FrancophonIA/ELRC3.0 huggingface dataset:
English: HBeAg seroconversion was increased in patients with elevated ALT levels; 77 % (20/26) of patients with pre-treatment ALT > 2 x ULN seroconverted.
Danish: HBeAg-serokonversion var øget hos patienter med forhøjede ALAT-niveauer; 77 % (20/26) patienter, med præ-behandling ALAT > 2 x ULN, serokonverterede.
English: • if you're allergic to lamivudine or to any of the other ingredients of this medicine (listed in Section 6).
Danish: • hvis du er allergisk over for lamivudin eller et af de øvrige indholdsstoffer i Zeffix (angivet i punkt 6).
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays low plasma protein binding to albumin.
Danish: Lamivudin udviser lineær farmakokinetik i hele det terapeutiske doseringsinterval med begrænset plasmaproteinbinding til albumin.
English: If overdose occurs the patient should be monitored and standard supportive treatment applied as required.
Danish: Hvis overdosering finder sted, bør patienten overvåges, og symptomatisk behandling iværksættes om nødvendigt.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Harmire Road
Danish: Glaxo Operations UK Limited (registreret som Glaxo Wellcome Operations) Harmire Road
English: County Durham DL12 8DT
Danish: Barnard Castle County Durham DL12 8DT Storbritannien
English: Initial data indicate the efficacy of lamivudine in patients with HBeAg negative CHB is similar to patients with HBeAg positive CHB, with 71 % of patients having HBV DNA suppressed below the detection limit of the assay, 67 % ALT normalisation and 38 % with improvement in HAI after one year of treatment.
Danish: Initiale data indikerer, at effekten af lamivudin hos patienter med HBeAg-negativ CHB er ens med effekten hos patienter med HBeAg-positiv CHB, 71 % af patienterne har HBV-DNA suppression under detektionsgrænsen for assayet, 67 % ALAT-normalisering og 38 % med forbedring i HAI efter et års behandling.
English: The tablets are butterscotch coloured, capsule shaped, biconvex and engraved “GX CG5” on one side.
Danish: Tabletterne er karamelfarvede, filmovertrukne, kapselformede, bikonvekse og præget “GX CG5” på den ene side.
English: A comparison of post-treatment ALT elevations between weeks 52 and 68 in patients who discontinued lamivudine at week 52 and patients in the same studies who received placebo throughout the treatment course is shown in Table 3.
Danish: En sammenligning af post-behandling ALAT-stigninger mellem uge 52 og uge 68 hos patienter, som ophørte med lamivudin behandling i uge 52 og patienter, fra samme studier, som modtog placebo under hele behandlingsforløbet er vist i tabel 3.
English: Film-coated tablet:
Danish: Filmovertrukken tablet:
English: Zeffix is used to treat long term (chronic) hepatitis B infection in adults.
Danish: Zeffix bruges til behandling af langvarig (kronisk) hepatitis B-infektion hos voksne.
English: In patients with decompensated liver disease, lamivudine should always be used in combination with a second agent, without cross-resistance to lamivudine, to reduce the risk of resistance and to achieve rapid viral suppression.
Danish: Hos patienter med dekompenseret leversygdom bør lamivudin altid anvendes i kombination med et andet lægemiddel uden krydsresistens over for lamivudin, for at nedsætte risikoen for resistens og for at opnå hurtig virussuppression.
English: Following HBeAg seroconversion, serologic response and clinical remission are generally durable after stopping lamivudine.
Danish: Efter HBeAg-serokonversion er serologisk respons og klinisk bedring generelt vedvarende når behandling med lamivudin stoppes.
English: A side effect which may show up in blood tests is:
Danish: En almindelig bivirkning, som kan vise sig i blodprøver, er:
English: In elderly patients, normal ageing with accompanying renal decline has no clinically significant effect on lamivudine exposure, except in patients with creatinine clearance of < 50 ml/min.
