FrancophonIA/ELRC3.0 huggingface dataset:
English: - Do not breast-feed during treatment with Sebivo.
Danish: - Lad være med at amme, mens du er i behandling med Sebivo.
English: For Ishak Fibrosis Score, improvement measured as ≥ 1 point reduction in Ishak Fibrosis Score from baseline to week 52.
Danish: Ishaks fibrosescore: Bedring målt som >1 points reduktion ved Ishaks fibrosescore fra studiestart til uge 52.
English: Sebivo contains the active substance telbivudine.
Danish: Sebivo indeholder det aktive stof telbivudin.
English: Therefore, virological response should be closely monitored in patients with increased dosage interval (see sections 4.2 and 5.2).
Danish: Virologisk respons skal derfor monitoreres tæt hos patienter med øget doseringsinterval (se pkt.
English: Overall, ALT flares occurred more frequently in HBeAg-positive patients than in HBeAg-negative patients.
Danish: Forhøjede ALAT-niveauer forekom hyppigere hos HBeAg-positive patienter end hos HBeAg-negative patienter.
English: Telbivudine is an inhibitor of both HBV first strand (EC50 = 0.4-1.3 M) and second strand (EC50 = 0.12-0.24 M) synthesis, and shows a distinct preference for inhibiting second strand production.
Danish: Telbivudin er en hæmmer af syntesen af både HBV's første streng (EC50=0,4-1,3 M) og anden streng (EC50=0,12-0,24 M) og viser en klar præference for at hæmme produktionen af anden streng.
English: Genotypic analysis of 50 HBV isolates from telbivudine-treated patients at week 208 (CLDT600A2303) revealed a similar resistance profile as reported at week 104.
Danish: Genotypeanalyse af 50 HBV-dyrkninger fra telbivudinbehandlede patienter i uge 208 (CLDT600A2303) viste en resistensprofil tilsvarende den, som blev rapporteret i uge 104.
English: By contrast, telbivudine-5'-triphosphate at concentrations up to 100 M did not inhibit cellular DNA polymerases , , or .
Danish: Derimod hæmmede telbivudin-5'-trifosfat i koncentrationer på op til 100 M ikke de cellulære DNApolymeraser ,  og .
English: There are no data on telbivudine treatment in patients with established adefovir-resistant hepatitis B virus single mutations of rtN236T or A181V.
Danish: telbivudin behandling til patienter med påvist adefovir-resistent hepatitis B-virus enkeltmutationer af rtN236T eller A181V.
English: Exacerbations of hepatitis B after discontinuation of treatment Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued antihepatitis B therapy including telbivudine (see section 4.4).
Danish: Eksacerbationer af hepatitis B efter behandlingsophør Svære akutte eksacerbationer af hepatitis B er beskrevet hos patienter, der er ophørt med anti-hepatitis B-behandling inklusive telbivudin (se pkt.
English: Pregnancy and breast-feeding - Do not use Sebivo during pregnancy unless your doctor recommends it.
Danish: - Brug ikke Sebivo under graviditet, medmindre din læge anbefaler det.
English: Race There are no significant race-related differences in telbivudine pharmacokinetics.
Danish: Race Der er ingen signifikante racerelaterede forskelle i telbivudins farmakokinetik.
English: In assays relating to mitochondrial structure, function and DNA content, telbivudine lacked appreciable toxic effect at concentrations up to at 10 M and did not increase lactic acid production in vitro.
Danish: I analyser, der relaterede til mitokondriestruktur, funktion og DNA-indhold, udviste telbivudin ingen væsentlig toksisk virkning ved koncentrationer op til 10 M.
English: Allow the syringe to air-dry and store with the bottle.
Danish: Lad sprøjten lufttørre og opbevar den sammen med flasken.
English: The primary endpoint of therapeutic response was a composite serological endpoint requiring suppression of HBV DNA to < 5 log10 copies/ml in conjunction with either loss of serum HBeAg or ALT normalised.
Danish: Det primære endepunkt for terapeutisk respons var et sammensat serologisk endepunkt, omfattende suppression af HBV-DNA til <5 log10 kopier/ml sammen med enten tab af serum-HBeAg eller normaliseret ALAT.
