FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common adverse reactions reported during treatment with lamivudine are headache, nausea, malaise, fatigue, nasal signs and symptoms, diarrhoea and cough.
Danish: De hyppigst rapporterede bivirkninger med lamivudin er hovedpine, kvalme, utilpashed, træthed, nasale tegn og symptomer, diarré og hoste.
English: • infection of the hair roots; influenza; skin infection due to virus; upper respiratory tract infection(such as inflammation of the nasal cavity or sinuses located around the nose; common cold); infection in the lymph node (gland in the neck, armpit, or groin)
Danish: • Infektion i hårsækkene, influenza, hudinfektion fremkaldt af virus, infektion i øvre luftveje (såsom betændelse i næsehulen eller bihulerne omkring næsen; almindelig forkølelse), infektion i lymfeknuderne (kirtler i halsen, armhulen eller lysken)
English: Rash occurred more commonly in treatment-experienced patients receiving regimens containing raltegravir + darunavir compared to patients receiving raltegravir without darunavir or darunavir
Danish: Udslæt forekom hyppigere hos behandlingserfarne patienter, der fik behandlingsregimer bestående af raltegravir og darunavir, end hos patienter, der fik raltegravir uden darunavir eller darunavir uden
English: Talk to your doctor immediately if you develop a rash.
Danish: Kontakt straks lægen, hvis du får udslæt.
English: Co-administration of DUTREBIS with medicinal products that are known to be potent UGT1A1 inhibitors (e.g., atazanavir) may increase plasma levels of raltegravir.
Danish: Administration af DUTREBIS sammen med lægemidler, der er kendt som potente UGT1A1-hæmmere (fx atazanavir), kan øge raltegravirs plasmakoncentrationer.
English: Severe, potentially life-threatening, and fatal skin reactions have been reported in patients taking raltegravir, in most cases concomitantly with other medicinal products associated with these reactions.
Danish: Alvorlige, potentielt livstruende og letale hudreaktioner, herunder tilfælde af Stevens-Johnsons syndrom og toksisk epidermal nekrolyse, er rapporteret hos patienter, der tager raltegravir, i de fleste tilfælde sammen med andre lægemidler associeret med disse reaktioner.
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 50 and 400 copies/ml.
Danish: Ved den prognostiske analyse blev virologisk svigt analyseret som "carry forward" for procent med henholdsvis < 50 og 400 kopier/ml.
English: Percent of patients with response and associated 95 % confidence interval (CI) are reported.
Danish: Antal patienter (%) med respons samt 95%
English: After dose selection, additional patients were enrolled for evaluation of long term safety, tolerability and efficacy.
Danish: evaluering af sikkerhed på langt sigt, tolerabilitet samt effektivitet.
English: The following adverse reactions were identified through post-marketing surveillance of raltegravir: thrombocytopenia, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness), hepatic failure, Stevens Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis.
Danish: Følgende bivirkninger blev identificeret ved bivirkningsovervågning af raltegravir efter markedsføring: trombocytopeni, suicidale tanker, suicidal adfærd (især hos patienter med psykisk sygdom i anamnesen), leversvigt, Stevens-Johnsons syndrom, lægemiddeludslæt med eosinofili og systemiske symptomer
English: Raltegravir is also available in a chewable tablet formulation for children weighing at least 11 kg and in granules for oral suspension formulation for infants and toddlers from 4 weeks of age and weighing at least 3 kg to less than 20 kg.
Danish: Raltegravir fås også som tyggetablet til børn, der vejer mindst 11 kg, og som granulat til oral suspension til spædbørn og småbørn fra 4-ugers alderen, der vejer mindst 3 kg og under 20 kg. Se produktresuméerne for tyggetabletten og granulatet til oral suspension for yderligere oplysninger om dosering.
English: For analysis by prognostic factors, virologic failures were carried forward for percent < 400 and 50 copies/ml.
Danish: Ved den prognostiske analyse blev virologisk svigt analyseret som "carry forward" for procent med henholdsvis < 400 og 50 kopier/ml.
English: CART has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump).
Danish: Kombinationsbehandling med antiretrovirale lægemidler er hos hiv-patienter associeret med omfordeling af kropsfedt (lipodystrofi), herunder tab af subkutant fedt perifert i ansigtet, øget intraabdominalt og visceralt fedt, brysthypertrofi og dorsocervical fedtakkumulering (tyrenakke).
