natgillin/translations-raw huggingface dataset:
Behandling med VIRAMUNE må ikke iværksættes igen for patienter, som tidligere har været nødsaget til at afbryde behandling med dette lægemiddel på grund af udslæt, allergiske reaktioner eller hepatitis, eller som har haft tegn på leverproblemer, mens de tog VIRAMUNE, som vendte tilbage, da behandling med dette lægemiddel blev genoptaget.
Treatment with VIRAMUNE should not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who have had signs of liver problems while they were taking VIRAMUNE that returned when the medicine was started again.
VIRAMUNE skal anvendes med forsigtighed, når det tages i kombination med andre lægemidler.
Caution is needed when VIRAMUNE is taken at the same time as other medicines.
Ligesom med andre lægemidler mod hiv kan der ved brug af VIRAMUNE være risiko for, at patienterne får lipodystrofi (forandringer i fordelingen af kropsfedt), knoglenekrose (knoglevævsdød) eller immunreaktiveringssyndrom (symptomer på infektion, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking VIRAMUNE may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Patienter med leverproblemer (herunder hepatitis B - eller C- infektion) kan have øget risiko for leverbeskadigelse, når de tager VIRAMUNE.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking VIRAMUNE.
Hvorfor blev VIRAMUNE godkendt?
Why has VIRAMUNE been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved VIRAMUNE opvejede de risici, der er forbundet med stoffet som del af en kombinationsterapi til antiviral behandling af hiv- 1- smittede patienter med fremskreden eller progressiv immuninsufficiens.
The Committee for Medicinal products for Human Use (CHMP) decided that VIRAMUNE’ S benefits are greater than its risks as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency.
Størstedelen af de tilgængelige erfaringer med VIRAMUNE har været i kombination med nukleoside revers transkriptase- hæmmere (NRTI' er, en type antiviralt lægemiddel).
Most of the experience with VIRAMUNE was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Der forelå desuden ikke tilstrækkelige videnskabelige data om brugen af kombinationsbehandling, heriblandt en proteasehæmmer (en anden type antiviralt lægemiddel), efter behandling med VIRAMUNE.
There was also insufficient evidence on the use of combination treatment including a protease inhibitor (another type of antiviral medicine) after VIRAMUNE treatment.
Udvalget anbefalede udstedelse af markedsføringstilladelse for VIRAMUNE.
The committee recommended that VIRAMUNE be given marketing authorisation.
Den fuldstændige EPAR for VIRAMUNE findes her.
This summary was last updated in 02-2007.
EU- nummer EU/ 1/ 97/ 055/ 001
EU/ 1/ 97/ 055/ 001
Særnavn Viramune
Viramune
Styrke 200 mg
200 mg
Lægemiddelform Tabletter
Tablet
Emballage Blister (PVC/ Alu)
blister (PVC/ alu)
Paknings- størrelse 60 tabletter
60 tablets
Oral suspension
Oral suspension Tablet Tablet
Flaske (HDPE)
bottle (HDPE) blister (PVC/ alu) blister (PVC/ alu)
1 flaske + 5 ml dipenserings- sprøjte
1 bottle + 5 ml measuring syringe 120 tablets 14 tablets
VIRAMUNE 200 mg tabletter
VIRAMUNE 200 mg tablets
En tablet indeholder 200 mg nevirapin (som anhydrat).
Each tablet contains 200 mg of nevirapine (as anhydrate).
En tablet indeholder 318 mg lactosemonohydrat.
Excipient: each tablet contains 318 mg of lactose monohydrate.
Den ene side er præget med koden ” 54 193 ”, med en markeringslinie mellem ” 54 ” og ” 193 ”.
One side is embossed with the code “ 54 193”, with a single bisect separating the “ 54” and “ 193”.
Tabletten bør ikke deles.
The tablet should not be divided.
4. 4).
VIRAMUNE is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4.).
Hovedparten af erfaringen med VIRAMUNE er i kombinationen med nukleosid "reverse transcriptase" hæmmere.