English: Sebivo may reduce the risk of passing your hepatitis B virus on to your unborn baby if taken in combination with Hepatitis B immune globulin and Hepatitis B vaccine.
Danish: Sebivo kan nedsætte risikoen for at overføre hepatitis B-virus til det ufødte barn, hvis Sebivo tages i kombination med hepatitis B immunglobulin og hepatitis B-vaccine.
English: n = 432 and 442, for telbivudine and lamivudine groups, respectively.
Danish: n=432 og 442 for henholdsvis telbivudin- og lamivudingruppen.
English: 600 mg (30 ml) once daily 600 mg once daily 400 mg (20 ml) once daily 600 mg once every 48 hours
Danish: 600 mg (30 ml) 1 gang dagligt 600 mg 1 gang dagligt 400 mg (20 ml) 1 gang dagligt 600 mg 1 gang hver 48. time
English: Some side effects could be serious: - Persistent muscle weakness or muscle pain - Numbness, tingling, pain and/or burning sensation in the arms and/or legs If you experience any of these, call your doctor immediately.
Danish: Nogle bivirkninger kan være alvorlige: - Vedvarende muskelsvaghed eller muskelsmerte - Følelsesløshed, prikken, smerte og/eller brændende fornemmelse i armene og/eller benene Kontakt straks din læge, hvis du oplever nogen af disse symptomer.
English: Creatinine clearance (ml/min)
Danish: Kreatininclearance (ml/min)
English: Patients with cirrhosis without decompensation
Danish: Patienter med cirrose uden dekompensation
English: Myopathy/myositis, arthralgia, myalgia, pain in the extremities, back pain, muscle spasm, neck pain, flank pain
Danish: Myopati/myositis, artralgi, myalgi, smerte i ekstremiteterne, rygsmerter, muskelspasmer, smerter i nakken, smerter i siden
English: In adult rats, fertility was reduced when both male and female rats were treated with telbivudine at doses of 500 or 1000 mg/kg/day (lower fertility index compared to concurrent controls).
Danish: I voksne rotter var fertiliteten nedsat, når både han- og hunrotter blev behandlet med telbivudin ved doser på 500 eller 1.000 mg/kg/dag (lavere fertilitetsindeks sammelignet med kontrolgruppen).
English: - if you are being treated with pegylated or standard interferon alfa (see “Taking other medicines”).
Danish: - hvis du bliver behandlet med pegyleret eller standard interferon alfa (se ”Brug af anden medicin”).
English: Film-coated tablets containing 600 mg telbivudine are bioequivalent to 30 ml telbivudine oral solution (20 mg/ml).
Danish: Filmovertrukne tabletter indeholdende 600 mg telbivudin er bioækvivalent med 30 ml telbivudin oral opløsning (20 mg/ml).
English: The steady-state pharmacokinetics of telbivudine were unaltered following multiple dose administration in combination with lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate, ciclosporin or pegylated interferon alfa-2a.
Danish: Telbivudins farmakokinetik ved steady-state var uændret efter multidosisadministration i kombination med lamivudin, adefovir, dipivoxil, tenofovirdisoproxilfumarat, ciclosporin eller pegyleret interferon alfa-2a.
English: HBeAg-negative patients (n = 209*)
Danish: HBeAg-negative patienter (n=209*)
English: Turn the syringe to the upright position and incline it slightly so that the air bubbles rise to the top.
Danish: Vend sprøjten lodret og hold den let på skrå, så luftboblerne kan stige til toppen.
English: Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate
Danish: Natriumstivelsesglycolat Silica, kolloid vandfri Magnesiumstearat
English: An increased risk of developing peripheral neuropathy has been observed in one study when telbivudine and pegylated interferon alfa-2a were co-administered (see section 4.5).
Danish: I et studie blev der observeret en øget risiko for udvikling af perifer neuropati, når telbivudin og pegyleret interferon alfa-2a blev administreret samtidig (se pkt.
English: Results from cell-based assays showed that the adefovir resistance-associated substitution A181V had 1.5- to approximately 4-fold reduced susceptibility to telbivudine.
Danish: Resultater fra cellebaserede analyser viste, at adefovir-resistensassocieret substitution A181V havde 1,5- til ca. 4 gange reduceret følsomhed for telbuvidin.
