FrancophonIA/ELRC3.0 huggingface dataset:
English: In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39 % of the subjects.
Danish: I et længerevarende follow-up-studie med patienter, som tidligere havde serokonverteret og som var stoppet med lamivudin, opstod der sent virologisk tilbagefald hos 39 % af personerne.
English: These medicines should not be used with Zeffix:
Danish: Disse lægemidler må ikke tages sammen med Zeffix:
English: Substances shown to be predominately excreted either via the active organic anionic pathway, or by glomerular filtration are unlikely to yield clinically significant interactions with lamivudine.
Danish: Det er ikke sandsynligt, at stoffer som påviseligt overvejende udskilles enten via den aktive organiske anioniske vej eller ved glomerulær filtration giver klinisk betydende interaktioner med lamivudin.
English: There were no observed clinically significant adverse interactions in patients taking lamivudine concurrently with commonly used immunosuppressant medicinal products (e.g. cyclosporin A).
Danish: Der er ikke set nogen uønskede klinisk betydende interaktioner hos patienter, som tager lamivudin samtidig med almindeligt anvendte immunsupprimerende lægemidler (f.eks. ciclosporin A).
English: Lamivudine-TP acts as a substrate for the HBV viral polymerase.
Danish: Lamivudin-TP fungerer som et substrat for HBV viral polymerase.
English: Based on more than 200 mother/child pairs treated for HIV, serum concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (less than 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Danish: Baseret på erfaringer fra mere end 200 mor/barn par i hiv-behandling var serumkoncentationen af lamivudin hos ammede spædbørn, hvis mødre var i hiv-behandling, meget lav (mindre end 4 % af maternal serumkoncentration) og faldt gradvist til udetekterbare niveauer, når de ammede spædbørn nåede 24 ugers alderen.
English: Lamivudine serum concentrations (AUC) are increased in patients with moderate to severe renal impairment due to decreased renal clearance.
Danish: Serumkoncentrationen af lamivudin (AUC) er øget hos patienter med moderat til svært nedsat nyrefunktion som følge af nedsat renal clearance.
English: Available human data from the Antiretroviral Pregnancy Registry reporting more than 1000 outcomes from first trimester and more than 1000 outcomes from second and third trimester exposure in pregnant women indicate no malformative and foeto/neonatal effect.
Danish: Tilgængelige humane data fra det Antiretrovirale Graviditetsregister rapporterer om flere end 1.000 graviditeter med eksponering i første trimester og flere end 1.000 graviditeter med eksponering i andet og tredje trimester; data tyder ikke på misdannelser og føtal/neonatal effekt.
English: The risk for developing YMDD mutant was 63% versus 13% with a cut off of 1000 copies/ml (NUCB3009 and NUCB3018).
Danish: Risikoen for udvikling af YMDD-mutation var 63 % versus 13 % ved cut off værdi på 1.000 kopier/ml (NUCB3009 og NUCB3018).
English: 1 Remove the child-proof bottle cap (A).
Danish: 1 Fjern det børnesikre låg (A).
English: The standard recommended procedures for hepatitis B virus immunisation in infants should be followed.
Danish: Det anbefalede standard hepatitis B-vaccinationsprogram til spædbørn bør følges.
English: With prolonged treatment, regular reassessment is recommended to confirm that continuation of the selected therapy remains appropriate for the patient.
Danish: Med forlænget behandling anbefales det, at der foretages regelmæssige revurderinger, for at fastslå at fortsættelse af behandlingen er passende for den enkelte patient.
English: When lamivudine therapy was continued post transplantation there was reduced graft re-infection by HBV, increased HBsAg loss and on one-year survival rate of 76 - 100 %.
Danish: Hvis behandling med lamivudin blev fortsat efter transplantationen, var der nedsat HBV-reinfektion af transplantatet, øget tab af HBsAg og på et år en overlevelsesrate på 76-100 %.
English: Lamivudine has no pharmacokinetic interaction with alpha-interferon when the two medicinal products are concurrently administered.