Most of the experience with VIRAMUNE is in combination with nucleoside reverse transcriptase inhibitors (NRTIs).
5. 1).
The choice of a subsequent therapy after VIRAMUNE should be based on clinical experience and resistance testing (see section 5.1).
VIRAMUNE bør ordineres af læger med erfaring i behandling af HIV- infektion.
VIRAMUNE should be administered by physicians who are experienced in the treatment of HIV infection.
Den anbefalede dosis VIRAMUNE er én tablet 200 mg daglig i de første 14 dage (denne optrapningsperiode bør benyttes, idet den har vist sig at mindske hyppigheden af udslæt) efterfulgt af én tablet 200 mg 2 gange daglig i kombination med mindst to antiretrovirale lægemidler.
The recommended dose of VIRAMUNE is one 200 mg tablet daily for the first 14 days (this lead-in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents.
Pædiatriske (unge) patienter
Paediatric (adolescent) patients
VIRAMUNE 200 mg tabletter, kan anvendes til at følge det ovenfor beskrevne dosering, for større børn specielt unge, yngre end 16 år, der vejer mere end 50 kg eller hvis legemsoverflade er mere end 1, 25 m² i henhold til Mosteller formlen.
VIRAMUNE 200 mg tablets, following the dosing schedule described above, are suitable for larger children, particularly adolescents, below the age of 16 who weigh more than 50 kg or whose body surface area is above 1.25 m2 according to the Mosteller formula.
Ligeledes findes der en oral suspension, der kan doseres i henhold til vægt eller legemsoverflade, som er anvendelig til børn, der vejer mindre end 50 kg, eller hvis legemsoverflade er mindre end 1, 25 m² (se venligst produktresuméet for VIRAMUNE oral suspension).
An oral suspension dosage form, which can be dosed according to body weight or body surface area, is available for children in this age group weighing less than 50 kg or whose body surface area is below 1.25 m2 (please refer to the Summary of Product Characteristics of VIRAMUNE oral suspension).
VIRAMUNE kan tages med eller uden mad.
VIRAMUNE may be taken with or without food.
2 Nedsat nyrefunktion Patienter med nedsat nyrefunktion, som har behov for dialyse, bør efter hver dialysebehandling have en ekstra dosis på 200 mg VIRAMUNE.
2 Renal impairment For patients with renal dysfunction requiring dialysis an additional 200 mg dose of VIRAMUNE following each dialysis treatment is recommended.
5. 2.
Patients with CLcr ≥ 20 ml/ min do not require a dose adjustment, see section 5.2.
Nedsat leverfunktion VIRAMUNE bør ikke bruges til patienter med svært nedsat leverfunktion (Child- Pugh C, se pkt.
Hepatic impairment VIRAMUNE should not be used in patients with severe hepatic impairment (Child-Pugh C, see section 4.3).
4. 4 og 5. 2).
No dose adjustment is necessary in patients with mild to moderate hepatic impairment (see sections 4.4 and 5.2).
Ældre Viramune har ikke været afprøvet på patienter over 65 år eller ældre.
VIRAMUNE has not been specifically investigated in patients over the age of 65.
Patienter, som udvikler udslæt i optrapningsperioden på 14 dage med 200 mg/ dag, bør ikke øge dosis af VIRAMUNE, før udslættet er forsvundet.
Patients experiencing rash during the 14-day lead-in period of 200 mg/ day should not have their VIRAMUNE dose increased until the rash has resolved.
4. 4).
The isolated rash should be closely monitored (please refer to section 4.4).
Patienter, som afbryder behandling med VIRAMUNE 7 dage, bør starte med den anbefalede 2 ugers indkøringsperiode.
Patients who interrupt VIRAMUNE dosing for more than 7 days should restart the recommended dosing regimen using the two week lead-in period.
4. 4..
For toxicities that require interruption of VIRAMUNE therapy, see section 4.4.
