FrancophonIA/ELRC3.0 huggingface dataset:
English: Unchanged stavudine was the major drug-related component in total plasma radioactivity circulating after an oral 80 mg dose of 14C-stavudine in healthy subjects.
Danish: Uomdannet stavudin var den lægemiddelrelaterede hovedkomponent i total plasma- radioaktivitet cirkulerende efter en oral dosis på 80 mg af 14C-stavudin hos raske personer.
English: For infants who require a dose less than 10 ml, ask your pharmacist for a syringe to use to accurately measure the oral dose.
Danish: For spædbørn, hvor en dosis på mindre end 10 ml er påkrævet, skal man bede om en sprøjte på apoteket til at afmåle den nøjagtige dosis.
English: The incidence and severity of lipoatrophy are related to cumulative exposure, and is often not reversible when stavudine treatment is stopped.
Danish: Incidensen og sværhedsgraden af lipoatrofi er relateret til kumulativ eksponering og er ofte irreversibel efter ophør af stavudinbehandling.
English: Treatment with stavudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Danish: Behandlingen med stavudin bør seponeres i tilfælde af symptomatisk hyperlaktatæmi og metabolisk/laktatacidose, progressiv hepatomegali eller hurtigt stigende aminotransferaseniveauer.
English: Pancreatitis was reported in < 1% of patients in combination therapy studies with Zerit.
Danish: Pankreatitis blev rapporteret hos < 1% af patienterne i studier med kombinationbehandling med Zerit.
English: Zerit can cause a sometimes fatal condition called lactic acidosis, together with an enlarged liver.
Danish: Zerit kan i nogle tilfælde medføre en livsfarlig tilstand, som kaldes laktatacidose sammen med en forstørret lever.
English: common: depression uncommon: anxiety, emotional lability
Danish: Almindelig: depression Ikke almindelig: angst, emotionel labilitet
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Danish: Patienter med samtidig hepatitis C infektion, som behandles med α-interferon og ribavirin kan udgøre en speciel risiko.
English: Hepatitis or liver failure, which was fatal in some cases, has been reported with the use of stavudine (see section 4.4).
Danish: Der er rapporteret hepatitis eller leversvigt, som i nogle tilfælde var letal, ved brug af stavudin (se pkt 4.4).
English: Stavudine does not inhibit the major cytochrome P450 isoforms CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4; therefore, it is unlikely that clinically significant drug interactions will occur with medicines metabolised through these pathways.
Danish: Stavudin hæmmer ikke de væsentligste CYP-isoformer CYP1A2, CYP2C9, CYP2C19, CYP2D6 og CYP3A4; det er derfor ikke sandsynligt at klinisk signifikante lægemiddelinteraktioner vil optræde med lægemidler, der metaboliseres via disse metaboliseringsveje.
English: Endocrine disorders:
Danish: Det endokrine system:
English: It is recommended that HIV infected women should not breast-feed under any circumstances in order to avoid transmission of HIV.
Danish: Det anbefales, at kvinder med HIV-infektion ikke ammer under nogen omstændigheder for at undgå overførsel af HIV.
English: The corresponding values after oral single and multiple dose administration are 35% (range: 8% to 72%) and 40% (range: 12% to 82%), respectively.
Danish: De tilsvarende værdier efter oral enkelt og multipel dosisadministration er henholdsvis 35% (8%-72%) og 40% (12%-82%).
English: Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure, renal failure, or motor paralysis.
Danish: Laktatacidose har en høj mortalitet og kan være forbundet med pankreatitis, leversvigt, nyresvigt eller motorisk lammelse.
English: Animal data showed embryo-foetal toxicity at very high exposure levels.
Danish: Dyreforsøg viste embryo-føtal toksicitet ved meget høje eksponeringsniveauer.
English: Zerit dosage
Danish: Zerit-dosis
English: Metabolites include oxidised stavudine, glucuronide conjugates of stavudine and its oxidised metabolite, and an N-acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine.
Danish: Metabolitter inkluderer oxideret stavudin, glukuronidkonjugater af stavudin og dens oxiderede metabolit og et N-acetylcysteinkonjugat af ribosen efter glykosidkløvning, hvilket antyder, at thymin også er en metabolit af stavudin.
English: Adolescents, children and infants: adverse reactions and serious laboratory abnormalities reported to occur in paediatric patients ranging in age from birth through adolescence who received stavudine in clinical studies were generally similar in type and frequency to those seen in adults.
