FrancophonIA/ELRC3.0 huggingface dataset:
English: See your doctor as soon as possible.
Danish: Kontakt lægen så hurtigt som muligt.
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 hiv-sygdom 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: There are no data available on the safety of lamivudine when administered to babies less than three months old.
Danish: Der foreligger ingen data om sikkerheden af lamivudin hos spædbørn under 3 måneder.
English: The incidence and severity of lipoatrophy are related to cumulative exposure.
Danish: Incidensen og sværhedsgraden af lipoatrofi er relateret til kumulativ eksponering.
English: While the clinical relevance of these findings is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit.
Danish: Så længe den kliniske relevans af disse fund er ukendt, indikerer disse data, at den karcinogene risiko hos mennesker opvejes af de potentielle kliniske fordele
English: Lamivudine/Zidovudine Teva tablets should not be used for children weighing less than 14 kg, since doses cannot be appropriately adjusted for the weight of the child.
Danish: Lamivudin/Zidovudin “Teva” tabletter bør ikke anvendes til børn under 14 kg, da dosis ikke kan justeres hensigtsmæssigt til barnets vægt.
English: There were no other zidovudine-related tumours observed in either sex of either species.
Danish: Der blev ikke observeret andre zidovudinrelaterede tumorer hos begge køn af begge arter.
English: Systemic exposures (daily AUC and Cmax) in plasma from the twice daily regimen appeared equivalent to those from the same total daily dose given in three divided doses [Bergshoeff, 2004].
Danish: Systemisk eksponering (daglig AUC og Cmax) i plasma fra den 2 gange daglige dosering synes at være ækvivalent med samme totale daglige dosering fordelt på 3 doser [Bergshoeff, 2004].
English: If you have taken Lamivudine/Zidovudine Teva 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 Lamivudin/Zidovudin Teva under din graviditet, kan din læge bede om regelmæssige blodprøver og andre diagnostiske undersøgelser for at overvåge barnets udvikling.
English: Further data addressing this issue are currently awaited.
Danish: Yderligere data afventes.
English: Monitor phenytoin concentrations.
Danish: Monitorer phenytoinkoncentrationen.
English: • if they are also taking anti-inflammatory medicines called corticosteroids
Danish: • hvis du også tager betændelseshæmmende medicin, kaldet kortikosteroider.
English: Sorbitol solution (3.2g , 10.2 g, 13.4 g)/ Lamivudine
Danish: Sorbitol opløsning (3,2 g, 10,2 g, 13,4 g) / lamivudin
English: • methadone, used as a heroin substitute
Danish: • methadon som erstatning for heroin.
English: This dose will achieve an average AUC0-12 ranging from approximately 3,800 to 5,300 ng h/ml.
Danish: Denne dosis vil medføre en gennemsnitlig AUC0-12 i intervallet fra ca. 3800 til 5300 ng.h/ml.
English: • lactic acidosis (excess lactic acid in the blood; see the next section, ‘Other possible side effects of combination therapy for HIV')
Danish: • laktacidose (for meget mælkesyre i blodet; se næste afsnit 'Andre mulige bivirkninger ved kombinationsbehandling af hiv')
English: In addition, systemic clearance values were greater in younger paediatric patients and decreased with age, approaching adult values around 12 years of age.
Danish: Desuden er værdierne for systemisk clearance højere for yngre pædiatriske patienter, men faldende med alderen, indtil de nærmer sig værdierne hos voksne ved 12-års alderen.
English: Drugs by Therapeutic Area Interaction Geometric mean change (%) (Possible mechanism)
Danish: Geometrisk middelændring (%) (Mulig mekanisme)
English: Blood and lymphatic systems disorders
Danish: Blod og lymfesystem
English: Lactic acidosis generally occurred after a few or several months of treatment.
Danish: Laktacidose opstod almindeligvis efter få eller nogle måneders behandling.
English: • serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
Danish: • alvorlige allergiske reaktioner, med hævelser i ansigt, tungen eller svælget, som kan gøre det svært at synke eller at trække vejret
English: • if you have kidney disease
Danish: • hvis du har en nyresygdom.
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: Due to these differences, the recommended dose for lamivudine in children (aged more than three months and weighing less than 30 kg) is 4 mg/kg twice a day.