VIRAMUNE må ikke genadministreres til patienter, hvor permanent seponering har været krævet pga. alvorligt udslæt, udslæt ledsaget af konstitutionelle symptomer, overfølsomhedsreaktioner eller klinisk hepatitis pga. nevirapin.
VIRAMUNE must not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine.
VIRAMUNE må ikke gives til patienter med svær hepatisk insufficiens (Child- Pugh C) eller der forud for behandling har ASAT eller ALAT > 5 ULN før baseline ASAT/ ALAT er stabiliseret < 5 ULN.
VIRAMUNE must not be used in patients with severe hepatic impairment (Child-Pugh C) or pre- treatment ASAT or ALAT > 5 ULN until baseline ASAT/ ALAT are stabilised < 5 ULN.
4. 4).
VIRAMUNE must not be readministered in patients who previously had ASAT or ALAT > 5 ULN during VIRAMUNE therapy and had recurrence of liver function abnormalities upon readministration of VIRAMUNE (see section 4.4).
4. 5).
Herbal preparations containing St John’ s wort (Hypericum perforatum) must not be used while taking VIRAMUNE due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine (see section 4.5).
5. 1).
VIRAMUNE should only be used with at least two other antiretroviral agents (see section 5.1).
VIRAMUNE bør ikke anvendes som eneste aktive antiretrovirale behandling, da det er påvist, at monoterapi med antivirale 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.
3 De første 18 uger af behandlingen med VIRAMUNE er en kritisk periode, som kræver tæt monitorering af patienterne for at opdage den potentielle fremkomst af alvorlige og livstruende hudreaktioner (inkl. tilfælde af Stevens- Johnson syndrom (SJS) og toksisk epidermal nekrolyse (TEN)) eller alvorlig hepatitis/ leversvigt.
3 The first 18 weeks of therapy with VIRAMUNE are a critical period which requires close monitoring of patients to disclose the potential appearance of severe and life-threatening skin reactions (including cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)) or serious hepatitis/ hepatic failure.
Størst risiko for hepatitis og hudreaktioner opstår i løbet af de første 6 uger af behandlingen.
The greatest risk of hepatic events and skin reactions occurs in the first 6 weeks of therapy.
Det at være kvinde samt have et forhøjet CD4- tal ved behandlingsstart medfører en større risiko for leverbivirkninger.
Female gender and higher CD4 counts at the initiation of therapy place patients at greater risk of hepatic adverse events.
Medmindre fordelen vejer tungere end risikoen bør VIRAMUNE ikke anvendes til voksne kvinder med CD4 celletal større end 250 celler/ mm3 eller hos voksne mænd med CD4 celletal større end 400 celler/ mm3.
Unless the benefit outweighs the risk VIRAMUNE should not be initiated in adult females with CD4 cell counts greater than 250 cells/ mm3 or in adult males with CD4 cell counts greater than 400 cells/ mm3.
Dette er baseret på forekomsten af alvorlig og livstruende hepatotoksicitet set i kontrollerede og ukontrollerede studier.
This is based on the occurrence of serious and life threatening hepatotoxicity in controlled and uncontrolled studies.
Patienter, som udvikler tegn eller symptomer på hepatitis, svært hududslæt eller overfølsomhedsreaktioner, skal stoppe VIRAMUNE behandling og søge lægehjælp omgående.
Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must discontinue VIRAMUNE and seek medical evaluation immediately.
Behandling med VIRAMUNE må ikke genstartes efter svær lever - hud - eller overfølsomhedsreaktioner (se pkt.
Viramune must not be restarted following severe hepatic, skin or hypersensitivity reactions (see section 4.3).
4. 2).
The dosage must be strictly adhered to, especially the 14-days lead-in period (see section 4.2).
Alvorlige og livstruende hudreaktioner, inkl. fatale tilfælde er forekommet hos patienter behandlet med VIRAMUNE, hovedsagelig i løbet af de første 6 uger af behandlingen.
Severe and life-threatening skin reactions, including fatal cases, have occurred in patients treated with VIRAMUNE mainly during the first 6 weeks of therapy.