English: DUTREBIS must be used in combination with other
Danish: Dutrebis skal tages sammen med
English: At 240-weeks, in treatment-naïve patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 22 %, 44 % and 17 %, respectively, of co-infected subjects treated with raltegravir as compared to 13 %, 13 % and 5 % of all other subjects treated with raltegravir.
Danish: Abnorme laboratorieværdier af grad 2 eller højere hos behandlingsnaive patienter, som viser en forværring af ASAT, ALAT eller totalbilirubin i forhold til baseline, forekom ved uge 240 hos henholdsvis 22%, 44% og 17% af de koinficerede forsøgspersoner, der fik raltegravir, sammenlignet med henholdsvis 13%, 13% og 5% af alle andre forsøgspersoner, der blev behandlet med raltegravir.
English: The combination of lamivudine with cladribine is not-recommended (see section 4.5).
Danish: Kombinationen af lamivudin og cladribin frarådes (se pkt.
English: What DUTREBIS looks like and contents of the pack The film-coated tablet is oval-shaped, green, marked with "144" on one side.
Danish: Den filmovertrukne tablet er oval, grøn, mærket med "144" på den ene side.
English: It can be life-threatening, and cause internal organs to fail.
Danish: Det kan være livstruende og kan sætte
English: Use DUTREBIS with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other medicinal products associated with these conditions (see section 4.4).
Danish: DUTREBIS skal anvendes med forsigtighed hos patienter, der tidligere har haft myopati eller rhabdomyolyse eller er prædisponerede herfor, inklusive andre lægemidler associeret med disse tilstande (se pkt.
English: Co-administration of DUTREBIS with other agents that increase gastric pH (e.g., omeprazole and famotidine) may increase the rate of raltegravir absorption and result in increased plasma levels of raltegravir (see Table 1).
Danish: Samtidig administration af DUTREBIS og andre lægemidler, der øger pH i mavesækken (fx omeprazol og famotidin), kan øge absorptionen af raltegravir og resultere i øget plasmakoncentration af raltegravir (se tabel 1).
English: Renal function should be monitored in patients more likely to have decreased renal function.
Danish: Nyrefunktionen skal monitoreres hos patienter, hvor nedsat nyrefunktion er mest sandsynlig.
English: Week 48 and Week 240 outcomes for patients on the recommended dose of raltegravir 400 mg twice daily from STARTMRK are shown in Table 3.
Danish: Resultaterne fra STARTMRK ved uge 48 og uge 240 for patienter på den anbefalede dosis raltegravir på 400 mg to gange dagligt ses i tabel 3.
English: uncommon immune reconstitution syndrome, drug hypersensitivity,
Danish: Immunreaktiveringssyndrom, lægemiddeloverfølsomhed,
English: Some late-onset neurological disorders have been reported (hypertonia, convulsion, abnormal behaviour).
Danish: Der er rapporteret om senreaktioner i form af neurologiske forstyrrelser (hypertoni, kramper, usædvanlig opførsel).
English: • feeling anxious; feeling of confusion; depressed mood; mood changes; panic attack
Danish: • Angst, forvirring, nedtrykthed, humørsvingninger, panikanfald
English: The safety profile of DUTREBIS is based on the safety data from the individual components of DUTREBIS (lamivudine
Danish: DUTREBIS' sikkerhedsprofil er baseret på sikkerhedsdata fra de enkelte komponenter i DUTREBIS (lamivudin og raltegravir).
English: Remember that DUTREBIS is not a cure for HIV infection.
Danish: Husk, at Dutrebis ikke helbreder hiv-infektion.
English: At 96-weeks, in treatment-experienced patients, Grade 2 or higher laboratory abnormalities that represent a worsening Grade from baseline of AST, ALT or total bilirubin occurred in 29 %, 34 % and 13 %, respectively, of co-infected subjects treated with raltegravir as compared to 11 %, 10 % and 9 % of all other subjects treated with raltegravir.
Danish: Abnorme laboratorieværdier af grad 2 eller højere hos behandlingserfarne patienter, som viste en forværring af ASAT, ALAT eller totalbilirubin i forhold til baseline, forekom ved uge 96 hos henholdsvis 29%, 34% og 13% af de koinficerede forsøgspersoner, der fik raltegravir, sammenlignet med henholdsvis 11%, 10% og 9% af alle andre forsøgspersoner, der blev behandlet med raltegravir.
English: Talk to your doctor about other medicines you can take.