English: The cumulative genotypic rates by week 104 were 25.1% (115/458) for HBeAg-positive patients and 10.8% (24/222) for HBeAg-negative patients.
Danish: De kumulative genotypiske hyppigheder efter 104 uger var 25,1 % (115/458) for HBeAg-positive patienter og 10,8 % (24/222) for HBeAg-negative patienter.
English: Detailed instructions on how to use this are given in the section “Instructions for use”.
Danish: Detaljeret information om, hvordan du bruger denne, kan du finde i afsnittet 'Brugsanvisning' sidst i indlægssedlen.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA [folding box only]
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA [kun karton]
English: 300 copies/ml to < 3 log10 copies/ml
Danish: 300 kopier/ml til <3 log10 kopier/ml
English: 28 film-coated tablets 98 film-coated tablets
Danish: 28 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Muscle symptoms may progress and become serious, sometimes leading to muscle breakdown
Danish: Symptomerne fra musklerne kan tiltage og blive alvorlige, sommetider førende til muskelnedbrydelse (rabdomyolyse), som kan føre til nyreskade.
English: Cases of myopathy and myalgia have been reported with telbivudine use several weeks to months after starting therapy (see section 4.8).
Danish: Ved behandling med telbivudin er der rapporteret tilfælde af myopati og myalgi flere uger til måneder efter påbegyndelse af behandlingen (se pkt.
English: The single- and multiple-dose pharmacokinetics of telbivudine were evaluated in healthy subjects and in patients with chronic hepatitis B. The pharmacokinetics of telbivudine were not evaluated with the recommended dose of 600 mg in patients with chronic hepatitis B. However telbivudine pharmacokinetics are similar between both populations.
Danish: Farmakokinetikken for enkeltdosis- og flerdosis telbivudin blev vurderet på raske forsøgspersoner og patienter med kronisk hepatitis B. Telbivudins farmakokinetik blev ikke evalueret med den anbefalede dosis på 600 mg i patienter med kronisk hepatitis B. Telbivudins farmakokinetik er dog den samme hos begge populationer.
English: If you have taken too much Sebivo, or if someone else accidentally takes your tablets, go to your doctor or hospital for advice straight away.
Danish: Hvis du har taget for mange Sebivo-tabletter, eller hvis andre ved et uheld har taget dine tabletter, skal du straks tage til lægen eller på hospitalet for at blive vejledt.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”Udløbsdato”.
English: HBeAg-positive (n = 921)
Danish: HBeAg-positiv (n=921)
English: Sebivo oral solution contains approximately 47 mg sodium per 600 mg dose (30 ml), which should be taken into consideration by patients on a controlled sodium diet.
Danish: Sebivo oral opløsning indeholder ca. 47 mg natrium per 600 mg dosis (30 ml), hvilket der skal tages hensyn til hos patienter på kontrolleret natrium diæt.
English: In HBeAg-negative patients, telbivudine was non-inferior to lamivudine (75.2% and 77.2% responders; p = 0.6187).
Danish: Blandt HBeAg-negative patienter var telbivudin ikke dårligere end lamivudin (75,2 % og 77,2 % respondenter; p=0,6187).
English: As renal excretion is the predominant route of elimination, patients with moderate to severe renal dysfunction and those undergoing haemodialysis require a dose interval adjustment (see section 4.2).
Danish: Da renal udskillelse er den fremherskende eliminationsvej har patienter med moderat til svær renal dysfunktion og patienter i hæmodialyse behov for en justering af dosisinterval (se pkt.
English: Patients with sustained HBeAg seroconversion had a mean HBV DNA of 3.3 log10 copies/ml; and 73.7% had HBV DNA < 4 log10 copies/ml.
Danish: Patienter med vedvarende HBeAg serokonvertering havde en gennemsnitlig HBV-DNA på 3,3 log10 kopier/ml; og 73,7 % havde HBV-DNA <4 log10 kopier/ml.
English: Study NV-02B-015
Danish: NV-02B-015 studiet
English: The effectiveness of dosing interval adjustment has not been clinically evaluated.
Danish: Effekten af doseringsintervaljustering er ikke vurderet klinisk.
English: The single-dose pharmacokinetics of telbivudine (200, 400 and 600 mg) have been evaluated in patients (without chronic hepatitis B) with various degrees of renal impairment (as assessed by creatinine clearance).