Disse tilfælde omfatter Stevens- Johnson syndrom toksisk epidermal nekrolyse og overfølsomhedsreaktioner karakteriseret ved udslæt, konstitutionelle symptomer og andre organpåvirkninger.
These have included cases of Stevens- Johnson syndrome, toxic epidermal necrolysis and hypersensitivity reactions characterised by rash, constitutional findings and visceral involvement.
VIRAMUNE skal seponeres permanent hos enhver patient, som udvikler et alvorligt udslæt eller udslæt ledsaget af konstitutionelle symptomer (såsom feber, blæredannelse, orale læsioner, conjunctivitis, ødemer i ansigt, muskel - eller ledsmerter eller generel utilpashed) inkluderende Stevens- Johnson syndrom eller toksisk epidermal nekrolyse.
VIRAMUNE must be permanently discontinued in any patient experiencing severe rash or a rash accompanied by constitutional symptoms (such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise), including Stevens-Johnson syndrome, or toxic epidermal necrolysis.
4. 4)
VIRAMUNE must be permanently discontinued in any patient experiencing hypersensitivity reaction (characterised by rash with constitutional symptoms, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction), see section 4.4.
Administration af VIRAMUNE i højere doser end anbefalet kan forøge frekvensen og alvorligheden af hudreaktioner, såsom Stevens- Johnson syndrom og toksisk epidermal nekrolyse.
VIRAMUNE administration above the recommended dose might increase the frequency and seriousness of skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
Rhabdomyolose er observeret hos patienter med hud - og/ eller leverpåvirkning i forbindelse med VIRAMUNE- behandling.
Rhabdomyolysis has been observed in patients experiencing skin and/ or liver reactions associated with VIRAMUNE use.
Samtidig prednisonbrug (40 mg/ dag i de første 14 dage af VIRAMUNE administrationen) har vist sig ikke at nedsætte tilfældene af VIRAMUNE associeret udslæt, og kan være associeret med en stigning tilfælde og alvorlighed af udslæt under de første 6 uger af VIRAMUNEbehandlingen.
Concomitant prednisone use (40 mg/ day for the first 14 days of VIRAMUNE administration) has been shown not to decrease the incidence of VIRAMUNE-associated rash, and may be associated with an increase in incidence and severity of rash during the first 6 weeks of VIRAMUNE therapy.
Nogle risikofaktorer for at udvikle alvorlige kutane reaktioner er blevet identificeret og inkluderer undladelse i at følge den første dosismængde på 200 mg om dagen i løbet af optrapningsperioden og en lang forsinkelse mellem de første symptomer og lægekonsultation.
Some risk factors for developing serious cutaneous reactions have been identified, they include failure to follow the initial dosing of 200 mg daily during the lead-in period and a long delay between the initial symptoms and medical consultation.
Kvinder synes at have en større risiko end mænd for udvikling af udslæt, hvad enten de får behandling indeholdende VIRAMUNE eller ej.
Women appear to be at higher risk than men of developing rash, whether receiving VIRAMUNE or non-VIRAMUNE containing therapy.
Patienter bør underrettes om, at en alvorlig toksicitet ved VIRAMUNE er udslæt.
Patients should be instructed that a major toxicity of VIRAMUNE is rash.
Hovedparten af udslæt i forbindelse med VIRAMUNE opstår inden for de første 6 uger efter behandlingsstart.
The majority of rashes associated with VIRAMUNE occur within the first 6 weeks of initiation of therapy.
Derfor skal patienterne monitoreres omhyggeligt for
Therefore, patients should be monitored carefully for the appearance of rash during this period.
Patienterne skal instrueres i at dosisøgning ikke må foretages, hvis nogen form for udslæt opstår i løbet af den to- ugers optrapningsperiode, før udslættet er forsvundet.
Patients should be instructed that dose escalation is not to occur if any rash occurs during the two-week lead-in dosing period, until the rash resolves.