Danish: Tal med lægen om andre lægemidler, du kan tage mod for meget mavesyre.
English: atazanavir /ritonavir /lamivudine Interaction not studied
Danish: atazanavir /ritonavir /lamivudin Interaktion er ikke undersøgt.
English: DUTREBIS should be used with caution in patients who have had myopathy or rhabdomyolysis in the past or have any predisposing issues including other medicinal products associated with these conditions (see section 4.8).
Danish: DUTREBIS bør anvendes med forsigtighed hos patienter, der tidligere har haft myopati eller rhabdomyolyse eller er prædisponerede for det, inklusive andre lægemidler, der er associeret med disse tilstande (se pkt.
English: Interaction studies with these agents have only
Danish: Interaktionsstudier er kun udført hos voksne.
English: The M184V RT mutant shows a <4-fold decrease in susceptibility to didanosine; the clinical significance of these findings is unknown.
Danish: M184V RT-mutanten udviser et < 4-folds fald i følsomheden over for didanosin.
English: • you have kidney problems - Your doctor may decide to change your dose by using the
Danish: Din læge kan beslutte at ændre din dosis ved at anvende
English: • feeling or being sick (nausea or vomiting), diarrhoea, stomach pain
Danish: • Kvalme eller opkastning, diarré, mavesmerter
English: tipranavir /ritonavir /lamivudine Interaction not studied
Danish: tipranavir /ritonavir /lamivudin Interaktion er ikke undersøgt.
English: Co-administration of rifampicin with DUTREBIS is not recommended.
Danish: Samtidig administration af rifampicin og DUTREBIS frarådes.
English: DUTREBIS 150 mg/300 mg film-coated tablets lamivudine/raltegravir
Danish: DUTREBIS 150 mg/300 mg filmovertrukne tabletter lamivudin/raltegravir
English: DUTREBIS is not recommended for use as monotherapy.
Danish: DUTREBIS bør ikke gives som monoterapi.
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are pregnant or
Danish: Spørg din læge, apotekspersonalet eller sundhedspersonalet til råds, før du tager nogen form for medicin,
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside reverse transcriptase inhibitors.
Danish: Der foreligger rapporter om mitokondriel dysfunktion hos hiv-negative spædbørn, som har været eksponeret for nukleosid revers-transkriptasehæmmere in utero og/eller efter fødslen.
English: Some people taking DUTREBIS or other antiretroviral medicines may have other effects show up
Danish: Nogle personer, der tager Dutrebis eller andre antiretrovirale lægemidler, kan få andre bivirkninger, som kan ses i de blodprøver, de får taget:
English: There were no clinically important pharmacokinetic differences between patients with severe renal insufficiency
Danish: Der var ingen klinisk betydningsfulde farmakokinetiske forskelle mellem patienter med svært nedsat nyrefunktion og raske
English: Patients with HIV and hepatitis B or C virus co-infection Patients with chronic hepatitis B or C treated with ART are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Danish: Patienter med kronisk hepatitis B eller C, som bliver behandlet med ART, har øget risiko for svære og potentielt letale leverbivirkninger.
English: The main adverse reactions reported are haematological disorders (anaemia, neutropenia), metabolic disorders (hyperlactatemia, hyperlipasemia).
Danish: De hyppigst indrapporterede bivirkninger er hæmatologiske forstyrrelser (anæmi, neutropeni) og metaboliske forstyrrelser (hyperlaktatæmi, hyperlipasæmi).
English: A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and NRTIs has been hypothesised.
Danish: Det antages, at der er en forbindelse mellem visceral lipomatose og proteasehæmmere (PIer) samt lipoatrofi og NRTIer.
English: Currently available data are described in sections 5.1 and 5.2.
Danish: 5.1 og 5.2).
English: Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking raltegravir (one of the medicines
Danish: Der er rapporteret om alvorlige og livstruende hudreaktioner og overfølsomhedsreaktioner hos nogle patienter, der tager raltegravir (et af lægemidlerne i Dutrebis).
English: • acne; unusual hair loss or thinning; redness of skin; unusual distribution of fat on the body, this may include loss of fat from legs, arms, and face, and increase in abdomen fat; excessive sweating; night sweats; thickening and itching of the skin due to repeated
Danish: • Uren hud (akne), usædvanligt hårtab eller udtynding af hår, rødme af huden, unormal fordeling af fedt på kroppen, som kan omfatte fedttab fra ben, arme og ansigt og øget fedt på maven, kraftig svedafsondring, nattesved, fortykkelse af huden og kløe i huden på grund af
English: Taking an aluminium and magnesium antacid within 6 hours of raltegravir administration significantly decreased raltegravir plasma levels.