Danish: Telbivudins enkeltdosisfarmakokinetik (200, 400 og 600 mg) er blevet vurderet hos patienter (uden kronisk hepatitis B) med forskellige grader af nedsat nyrefunktion (målt ved kreatininclearance).
English: • In HBeAg-negative patients without cirrhosis, treatment should be administered at least until HBsAg seroconversion or until there is evidence of loss of efficacy.
Danish: • Hos HBeAg-negative patienter uden cirrose skal behandlingen mindst gives indtil HBsAgserokonvertering, eller indtil der er tegn på ophør af effekt.
English: Rare (may affect up to 1 in 1,000 people) - Excess of lactic acid in the blood (lactic acidosis) - Muscle breakdown (rhabdomyolysis)
Danish: Sjælden (kan forekomme hos 1 ud af 1.000 patienter) Forhøjet indhold af mælkesyre i blodet (laktatacidose) Muskelnedbrydning (rabdomyolyse)
English: Adjustment of the dose is required in patients with creatinine clearance < 50 ml/min, including those with end-stage renal disease (ESRD) on haemodialysis.
Danish: Justering af dosis er påkrævet hos patienter med kreatininclearance <50 ml/min, herunder patienter med nyresygdom i slutstadiet (end-stage renal disease (ESRD)) i hæmodialyse.
English: How much Sebivo to take
Danish: Så meget Sebivo skal du tage
English: • In HBeAg-positive patients without cirrhosis, treatment should be administered for at least 6-12 months after HBeAg seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBsAg seroconversion or there is evidence of loss of efficacy.
Danish: • Hos HBeAg-positive patienter uden cirrose skal behandlingen mindst gives i 6-12 måneder efter HBeAg-serokonvertering (clearing af HBeAg og HBV-DNA med påvisning af anti-HBe) er bekræftet eller indtil HBsAg-serokonvertering eller der er bevis for ophør af effekt.
English: Telbivudine-treated patients who achieved undetectable HBV DNA by PCR by week 24 had the highest rates of HBV DNA undetectability and HBeAg seroconversion (in HBeAg-positive patients), and the lowest overall rates of virological breakthrough at week 104.
Danish: Telbivudinbehandlede patienter, som opnåede ikke målbart HBV-DNA ved PCR i uge 24, havde højest forekomst af ikke målbart HBV-DNA og HBeAg serokonvertering (hos HBeAg-positive patienter), og den laveste samlede forekomst af virologisk gennembrud i uge 104.
English: 300 ml brown glass bottle with a child-resistant closure, including a polyethylene sealing disc and a guarantee ring, a polypropylene dosing cup with embossed graduations from 5 to 30 ml in 5 ml increments, and a polypropylene oral syringe with graduations of 1 ml to 10 ml in 0.5 ml increments.
Danish: 300 ml brun glasflaske med børnesikret låg, inklusive en polyethylenforseglingsskive og en sikkerhedsring, en polypropylendoseringskop præget med målestreger fra 5 til 30 ml med inddelinger på 5 ml samt en polypropylen oral sprøjte med gradueringer fra 1 ml til 10 ml med inddelinger på 0,5 ml.
English: The pharmacokinetics of telbivudine have been studied in patients (without chronic hepatitis B) with various degrees of hepatic impairment and in some patients with decompensated liver disease.
Danish: Telbivudins farmakokinetik er blevet undersøgt hos patienter (uden kronisk hepatitis B) med forskellige grader af nedsat leverfunktion og hos enkelte patienter med dekompenseret leversygdom.
English: Genotypic resistance test was performed in study NV-02B-007 (GLOBE; n = 680) in patients with virological rebound (confirmed increase of ≥ 1 log10 copies/ml HBV DNA from nadir).
Danish: Genotypisk resistens test blev udført i NV-02B-007-studiet (GLOBE; n=680) hos patienter med virologisk tilbagefald (bekræftet øgning af ≥1 log10 kopier/ml HBV-DNA fra nadir).
English: The tablet can be taken with or without food.
Danish: Tabletten kan tages sammen med mad eller uden mad.
English: HBeAg seroconversion and loss assessed only in patients with detectable HBeAg at baseline.
