FrancophonIA/ELRC3.0 huggingface dataset:
English: In long-term oral carcinogenicity studies in rats and mice, lamivudine did not show any carcinogenic potential.
Danish: I langtidskarcinogenicitetsundersøgelser hos rotter og mus efter oral administration viste lamivudin intet karcinogent potentiale.
English: A pilot study has demonstrated that zidovudine is incorporated into leukocyte nuclear DNA of adults, including pregnant women, taking zidovudine as treatment for HIV-1 infection, or for the prevention of mother to child viral transmission.
Danish: En pilotundersøgelse har vist, at zidovudin findes i leukocyt-nuklear dna hos voksne, herunder hos gravide, i behandling med zidovudin for hiv-1-infektion eller som forebyggelse af smitte fra mor til barn.
English: No specific symptoms or signs have been identified following acute overdose with zidovudine or lamivudine apart from those listed as undesirable effects.
Danish: Der er ikke iagttaget særlige tegn eller symptomer efter akut overdosering med zidovudin eller lamivudin udover dem, der er nævnt under bivirkninger.
English: Treatment with Lamivudine/Zidovudine Teva often causes a loss of fat from legs, arms and face (lipoatrophy).
Danish: Behandling med Lamivudin/Zidovudin Teva resulterer ofte i tab af fedt på benene og armene og i ansigtet (lipoatrofi).
English: Zidovudine AUC ↓12%
Danish: Zidovudin: AUC ↓12 %
English: A large amount of data on pregnant women taking lamivudine or zidovudine indicate no malformative toxicity (more than 3000 outcomes from first trimester exposure each of which over 2000 outcomes involved exposure to both lamivudine and zidovudine).
Danish: En stor datamængde fra gravide, der har fået lamivudin eller zidovudin indikerede ingen tegn på malformationer (mere end 3.000 graviditeter, hvor der er forekommet eksponering i første trimester for hvert af de to indholdsstoffer, hvoraf mere end 2.000 graviditeter involverede eksponering over for både lamivudin og zidovudin).
English: This loss of body fat has been shown to be not fully reversible after discontinuation of zidovudine.
Danish: Dette tab af kropsfedt har vist sig ikke at være fuldt reversibelt, når behandlingen med zidovudin stoppes.
English: Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited binding to the major plasma protein albumin (<36 % serum albumin in vitro).
Danish: Lamivudin udviser lineær farmakokinetik i hele det terapeutiske doseringsinterval med begrænset binding til det væsentligste plasmaprotein albumin (<36 % til serumalbumin in vitro).
English: Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of adult patients with chronic HBV infection (for details of clinical studies, see the prescribing information for lamivudine 100 mg).
Danish: Lamivudin i en dosering på 100 mg en gang daglig har vist sig også at være effektiv i behandlingen af voksne patienter med kronisk HBV-infektion (for detaljer vedrørende kliniske studier henvises til produktinformationen for lamivudin 100 mg).
English: It is rare; if it happens, it usually develops after a few months of treatment.
Danish: Hvis det indtræder, sker det oftest efter et par måneders behandling.
English: In vitro antagonism of anti-HIV activity between stavudine and zidovudine could result in decreased efficacy of both drugs.
Danish: In vitro antagonisme af anti-hivaktivitet mellem stavudin og zidovudin kan resultere i nedsat virkning af begge lægemidler.
English: Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of overdosage, although this has not been studied.
Danish: Da lamivudin kan fjernes ved dialyse, kan kontinuerlig hæmodialyse benyttes ved behandling af overdosering, skønt det ikke er undersøgt.
English: Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of antiretroviral agents.
Danish: Krydsresistens overført af M184V RT er begrænset indenfor klassen af nucleosidinhibitorer af antivirale stoffer.
English: Dosages of 180 mg/m2 four times daily in children produced similar systemic exposure (24 hour AUC 40.0 h μM or 10.7 h μg/ml) as doses of 200 mg six times daily in adults (40.7 h μM or 10.9 h μg/ml).
Danish: Doseringer til børn på 180 mg/m gange daglig giver samme systemiske eksponering (24 timers AUC: 40,0 timer μM eller 10,7 timer μg/ml) som doser på 200 mg 6 gange daglig til voksne (40,7 timer μM eller 10,9 timer μg/ml).