Patienter, der oplever alvorligt udslæt eller udslæt ledsaget af konstitutionelle symptomer såsom feber, blæredannelse, orale læsioner, conjunctivitis, ødemer i ansigt, muskel - og ledsmerter eller generelt ubehag, skal ophøre med lægemidlet og omgående søge lægehjælp.
4 Any patient experiencing severe rash or a rash accompanied by constitutional symptoms such as fever, blistering, oral lesions, conjunctivitis, facial oedema, muscle or joint aches, or general malaise should discontinue the medicinal product and immediately seek medical evaluation.
Disse patienter må ikke genstartes på VIRAMUNE.
In these patients VIRAMUNE must not be restarted.
Hvis patienter udvikler et udslæt der kan være forbundet med VIRAMUNE, bør der udføres levertests.
If patients present with a suspected VIRAMUNE-associated rash, liver function tests should be performed.
VIRAMUNE bør permanent seponeres hos patienter med moderate til svære stigninger (ASAT eller ALAT > 5 ULN).
Patients with moderate to severe elevations (ASAT or ALAT > 5 ULN) should be permanently discontinued from VIRAMUNE.
4. 3).
If a hypersensitivity reaction occurs, characterised by rash with constitutional symptoms such as fever, arthralgia, myalgia and lymphadenopathy, plus visceral involvement, such as hepatitis, eosinophilia, granulocytopenia, and renal dysfunction, VIRAMUNE must be permanently stopped and not be re- introduced (see section 4.3).
Alvorlig og livstruende hepatotoksicitet, inkl. fatal fulminant hepatitis er set hos patienter behandlet med VIRAMUNE.
Severe and life-threatening hepatoxicity, including fatal fulminant hepatitis, has occurred in patients treated with VIRAMUNE.
Risikoen for hepatiske bivirkninger er størst i de første 6 uger af behandlingen.
The risk of hepatic events is greatest in the first 6 weeks of therapy.
Generelt er stigende ASAT - eller ALAT- niveauer > 2, 5 ULN og/ eller samtidig infektion med hepatitis B og/ eller C ved starten af antiretroviral behandling forbundet med større risiko for leverbivirkninger under antiretroviral behandling inklusiv regimer indeholdende VIRAMUNE.
Increased ASAT or ALAT levels > 2.5 ULN and/ or co-infection with hepatitis B and/ or C at the start of antiretroviral therapy is associated with greater risk of hepatic adverse reactions during antiretroviral therapy in general, including VIRAMUNE containing regimens.
Det at være kvinde samt patienter med højere CD4- tal har større risiko for hepatiske bivirkninger.
Female gender and patients with higher CD4 counts are at increased risk of hepatic adverse events.
Kvinder har 3 gange større risiko end mænd for symptomatiske, ofte udslæt associerede leverpåvirkninger (5, 8% versus 2, 2%), og patienter med højere CD4- tal ved start af VIRAMUNE behandling har en større risiko for symptomatisk leverpåvirkning med VIRAMUNE.
Women have a three fold higher risk than men for symptomatic, often rash-associated, hepatic events (5.8% versus 2.2%), and patients with higher CD4 counts at initiation of VIRAMUNE therapy are at higher risk for symptomatic hepatic events with VIRAMUNE.
I en retrospektiv undersøgelse havde kvinder med CD4- tal > 250 celler/ mm3 12 gange større risiko for symptomatiske leverpåvirkninger sammenlignet med kvinder med CD4- tal < 250 celler/ mm3 (11, 0% versus 0, 9%).
In a retrospective review, women with CD4 counts > 250 cells/ mm3 had a 12 fold higher risk of symptomatic hepatic adverse events compared to women with CD4 counts < 250 cells/ mm3 (11.0% versus 0.9%).
En øget risiko blev observeret hos mænd med CD4- tal > 400 celler/ mm3 (6, 3% versus 1, 2% for mænd med CD4- tal < 400 celler/ mm3).