Danish: HBeAg-serokonvertering og -tab kun vurderet hos patienter med detekterbart HBeAg ved studiestart.
English: If you experience muscle pain, severe and persistent stomach pain with nausea and vomiting, severe and persistent trouble breathing, tiredness or abdominal discomfort while taking Sebivo, call your doctor immediately.
Danish: Hvis du oplever muskelsmerter, svære og vedvarende mavesmerter med kvalme og opkastning, svær og vedvarende vejrtrækningsbesvær, træthed eller mavegener ubehag, mens du tager Sebivo, skal du straks kontakte din læge.
English: What you need to know before you take Sebivo
Danish: Det skal du vide, før du begynder at tage Sebivo
English: Moreover, in the subgroup of patients with baseline ALT levels ≥ 2x ULN (320), a significantly higher proportion of telbivudine patients than lamivudine patients achieved HBeAg seroconversions at week 104 (36% vs 28%, respectively).
Danish: I undergruppen af patienter med baseline ALAT-niveauer ≥2x ULN (320), var der yderligere en signifikant højere andel af telbivudin-patienter i forhold til lamivudin-patienter, der modtog HBeAg serokonvertering i uge 104 (henholdsvis 36 % og 28 %).
English: The pack contains an oral dosing cup made of polypropylene with embossed graduations from 5 to 30 ml in 5 ml increments and a polypropylene oral syringe with graduations of 1 ml to 10 ml in 0.5 ml increments.
Danish: Pakningen indeholder en oral doseringskop af polypropylen præget med målestreger fra 5 til 30 ml med indelinger på 5 ml samt en polypropylen oral sprøjte med målestreger fra 1 ml til 10 ml med inddelinger på 0,5 ml.
English: HBeAg-positive n = 443 and 444, HBeAg-negative n = 219 and 219, for both telbivudine and lamivudine groups, respectively.
Danish: HBeAg-positive n=443 og 444, HBeAg-negative n=219 og 219 for henholdsvis telbivudin- og lamivudingruppen.
English: PCR Assay (lower limit of quantification  300 copies/ml).
Danish: PCR-analyse (nedre kvantificeringsgrænse ≤300 kopier/ml).
English: On-treatment response parameters at week 24 that predicted emergence of drug resistant virus by week 104 were HBV DNA > 300 copies/ml and elevation of serum ALT.
Danish: Parametre der, under behandling i uge 24, kunne forudsige udvikling af lægemiddelresistent virus efter 104 uger, var HBV-DNA>300 kopier/ml og øgning af serum ALAT.
English: In the overall ITT population the cumulative resistance rates at year 4 for HBeAg-positive and HBeAg-negative patients, was 40.8% (131/321) and 18.9% (37/196), respectively.
Danish: I den samlede ITT population var den kumilative resistenshyppighed for HBeAg-positive og HbeAgnegative patienter respektivt 40,8 % (131/321) og 18,9 % (37/196) efter 4 år.
English: HBeAg-positive n = 440 and 446, HBeAg-negative n = 203 and 207, for telbivudine and lamivudine groups, respectively.
Danish: HBeAg-positive n=440 og 446, HBeAg-negative n=203 og 207 for henholdsvis telbivudin- og lamivudingruppen.
English: - Uncommonly Sebivo can induce numbness, tingling, pain and/or burning sensations in the arms and/or legs (peripheral neuropathy).
Danish: - I sjældne tilfælde kan Sebivo forårsage følelsesløshed, prikken, smerte og/eller brændende fornemmelser i armene og/eller benene (perifer neuropati).
English: Patients with cirrhosis with decompensation
Danish: Patienter med cirrose med dekompensation
English: Close the bottle by screwing the cap back on tightly.
Danish: Luk flasken ved at skrue låget fast på igen.
English: Benzoic acid (E210) Sodium saccharin Passion fruit flavouring Sodium hydroxide Citric acid anhydrous Water, purified
Danish: Benzoesyre (E210) Saccharinnatrium Passionsfrugtsmagstof Natriumhydroxid Citronsyre, vandfri Vand, renset
English: Sebivo can cause an excess of lactic acid in the blood (lactic acidosis) which is usually associated with an enlargement of the liver (hepatomegaly).