Danish: Hos ældre patienter, har normal aldring og ledsagende nedsat nyrefunktion ingen klinisk signifikant virkning på eksponering for lamivudin, bortset fra hos patienter med kreatininclearance < 50 ml/min.
English: Most events have been self-limited, however fatalities have been observed very rarely (see section 4.4).
Danish: De fleste tilfælde har været selvbegrænsende, men dødelig udgang er rapporteret i meget sjældne tilfælde (se pkt.
English: When possible, avoid chronic co-administration of Zeffix with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Danish: Undgå vedvarende anvendelse af Zeffix sammen med sorbitolholdige lægemidler eller andre osmotisk virkende polyalkoholer eller monosaccaharidalkoholer (f.eks. xylitol, mannitol, lactitol, maltitol), når det er muligt.
English: Zeffix helps to control your hepatitis B infection.
Danish: Zeffix hjælper med til at få kontrol over din hepatitis B-infektion.
English: 100 mg once daily, Cmax is in the order of 1.1-1.5 µg/ml and trough levels were 0.015-0.020 µg/ml.
Danish: Ved terapeutiske dosisniveauer, dvs. 100 mg 1 gang daglig, er Cmax ca. 1,1-1,5 µg/ml, og Cmin-niveauer er 0,015-0,020 µg/ml.
English: Zeffix can pass into breast-milk.
Danish: Zeffix kan udskilles i mælken.
English: The most common adverse reactions reported were malaise and fatigue, respiratory tract infections, throat and tonsil discomfort, headache, abdominal discomfort and pain, nausea, vomiting and diarrhoea.
Danish: De hyppigst rapporterede bivirkninger var utilpashed og træthed, luftvejsinfektioner, ubehag i hals og fra mandler, hovedpine, mavesmerter og -ubehag, kvalme, opkastning og diarré.
English: Therefore breastfeeding may be considered in breastfeeding mothers being treated with lamivudine for HBV taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Amning kan derfor overvejes hos ammende mødre i behandling med lamivudin mod HBV under hensyntagen til fordele ved amning for barnet samt fordele ved behandling for moderen.
English: If you forget to take Zeffix
Danish: Hvis du har glemt at tage Zeffix
English: Progression to cirrhosis occurred in 4/68 (6 %) patients with the YMDD mutant, whereas no patients without the mutant progressed to cirrhosis.
Danish: Udvikling af cirrose opstod hos 4/68 (6 %) patienter med YMDD-mutation, hvorimod ingen patienter uden mutation udviklede cirrose.
English: Zeffix will not stop you passing hepatitis B infection on to other people.
Danish: Zeffix vil ikke forhindre, at du kan overføre hepatitis B-infektion til andre.
English: It has a very low potential to decrease mitochondrial DNA content, is not permanently incorporated into mitochondrial DNA, and does not act as an inhibitor of mitochondrial DNA polymerase gamma.
Danish: Det inkorporeres ikke permanent i mitokondrie-DNA, og virker ikke som hæmmer af mitokondrie-DNA gamma-polymerase.
English: Boxes containing 28 or 84 film-coated tablets in double foil blisters, laminated with polyvinyl chloride.
Danish: Pakninger med 28 eller 84 filmovertrukne tabletter i dobbeltfolie blisterpakning belagt med PVC.
English: These patients should be monitored for clinical, virological and serological parameters associated with hepatitis B, liver and renal function, and antiviral response during treatment (at least every month), and, if treatment is discontinued for any reason, for at least 6 months after treatment.
Danish: Under behandlingen bør disse patienter undersøges for kliniske, virologiske og serologiske parametre knyttet til hepatitis B, lever- og nyrefunktion og antiviralt respons (mindst hver måned) og i mindst 6 måneder efter behandling, hvis behandlingen af en eller anden grund seponeres.
English: Allergic reaction These are rare (may affect up to 1 in 1,000 people).
Danish: Disse er sjældne (kan forekomme hos op til 1 ud af 1.000 personer).
English: Improvement in bridging fibrosis occurred in 19/30 (63 %) patients without YMDD mutant and 22/44 (50 %) patients with the mutant.
Danish: Forbedring i brofibrose viste sig hos 19/30 (63 %) patienter uden YMDD-mutation og hos 22/44 (50 %) patienter med mutation.
English: In patients with either HBeAg positive or HBeAg negative CHB, the development of YMDD (tyrosine-methionine-aspartate-aspartate) mutant HBV may result in a diminished therapeutic response to lamivudine, indicated by a rise in HBV DNA and ALT from previous on-treatment levels.
Danish: Hos patienter med enten HBeAg-positiv eller HBeAg-negativ CHB kan udvikling af YMDD (tyrosinmethionin-aspartat-aspartat)-mutation-HBV resultere i et formindsket terapeutisk respons over for lamivudin, indikeret ved en stigning i HBV-DNA- og ALAT-niveauer i forhold til tidligere målte værdier under behandling.
English: Diabetic patients should be advised that each dose of oral solution (100 mg = 20 ml) contains 4 g of sucrose.
Danish: Patienter med diabetes bør orienteres om, at hver dosis oral opløsning (100 mg = 20 ml) indeholder 4 g sukker.
English: 2 Upper limit of normal
Danish: 2 Øvre normalgrænse.
English: At the highest dosage levels, minor effects on indicators of liver and kidney function were seen together with occasional reduction in liver weights.
Danish: Ved de højeste doser fandtes mindre påvirkning af indikatorer for lever- og nyrefunktion samt af og til reduktioner af levervægt.
English: Based on these data, no dose adjustment is necessary in patients with hepatic impairment unless accompanied by renal impairment.
Danish: Baseret på disse data er dosisjustering ikke nødvendig hos patienter med nedsat leverfunktion, medmindre den er ledsaget af nedsat nyrefunktion.
English: The main adverse events reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlipasemia).
Danish: De hyppigst indrapporterede bivirkninger er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlipasæmi).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR ORAL SOLUTION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL ORAL OPLØSNING
English: 84 film-coated tablets
Danish: 28 filmovertrukne tabletter 84 filmovertrukne tabletter
English: Herts SG12 0DJ United Kingdom or
Danish: Herts SG12 0DJ
English: compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and/or fibrosis.
Danish: • Kompenseret leversygdom med tegn på aktiv virusreplikation, vedvarende forhøjet niveau af serum alaninaminotransferase (ALAT) og histologiske tegn på aktiv inflammation af leveren og/eller fibrose.
English: Co-administration of sorbitol solution (3.2 g, 10.2 g, 13.4 g) with a single 300 mg dose (Adult HIV daily dose) of lamivudine oral solution resulted in dose-dependent decreases of 14%, 32%, and 36% in lamivudine exposure (AUC) and 28%, 52%, and 55% in the Cmax of lamivudine in adults.
Danish: Samtidig administration af sorbitolopløsning (3,2 g, 10,2 g, 13,4 g) med en enkelt 300 mg dosis (daglig dosis til voksen med hiv) lamivudin oral opløsning resulterede i dosisafhængige fald på 14 %, 32 % og 36 % i lamivudineksponering (AUC∞) og 28 % , 52 % og 55 % fald i lamivudins Cmax hos voksne.
English: Stop taking Zeffix.
Danish: Stop med at tage Zeffix.
English: Frequency categories are only assigned to those adverse reactions considered to be at least possibly causally related to lamivudine.
Danish: Kategorisering efter frekvens er kun foretaget for de bivirkninger, som vurderes at have en kausal sammenhæng med lamivudin.
English: First dose of Zeffix oral solution *
Danish: Initialdosis Zeffix oral opløsning *
English: Zeffix contains sucrose.
Danish: Zeffix indeholder saccharose.
English: Given the risk of YMDD mutant HBV, maintenance of lamivudine monotherapy is not appropriate in patients with detectable serum HBV DNA at or beyond 24 weeks of treatment (see section 4.4).
Danish: På grund af risikoen for YMDD-mutation-HBV er lamivudin monoterapi ikke hensigtsmæssig hos patienter med målbart serum HBV-DNA ved eller efter 24 ugers behandling (se pkt.
English: HBV viral subpopulations with reduced susceptibility to lamivudine (YMDD mutant HBV) have been identified with extended therapy.
Danish: Der er identificeret virale HBV-undergrupper med nedsat følsomhed over for lamivudin (YMDD-mutation HBV) ved langvarig behandling.
English: Side effects that were commonly reported in Zeffix clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles (see below).
Danish: I kliniske studier blev følgende bivirkninger rapporteret som almindelige: træthed, luftvejsinfektioner, ondt i halsen, hovedpine, mavepine eller -ubehag, kvalme, opkastning og diarré, stigning i leverenzymer og enzymer produceret i musklerne (se nedenfor).
English: Administration of lamivudine in animal toxicity studies at high doses was not associated with any major organ toxicity.
Danish: Administration af høje doser lamivudin i dyretoksicitetsstudier var ikke forbundet med nogen særlig organtoksicitet.
English: Frequency of emergence of YMDD mutant HBV and impact on the treatment response Lamivudine monotherapy results in the selection of YMDD mutant HBV in approximately 24 % of patients following one year of therapy, increasing to 69 % following 5 years of therapy.
Danish: Hyppighed af YMDD-mutation-HBV og påvirkning af behandlingsrespons Lamivudin-monoterapi resulterer i selektion af YMDD-mutation-HBV hos ca. 24 % af patienterne efter 1 års behandling, og stiger til 69 % efter 5 års behandling.
English: Where there is maternal transmission of HBV, despite adequate prophylaxis, consideration should be given to discontinuing breastfeeding to reduce the risk of the emergence of lamivudine resistant mutants in the infant.
Danish: I tilfælde hvor der på trods af passende forebyggende behandling sker overførsel af HBV fra moder til barn, bør det overvejes at afbryde amningen for at nedsætte risikoen for udvikling af resistens over for lamivudin hos spædbarnet.
English: Nucleoside and nucleotide analogues have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Danish: Det er påvist in vitro og in vivo, at nukleosid- og nukleotidanaloger i forskellig udstrækning forårsager skader på mitokondrierne.
English: If you are diabetic, please note that each dose of Zeffix (100 mg = 20 ml) contains 4 g of sucrose.
Danish: Hvis du har sukkersyge, skal du være opmærksom på, at hver dosis Zeffix (100 mg = 20 ml) indeholder 4 g saccharose.
English: Those with HBV DNA levels greater than 200 copies/mL at 6 months (24 weeks) of lamivudine therapy had a 60 % chance of developing the YMDD mutant compared with 8 % of those with HBV DNA levels less than 200 copies/mL at 24 weeks of lamivudine therapy.
Danish: De patienter, der havde HBV-DNA-niveauer på over 200 kopier/ml efter 6 måneders (24 ugers) behandling med lamivudin, havde en sandsynlighed på 60 % for at udvikle YMDD-mutation sammenlignet med 8 % hos de patienter, der havde HBV-DNA-niveauer på under 200 kopier/ml efter 24 måneders behandling med lamivudin.
English: Lamivudine induces early embryolethality when administered to pregnant rabbits at exposure levels comparable to those achieved in man, but not in the rat even at very high systemic exposures.
Danish: Hos gravide kaniner inducerer lamivudin tidlig embryoletalitet ved doser sammenlignelige med dem opnået hos mennesker, men dette ses ikke hos rotter selv ved meget høje systemiske eksponeringer.
English: As anticipated due to the concomitant immunosuppression, the rate of emergence of YMDD mutant HBV after 52 weeks treatment was higher (36 % - 64 %) in the liver transplant population than in the immunocompetent CHB patients (14 % - 32 %).
Danish: Som forventet på grund af den samtidige immunsuppression er der en højere grad af fremkomst af YMDDmutation-HBV efter 52 ugers behandling (36 % - 64 %) i gruppen af levertransplanterede end blandt immunkompetente CHB patienter (14 % - 32 %).
English: Viral suppression was maintained (follow-on study NUC20917) with combined therapy during the second year of treatment to week 104 with patients having continued improvement in virologic and biochemical responses.
Danish: Virussuppression blev opretholdt (follow on studie NUC20917) med kombinationsbehandling under det andet behandlingsår frem til uge 104 hos patienter, der fortsat havde forbedret virologiske og biokemiske respons.
English: From intravenous studies the mean volume of distribution is 1.3 l/kg.
Danish: Det gennemsnitlige fordelingsvolumen er 1,3 l/kg ifølge intravenøse studier.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 28 tablet box, 84 tablet box
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP 28 TABLETTER, 84 TABLETTER
English: When full, the applicator contains 10 ml of solution.
Danish: Applikatoren indeholder 10 ml opløsning, når den er fuld.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL FOR ORAL SOLUTION
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE FLASKEETIKET TIL ORAL OPLØSNING
English: In patients with YMDD mutant HBV, 18/39 (46 %) had improvements in necroinflammatory activity and 9/39 (23 %) had worsening.
Danish: Hos patienter med YMDD-mutation-HBV udviste 18/39 (46 %) forbedringer i nekroinflammatorisk aktivitet og 9/39 (23 %) udviste forværring.
English: What you need to know before you take Zeffix Do not take Zeffix:
Danish: Det skal du vide, før du begynder at tage Zeffix Tag ikke Zeffix:
English: The efficacy of lamivudine in patients co-infected with Delta hepatitis or hepatitis C has not been established and caution is advised.
Danish: Lamivudins virkning hos patienter, som er co-inficerede med hepatitis Delta eller hepatitis C er ikke klarlagt.
English: If you have further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller apotekspersonalet.
English: Accidentally taking too much Zeffix is unlikely to cause any serious problems.
Danish: Der opstår sandsynligvis ikke alvorlige problemer, hvis du ved et uheld har taget for meget Zeffix.
English: The proportion of patients who had post-treatment ALT elevations in association with an increase in bilirubin levels was low and similar in patients receiving either lamivudine or placebo.
Danish: Andelen af patienter, som havde post-behandling ALAT-stigninger i forbindelse med en stigning i bilirubin-niveauer, var lav og ensartet hos patienter, der fik enten lamivudin eller placebo.
English: EU/1/99/114/002 84 tablets
Danish: EU/1/99/114/001 28 tabletter EU/1/99/114/002 84 tabletter
English: The pharmacokinetics of lamivudine are unaffected by hepatic impairment.
Danish: Farmakokinetikken af lamivudin er upåvirket af nedsat leverfunktion.
English: Moreover, Zeffix should not be taken with any other medicinal products containing lamivudine (see section 4.4).
Danish: Derudover må Zeffix ikke tages sammen med andre lægemidler, der indeholder lamivudin (se pkt.
English: Rhabdomyolysis * In Phase III studies frequency observed in the lamivudine treatment group was not greater than observed in the placebo group
Danish: Muskellidelser, herunder myalgi og kramper* Frekvens ikke kendt Rabdomyolyse * I fase III studier var hyppigheden observeret i lamivudin-behandlingsgruppen ikke større end hyppigheden observeret i placebogruppen.
English: Normalisation of ALT levels occurred in 31 % (14/45) of patients receiving combined therapy versus 6 % (3/47) receiving lamivudine alone.
Danish: Normalisering af ALATniveauer opstod hos 31 % (14/45) af de patienter, der modtog kombinationsbehandling versus hos 6 % (3/47) af de patienter, der fik lamivudin monoterapi.
English: Acute exacerbation of hepatitis has been observed in patients who have discontinued hepatitis B therapy and is usually detected by serum ALT elevations and re-emergence of HBV DNA.
