FrancophonIA/ELRC3.0 huggingface dataset:
English: However, it is not clear whether these cases were due to treatment with these medicinal products or to the underlying HIV disease.
Danish: Det er dog usikkert, om tilfældene skyldtes behandling med disse lægemidler eller den underliggende hiv-sygdom.
English: This helps your body to increase the CD4 cell count in your blood.
Danish: Dette hjælper din krop med at øge antallet af CD4-celler i dit blod.
English: The effects of higher doses are not known.
Danish: Effekten af højere doser kendes ikke.
English: Symptoms usually include fever, plus some of the following:
Danish: Symptomerne omfatter som regel feber samt nogle af følgende:
English: These adverse reactions have often been transitory.
Danish: Bivirkningerne har ofte været forbigående.
English: Due to the high proportion of premature discontinuation (42 % of patients discontinued randomised treatment by week 48), no definitive conclusion can be drawn regarding the equivalence between the treatment regimens at week 48.
Danish: På grund af den høje andel af tidligt ophør (42 % af patienterne var stoppet med randomiseret behandling senest i uge 48) kan der ikke drages nogen definitiv konklusion med hensyn til ækvivalensen mellem behandlingsregimerne ved uge 48.
English: Don't drive or operate machines unless you're feeling well.
Danish: Før ikke motorkøretøjer eller betjen maskiner, medmindre du føler, at du har det godt.
English: Frequencies are defined as very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1000 to < 1/100), rare (> 1/10,000 to < 1/1000), very rare (< 1/10,000).
Danish: Frekvenser er defineret som meget almindelig (> 1/10), almindelig (> 1/100 til < 1/10), ikke almindelig (> 1/1.000 til < 1/100), sjælden (> 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000).
English: Swallow the tablets whole, with some water.
Danish: Synk tabletterne hele med et glas vand.
English: Talk to your doctor before you start again.
Danish: Kontakt lægen, før du starter igen.
English: Date of latest renewal: 2 January 2011
Danish: Dato for første markedsføringstilladelse: 2. januar 2001 Dato for seneste fornyelse: 2. januar 2011
English: The most common symptoms are:
Danish: De mest almindelige symptomer er:
English: Trizivir does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Trizivir helbreder ikke hiv-infektion, men det nedsætter mængden af virus i din krop og holder det på et lavt niveau.
English: It is rare; if it happens, it usually develops after a few months of treatment.
Danish: Det sker sjældent, men hvis det sker, kommer det normalt efter nogle få måneders behandling.
English: If you have taken Trizivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Danish: Hvis du har taget Trizivir under din graviditet, kan din læge bede om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
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 dette lægemiddel, da den indeholder vigtige informationer.
English: People may be more likely to get this condition:
Danish: Der er større risiko for at få denne tilstand:
English: It can be life-threatening, causing failure of internal organs.
Danish: Det kan være livstruende, fordi det kan sætte de indre organer ud af funktion.
English: Your doctor will monitor the effectiveness of your treatment.
Danish: Lægen vil følge virkningen af din behandling.
English: It cannot be excluded that abacavir may increase the risk of having a heart attack.
Danish: Det kan ikke udelukkes, at abacavir kan øge risikoen for hjerteanfald.
English: These symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections.
Danish: Disse symptomer skyldes sandsynligvis, at kroppens immunforsvar bliver stærkere, så kroppen begynder at bekæmpe infektionerne.
English: Metabolism of lamivudine is a minor route of elimination.
Danish: Metabolisme af lamivudin er en mindre eliminationsvej.
English: There was no significant difference in the time to first virologic failure (p=0.73, log-rank test) between the 2 arms.
Danish: Der var ingen signifikant forskel i tiden indtil første virologiske svigt (p=0,73; log- rank test) mellem de to arme.
English: Trizivir helps to control your condition.
Danish: Trizivir hjælper med at kontrollere din sygdom.
English: • methadone, used as a heroin substitute
Danish: • methadon, som anvendes som erstatning for heroin
English: Similarly, the presence of TAMs gives rise to resistance to ZDV.