Danish: På grund af disse forskelle er den anbefalede dosis af lamivudin til børn (over 3 måneder og med en vægt på mindre end 30 kg) 4 mg/kg to gange daglig.
English: • aches and pains (especially in the hip, knee or shoulder)
Danish: • Smerter (særligt i hofterne, knæene eller skuldrene).
English: Two patterns of multi-drug resistance mutations, the first characterised by mutations in the HIV reverse transcriptase at codons 62, 75, 77, 116 and 151 and the second involving a T69S mutation plus a 6-base pair insert at the same position, result in phenotypic resistance to AZT as well as to the other approved NRTIs.
Danish: To typer af flerstof resistens mutationer, den første karakteriseret ved mutationer i hiv-revers transkriptase ved codon 62, 75, 77, 116 og 151 og den anden omfatter en T69S mutation samt en indsætning af 6-base par ved den samme position, hvilket resulterer i en fænotypisk resistens over for AZT såvel som andre godkendte NRTI'er.
English: The observed lamivudine half-life of elimination is 5 to 7 hours.
Danish: Elimination: Den observerede elimineringshalveringstid af lamivudin er 5 til 7 timer.
English: Each pack type contains 60 film-coated tablets.
Danish: Begge typer pakninger indeholder 60 filmovertrukne tabletter.
English: No dosage adjustment necessary.
Danish: Dosisjustering ikke nødvendig.
English: The incidence of neutropenia was also increased in those patients whose neutrophil counts, haemoglobin levels and serum vitamin B12 levels were low at the start of zidovudine therapy.
Danish: Forekomsten af neutropeni var ligeledes øget hos de patienter, hvis neutrofiltal, hæmoglobinniveau og serum-vitamin B12-niveau var lavt ved starten af behandlingen med zidovudin.
English: Metabolism of lamivudine is a minor route of elimination.
Danish: Metabolisme: Metabolisme af lamivudin er en mindre eliminationsvej.
English: Children who weigh between 14 and 21 kg
Danish: Børn, der vejer mellem 14 kg og 21 kg
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 Lamivudine/Zidovudine Teva.
Danish: Hvis du er gravid, bliver gravid eller planlægger at blive gravid, skal du tale med lægen om risici og fordele ved Lamivudin/Zidovudin Teva for dig og dit barn.
English: Lamivudine has not shown any genotoxic activity in in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma levels.
Danish: Lamivudin har ikke vist nogen genotoksisk aktivitet i in vivo-forsøg ved doser, der medførte plasmakoncentrationer op til 40-50 gange højere end de kliniske plasmakoncentrationer.
English: The bioavailability of oral lamivudine in adults is normally between 80-85 % and for zidovudine 60-70 %.
Danish: Den orale biotilgængelighed af lamivudin hos voksne er normalt 80-85 % og af zidovudin 60-70 %.
English: These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Danish: Disse fund påvirker ikke de aktuelle nationale anbefalinger vedrørende brug af antiretroviral behandling hos gravide med henblik på at undgå vertikal hiv-overførsel.
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 (< 4% of maternal serum concentrations) and progressively decrease to undetectable levels when breastfed infants reach 24 weeks of age.
Danish: Baseret på mere end 200 mor/barn-par behandlet for hiv er serumkoncentrationen af lamivudin hos ammende børn, hvis mor er behandlet for hiv, meget lav (< 4 % af moderens serumkoncentration) og falder gradvist til et ikke-detekterbart niveau, når det ammende barn når en alder på 24 uger.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu .
English: The 5'-glucuronide of zidovudine is the major metabolite in both plasma and urine, accounting for approximately 50-80 % of the administered dose eliminated by renal excretion.
Danish: 5´-glucuronidet af zidovudin er hovedmetabolitten i både plasma og urin, og udgør ca. 50-80 % af den indgivne dosis, som elimineres ved renal ekskretion.
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 en anden undersøgelse blev der givet zidovudin i doser op til 40 mg/kg i 24 måneder til mus, hvor eksponeringen startede prænatalt på 10. gestationsdag.