Danish: Unge, børn og spædbørn: Bivirkninger og svært abnorme laboratorieværdier rapporteret til at forekomme hos pædiatriske patienter fra fødslen og i løbet af ungdommen, som fik stavudin i kliniske studier, var generelt overensstemmende i type og frekvens som set hos voksne.
English: Please refer to the Summary of Product Characteristics of the powder formulation.
Danish: Der henvises til produktresuméet for pulverformuleringen.
English: Patients were primarily males (76%) and white (66%) with a median age of 34 years (range 22 to 67 years).
Danish: Patienterne var primært mænd (76%) af europæisk afstamning (66%) med en gennemsnitsalder på 34 år (22 til 67 år).
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF04
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, nucleosid og nucleotid revers transkriptase-hæmmere, ATC-kode: J05AF04.
English: Patients receiving Zerit should be frequently examined and questioned for signs of lipoatrophy.
Danish: Patienter, der behandles med Zerit, skal jævnligt undersøges og udspørges for tegn på lipoatrofi.
English: Stavudine was carcinogenic in mice (liver tumours) and rats (liver tumours: cholangiocellular, hepatocellular, mixed hepatocholangiocellular, and/or vascular; and urinary bladder carcinomas) at very high exposure levels.
Danish: Stavudin var karcinogent hos mus (levertumorer) og rotter (levertumorer, cholangiocellulær, hepatocellulær, blandet hepatocholangiocellulær og/eller vaskulær; og urinblærekarcinomer) ved meget høje ekspositionsniveauer.
English: The decrease of susceptibility in vitro is subtle requiring two or more TAMs (generally M41L and T215Y) before stavudine susceptibility is decreased (>1.5 fold).
Danish: Faldet i følsomhed in vitro er lille og kræver to eller flere TAM'er (normalt M41L og T215Y), før stavudinfølsomheden falder (> 1,5 fold).
English: Hepatic impairment: stavudine pharmacokinetics in patients with hepatic impairment were similar to those in patients with normal hepatic function.
Danish: Nedsat leverfunktion: Stavudins farmakokinetik hos patienter med nedsat leverfunktion var den samme som hos patienter med normal leverfunktion.
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Danish: Patienter med allerede eksisterende leverdysfunktion inklusiv kronisk, aktiv hepatitis har en øget frekvens af leverfunktionsabnormiteter ved antiretroviral kombinationsbehandling og bør kontrolleres efter gældende praksis.
English: These TAMs are seen at a similar frequency with stavudine and zidovudine in virological treatment.
Danish: Disse TAM'er er set med samme frekvens for stavudin og zidovudin ved virologisk behandling.
English: It occurs in ~1% of patients receiving stavudine.
Danish: Dette forekommer hos ca. 1% af patienterne, som får stavudin.
English: If you stop taking Zerit The decision to stop using Zerit should be discussed with your doctor.
Danish: Hvis du holder op med at tage Zerit Du skal diskutere beslutningen om at stoppe behandlingen med din læge.
English: Keep the bottle tightly closed in order to protect from excessive moisture.
Danish: Flasken skal opbevares tæt tillukket for at beskytte mod fugt.
English: Patients were primarily males (70%) and non-white (58%) with a median age of 33 years (range 18 to 68 years).
Danish: Patienterne var primært mænd (70%), af anden etnisk afstamning end europæisk (58%) og med en gennemsnitsalder på 33 år (18 til 68 år).
English: Do not store above 30°C (HDPE bottles).
Danish: Må ikke opbevares ved temperaturer over 30 °C (HDPE-beholdere).
English: Store below 25°C (aclar/alu blisters).
Danish: Opbevares ved temperaturer under 25°C (Aclar/Aluminium blisterpakninger).
English: Response to treatment with Zerit varies between patients.
Danish: Der er forskel på, hvor godt behandling med Zerit virker på patienterne.
English: HIV RNA < 50 copies/ml, treatment response, % All patients
Danish: HIV-RNA < 50 kopier/ml, behandlingsrespons, % Alle patienter
English: The incidence and severity of lipoatrophy are cumulative over time with stavudine-containing regimens.
Danish: Hyppigheden og sværhedsgraden af lipoatrofi er kumulativ over tid ved behandling med stavudinholdige regimer.
English: Liver disease: hepatitis or liver failure, which was fatal in some cases, has been reported.
Danish: Leversygdom: Der er rapporteret hepatitis eller leversvigt, som i nogle tilfælde var letal.