Danish: Indtagelse af aluminium og/eller magnesiumholdige antacida inden for 6 timer efter administration af raltegravir reducerede raltegravirs plasmakoncentration væsentligt.
English: Possible side effects
Danish: Den potentielle risiko
English: DUTREBIS with cladribine is not recommended.
Danish: Samtidig administration af DUTREBIS og cladribin frarådes.
English: This does not require dose adjustment unless the patient also has renal impairment (see sections 4.5 and 4.2).
Danish: Dette kræver ikke justering af dosis, medmindre patienten også lider af nedsat nyrefunktion (se pkt.
English: Lipid disorders should be managed as clinically appropriate (see section 4.8).
Danish: Lipidforstyrrelser bør behandles i henhold til klinisk praksis (se pkt.
English: • loss of memory; pain in the hand due to nerve compression; disturbance in attention; dizziness with rapid changes in posture; abnormal taste; increased sleepiness; lack of energy; forgetfulness; migraine headache; reduced sense of touch, numbness or weakness of the arms and/or legs; tingling; sleepiness; tension headache; tremors; poor quality sleep
Danish: • Hukommelsestab, smerter i hænderne på grund af tryk på nerver, opmærksomhedsforstyrrelse, svimmelhed i forbindelse med hurtig ændring af stilling, smagsforstyrrelse, øget søvnbehov, mangel på energi, glemsomhed, migrænelignende hovedpine, nedsat følesans, følelsesløshed eller svaghed i arme og/eller ben, snurrende fornemmelse, søvnighed, spændingshovedpine, rysten, dårlig søvnkvalitet
English: DUTREBIS is not for use in children below 6 years of age.
Danish: Dutrebis må ikke anvendes til børn under 6 år.
English: No dose adjustment required for DUTREBIS or tenofovir disoproxil fumarate.
Danish: Dosisjustering af DUTREBIS eller tenofovirdisoproxilfumarat er ikke nødvendig.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Dutrebis.
English: As a general rule, when deciding to use anti-retroviral agents for the treatment of HIV infection in pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, the animal data as well as the clinical experience in pregnant women should be taken into account in order to characterise the safety for the foetus.
Danish: Generelt bør data fra både dyrestudier og klinisk erfaring hos gravide tages i betragtning for at kunne beskrive sikkerheden for fostret ved beslutning om anvendelse af antiretrovirale lægemidler til behandling af hiv-infektion hos gravide for dermed at reducere risikoen for vertikal overførsel af hiv til det nyfødte
English: A slight increase in incidence of supernumerary ribs was observed in rat pups of dams exposed to raltegravir at approximately 4.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr. No development effects were seen at 3.4-fold human exposure at 400 mg twice daily based on AUC0-24 hr (see section 4.6).
Danish: En lille stigning i forekomsten af overtallige ribben blev set hos rotteunger fra moderdyr, der havde været eksponeret for raltegravir i doser, der var cirka 4,4 gange højere end human eksponering ved 400 mg to gange dagligt baseret på AUC0-24t.
English: Hepato-biliary disorders uncommon hepatitis, hepatic steatosis, hepatitis alcoholic, hepatic failure
Danish: Hepatitis, leversteatose, alkoholisk hepatitis, leversvigt
English: Nucleoside and nucleotide reverse transcriptase inhibitors have been demonstrated in vitro and in vivo to cause a variable degree of mitochondrial damage.
Danish: Det er påvist in vitro og in vivo, at nukleosid- og nukleotid-revers- transkriptasehæmmere forårsager skade på mitokondrierne i varierende udstrækning.
English: DUTREBIS is used in combination with other medicines to treat adults, adolescents, and children 6 years of age and older and weighing at least 30 kg who are infected by HIV.
Danish: Dutrebis bruges sammen med andre lægemidler (kombinationsbehandling) til at behandle hiv-smittede voksne, unge og børn, som er mindst 6 år og vejer mindst 30 kg. Din læge har ordineret Dutrebis som middel til at hjælpe med at holde din hiv-infektion under kontrol.