Danish: På samme måde som tilstedeværelsen af TAM'er giver resistens over for ZDV.
English: ANNEX II A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes.
Danish: Tal med lægen, hvis du har problemer med hjertet, hvis du ryger, eller hvis du har andre sygdomme, der kan øge din risiko for hjertesygdomme såsom forhøjet blodtryk eller sukkersyge.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal
Danish: Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: See your doctor as soon as possible.
Danish: Gå til lægen så hurtigt som muligt.
English: In addition, two transplacental carcinogenicity studies have been conducted in mice.
Danish: Derudover er der gennemført to transplacentale karcinogenicitetsstudier hos mus.
English: • increase in an enzyme called amylase
Danish: • Forhøjet koncentration af et enzym, der hedder amylase
English: Recommendation concerning coadministration
Danish: Anbefalinger vedrørende samtidig administration
English: If you are pregnant, if you become pregnant or if you are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking Trizivir during your pregnancy.
Danish: Hvis du er gravid, bliver gravid eller planlægger at blive gravid, skal du tale med lægen om fordele og ulemper for dig og dit barn ved at tage Trizivir under graviditeten.
English: Abbreviations: ↑ = Increase; ↓=decrease; ↔= no significant change; AUC=area under the concentration versus time curve; Cmax=maximum observed concentration; CL/F=apparent oral clearance
Danish: Forkortelser:  = Stigning;  = Fald;  = Ingen signifikant ændring; AUC = Arealet under kurven koncentration versus tid; Cmax= Maksimalt observeret koncentration; CL/F = Tilsyneladende oral clearance
English: For patients with advanced symptomatic HIV disease, it is generally recommended that blood tests are performed at least every two weeks for the first three months of therapy and at least monthly thereafter.
Danish: Hos patienter med fremskreden symptomatisk hivsygdom anbefales det generelt, at der tages blodprøver mindst hver anden uge i de første 3 måneder af behandlingen og derefter mindst en gang om måneden.
English: The choice of this fixed combination should be based not only on potential adherence criteria, but mainly on expected efficacy and risk related to the three nucleoside analogues.
Danish: Valget af denne faste kombination bør ikke alene baseres på kriterier for mulig compliance, men fortrinsvis på den forventede effekt og sikkerhed, som er knyttet til de tre nukleosidanaloger.
English: Risk of heart attack
Danish: Risiko for hjerteanfald
English: There are no additional precautions or warnings relevant to the combination Trizivir.
Danish: Der er ingen yderligere relevante forsigtighedsregler eller advarsler for kombinationen Trizivir.
English: • tiredness, lack of energy
Danish: • træthed, mangel på energi
English: Care must be taken to eliminate the possibility of a hypersensitivity reaction if any of these symptoms occur.
Danish: Der skal udvises omhu for at udelukke muligheden for en overfølsomhedsreaktion, hvis nogle af disse symptomer opstår.
English: Do not take Trizivir:
Danish: Tag ikke Trizivir:
English: • if they are overweight
Danish: • hvis du er overvægtig.
English: Lamivudine: AUC ↓ 14%; 32%; 36%
Danish: Lamivudin: AUC  14 %; 32 %; 36 %
English: Grunwaldzka 189 , 60-322 Poznan, Poland
Danish: Grunwaldzka 189 , 60-322 Poznan, Polen.
English: It is concluded that as the increase in incidence of tumours in the first transplacental carcinogenicity study represents a hypothetical risk, this should be balanced against the proven therapeutic benefit.
Danish: Det konkluderes, at mens den øgede forekomst af tumorer i det første transplacentale karcinogenicitetsstudie repræsenterer en hypotetisk risiko, bør dette afvejes mod den beviste terapeutiske fordel.
English: If you notice any of these symptoms:
Danish: Hvis du får et af disse symptomer:
English: There is no experience of overdose with Trizivir.
Danish: Der er ingen erfaring om overdosering med Trizivir.
English: Therefore, there is little potential for interactions with antiretroviral protease inhibitors, nonnucleosides and other medicinal products metabolised by major P450 enzymes.