English: In clinical trials, switching from stavudine to other nucleosides (tenofovir or abacavir) resulted in increases in limb fat with modest to no improvements in clinical lipoatrophy.
Danish: I kliniske forsøg har skift fra stavudin til andre nukleosider (tenofovir eller abacavir) medført øget perifer fedtakkumulation med moderat til ingen forbedring af klinisk lipoatrofi.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Danish: Hvis der er tegn på forværret leversygdom hos disse patienter bør det overvejes enten at afbryde eller seponere behandlingen.
English: The duration of therapy with Zerit should be limited to the shortest time possible (see section
Danish: Behandlingsvarigheden med Zerit skal begrænses til kortest muligt (se pkt.
English: Mitochondrial dysfunction following exposure in utero: nucleos(t)ide 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-/nukleotidanaloger kan påvirke mitokondriefunktionen i varierende grad, hvilket er mest udtalt med stavudin, didanosin og zidovudin.
English: For optimal absorption, Zerit should be taken on an empty stomach (i.e. at least 1 hour prior to meals) but, if this is not possible, it may be taken with a light meal.
Danish: For at opnå optimal absorption skal Zerit tages på tom mave (dvs. mindst 1 time før et måltid), men hvis dette ikke er muligt, kan det tages sammen med et let måltid.
English: Zerit belongs to a particular group of antiviral medicines, also known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
Danish: Zerit tilhører en særlig gruppe af antiviral medicin, også kendt som antiretroviral medicin, som kaldes nukleosid reverse transkriptasehæmmere (NRTIs).
English: In HIV-infected patients, total clearance of stavudine is 594±164 ml/min, and renal clearance is 237±98 ml/min.
Danish: Hos HIV-inficerede patienter er den totale clearance af stavudin 594±164 ml/min, og den renale clearance er 237±98 ml/min.
English: A study in asymptomatic patients demonstrated that systemic exposure is similar while Cmax is lower and Tmax is prolonged when stavudine is administered with a standardised, high-fat meal compared with fasting conditions.
Danish: Et studie med asymptomatiske patienter viste, at den systemiske påvirkning er den samme, når stavudin administreres med et fedtrigt måltid sammenlignet med fastende administration, idet Cmax er lavere og Tmax forlænges.
English: HIV RNA < 400 copies/ml, treatment response, % All patients
Danish: HIV-RNA < 400 kopier/ml, behandlingsrespons, % Alle patienter
English: Pancreatitis: patients with a history of pancreatitis had an incidence of approximately 5% on Zerit, as compared to approximately 2% in patients without such a history.
Danish: Pankreatitis: Patienter, der tidligere har haft pankreatitis, havde en incidens på ca. 5% ved behandling med Zerit sammenlignet med ca. 2% for patienter uden denne anamnese.
English: In the event of rapidly elevating transaminase levels (ALT/AST, > 5 times upper limit of normal, ULN), discontinuation of Zerit and any potentially hepatotoxic medicinal products should be considered.
Danish: I tilfælde af hastigt stigende transaminaseværdier (ALAT/ASAT, > 5 gange øvre normalgrænse), skal seponering af Zerit og alle potentielt levertoksiske lægemidler overvejes.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Shake well before use.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Omrystes grundigt før brug.
English: Data on lactic acid in serum were not collected.
Danish: Der blev ikke indsamlet data om mælkesyre i serum.
English: Stavudine may cause dizziness and/or somnolence.
Danish: Stavudin kan medføre svimmelhed og/eller døsighed.
English: What you need to know before you take Zerit
Danish: Det skal du vide, før du begynder at tage Zerit
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisninger.
English: In randomized controlled trials of treatment-naive patients, clinical lipoatrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir).
Danish: I randomiserede, kontrollerede forsøg med behandlingsnaive patienter udvikledes klinisk lipoatrofi hos en større andel af patienter behandlet med stavudin sammenlignet med patienter behandlet med andre nukleosider (tenofovir eller abacavir).
English: Store in the original package in order to protect from excessive moisture.
Danish: Skal opbevares i den originale pakning for at beskytte mod fugt.
English: Given the potential risks of using Zerit including lipoatrophy, a benefit-risk assessment for each patient should be made and an alternative antiretroviral carefully considered.
Danish: I betragtning af de potentielle risici ved at bruge Zerit, herunder lipoatrofi, skal der foretages en afvejning af fordele og risici for hver enkelt patient, og et alternativt antiretroviralt præparat bør nøje overvejes.