English: The extent of lamivudine and zidovudine absorption (AUC∞) and estimates of half-life following administration of lamivudine/zidovudine with food were similar when compared to fasting subjects, although the rates of absorption (Cmax, tmax) were slowed.
Danish: Omfanget af absorptionen af lamivudin og zidovudin (AUC∞) og den estimerede halveringstid efter indtagelse af lamivudin/zidovudin sammen med mad var den samme som for fastende individer, skønt absorptionshastighederne (Cmax, tmax) var nedsat.
English: • enlarged breasts in men.
Danish: • brystforstørrelse hos mænd
English: It is recommended that separate preparations of lamivudine and zidovudine should be administered in cases where dosage adjustment is necessary (see section 4.2).
Danish: Det anbefales, at der anvendes særskilte præparater med zidovudin og lamivudin i tilfælde, hvor dosisjustering er påkrævet (se pkt.
English: In vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine sensitive when they simultaneously acquire resistance to lamivudine.
Danish: In vitro-studier tyder på, at zidovudin-resistente virusisolater kan blive zidovudin-følsomme, hvis de samtidig udvikler resistens over for lamivudin.
English: White, capsule shaped, biconvex, film-coated scored tablet - engraved with “L/Z” on one side and “150/300” on the other side.
Danish: Hvide kapselformede, bikonvekse, filmovertrukne tabletter med delekærv, der er præget med ”L/Z” på den ene side og ”150/300” på den anden side.
English: HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the active site of the viral reverse transcriptase (RT).
Danish: Hiv-1-resistens over for lamivudin involverer udviklingen af M184V-aminosyreændringer tæt ved den aktive del af viral revers transkriptase (RT).
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør initieres af en læge med erfaring i behandling af hiv-infektion.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Danish: Nogle patienter, der tager medicin mod hiv-infektioner, får andre sygdomme, der kan være alvorlige.
English: Lamivudine: AUC ↑40% Trimethoprim: AUC ↔ Sulfamethoxazole: AUC ↔ (organic cation transporter inhibition)
Danish: Lamivudin: AUC ↑ 40 % Trimethoprim: AUC ↔ Sulfamethoxazol: AUC ↔ (Hæmning af organisk kation transportører)
English: In reproductive toxicity studies lamivudine has demonstrated evidence of causing an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in man, but not in the rat even at very high systemic exposure.
Danish: I reproduktionstoksicitetsundersøgelser har lamivudin vist tegn på at forårsage en øget forekomst af tidlig fosterdød hos kaniner ved relativt lave systemiske koncentrationer sammenlignet med dem, der opnås hos mennesker, men ikke hos rotter selv ved meget høje systemiske koncentrationer.
English: Lactic acidosis is caused by a build up of lactic acid in the body.
Danish: Laktacidose skyldes en ophobning af mælkesyre i kroppen.
English: People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections).
Danish: Patienter med fremskreden hiv-infektion (aids) kan have et svækket immunsystem og har større risiko for at få alvorlige infektioner (opportunistiske infektioner).
English: M184V mutants display greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro.
Danish: M184V mutanter udviser markant reduceret følsomhed over for lamivudin, og udviser mindsket viral replikationskapacitet in vitro.
English: The most serious adverse reactions include anaemia (which may require transfusions), neutropenia and leucopenia.
Danish: De alvorligste bivirkninger inkluderer anæmi (som kan kræve transfusion), neutropeni og leukopeni.
English: • vincristine, vinblastine or doxorubicin, to treat cancer.
Danish: • vincristin, vinblastin og doxorubicin til behandling af kræft.
English: Renal clearance of zidovudine is estimated to be 0.34 l/h/kg, indicating glomerular filtration and active tubular secretion by the kidneys.
Danish: Den renale clearance af zidovudin er estimeret til 0,34 l/time/kg, hvilket tyder på glomerulær filtration og aktiv tubulær sekretion i nyrerne.
English: Caution should be exercised when administering zidovudine to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
Danish: Der bør udvises forsigtighed ved administration af zidovudin til patienter (specielt overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdomme og fedtinfiltration på leveren (herunder visse typer medicin og alkohol).
English: Lipoatrophy: Treatment with zidovudine has been associated with loss of subcutaneous fat, which has been linked to mitochondrial toxicity.
Danish: Lipoatrofi: Behandling med zidovudin er blevet forbundet med tab af subkutant fedt, hvilket er blevet kædet sammen med mitokondriel toksicitet.