Danish: Der er derfor ringe risiko for interaktioner med antiretrovirale proteaseinhibitorer, nonnukleosider og andre lægemidler, som metaboliseres af væsentlige P450-enzymer.
English: Detach this card and keep it with you at all times.
Danish: Dette kort skal du tage ud og altid have med dig.
English: If you know you have this gene, tell your doctor before you take Trizivir.
Danish: Hvis du ved, at du har dette gen, skal du fortælle det til lægen, før du tager Trizivir.
English: These haematological effects are not usually observed before four to six week's therapy.
Danish: Disse hæmatologiske påvirkninger observeres sædvanligvis først efter 4 til 6 ugers behandling.
English: Interactions involving binding site displacement are not anticipated with Trizivir.
Danish: Interaktioner, der involverer fortrængning af bindingssted, forventes ikke med Trizivir.
English: Hertfordshire, SG 12 0DJ, UK
Danish: Hertfordshire, SG 12 0DJ, Storbritannien eller
English: CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Danish: CD4-celler er en type hvide blodlegemer, der er vigtige for bekæmpelse af infektion.
English: If you have any of the symptoms listed above or any other symptoms that worry you:
Danish: Hvis du får nogen af ovennævnte symptomer eller andre symptomer, som bekymrer dig:
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Danish: Hiv-infektion spredes via seksuel kontakt med en hiv-smittet eller via overførsel med inficeret blod (f.eks. ved at dele injektionsnåle med andre).
English: Lactic acidosis generally occurred after a few or several months of treatment.
Danish: Laktacidose opstod almindeligvis efter få eller flere måneders behandling.
English: If you forget to take a dose, take it as soon as you remember.
Danish: Hvis du glemmer at tage en dosis, skal du tage den, så snart du husker det. Fortsæt derefter behandlingen som før.
English: • if you have severe kidney problems
Danish: • hvis du har alvorlige nyreproblemer
English: There are no data on the use of Trizivir in pregnancy.
Danish: Der findes ingen data fra anvendelse af Trizivir under graviditet.
English: • enlarged breasts in men
Danish: • forstørrede bryster hos mænd.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Danish: Når disse personer begynder på behandlingen, oplever de måske, at gamle skjulte infektioner blusser op og giver tegn og symptomer på betændelse.
English: • an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow
Danish: • øget mængde bilirubin i blodet (et stof, der dannes i leveren), som kan få huden til at se gul ud.
English: • deep, rapid, difficult breathing
Danish: • dyb, hurtig, besværet vejrtrækning
English: Trizivir should not be taken with any other medicinal products containing lamivudine or medicinal products containing emtricitabine.
Danish: Trizivir må ikke tages sammen med andre lægemidler indeholdende lamivudin eller lægemidler indeholdende emtricitabin.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C
English: In vivo resistance (therapy naïve patients)
Danish: In vivo-resistens (behandlingsnaive patienter)
English: Trizivir and similar medicines may cause side effects in unborn babies.
Danish: Trizivir og lignende medicin kan give bivirkninger hos det ufødte barn.
English: The second study thus provided no evidence that zidovudine acts as a transplacental carcinogen.
Danish: Det andet studie frembragte således ingen tegn på, at zidovudin optræder som transplacental karcinogen.
English: Some people taking Trizivir are more at risk of serious side effects.
Danish: Nogle personer, som tager Trizivir, har større risiko for alvorlige bivirkninger.
English: The clinical status of the patient and the adverse event profile of Trizivir should be borne in mind when considering the patient's ability to drive or operate machinery.
Danish: Patientens kliniske tilstand og bivirkningsprofilen af Trizivir bør overvejes, når patientens evne til at køre bil eller betjene maskiner vurderes.
English: Some people taking Trizivir develop other conditions, which can be serious.
Danish: Nogle personer, som tager Trizivir, udvikler andre tilstande, som kan være alvorlige.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Danish: Den observerede elimineringshalveringstid af lamivudin er 5 til 7 timer.
English: Abacavir is also excreted into human milk.
Danish: Abacavir udskilles også i human mælk.
English: You need to know about important signs and symptoms to look out for while you are taking Trizivir.