Danish: Lamivudin har ingen farmakokinetisk interaktion med alfa-interferon, når de to lægemidler gives samtidigt.
English: This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage.
Danish: Det betyder, at der vil blive taget blodprøver for at kontrollere, om der er forhøjet niveau af leverenzymer, som kan tyde på leverskade.
English: The incidence of YMDD mutant HBV was similar to that observed in adults, ranging from 19 % at week 52 up to 45 % in patients treated continuously for 24 months.
Danish: Forekomsten af YMDD-mutationHBV var ens med den, der blev observeret hos voksne, fra 19 % ved uge 52 op til 45 % hos patienter i vedvarende behandling i 24 måneder.
English: Patients categorised as non-YMDD mutant were those with > 95% wild-type HBV at all annual time-points during the 5-year study period
Danish: Patienter kategoriseret som uden YMDD-mutation var patienter med > 95 % wild-type HBV på alle årlige tidspunkter under den 5-årige studieperiode.
English: The active ingredient in Zeffix is lamivudine.
Danish: Det aktive lægemiddelstof i Zeffix er lamivudin.
English: Limited data shows lamivudine penetrates the central nervous system and reaches the cerebro-spinal fluid (CSF).
Danish: Begrænsede data viser, at lamivudin penetrerer centralnervesystemet og når ud i cerebrospinalvæsken.
English: The oral solution contains propyl and methyl parahydroxybenzoate.
Danish: Den orale opløsning indeholder propyl- og methylparahydroxybenzoat.
English: Treatment with Zeffix can reduce the amount of hepatitis B virus in your body.
Danish: Behandling med Zeffix kan nedsætte mængden af hepatitis B-virus i kroppen.
English: Lamivudine is predominantly eliminated by active organic cationic secretion.
Danish: Lamivudin udskilles hovedsageligt ved aktiv organisk kationisk sekretion.
English: Lamivudine is predominately cleared by renal excretion of unchanged substance.
Danish: Lamivudin udskilles hovedsageligt ved renal ekskretion af uomdannet stof.
English: ALT  2 x baseline value and absolute ALT > 500 IU/l ALT  2 x baseline value; and bilirubin > 2 x ULN and  2 x baseline value *Each patient may be represented in one or more category.
Danish: ALAT ≥ 2 x baseline-værdien og absolut ALAT > 500 IU/I ALAT ≥ 2 x baseline-værdien; og bilirubin > 2 x ULN og ≥ 2 x baseline-værdien *Hver patient kan være repræsenteret i en eller flere kategorier.
English: As the in vitro mutagenic activity of lamivudine could not be confirmed by in vivo tests, it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing treatment.
Danish: Da lamivudins mutagene aktivitet in vitro ikke bekræftes i in vivo tests, kan det konkluderes, at der ikke skulle være risiko for genotoksicitet hos patienter i behandling med lamivudin.
English: The other ingredients are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, polysorbate 80, synthetic yellow and red iron oxide.
Danish: De øvrige indholdsstoffer er: Mikrokrystallinsk cellulose, natriumstivelsesglycolat, magnesiumstearat, hypromellose, titandioxid, macrogol 400, polysorbat 80, syntetisk gul og rød jernoxid.
English: The mean systemic clearance of lamivudine is approximately 0.3 l/h/kg.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er ca. 0,3 l/h/kg.
English: In assays relating to potential substance effects on mitochondrial structure and DNA content and function, lamivudine lacked appreciable toxic effects.
Danish: I studier med henblik på at fastslå potentiel stofeffekt på mitokondriestruktur, DNA-indhold og funktion havde lamivudin ingen væsentlige toksiske virkninger.
English: There is no information available on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with lamivudine.
Danish: Der er begrænset information om maternel-føtal transmission af hepatitis B-virus hos gravide kvinder i behandling med lamivudin.
English: Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues showed activity in an in vitro cytogenetic assay and the mouse lymphoma assay.