English: Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used.
Danish: Zerit er i kombination med andre antiretrovirale lægemidler indiceret til behandling af HIV-inficerede voksne patienter og kun til pædiatriske patienter (fra fødsel), når andre antiretrovirale lægemidler ikke kan anvendes.
English: Not recommended combinations: pancreatitis (fatal and nonfatal) and peripheral neuropathy (severe in some cases) have been reported in HIV infected patients receiving stavudine in association with hydroxyurea and didanosine (see section 4.3).
Danish: Kombinationer, som ikke kan anbefales: Pankreatitis (letal og ikke-letal) og perifer neuropati (alvorlig i nogle tilfælde) er blevet rapporteret hos HIV-smittede patienter, som har fået stavudin sammen med hydroxycarbamid og didanosin (se pkt.
English: HDPE bottle with child resistant screw cap, fill mark (200 ml of solution after reconstitution) and measuring cup.
Danish: HDPE-flaske med børnesikret skruelåg, mærke til påfyldning (200 ml opløsning efter blanding) samt et målebæger.
English: Zerit may cause dizziness and drowsiness.
Danish: Zerit kan medføre svimmelhed og døsighed.
English: Adverse reactions of moderate or greater severity with at least a possible relationship to treatment regimen (based on investigator attribution) reported from 467 patients treated with Zerit in combination with lamivudine and efavirenz in two randomised clinical trials and along-term follow-up study (follow-up: median 56 weeks ranging up to 119 weeks) are listed below.
Danish: Nedenfor er anført moderat alvorlige eller meget alvorlige bivirkninger, der som minimum muligvis er relateret til behandlingsregimet (baseret på investigators vurdering), og som er rapporteret hos 467 patienter behandlet med Zerit i kombination med lamivudin og efavirenz i to randomiserede, kliniske forsøg og et opfølgende langtidsstudie (opfølgning: i gennemsnit 56 uger strækkende sig op til 119 uger).
English: Then screw the cap on tightly and shake the bottle well until the powder dissolves completely, and take or dispense the solution with the measuring cup provided.
Danish: Skru dernæst låget tæt på og omryst flasken grundigt, indtil pulveret er fuldstændig opløst, og anvend det vedlagte målebæger til at indtage opløsningen.
English: common: diarrhoea, abdominal pain, nausea, dyspepsia uncommon: pancreatitis, vomiting
Danish: Almindelig: diarré, abdominalsmerter, kvalme, dyspepsi Ikke almindelig: pankreatitis, opkastning
English: Instructions for preparation
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Zidovudine and stavudine are phosphorylated by the cellular enzyme (thymidine kinase), which preferentially phosphorylates zidovudine, thereby decreasing the phosphorylation of stavudine to its active triphosphate form.
Danish: Zidovudin og stavudin fosforyleres ved det cellulære enzym (thymidin kinase), som fortrinsvis fosforylerer zidovudin og dermed øger fosforyleringen af stavudin til dets aktive trifosfat form.
English: The powder formulation of Zerit should be used for infants under the age of 3 months.
Danish: Zerit pulver til oral opløsning skal anvendes til spædbørn under 3 måneder.
English: Osteonecrosis: although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Osteonekrose: Selvom ætiologien anses for at være multifaktoriel (inklusive anvendelse af kortikosteroider, alkoholforbrug, svær immunsuppression, højere Body Mass Index (BMI)), er der rapporteret om tilfælde af osteonekrose, specielt hos patienter med fremskreden HIV-sygdom og/eller hos patienter i langvarig kombinationsbehandling med antiretrovirale lægemidler (CART).
English: The reconstituted solution contains 1 mg of stavudine per ml.
Danish: Den tilberedte opløsning indeholder 1 mg stavudin per ml.
English: Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV infected adult patients and paediatric patients (over the age of 3 months) only when other antiretrovirals can not be used.
Danish: Zerit er i kombination med andre antiretrovirale lægemidler indiceret til behandling af HIV-inficerede voksne patienter og kun til pædiatriske patienter (over 3 måneder), når andre antiretrovirale lægemidler ikke kan anvendes.
English: (range 63 to 962 cells/mm
Danish: 962 celler/mm
English: Stavudine therapy is associated with several severe side effects, such as lactic acidosis, lipoatrophy and polyneuropathy, for which a potential underlying mechanism is mitochondrial toxicity.