Danish: Sebivo kan være årsag til en stor mængde mælkesyre i blodet (mælkesyreacidose), som for det meste er forbundet med leverforstørrelse (hepatomegali).
English: HBeAg-positive patients (n = 293*)
Danish: HBeAg-positiv patienter (n=293*)
English: At week 24, 203 HBeAg-positive and 177 HBeAg-negative subjects achieved non-detectable HBV DNA levels.
Danish: I uge 24 havde 203 HBeAg-positive og 177 HBeAg-negative forsøgspersoner opnået ikkedetekterbare HBV-DNA-niveauer.
English: Liver transplant recipients
Danish: Levertransplanterede patienter
English: Study CLDT600ACN04E1 - Impact of treatment on liver histology In study CLDT600ACN04E1, 57 patients with available paired liver biopsies at baseline and after mean treatment of 260.8 weeks were evaluated for changes in liver histology (38 HBeAg-positive and 19 HBeAg-negative patients).
Danish: CLDT600ACN04E1-studiet - Betydning af behandling på lever histologi I CLDT600ACN04E1-studiet blev 57 patienter med tilgængelige parrede lever biopsier ved baseline og efter gennemsnitlig behandling i 260,8 uger evalueret for potentielle forandringer i lever histologi (38 HBeAg-positive og 19 HBeAg-negative patienter).
English: Creatine kinase elevation
Danish: Kreatinkinaseforhøjelse
English: The safety and efficacy of telbivudine in liver transplant recipients are unknown.
Danish: Man har ingen viden om telbivudins sikkerhed og effekt hos levertransplanterede patienter.
English: Following once-daily administration of telbivudine 600 mg, steady-state trough plasma concentrations were approximately 0.2-0.3 g/ml.
Danish: Efter administration 1 gang dagligt af telbivudin 600 mg var laveste plasmakoncentrationer ved steady-state ca. 0,2-0,3 µg/ml.
English: Immediately rinse the dosing cup with water.
Danish: Rengør straks doseringskoppen med vand.
English: Peripheral neuropathy, dysgeusia, hypoaesthesia, paresthesia, sciatica
Danish: Perifer neuropati, smagsforstyrrelse, nedsat følsomhed, paræstesi, iskias
English: HBV encoding the adefovir resistance-associated substitutions rtN236T or rtA181V had around 0.3- and 4fold change in susceptibility to telbivudine in cell culture, respectively (see section 4.4).
Danish: HBV, der indkodede de adefovirresistens-associerede substitutioner, rtN236T eller rtA181V, havde henholdsvis omkring 0,3og 4-gange ændring i følsomhed for telbivudin i cellekultur (se pkt.
English: No adjustment of the recommended dose of telbivudine is necessary in patients whose creatinine clearance is  50 ml/min.
Danish: Justering af den anbefalede dosis af telbivudin er ikke nødvendig hos patienter, hvis kreatininclearance er 50 ml/min.
English: The safety and efficacy of long-term (104 weeks) Sebivo treatment were evaluated in two activecontrolled clinical studies that included 1,699 patients with chronic hepatitis B (NV-02B-007 (GLOBE) and NV-02B-015).
Danish: Sikkerhed og effekt af langtidsbehandling (104 uger) med Sebivo blev evauleret i to aktivt kontrollerede kliniske studier, hvori der blev inkluderet 1.699 patienter med kronisk hepatitis B (NV02B-007 (GLOBE) og NV-02B-015).
English: Based on the results shown in Table 9, adjustment of the dose interval for telbivudine is recommended in patients with creatinine clearance of  50 ml/min (see sections 4.2 and
Danish: På basis af de resultater, der er vist i Tabel 9, anbefales justering af dosisintervallet for telbivudin hos patienter med kreatininclearance på <50 ml/min (se pkt.
English: Oral dosing cup for measuring out the dose.
Danish: Oral doseringskop til at udmåle dosis.
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system (see section 5.2).
Danish: Telbivudin er ikke et substrat, en hæmmer eller inducer af cytokrom P450 (CYP450)-enzymsystemet (se pkt.
English: The efficacy and safety results of the NV-02B-007 (GLOBE) study were confirmed in study NV-02B015.
Danish: Resultaterne af effekt og sikkerhed fra NV-02B-007 (GLOBE)-studiet blev bekræftet i NV-02B-015studiet.