Danish: Lamivudin var ikke mutagent i bakterietests, men viste som mange andre nukleosidanaloger aktivitet i en in vitro cytogenprøve og i muse-lymfomprøven.
English: Cladribine
Danish: Cladribin
English: Therapy with Zeffix should be initiated by a physician experienced in the management of chronic hepatitis B.
Danish: Behandling med Zeffix bør initieres af en læge med erfaring i behandling af kronisk hepatitis B.
English: Therefore, following HBeAg seroconversion, patients should be periodically monitored to determine that serologic and clinical responses are being maintained.
Danish: Efter HBeAg-serokonversion bør patienterne derfor monitoreres periodisk for at afgøre om det serologiske og kliniske respons opretholdes.
English: Forty patients (HBeAg negative or HBeAg positive) with either decompensated liver disease or recurrent HBV following liver transplantation and YMDD mutant were enrolled into an open label arm of study NUC20904.
Danish: Fyrre patienter (HbeAg-negative eller HbeAg-positive) med enten dekompenseret leversygdom eller recidiverende HBV efter levertransplantation og med YMDD-mutation blev inkluderet i en åben arm i studiet NUC20904.
English: Lamivudine is an antiviral agent which is active against hepatitis B virus in all cell lines tested and in experimentally infected animals.
Danish: Lamivudin er et antiviralt stof, som er yderst aktivt mod hepatitis B-virus i alle afprøvede cellelinjer og i eksperimentelt inficerede forsøgsdyr.
English: Zeffix film-coated tablets are supplied in tamper evident foil blisters containing 28 or 84 tablets.
Danish: Zeffix filmovertrukne tabletter leveres i forseglede blisterfolie med 28 eller 84 tabletter.
English: Lamivudine is metabolised by both infected and uninfected cells to the triphosphate (TP) derivative which is the active form of the parent compound.
Danish: Lamivudin metaboliseres af både inficerede og ikke-inficerede celler til triphosphat (TP)-derivatet, som er den aktive form af udgangsstoffet.
English: Furthermore, lamivudine-TP has little effect on mammalian cell DNA content.
Danish: Desuden har lamivudin-TP lille indvirkning på DNA-indholdet i mammale celler.
English: For lamivudine-treated patients, the majority of post-treatment ALT elevations occurred between 8 and 12 weeks post-treatment.
Danish: For patienter, der havde været i behandling med lamivudin, forekom de fleste tilfælde af stigning i ALAT efter behandlingsophør mellem 8 og 12 uger efter behandlingen.
English: However, disease progression in YMDD subjects in the lamivudine group was lower than the disease progression in the placebo group (23/209, 11 % versus 38/214, 18 % respectively).
Danish: Sygdomsprogressionen hos YMDD-patienterne i lamivudingruppen var dog lavere end sygdomsprogressionen i placebogruppen (henholdsvis 23/209, 11 % versus 38/214, 18 %).
English: If you are already taking another medicine that contains lamivudine for HIV infection, your doctor will continue to treat you with the higher dose, (usually 150 mg twice a day), because the dose of lamivudine in Zeffix (100 mg) is not enough to treat HIV infection.
Danish: Hvis du allerede tager anden medicin, der indeholder lamivudin, for hiv-infektion, vil lægen fortsætte med at behandle dig med en højere dosis (sædvanligvis 150 mg 2 gange daglig), fordi dosis af lamivudin i Zeffix (100 mg) ikke er tilstrækkelig høj til at behandle en hiv-infektion.
English: Cartons containing 240 ml lamivudine oral solution in an opaque, white, high-density polyethylene (HDPE) bottle with a polypropylene child resistant closure.
Danish: Pakning med 240 ml lamivudin oral opløsning i en uigennemsigtig, hvid high density polyethylen (HDPE)flaske med børnesikret låg af polypropylen.
English: In an extended treatment study in Asian patients (NUCB3018) the HBeAg seroconversion rate and ALT normalisation rate at the end of the 5 year treatment period was 48 % (28/58) and 47 % (15/32), respectively.
Danish: I et udvidet behandlingsstudie med asiatiske patienter (NUCB3018) var HBeAg-serokonversionsraten og ALAT-normaliseringsraten ved slutningen af den 5-årige behandlingsperiode henholdsvis 48 % (28/58) og 47 % (15/32).
English: A very rare side effect (these may affect up to 1 in 10,000 people) is: • lactic acidosis (excess lactic acid in the blood).
Danish: En meget sjælden bivirkning (kan forekomme hos op til 1 ud af 10.000 personer) er: • laktacidose (for meget mælkesyre i blodet).
English: Data are limited on the use of lamivudine in HBeAg negative (pre-core mutant) patients and in those receiving concurrent immunosuppressive regimes, including cancer chemotherapy.
Danish: Der er begrænsede oplysninger om brugen af lamivudin til HBeAg-negative (præ-core mutant) patienter og til de brugere, som samtidig er i immunsupprimerende behandling, herunder cancerkemoterapi.
English: Due to similarities, Zeffix should not be administered concomitantly with other cytidine analogues, such as emtricitabine.
Danish: På grund af lighedspunkter må Zeffix ikke administreres sammen med andre cytidinanaloger, såsom emtricitabin.
English: In the controlled Phase III trials with no-active-treatment follow-up, the incidence of post-treatment ALT elevations (more than 3 times baseline) was higher in lamivudine-treated patients (21%) compared with those receiving placebo (8%).
Danish: I kontrollerede fase III-studier med ikke-aktiv behandlings-follow up var hyppigheden af stigning i ALAT (mere end tre gange baseline) efter behandlingsophør højere hos patienter i behandling med lamivudin (21 %) sammenlignet med patienter i behandling med placebo (8 %).
English: Zeffix can be used in people whose liver is damaged, but still functions normally (compensated liver disease) and in combination with other medicines in people whose liver is damaged and does not function normally (decompensated liver disease).
Danish: Zeffix kan bruges til patienter, hvis lever er skadet, men stadig fungerer normalt (kompenseret leversygdom), og i kombination med anden medicin til patienter, hvis lever er skadet, og som ikke længere fungerer normalt (dekompenseret leversygdom).
English: - Week 260 4 negative positive < baseline positive > baseline
Danish: - Uge 2604 negativ positiv < baseline positiv > baseline
English: Lamivudine-TP does not interfere with normal cellular deoxynucleotide metabolism.
Danish: Lamivudin-TP påvirker ikke den normale cellulære deoxynukleotidmetabolisme.
English: Reproductive studies in animals have shown no effect on male or female fertility (see section 5.3).
Danish: Fertilitet Reproduktionsstudier i dyr har ikke vist nogen virkning på mandlig eller kvindelig fertilitet (se pkt.
English: • emtricitabine, used to treat HIV or hepatitis B infection
Danish: • emtricitabin, der bruges til behandling af hiv- eller hepatitis B-infektion
English: Pharmacotherapeutic group - Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC Code: J05AF05.
Danish: Farmakoterapeutisk klassifikation - Antivirale midler til systemisk brug, nukleosid og nukleotid revers transkriptase-hæmmere, ATC-kode: J05AF05.
English: • swelling of eyelids, face or lips
Danish: • hævelser i ansigtet, hævede øjenlåg eller læber
English: Lamivudine had no effect on the pharmacokinetics of trimethoprim or sulphamethoxazole.
Danish: Lamivudin påvirker ikke farmakokinetikken af trimethoprim eller sulfamethoxazol.
English: Summary of the safety profile
Danish: Sammenfatning af bivirkningsprofilen
English: Any child exposed in utero to nucleoside and nucleotide analogues, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in cases which have relevant signs or symptoms.