Danish: Du skal derfor kende vigtige tegn og symptomer, som du kan holde øje med, mens du tager Trizivir.
English: Trizivir can make you dizzy and have other side effects that make you less alert.
Danish: Trizivir kan gøre dig svimmel og have andre bivirkninger, der gør dig mindre opmærksom.
English: Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Danish: Nogle personer, som er i kombinationsbehandling for hiv, udvikler en tilstand, der hedder osteonekrose.
English: Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated.
Danish: Genoptagelse af behandlingen kan resultere i en hurtigere og mere alvorlige reaktion, som kan være dødelig, og er derfor kontraindiceret.
English: The clinically relevant toxicological effects of these three medicinal products are anaemia, neutropenia and leucopenia.
Danish: De klinisk relevante toksikologiske virkninger af disse tre lægemidler er anæmi, neutropeni og leukopeni.
English: Separate administration of Trizivir and clarithromycin by at least 2 hours
Danish: Administration af Trizivir og clarithromycin skal ske med mindst 2 timers interval
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis du tager en slags antiinflammatorisk medicin, der hedder kortikosteroider
English: When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Trizivir or other medicines you are taking, or an effect of the HIV infection itself.
Danish: Når du er i behandling for hiv, kan det være svært at afgøre, om et symptom er en bivirkning ved Trizivir eller anden medicin, eller om det skyldes selve hiv-infektionen.
English: No unexpected adverse reactions were reported.
Danish: Der blev ikke rapporteret uventede bivirkninger.
English: The absolute bioavailability of oral abacavir, lamivudine and zidovudine in adults is about 83 %, 80 - 85 % and 60 - 70 % respectively.
Danish: Den absolutte orale biotilgængelighed af abacavir, lamivudin og zidovudin hos voksne er henholdsvis ca. 83 %, 80-85 % og 60-70 %.
English: These changes are not considered clinically relevant and no food restrictions are recommended for administration of Trizivir.
Danish: Disse ændringer betragtes ikke som klinisk relevante, og der anbefales ingen føderestriktioner for anvendelse af Trizivir.
English: Studies with abacavir demonstrate a CSF to plasma AUC ratio of between 30 to 44 %.
Danish: Studier med abacavir viser et fordelingsforhold mellem CSF og plasma-AUC på mellem 30 og 44 %.
English: Because insufficient data are available, the use of Trizivir in children or adolescents is not recommended.
Danish: Da de tilgængelige data er utilstrækkelige, anbefales brugen af Trizivir ikke til børn eller unge.
English: Your doctor will check whether your symptoms were related to a hypersensitivity reaction.
Danish: Lægen vil undersøge, om dine symptomer skyldes en overfølsomhedsreaktion.
English: • pentamidine or atovaquone, to treat parasitic infections such as Pneumocystis jirovecii pneumonia (often referred to as PCP)
Danish: • pentamidin eller atovaquon, til behandling af parasitinfektioner som f.eks. pneumocystis jirovecii lungebetændelse (ofte omtalt som PCP)
English: Abacavir increases the rate at which methadone is removed from the body.
Danish: Abacavir øger den hastighed, hvormed methadon fjernes fra kroppen.
English: See sections 4.4 and 4.8
Danish: 4.4 og 4.8.
English: Viral resistance to abacavir develops relatively slowly in vitro, requiring multiple mutations for a clinically relevant increase in EC50 over wild-type virus.
Danish: Viral resistens over for abacavir udvikles relativt langsomt in vitro og kræver multiple mutationer for at nå en klinisk relevant stigning i EC50 i forhold til vildtype virus.
English: Currently there are no data on the use of Trizivir in heavily pre-treated patients, patients failing on other therapies or patients with advanced disease (CD4 cells < 50 cells/mm3).
Danish: På nuværende tidspunkt er der ingen data om anvendelsen af Trizivir hos tidligere massivt behandlede patienter, patienter med manglende effekt af andre behandlinger eller patienter med fremskreden sygdom (CD4-celletal < 50 celler/mm3).
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Trizivir.