English: Teva UK Limited Tel: +44 1977628500
Danish: United Kingdom Teva UK Limited Tel: +44 1977628500
English: Lamivudine and zidovudine are not significantly metabolised by cytochrome P450 enzymes (such as CYP 3A4, CYP 2C9 or CYP 2D6) nor do they inhibit or induce this enzyme system.
Danish: Lamivudin og zidovudin bliver ikke metaboliseret signifikant af cytokrom P450-enzymer (såsom CYP3A4, CYP2C9 eller CYP2D6) og de hverken hæmmer eller inducerer dette enzymsystem.
English: If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Danish: Hvis du bemærker nogen som helst symptomer på infektion eller andre symptomer, som f.eks. muskelsvaghed, svaghed, som starter i hænderne og fødderne, og som bevæger sig ind mod kropsstammen, hjertebanken, rysten eller hyperaktivitet, skal du omgående kontakte lægen for at få den nødvendige behandling.
English: High doses of trimethoprim/ sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis have not been studied and should be avoided.
Danish: Høje doser af trimethoprim/sulfamethoxazol til behandling af Pneumocystis jirovecii pneumoni (PCP) og toksoplasmose er ikke undersøgt og bør undgås.
English: When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Danish: Når sådanne patienter starter behandlingen, kan gamle, skjulte infektioner blusse op igen og medføre tegn og symptomer på betændelse.
English: Do not take other medicines for the infection without your doctor's advice.
Danish: Tag ikke anden medicin mod infektioner uden at tale med lægen først.
English: • fever (high temperature)
Danish: • feber (høj kropstemperatur)
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP).
Danish: Relevante eksempler er cytomegalovirus retinitis, generaliserede og/eller fokale mycobakterielle infektioner og pneumocystis jirovecii pneumoni (ofte omtalt som PCP).
English: Lamivudine/Zidovudine Teva does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Danish: Lamivudin/Zidovudin Teva helbreder ikke hiv-infektionen fuldstændigt, men nedsætter mængden af virus i kroppen og bevarer den på et lavt niveau.
English: The adverse reactions considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency.
Danish: De bivirkninger, der anses for at kunne relateres til behandlingen, er nævnt nedenfor fordelt efter organklasse og absolut frekvens.
English: Zidovudine is well absorbed from the gut and at all dose levels studied in adults and children, the bioavailability was between 60-74 % with a mean of 65 %.
Danish: Zidovudin absorberes godt fra tarmen, og ved alle undersøgte doser undersøgt hos børn og voksne var biotilgængeligheden 60-74 % med en middelværdi på 65 %.
English: • hair loss (alopecia).
Danish: • hårtab (alopeci)
English: Teva Denmark A/S Tlf: +45 44 98 55 11
Danish: Danmark Teva Denmark A/S Tlf: +45 44 98 55 11
English: For these patients and for patients, who are unable to swallow tablets, oral solutions of lamivudine and zidovudine are available.
Danish: Til disse patienter og til patienter, der ikke kan sluge en tablet, findes der en oral opløsning af både lamivudin og zidovudin.
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 en undersøgelse, gennemført af US National Cancer Institute, blev zidovudin givet i maksimalt tolererede doser til drægtige mus fra 12. til 18. gestationsdag.
English: Tablet film-coat: Hypromellose 3cP, hypromellose 6cP, polysorbate 80, macrogol 400, titanium dioxide E171.
Danish: Filmovertræk: hypromellose 3cP, hypromellose 6cP, polysorbat 80, macrogol 400, titandioxid E171.
English: Children who weigh between 21 and 30 kg
Danish: Børn, der vejer mellem 21 kg og 30 kg
English: The available data from both placebo-controlled and open-label studies indicate that the incidence of nausea and other frequently reported clinical adverse events consistently decreases over time during the first few weeks of therapy with zidovudine.
Danish: De tilgængelige data fra såvel placebokontrollerede som åbne undersøgelser tyder på, at forekomsten af kvalme og andre hyppigt rapporterede kliniske bivirkninger aftager konsistent med tiden i de første få uger af behandlingen med zidovudin.
English: Psychiatric disorders Rare: Anxiety and depression
Danish: Psykiske forstyrrelser Sjælden: angst og depression.