Danish: Stavudinbehandling er forbundet med adskillige, alvorlige bivirkninger, som for eksempel laktatacidose, lipoatrofi og polyneuropati, hvor en potentiel underliggende mekanisme er mitokondriel toksicitet.
English: The profile of the adverse events for newborns and infants ≤ 3 months of age showed increases in lactic acid levels, neutropenia, anaemia, thrombocytopenia, hepatic transaminase increases and increased lipids, including hypertriglyceridaemia.
Danish: Bivirkningsprofilen for nyfødte og spædbørn ≤ 3 måneder viste stigninger i mælkesyreniveau, neutropeni, anæmi, trombocytopeni samt forhøjede lever-aminotransferaser og lipider, inklusive hypertriglyceridæmi.
English: Two to three hours post-dose, CSF/plasma ratios of stavudine ranged from 16% to 125% (mean of 59%±35%).
Danish: To til tre timer efter administration lå CSF/plasma ratio af stavudin på mellem 16125% (middel på 59% ± 35%).
English: Stavudine, a thymidine analogue, is phosphorylated by cellular kinases to stavudine triphosphate which inhibits HIV reverse transcriptase by competing with the natural substrate, thymidine triphosphate.
Danish: Stavudin, en thymidinanalog, bliver fosforyleret af cellulære kinaser til stavudintrifosfat, som hæmmer HIV revers transkriptase ved at konkurrere med det naturlige substrat thymidintrifosfat.
English: Before reconstitution the Zerit powder appears as off-white to pale-pink, gritty powder.
Danish: Før tilberedning er Zerit pulver er grålighvidt til lyserødt grynet pulver.
English: rare: anaemia* very rare: neutropenia*, thrombocytopenia*
Danish: Sjælden: anæmi* Meget sjælden: neutropeni*, trombocytopeni*
English: When such development is found, discontinuation of Zerit should be considered.
Danish: Ses udvikling af lipoatrofi, bør seponering af Zerit overvejes.
English: Some patients taking Zerit may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle af de patienter, der får Zerit, kan udvikle en knoglesygdom, der kaldes knoglenekrose (hvor knoglevævet dør på grund af nedsat blodtilførsel til knoglen).
English: The combination of stavudine with didanosine is contraindicated given that both drugs exhibits high risk of mitochondrial toxicity (see sections 4.3 and 4.4).
Danish: Kombinationen af stavudin og didanosin er kontraindiceret, da begge stoffer udviser en stor risiko for mitokondriel toksicitet (se pkt.
English: This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Danish: Lægemidlet indeholder methylhydroxybenzoat (E218) og propylhydroxybenzoat (E216) som kan fremkalde allergiske reaktioner (evt. forsinkede).
English: Zerit 200 mg powder for oral solution is supplied in a bottle containing 200 ml solution.
Danish: Zerit 200 mg pulver til oral opløsning leveres i en 200 ml flaske.
English: Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på flasken og på kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Peripheral neuropathy was seen in combination studies of Zerit with lamivudine plus efavirenz; the frequency of peripheral neurologic symptoms was 19% (6% for moderate to severe) with a rate of discontinuation due to neuropathy of 2%.
Danish: Hyppigheden af perifere neurologiske symptomer var 19% (6% af moderat til svær grad) med en seponeringsrate pga. neuropati på 2 %.
English: Patients continuing treatment with Zerit should be assessed frequently and switched to an alternative appropriate therapy whenever possible (see section 4.4).
Danish: Patienter, der fortsætter behandling med Zerit, skal undersøges ofte og skifte til anden mere passende behandling, så snart muligt (se pkt.
English: uncommon: hepatitis or jaundice rare: hepatic steatosis* very rare: liver failure*
Danish: Ikke almindelig: hepatitis eller gulsot Sjælden: hepatisk steatose* Meget sjælden: leversvigt*
English: Hepatotoxicity and hepatic failure resulting in death were reported during postmarketing surveillance in HIV infected patients treated with antiretroviral agents and hydroxyurea; fatal hepatic events were reported most often in patients treated with stavudine, hydroxyurea and didanosine.
Danish: Levertoksicitet og leversvigt, som har resulteret i dødsfald, har under post-marketing-overvågning været rapporteret hos HIV-smittede patienter, som har været i behandling med antiretrovirale midler og hydroxycarbamid; de letale levertilfælde blev oftest rapporteret hos patienter i behandling med stavudin, hydroxycarbamid og didanosin.