English: Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products (e.g. systemic pentamidine, dapsone, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, ganciclovir, interferon, vincristine, vinblastine and doxorubicin) may also increase the risk of adverse reactions to zidovudine.
Danish: Samtidig behandling, specielt akut behandling, med potentielt nefrotoksiske eller myelosuppressive lægemidler (f.eks. systemisk pentamidin, dapson, pyrimethamin, sulfa/trim, amphotericin B, flucytosin, ganciclovir, interferon, vincristin, vinblastin og doxorubicin) kan også øge risikoen for
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Danish: Patienter med hepatitis C, som er i behandling med alfa interferon og ribavirin, kan være specielt udsatte.
English: Monitor for signs of zidovudine toxicity (see section 4.8).
Danish: Monitorer for tegn på zidovudintoksicitet (se pkt.
English: Treatment with zidovudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Danish: Behandling med zidovudin bør stoppes hvis der opstår symptomatisk hyperlaktatæmi og metabolisk acidose/laktacidose, fremadskridende hepatomegali eller hurtigt stigende aminotransferaseniveauer.
English: Clinical end-point data indicate that lamivudine in combination with zidovudine, results in a significant reduction in the risk of disease progression and mortality.
Danish: Kliniske end-point-data indikerer, at lamivudin i kombination med zidovudin medfører en signifikant reduktion af risici for forværring af sygdommen og dødeligheden.
English: Both medicinal products are metabolised intracellularly to their active moieties, lamivudine 5'-triphosphate (TP) and zidovudine 5'-TP respectively.
Danish: Begge lægemidler metaboliseres intracellulært til deres aktive dele, henholdsvis lamivudin 5′-triphosphat (TF) og zidovudin 5'-triphosphat.
English: This conclusion is based on the physicochemical and pharmacokinetic data assuming that the patient crushes and transfers 100 % of the tablet and ingests immediately.
Danish: Dette er baseret på fysiskkemiske og farmakokinetiske data og forudsætter, at patienten opblander hele tabletten, og at hele mængden indtages straks.
English: If concomitant therapy with Lamivudine/Zidovudine Teva and any of these medicinal products is necessary then extra care should be taken in monitoring renal function and haematological parameters and, if required, the dosage of one or more agents should be reduced.
Danish: Såfremt samtidig behandling med Lamivudin/Zidovudin Teva og et af disse lægemidler er nødvendig, bør der udvises ekstra omhu med monitorering af nyrefunktion og hæmatologiske parametre, og om nødvendigt bør dosis af ét eller flere af lægemidlerne reduceres.
English: • changes in the colour of your nails, your skin or the skin inside your mouth
Danish: • farveforandringer i negle, hud og i munden
English: These occurred more frequently at higher zidovudine dosages (1200-1500 mg/day) and in patients with poor bone marrow reserve prior to treatment, particularly with advanced HIV disease.
Danish: Det ses hyppigere ved høje doser zidovudin (1200-1500 mg/dag) og hos patienter med dårlig knoglemarvsreserve forud for behandlingen, særligt ved fremskreden hiv-infektion.
English: • pentamidine or atovaquone to treat parasitic infections such as Pneumocystis jirovecii pneumonia
Danish: • pentamidin og atovaquon mod parasitinfektioner som Pneumocystis jirovecii lungebetændelse
English: Subjects receiving lamivudine and zidovudine with or without additional concomitant antiretroviral therapies and who already present with the M184V mutant virus also experience a delay in the onset of mutations that confer resistance to zidovudine and stavudine (Thymidine Analogue Mutations; TAMs).
Danish: Hos personer, der får lamivudin og zidovudin med eller uden tillæg af samtidig antiretroviral behandling, og som allerede har virus med M184V-mutationer, ses der senere fremkomst af mutationer, der medfører resistens over for zidovudin og stavudin (Thymidine Analogue Mutations: TAMs).
English: Keep in touch with your doctor, and do not stop taking Lamivudine/Zidovudine Teva without your doctor's advice.
Danish: Hold kontakt med lægen, og stop ikke med at tage Lamivudin/Zidovudin Teva uden at tale med lægen først.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt inden du begynder at tage medicinen.
English: You need to know about important signs and symptoms to look out for while you are taking Lamivudine/Zidovudine Teva.
Danish: Du bør kende til vigtige tegn og symptomer, som du skal holde øje med, mens du tager Lamivudin/Zidovudin Teva.