English: This variant arises both in vitro and in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Danish: Denne variant opstår både in vitro og i hiv-1-inficerede patienter behandlet med lamivudin-indeholdende antiretroviral behandling.
English: After administration of a single dose of 200 mg zidovudine to HIV-infected women, the mean concentration of zidovudine was similar in human milk and serum.
Danish: Efter administration af 200 mg zidovudin som enkeltdosis til hiv-smittede kvinder var den gennemsnitlige zidovudin-koncentration den samme i mælk og serum.
English: Insufficient data to recommend dosage adjustment.
Danish: Data er utilstrækkelige; der kan ikke gives anbefalinger om dosisjustering.
English: One year post-natally, there was an increase in the incidence of tumours in the lung, liver and female reproductive tract of offspring exposed to the highest dose level (420 mg/kg term body weight).
Danish: Et år efter fødslen var der en øget forekomst af tumorer i lunger, lever og hunlige reproduktionsorganer hos afkommet, som var udsat for de højeste doseringsniveauer (420 mg/kg kropsvægt ved termin).
English: In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: Ud over de opportunistiske infektioner kan autoimmune sygdomme (skyldes, at immunsystemet angriber kroppens raske celler) også forekomme, efter du er begyndt at tage medicin mod din hivinfektion.
English: Resistance to thymidine analogues (of which zidovudine is one) is well characterised and is conferred by the stepwise accumulation of up to six specific mutations in the HIV reverse transcriptase at codons 41, 67, 70, 210, 215 and 219.
Danish: Resistens overfor thymidin analoger (som zidovudin tilhører) er velkarakteriseret og kan henføres til den trinvise akkumulering af op til seks specifikke mutationer i hiv-revers transkriptase codon 41, 67, 70, 210, 215 og 219.
English: - if you have a very low red blood cell count (anaemia) or a very low white blood cell count
Danish: - hvis du har et meget lavt antal røde blodceller (anæmi) eller et meget lavt antal hvide blodceller
English: You need to be aware of the extra risks:
Danish: Vær opmærksom på, at du har en større risiko:
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-smitte spredes ved seksuel kontakt med en person, der har sygdommen, eller via smittet blod (fx ved at dele kanyler med andre).
English: In six HIV-infected children from 2 to 13 years of age, zidovudine plasma pharmacokinetics were evaluated while subjects were receiving 120 mg/m2 zidovudine three times daily and again after switching to 180 mg/m2 twice daily.
Danish: Hos 6 hiv-inficerede børn i alderen 2 til 13 år blev zidovudins plasmafarmakokinetik evalueret efter indgivelse af 120 mg/m zidovudin 3 gange daglig og igen efter skift til 180 mg/m2 gange daglig.
English: Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field.
Danish: De tilgængelige kliniske data er meget begrænsede og gør det ikke muligt at drage nogen konklusioner.
English: Pharmacokinetics in children: In children over the age of 5-6 months, the pharmacokinetic profile of zidovudine is similar to that in adults.
Danish: Farmakokinetik hos børn: Hos børn over 5-6 måneder ligner zidovudins farmakokinetik de forhold, der ses hos voksne.
English: There is no evidence of added toxicity following concurrent administration of the two compounds.
Danish: Der er ingen tegn på additiv toksicitet som følge af samtidig administration af de 2 stoffer.
English: AUC ↓ 14%; 32%; 36% Cmax ↓ 28%; 52%, 55%.
Danish: Cmax ↓ 28 %; 52 %; 55 %.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: • other medicinal products containing lamivudine, to treat HIV infection or hepatitis B infection
Danish: • anden medicin, der indeholder lamivudin, til behandling af hiv-infektion eller hepatitis B
English: Some medicines can make it more likely that you'll have side effects, or make side effects worse.
Danish: Nogle lægemidler kan øge risikoen for at få bivirkninger eller gøre bivirkningerne værre.
English: Clinical studies have shown that there are no clinically significant interactions between lamivudine and zidovudine.
Danish: Kliniske studier har vist, at der ikke er klinisk signifikante interaktioner mellem lamivudin og zidovudin.