Danish: Børn, som før fødslen har været eksponeret for nukleosid- og nukleotidanaloger, bør følges og monitoreres klinisk og undersøges grundigt for mulige mitokondrielle forstyrrelser i tilfælde af tegn og symptomer herpå.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Danish: Glaxo Operations UK Limited(registreret som Glaxo Wellcome Operations)
English: In patients who do not maintain a sustained serological response, consideration should be given to retreatment with either lamivudine or an alternative antiviral agent for resumption of clinical control of HBV.
Danish: Hos patienter, som ikke opretholder et vedvarende serologisk respons, bør behandling med enten lamivudin eller et andet antiviralt lægemiddel overvejes for at genoprette klinisk kontrol af HBV.
English: Zeffix oral solution is supplied in cartons containing a white polyethylene bottle, with a child resistant cap.
Danish: Zeffix oral opløsning leveres i æsker, der indeholder en hvid polyethylenflaske med børnesikret låg.
English: Do not throw away any medicines in your wastewater or household rubbish.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: The difference in the HBeAg seroconversion rates (HBeAg and HBV DNA loss with HBeAb detection) between placebo and lamivudine was not statistically significant in this population (rates after one year were 13 % (12/95) for placebo versus 22 % (42/191) for lamivudine; p=0.057).
Danish: Forskellen i HBeAg-serokonversions hastighed (HBeAg og HBV-DNA tab ved HbeAb-detektion) mellem placebo og lamivudin var ikke statistisk signifikant i denne population (forekomsten efter 1 år var 13 % (12/95) for placebo versus 22 % (42/191) for lamivudin; p=0,057).
English: Contents of the pack and other information What Zeffix contains
Danish: Pakningsstørrelser og yderligere oplysninger Zeffix indeholder
English: Reproductive studies in animals have not shown evidence of teratogenicity and showed no effect on male or female fertility.
Danish: Reproduktionsstudier i dyr har ikke vist tegn på teratogenese og viste ingen effekt på fertiliteten hos hverken hanner eller hunner.
English: Clear, colourless to pale yellow in colour.
Danish: Klar og farveløs til svagt gul.
English: PHARMACEUTICAL FORM AND CONTENTS Each bottle contains 240 ml oral solution The pack contains an oral applicator.
Danish: Hver flaske indeholder 240 ml oral opløsning Pakningen indeholder en oral applikator.
English: Table 2: Efficacy results 5 years by YMDD status (Asian Study) NUCB3018
Danish: Tabel 2: Resultater på effekt efter 5 år med YMDD-status (asiatisk studie) NUCB3018 Personer, % (nr.)
English: The rate of overall disease progression in the lamivudine group was higher for subjects with detectable YMDD mutant HBV DNA (23/209, 11 %) compared to those without detectable YMDD mutant HBV (11/221, 5 %).
Danish: Hyppigheden af overordnet sygdomsprogression i lamivudingruppen var højere for patienter med detekterbar YMDD-mutation-HBV-DNA (23/209, 11 %) sammenlignet med dem uden detekterbar YMDD-mutation-HBV (11/221, 5 %).
English: After two years of treatment in this study, ALT normalisation and undetectable HBV DNA occurred in 30/69 (43 %) and 32/68 (47 %) patients respectively and improvement in necroinflammatory score in 18/49 (37 %) patients.
Danish: Efter to års behandling i dette studie, opstod der ALATnormalisering og udetekterbar HBV-DNA hos henholdsvis 30/69 (43 %) og 32/68 (47 %) af patienterne, og forbedring af nekroinflammatorisk score hos 18/49 (37 %) af patienterne.
English: Maternal hepatitis B is not a contraindication to breast-feeding if the newborn is adequately managed for hepatitis B prevention at birth, and there is no evidence that the low concentration of lamivudine in human milk leads to adverse reactions in breastfed infants.
Danish: Amning er ikke kontraindiceret ved maternel hepatitis B, hvis barnet er blevet passende behandlet med hensyn til forebyggelse af hepatitis B ved fødslen, og der er ingen tegn på, at lave koncentrationer af lamivudin i modermælken fører til bivirkninger hos det ammede spædbarn.