Danish: Akut forværring af hepatitis er observeret hos patienter, hvor behandling af hepatitis B er seponeret, og konstateres normalt ved stigning i serum-ALAT samt tilbagevendende forekomst af HBV-DNA.
English: The incidence of adverse reactions and laboratory abnormalities (with the exception of elevations of ALT and CPK, see below) were similar between placebo and lamivudine treated patients.
Danish: Forekomsten af bivirkninger og unormale laboratoriefund (bortset fra stigninger i ALAT og CPK se nedenfor) var ens mellem de patienter, som blev behandlet med henholdsvis lamivudin og placebo.
English: Confirmed HBeAg seroconversion occurred in 47 % (118/252) of subjects treated with lamivudine and 93 % (320/345) of subjects receiving lamivudine became HBV DNA negative (VERSANT [version 1], bDNA assay, LLOD < 0.7 MEq/ml) during the study.
Danish: Bekræftet HBeAg-serokonversion opstod hos 47 % (118/252) af de patienter, der blev behandlet med lamivudin, og 93 % (320/345) af de patienter, der fik lamivudin, blev HBV-DNA negative, (VERSANT [version 1], bDNA assay, LLOD < 0,7 MEq/ml under studiet.
English: Serum ALT and HBV DNA levels should be monitored at 3 month intervals and in HBeAg positive patients HBeAg should be assessed every 6 months.
Danish: Serum-ALAT-niveauer bør monitoreres hver 3. måned, og HBV-DNA og HBeAg hver 6. måned.
English: A very common side effect (these may affect more than 1 in 10 people) which may show up in blood tests is:
Danish: En meget almindelig bivirkning (kan forekomme hos mere end 1 ud af 10 personer), som kan vise sig i blodprøver, er:
English: • In patients with decompensated liver disease or cirrhosis and in liver transplant recipients, treatment cessation is not recommended (see section 5.1).
Danish: • Hos patienter med dekompenseret leversygdom eller cirrose samt til levertransplanterede patienter frarådes indstilling af behandling (se pkt.
English: If Zeffix is discontinued , patients should be periodically monitored both clinically and by assessment of serum liver function tests (ALT and bilirubin levels), for at least four months, and then as clinically indicated.
Danish: Hvis Zeffix seponeres, bør patienter undersøges regelmæssigt både klinisk og ved vurdering af leverfunktionsprøver (serum-ALAT- og bilirubinniveauer) i mindst 4 måneder og derefter som klinisk indiceret.
English: In order to reduce the risk of resistance in patients receiving lamivudine monotherapy, a switch to or addition of an alternative agent without cross-resistance to lamivudine based on therapeutic guidelines should be considered if serum HBV DNA remains detectable at or beyond 24 weeks of treatment (see section
Danish: For at nedsætte risikoen for resistens hos patienter i lamivudin-monoterapi kan skift til eller tilføjelse af et lægemiddel uden krydsresistens over for lamivudin overvejes, baseret på terapeutiske retningslinjer, hvis serum-HBV-DNA forbliver målbart ved eller efter 24 ugers behandling (se pkt.
English: In patients without the mutant, 20/27 (74 %) had improvements in necroinflammatory activity and 2/27 (7 %) had worsening.
Danish: Hos patienter uden mutation udviste 20/27 (74 %) forbedringer i nekroinflammatorisk aktivitet og 2/27 (7 %) udviste forværring.
English: Talk to your doctor if this applies to you.
Danish: Kontakt lægen, hvis dette gælder for dig.
English: Zeffix should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine (see section 4.5).
Danish: Zeffix må ikke tages sammen med andre lægemidler, der indeholder lamivudin eller emtricitabin (se pkt.
English: A common side effect (these may affect up to 1 in 10 people) is:
Danish: En almindelig bivirkning (kan forekomme hos op til 1 ud af 10 personer) er:
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Danish: Efter ophør med behandling bør niveauerne for serum-ALAT og for HBV-DNA følges regelmæssigt for at opdage et evt. sent virologisk tilbagefald.