English: If you have any of the symptoms listed above, or any other symptoms that worry you:
Danish: Hvis du får et eller flere af ovennævnte symptomer eller andre symptomer, der bekymrer dig:
English: 3'-amino-3'deoxythymidine (AMT) has been identified as a metabolite of zidovudine following intravenous dosing.
Danish: 3´-amino-3´-deoxythymidin (AMT) er identificeret som en metabolit af zidovudin efter intravenøs administration.
English: For many of these events, it is unclear whether they are related to lamivudine, zidovudine, the wide range of medicinal products used in the management of HIV disease, or as a result of the underlying disease process.
Danish: For mange hændelser er det uklart, om de skyldes lamivudin, zidovudin, den vide udstrækning af lægemidler, der bruges ved behandling af hiv-sygdom, eller er et resultat af den underliggende sygdomsproces.
English: This fat loss, which is most evident in the face, limbs and buttocks, may not be reversible when switching to a zidovudine-free regimen.
Danish: Tab af fedt er mest tydeligt i ansigtet og på lemmer og balder og er muligvis ikke reversibelt, hvis der skiftes til en zidovudin-fri behandling.
English: Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Lamivudine/Zidovudine Teva.
Danish: Husk at fortælle det til lægen eller på apoteket, hvis du begynder at tage ny medicin, mens du er i behandling med Lamivudin/Zidovudin Teva.
English: The true extent of CNS penetration of lamivudine and its relationship with any clinical efficacy is unknown.
Danish: Det sande omfang af penetrationen af lamivudin til CNS og sammenhængen med klinisk effekt kendes ikke.
English: The special warnings and precautions relevant to both lamivudine and zidovudine are included in this section.
Danish: De særlige advarsler og forsigtighedsregler, som er relevante for både lamivudin og zidovudin, er inkluderet under dette punkt.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal products.
Danish: Ved samtidig behandling af hepatitis B eller C med antivirale lægemidler henvises til produktinformationer for disse lægemidler.
English: Viruses acquire phenotypic resistance to thymidine analogues through the combination of mutations at codons 41 and 215 or by the accumulation of at least four of the six mutations.
Danish: Vira kræver fænotypisk resistens over for thymidin analoger gennem kombination af mutationer ved codon 41 og 215 eller ved akkumulering af mindst 4 af de 6 mutationer.
English: Breast-feeding Women who are HIV-positive must not breastfeed, because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, som er hiv-positive, må ikke amme deres børn, fordi hiv-infektionen kan overføres til barnet med mælken.
English: Treatment with zidovudine has been associated with loss of subcutaneous fat which is most evident in the face, limbs and buttocks.
Danish: Behandling med zidovudin er blevet forbundet med tab af subkutant fedt, hvilket er mest tydeligt i ansigtet, på lemmer og på balder.
English: The mean systemic clearance of lamivudine is approximately 0.32 l/h/kg, with predominantly renal clearance (>70 %) via the organic cationic transport system.
Danish: Den gennemsnitlige systemiske clearance af lamivudin er omkring 0,32 l/time/kg; overvejende ved renal clearance (> 70 %) via organisk kation transportsystemet.
English: A subsequent intravaginal carcinogenicity study confirmed the hypothesis that the vaginal tumours were the result of long term local exposure of the rodent vaginal epithelium to high concentrations of unmetabolised zidovudine in urine.
Danish: En efterfølgende intravaginal karcinogenicitetsundersøgelse bekræftede hypotesen, at de vaginale tumorer var resultatet af længerevarende lokal eksponering af det vaginale gnaver-epitel med høje koncentrationer af uomdannet zidovudin i urin.
English: Data show that lamivudine and zidovudine penetrate the central nervous system (CNS) and reach the cerebrospinal fluid (CSF).
Danish: Data viser, at lamivudin og zidovudin penetrerer centralnervesystemet (CNS) og når ud i cerebrospinalvæsken (CSF).
English: Tell your doctor if you notice any loss of fat from your legs, arms, and face.
Danish: Fortæl det til lægen, hvis du oplever, at du mister fedt på benene eller armene eller i ansigtet.
English: It can be life-threatening, causing failure of internal organs.
Danish: Tilstanden kan være livstruende og forårsage organsvigt.
English: • difficulty in sleeping (insomnia)
Danish: • søvnproblemer (insomni).