English: Zeffix is indicated for the treatment of chronic hepatitis B in adults with:
Danish: Zeffix er indiceret til behandling af kronisk hepatitis B hos voksne med:
English: Five percent (3/56) of patients without the YMDD mutant and 13 % (11/82) of patients with YMDD mutant showed worsening in liver inflammation compared to pre-treatment.
Danish: Fem procent (3/56) af patienterne uden YMDD-mutation og 13 procent (11/82) af patienterne med YMDD-mutation udviste forværring i leverinflammation sammenlignet med præ-behandling.
English: Exacerbations after treatment discontinuation
Danish: Forværring efter seponering af behandling
English: For HIV co-infected patients not requiring anti-retroviral therapy, there is a risk of HIV mutation when using lamivudine alone for treating chronic hepatitis B.
Danish: Til patienter med samtidig hiv-infektion, som ikke behøver antiretroviral behandling, er der en risiko for hiv-mutation, når lamivudin bruges som monoterapi til behandling af kronisk hepatitis B.
English: Exacerbations in patients with decompensated cirrhosis Transplantation recipients and patients with decompensated cirrhosis are at greater risk from active viral replication.
Danish: Transplanterede og patienter med dekompenseret cirrose har større risiko for aktiv virusreplikation.
English: Development of YMDD mutant HBV is associated with reduced treatment response in some patients, as evidenced by increased HBV DNA levels and ALT elevations from previous on-therapy levels, progression of signs and symptoms of hepatitis disease and/or worsening of hepatic necroinflammatory findings.
Danish: Udvikling af YMDD-mutation-HBV er associeret med reduceret behandlingsrespons hos nogle patienter, som viser sig ved øgede HBV-DNA-niveauer og forhøjelse af ALAT fra tidligere terapiniveauer, progression af tegn og symptomer på hepatitis sygdom og/eller forværring af hepatiske nekroinflammatoriske fund.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR TABLETS: 28 tablet box, 84 tablet box
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL TABLETTER: 28 TABLETTER, 84 TABLETTER
English: ALT normalisation
Danish: ALAT-normalisering
English: If lamivudine is discontinued, patients should be periodically monitored for evidence of recurrent hepatitis (see section 4.4).
Danish: Hvis lamivudin seponeres, bør patienterne undersøges regelmæssigt for tegn på recidiverende hepatitis (se pkt.
English: Data available in patients undergoing intermittent haemodialysis (for less than or equal to 4 hrs dialysis 2-3 times weekly), indicate that following the initial dosage reduction of lamivudine to correct for the patient's creatinine clearance, no further dosage adjustments are required while undergoing dialysis.
Danish: Data fra patienter i intermitterende hæmodialyse (i op til 4 timers dialyse 2-3 gange ugentligt) indikerer, at der ikke er behov for yderligere dosisjustering under dialysebehandlingen efter den initiale dosisreduktion af lamivudin for at korrigere for patientens kreatininclearance.
English: This degree of viral suppression was maintained (follow-on study NUC20917) with combined therapy during the second year of treatment to week 104 and most patients had improved markers of liver function and continued to derive clinical benefit.
Danish: Denne grad af virussuppression blev opretholdt (follow on studie NUC20917) med kombinationsbehandling i det andet behandlingsår frem til uge 104, og størsteparten af patienterne havde forbedrede leverfunktionsmarkører og fortsat klinisk fordel af behandlingen.
English: Butterscotch coloured, film-coated, capsule shaped, biconvex, approximate dimensions 11mm x 5mm and engraved “GX CG5” on one face.
Danish: Karamelfarvede, filmovertrukne, kapselformede, bikonvekse, omtrentlig dimension 11 mm x 5 mm og præget “GX CG5” på den ene side.
English: The combination of lamivudine with cladribine is not recommended (see section 4.5).
Danish: Kombination af lamivudin med cladribin anbefales ikke (se pkt.