Danish: Husk også at fortælle det til lægen eller på apoteket, hvis du begynder at tage en ny medicin, mens du tager Trizivir.
English: The likelihood of metabolic drug interactions with lamivudine is low due to the small extent of hepatic metabolism (5 - 10 %) and low plasma binding.
Danish: Sandsynligheden for metaboliske lægemiddelinteraktioner med lamivudin er lav på grund af begrænset levermetabolisme (5-10 %) og lav plasmabinding.
English: Lamivudine was not teratogenic in animal studies but there were indications of an increase in early embryonic deaths in the rabbit at relatively low systemic exposures, comparable to those achieved in humans.
Danish: Lamivudin var ikke teratogent i dyrestudier, men der var tegn på en øget forekomst af tidlig fosterdød hos kaniner ved relativt lave systemiske koncentrationer sammenlignet med dem, der opnås hos mennesker.
English: If you have stopped taking Trizivir for any reason - especially because you think you are having side effects, or because you have other illness:
Danish: Hvis du af en eller anden grund er holdt op med at tage Trizivir, særligt hvis du mener, at du har bivirkninger eller på grund af anden sygdom:
English: A similar effect was not seen in rats even at very high systemic exposure.
Danish: En tilsvarende effekt sås ikke hos rotter selv ved meget høje systemiske koncentrationer.
English: IMPORTANT: for information on abacavir hypersensitivity see the information below, under the Description of selected adverse reactions
Danish: VIGTIGT: Vedrørende oplysninger om overfølsomhed over for abacavir, se beskrivelsen nedenfor under Beskrivelse af udvalgte bivirkninger.
English: • changes in the colour of your nails, your skin, or the skin inside your mouth
Danish: • ændring af farven på neglene, huden eller slimhinden inde i munden
English: No conclusion can be drawn with regard to the teratogenic potential of abacavir because of this embryo-foetal toxicity.
Danish: Der kan ikke drages nogen konklusion med hensyn til abacavirs potentielle teratogenicitet på grundlag af denne embryo-føtale toksicitet.
English: Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, der er hiv-positive, må ikke amme deres børn, fordi hiv-infektionen kan overføres til barnet gennem mælken.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia.
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mykobakterielle infektioner og pneumocystis jirovecii pneumoni.
English: If you accidentally take too much Trizivir, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Danish: Hvis du ved et uheld tager for mange Trizivir, skal du fortælle det til lægen eller på apoteket eller kontakte nærmeste skadestue for nærmere rådgivning.
English: In addition, the 69 insertion complex or the Q151M mutation, usually found in combination with A62V, V75I, F77L and F116Y, cause a high level of resistance to abacavir.
Danish: Ydermere kan 69-indsættelseskomplekset eller Q151Mmutationen, sædvanligvis fundet i kombination med A62V, V751, F77L og F116Y, forårsage et højt niveau af resistens over for abacavir.
English: It is recommended that treatment is started with abacavir, lamivudine, and zidovudine separately for the first 6-8 weeks (see section 4.4).
Danish: Det anbefales, at behandlingen startes med abacavir, lamivudin og zidovudin særskilt i de første 6-8 uger (se pkt.
English: A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, however overall exposure (AUC) was not significantly altered.
Danish: Der fandtes en beskeden stigning i Cmax (28 %) for zidovudin, når det blev givet sammen med lamivudin, men den samlede eksposition (AUC) var dog ikke ændret signifikant.
English: In one study, by the US National Cancer Institute, zidovudine was administered at maximum tolerated doses to pregnant mice from day 12 to 18 of gestation.
Danish: I et studie, gennemført af US National Cancer Institute, blev zidovudin givet i maksimalt tolererede doser til drægtige mus fra 12. til 18. gestationsdag.
English: In a second study, mice were administered zidovudine at doses up to 40 mg/kg for 24 months, with exposure beginning prenatally on gestation day 10.
Danish: I et andet studie blev der givet zidovudin i doser op til 40 mg/kg i 24 måneder til mus, hvor eksponeringen startede prænatalt på 10. gestationsdag.
English: D. CONDITIONS OR RESTRICTIONSWITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET