ 1/ 97/ 055/ 004 (14 tablets)
5. februar 1998 Dato for fornyelse af tilladelse:
5 February 1998 Date of latest renewal:
Yderligere information om dette lægemiddel er tilgængelig på det europæiske lægemiddelagenturs( EMEAs) hjemmeside http: // www. emea. europa. eu.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu
VIRAMUNE 50 mg/ 5 ml, oral suspension
VIRAMUNE 50 mg/ 5 ml oral suspension
En flaske indeholder 2, 4 g nevirapin.
Each bottle contains 2.4 g of nevirapine.