English: Lamivudine has not been specifically investigated in HIV patients co-infected with HBV.
Danish: Lamivudin er ikke specifikt undersøgt til behandling af hiv-patienter, som samtidig er smittet med HBV.
English: Very common: Headache
Danish: Meget almindelig: hovedpine
English: The study demonstrated that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening than in those exposed to zidovudine alone.
Danish: Studiet viste, at fostre, der in utero udsættes for kombinationsbehandlingen, opretholdte et højere niveau af nukleosidanalogt dna i multiple føtale organer og udviste også tegn på kortere telomere, end dem der kun fik zidovudin.
English: • muscle pain and discomfort
Danish: • muskelsmerter og ubehag
English: It also increases the CD4 cell count in your blood.
Danish: Lamivudin/Zidovudin Teva øger også antallet af CD4-celler i dit blod.
English: From studies with intravenous zidovudine, the mean terminal plasma half-life was 1.1 hours and the mean systemic clearance was 1.6 l/h/kg.
Danish: I undersøgelser med intravenøst administreret zidovudin var den terminale middel plasmahalveringstid 1,1 time, og den gennemsnitlige systemiske clearance var 1,6 l/time/kg.
English: A very rare side effect that may show up in blood tests is: • a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia).
Danish: Meget sjælden bivirkning, der kan ses i blodprøver: • Manglende dannelse af nye røde eller hvide blodceller i knoglemarven (aplastisk anæmi)
English: Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, or renal failure.
Danish: Laktacidose har en høj dødelighed og kan være forbundet med pancreatitis, leversvigt eller nyresvigt.
English: Some clinical findings also support a possible interaction between lamivudine and cladribine
Danish: Nogle kliniske fund understøtter også en mulig interaktion mellem lamivudin og cladribin.
English: Cimetidine eliminated only in part by renal organic cation transport system.
Danish: Cimetidin elimineres kun delvist via det renale organiske kation transportsystem.
English: Lamivudine/Zidovudine Teva should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
Danish: Lamivudin/Zidovudin ”Teva” må ikke tages sammen med andre lægemidler indeholdende lamivudin eller lægemidler indeholdende emtricitabin.
English: • probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
Danish: • probenecid, mod urinsur gigt (podagra) og lignende tilstande, og som gives sammen med antibiotika for at øge virkningen.
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain) non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Danish: Tidlige symptomer (symptomatisk hyperlaktatæmi) omfatter lette fordøjelsessymptomer (kvalme, opkastning og abdominalsmerter), uspecifik utilpashed, appetitløshed, vægttab, respiratoriske symptomer (hurtigt åndedræt og/eller dybe indåndinger) eller neurologiske symptomer (herunder svaghed i bevægelserne).
English: Lamivudine is predominately cleared unchanged by renal excretion.
Danish: Lamivudin udskilles hovedsageligt uomdannet ved renal ekskretion.
English: Haemodialysis and peritoneal dialysis appear to have a limited effect on elimination of zidovudine, but enhance the elimination of the glucuronide metabolite.
Danish: Hæmodialyse og peritonealdialyse synes at have begrænset effekt på udskillelsen af zidovudin, men øger udskillelsen af glucuronidmetabolitten.
English: Clinically significant interaction unlikely.
Danish: Der forventes ikke klinisk signifikant interaktion.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Danish: Nogle patienter, der får kombinationsbehandling mod hiv, får en sygdom, der kaldes osteonekrose.
English: Lamivudine-TP and zidovudine-TP have selective inhibitory activity against HIV-1 and HIV-2 replication in vitro; lamivudine is also active against zidovudine-resistant clinical isolates of HIV.
Danish: Lamivudin-TF og zidovudin-TF har en selektiv hæmmende effekt overfor hiv-1- og hiv-2-replikationen in vitro; lamivudin er også aktivt mod zidovudinresistente kliniske hiv-isolater.
English: Pancreatitis: Cases of pancreatitis have occurred rarely in patients treated with lamivudine and zidovudine.
Danish: Pancreatitis: Der er set sjældne tilfælde af pancreatitis hos patienter i behandling med lamivudin og zidovudin.
English: If gastrointestinal intolerance occurs in patients weighing 21-30 kg, an alternative dosing schedule with one-half tablet taken thrice daily can be applied in attempt to improve tolerability.