An increased risk was observed in men with CD4 counts > 400 cells/ mm3 (6.3% versus 1,2% for men with CD4 counts < 400 cells/ mm3).
Patienterne bør underrettes om, at leverreaktioner er en alvorlig toksicitet ved VIRAMUNE som kræver en tæt monitorering i de første 18 uger.
Patients should be informed that hepatic reactions are a major toxicity of VIRAMUNE requiring close monitoring during the first 18 weeks.
De skal informeres om, at hvis de oplever symptomer, der tyder på hepatitis, skal de straks stoppe med VIRAMUNE og omgående søge lægehjælp som bør omfatte leverfunktionstest.
They should be informed that occurrence of symptoms suggestive of hepatitis should lead them to discontinue VIRAMUNE and immediately seek medical evaluation, which should include liver function tests.
Før behandlingen med VIRAMUNE igangsættes samt med passende mellemrum undervejs i behandlingen, skal der udføres biokemiske tests herunder test af leverfunktion.
Clinical chemistry tests, which include liver function tests, should be performed prior to initiating VIRAMUNE therapy and at appropriate intervals during therapy.
Unormale leverfunktionstests har været rapporteret med VIRAMUNE, nogle i de første få uger af behandlingen.
Abnormal liver function tests have been reported with VIRAMUNE, some in the first few weeks of therapy.
5 Asymptomatiske elevationer af leverenzymer beskrives ofte og er ikke en nødvendigvis en kontraindikation ved brugen af VIRAMUNE.
Asymptomatic elevations of liver enzymes are frequently described and are not necessarily a contraindication to use VIRAMUNE.
Asymptomatiske GGT - elevationer er ikke en kontraindikation for fortsættelse af behandling.
Asymptomatic GGT elevations are not a contraindication to continue therapy.
Monitorering af levertests bør foretages hver anden uge i løbet af de første 2 måneder af behandlingen, efter 3 måneders behandling og derefter regelmæssigt.
5 Monitoring of hepatic tests should be done every two weeks during the first 2 months of treatment, at the 3rd month and then regularly thereafter.
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.
Hvis ASAT eller ALAT > 2, 5 ULN før eller under behandling må levertests monitorers oftere ved regelmæssige kontrol besøg.
If ASAT or ALAT > 2.5 ULN before or during treatment, then liver tests should be monitored more frequently during regular clinic visits.
4. 3).
VIRAMUNE must not be administered to patients with pre- treatment ASAT or ALAT > 5 ULN until baseline ASAT/ ALAT are stabilised < 5 ULN (see section 4.3).
Hvis ASAT eller ALAT stiger til > 5 ULN under behandling, bør VIRAMUNE straks seponeres.
If ASAT or ALAT increase to > 5 ULN during treatment, VIRAMUNE should be immediately stopped.
Hvis ASAT og ALAT vender tilbage til baselineværdier, og hvis patienten ikke har nogle kliniske tegn eller symptomer på hepatitis, udslæt eller andre symptomer eller fund, der tyder på organpåvirkning, er det muligt at genintroducere VIRAMUNE efter en individuel patientvurdering, med en startdosis på 200 mg/ dag i 14 dage efterfulgt af 400 mg/ dag.
If ASAT and ALAT return to baseline values and if the patient had no clinical signs or symptoms of hepatitis, rash, constitutional symptoms or other findings suggestive of organ dysfunction, it may be possible to reintroduce VIRAMUNE, on a case by case basis, at the starting dosage regimen of 200 mg/ day for 14 days followed by 400 mg/ day.
Hvis abnormaliteter i leverfunktionen genopstår, bør VIRAMUNE seponeres permanent.
If liver function abnormalities recur, VIRAMUNE should be permanently discontinued.
GGT)), skal VIRAMUNE stoppes permanent.
If clinical hepatitis occurs, characterised by anorexia, nausea, vomiting, icterus AND laboratory findings (such as moderate or severe liver function test abnormalities (excluding GGT), VIRAMUNE must be permanently stopped.