English: Psychiatric disorders common abnormal dreams, insomnia, nightmare, abnormal behaviour, depression uncommon mental disorder, suicide attempt, anxiety, confusional state, depressed mood, major depression, middle insomnia, mood altered, panic attack, sleep disorder, suicidal ideation, suicidal behaviour (particularly in patients with a pre-existing history of psychiatric illness)
Danish: Mentale forstyrrelser, selvmordsforsøg, angst, konfusion, forsænket stemningsleje, major depression, afbrudt søvnmønster, ændret stemningsleje, panikanfald, søvnforstyrrelser, suicidale tanker, suicidal adfærd (især hos patienter med psykisk sygdom i anamnesen)
English: However, the magnitude of the effect seems unlikely to result in clinically important drug-drug interactions.
Danish: Effekten er dog af en størrelsesorden, så det ikke er sandsynligt, at det medfører klinisk betydningsfulde
English: Each film-coated tablet contains 150 mg of lamivudine and 300 mg of raltegravir (as potassium).
Danish: Hver filmovertrukken tablet indeholder 150 mg lamivudin og 300 mg raltegravir (som kalium).
English: To monitor maternal-foetal outcomes in patients inadvertently administered DUTREBIS while pregnant, an Anti-retroviral Pregnancy Registry has been established.
Danish: Der er oprettet et antiretroviralt graviditetsregister med henblik på monitorering af maternelle/føtale resultater hos patienter, der uforvarende har fået DUTREBIS under graviditeten.
English: When used with other medicines, DUTREBIS may:
Danish: Når Dutrebis tages sammen med andre lægemidler kan det:
English: The pharmacokinetic properties of lamivudine have been determined in adults with impaired hepatic function.
Danish: Lamivudins farmakokinetik er vurderet hos voksne med nedsat leverfunktion.
English: Pharmacotherapeutic group: Antivirals for systemic use; antivirals for treatment of HIV infections,
Danish: Farmakoterapeutisk klassifikation: antivirale lægemidler til systemisk anvendelse ; antivirale lægemidler til behandling af hiv-infektion, kombinationsbehandling, ATC-kode: J05AR16
English: CART has been associated with metabolic abnormalities such as hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia and hyperlactataemia (see section 4.4).
Danish: Kombinationsbehandling med antiretrovirale lægemidler er associeret med metaboliske abnormiteter såsom hypertriglyceridæmi, hyperkolesterolæmi, insulinresistens, hyperglykæmi og hyperlaktatæmi (se
English: Talk to your doctor, pharmacist or nurse before taking DUTREBIS if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Dutrebis:
English: Please refer to the SmPC for the individual components of
Danish: Se produktresuméet for de enkelte komponenter i
English: • deep, fast, difficult breathing, feeling drowsy, numb or weak arms or legs, feeling or being sick
Danish: • dyb, hurtig, besværet vejrtrækning, døsighed, følelseshed eller svaghed i arme eller ben, kvalme
English: Therefore, DUTREBIS should be used with caution in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Derfor skal DUTREBIS anvendes med forsigtighed hos patienter med svært nedsat leverfunktion (se pkt.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint
Danish: Patienterne bør tilrådes at søge lægehjælp ved ledsmerter, ledstivhed eller bevægelsesbesvær.
English: Each film-coated tablet contains 150 mg of lamivudine and 300 mg of raltegravir (as potassium)
Danish: Hver filmovertrukken tablet indeholder 150 mg lamivudin og 300 mg raltegravir (som kalium)
English: No dosage adjustment for DUTREBIS is required for patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig for DUTREBIS hos patienter med let til moderat nedsat leverfunktion.
English: This is because DUTREBIS might interact with other medicines.
Danish: Dette skyldes, at Dutrebis kan påvirke virkningen af anden medicin, ligesom anden medicin kan påvirke virkningen af Dutrebis.
English: CART has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Danish: Antiretroviral kombinationsbehandling er hos hiv- patienter blevet associeret med omfordeling af kropsfedt (lipodystrofi).
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: Lægen henvises til aktuelle retningslinjer for hiv-behandling for optimal behandling af hiv-infektion hos patienter, der samtidigt er inficeret med HBV. I tilfælde af samtidig antiviral behandling for hepatitis B eller C henvises også til den relevante produktinformation for disse lægemidler.
English: Administration of lamivudine at very high dose levels in acute animal studies did not result in any organ toxicity.
Danish: I akutte dyrestudier resulterede administration af meget høje doser lamivudin ikke i organtoksicitet.