Danish: Hvis der opstår gastrointestinal intolerance hos børn mellem 21 kg og 30 kg, kan der anvendes en alternativ doseringsanbefaling på én halv tablet 3 gange daglig i et forsøg på at forbedre tolerancen.
English: The clinically relevant effects of lamivudine and zidovudine in combination are anaemia, neutropenia and leucopenia.
Danish: De klinisk relevante virkninger for lamivudin og zidovudin i kombination er anæmi, neutropeni og leukopeni.
English: The safety and efficacy of zidovudine has not been established in patients with significant underlying liver disorders.
Danish: Sikkerhed og effekt af zidovudin er ikke undersøgt for patienter med alvorlige leversygdomme.
English: As only limited data are available the clinical significance is not known.
Danish: På grund af begrænsede data kendes den kliniske betydning ikke.
English: • pyrimethamine, to treat malaria and other parasitic infections
Danish: • pyrimethamin mod malaria eller andre parasitære infektioner.
English: Zidovudine is contraindicated in patients with abnormally low neutrophil counts (<0.75 x 109/l), or abnormally low haemoglobin levels (<7.5 g/dl or 4.65 mmol/l).
Danish: Zidovudin er kontraindiceret hos patienter med unormalt lavt neutrofiltal (< 0,75 x 109/l), eller unormalt lavt hæmoglobinniveau (< 7,5 g/dl eller 4,65 mmol/l).
English: • breakdown of muscle tissue
Danish: • nedbrydning af muskelvæv
English: Treatment with Lamivudine/Zidovudine Teva should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of pancreatitis occur.
Danish: Behandling med Lamivudin/Zidovudin “Teva” bør stoppes omgående, hvis kliniske tegn, symptomer eller unormale laboratoriefund tyder på udvikling af pancreatitis.
English: • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
Danish: • leversygdom som gulsot, forstørret lever eller fedtlever, leverbetændelse (hepatitis)
English: Adverse reactions have been reported during therapy for HIV disease with lamivudine and zidovudine separately or in combination.
Danish: Der er rapporteret bivirkninger under behandling af hiv-sygdom med lamivudin og zidovudin hver for sig eller i kombination.
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Lamivudine/Zidovudine Teva or other medicines you are taking, or an effect of the HIV disease itself.
Danish: Når du bliver behandlet mod hiv, kan det være svært at afgøre, om dine symptomer skyldes Lamivudin/Zidovudin Teva eller anden medicin, eller om de skyldes hiv-sygdommen i sig selv.
English: • phenytoin, for treating epilepsy.
Danish: • phenytoin mod epilepsi.
English: Patients receiving Lamivudine/Zidovudine Teva should be frequently examined and questioned for signs of lipoatrophy.
Danish: Patienter, der behandles med Lamivudin/Zidovudin Teva, skal jævnligt undersøges og udspørges for tegn på lipoatrofi.
English: Mitochondrial dysfunction following exposure in utero: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Mitokondriel dysfunktion efter eksponering in utero: Nukleosid-/nukleotid-analoger kan påvirke mitokondriefunktionen i varierende grad, hvilket er mest udtalt for stavudin, didanosin og zidovudin.
English: Not everyone responds to treatment with Lamivudine/Zidovudine Teva in the same way.
Danish: Ikke alle reagerer ens på behandlingen med Lamivudin/Zidovudin Teva.
English: When possible, avoid chronic coadministration of Lamivudine/Zidovudine Teva with medicinal products containing sorbitol or other osmotic acting poly-alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol).
Danish: Undgå så vidt muligt vedvarende administration af Lamivudin/Zidovudin Teva sammen med sorbitolholdige lægemidler eller andre osmotisk virkende polyalkoholer eller monosaccharidalkoholer (f.eks. xylitol, mannitol, lactitol og maltitol).
English: In men zidovudine has not been shown to affect sperm count, morphology or motility.
Danish: Hos mænd er zidovudin vist hverken at påvirke spermmængde, morfologi eller motilitet.
English: The carcinogenic potential of a combination of lamivudine and zidovudine has not been tested.
Danish: Den potentielle karcinogenicitet af en kombination af lamivudin og zidovudin er ikke undersøgt.
English: When concomitant administration with cotrimoxazole is warranted, patients should be monitored clinically.
Danish: Når samtidig behandling med sulfa/trim er påkrævet, bør patienten monitoreres klinisk.