FrancophonIA/ELRC3.0 huggingface dataset:
English: • Try and space the doses evenly apart at times which are good for you - for example, first thing in the morning and then in the early evening.
Danish: • Prøv at tage medicinen på bestemte tidspunkter på dagen, der er praktiske for dig, og med et passende mellemrum - fx som det første om morgenen og først på aftenen.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: This side effect is rare (affects less than 1 in 1,000 people).
Danish: Denne bivirkning er sjælden (påvirker færre end 1 ud 1000 brugere).
English: Of these, 185 (98.9%) env genes carried specific substitutions in region of aa 36 - 45 of gp41.
Danish: Heraf havde 185 (98,9 %) env-gener specifikke substitutioner i området af gp41 aminosyrerne 36-45.
English: Fuzeon should be prescribed by physicians who are experienced in the treatment of HIV infection.
Danish: Fuzeon skal ordineres af læger med erfaring i behandling af hiv infektion.
English: Patients with liver disease
Danish: Patienter med leversygdom
English: * Based on results from pooled data of TORO 1 and TORO 2 on ITT population, week 48 viral load for subjects who were lost to follow-up, discontinued therapy, or had virological failure replaced by their last observation (LOCF).
Danish: * Baseret på resultaterne af sammenlagte data fra TORO 1 og TORO 2 for ITT-population, viral belastning ved uge 48 for patienter som ikke kom til follow-up, afbrød behandlingen eller fik virologisk svigt erstattet med deres sidste observation (LOCF).
English: • decreased appetite
Danish: • nedsat appetit
English: Gender and Weight: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide is 20% lower in females than males irrespective of weight and is increased with increased body weight irrespective of gender (20% higher in a 100 kg and 20% lower in a 40 kg body weight patient relative to a 70 kg reference patient).
Danish: Køn og vægt: Analyser af plasmakoncentrationsdata fra patienter i kliniske forsøg tyder på, at enfuvirtid-clearance er 20 % lavere hos kvinder end hos mænd, uanset vægt, og øges med stigende legemsvægt, uanset køn (20 % højere hos en patient, der vejer 100 kg og 20 % lavere hos en patient, der vejer 40 kg, sammenlignet med en patient, der vejer 70 kg).
English: There is no experience in patients with reduced hepatic function.
Danish: Der er ingen erfaringer hos patienter med nedsat leverfunktion.
English: Do not use too much force as the needle may loosen.
Danish: Brug ikke for mange kræfter, da det kan få nålen til at løsne sig.
English: Absorption: The absolute bioavailability after subcutaneous administration of enfuvirtide 90 mg in the abdomen was 84.3 ± 15.5%.
Danish: Absorption: Den absolutte biotilgængelighed efter subkutan administration af 90 mg enfuvirtid i abdomen var 84,3 ± 15,5 %.
English: • Make sure you have 1.1 ml of Water for Injections in the syringe.
Danish: • Vær sikker på, at der er 1,1 ml vand til injektionsvæsker i sprøjten.
English: Specific single substitutions at these residues in gp41 each resulted in a range of decreases from baseline in recombinant viral susceptibility to enfuvirtide.
Danish: Specifikke enkeltsubstitutioner ved disse positioner i gp41 resulterede alle i et varierende fald fra baseline i den rekombinante følsomhed over for enfuvirtid.
English: Table 1: Paediatric Dosing Weight (kg)
Danish: Tabel 1: Dosering til børn Vægt (kg)
English: • not being able to concentrate
Danish: • manglende koncentrationsevne
English: Fuzeon can cause a build-up of a type of protein, called amyloid, under the skin at the injection site.
Danish: Fuzeon kan forårsage ophobning af en type protein, kaldet amyloid, under huden på injektionsstedet.
English: Step C: Preparing for the injection
Danish: Trin C: Forbered indsprøjtningen
English: Fuzeon contains no preservative.
Danish: Fuzeon indeholder ikke konserveringsmidler.
English: Animal studies have shown that enfuvirtide may impair some immune functions (see section 5.3).
Danish: Dyrestudier har vist, at enfuvirtid måske kan nedsætte nogle af immunsystemets funktioner (se pkt.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept og naturlægemidler.
English: There were insufficient examples of multiple substitutions to determine any consistent patterns of substitutions or their effect on viral susceptibility to enfuvirtide.
Danish: Antallet af eksempler på flerfolds substitutioner var utilstrækkeligt til at bestemme et fast mønster af substitutioner eller deres effekt på den virale følsomhed over for enfuvirtid.
English: Elderly: The pharmacokinetics of enfuvirtide have not been formally studied in elderly patients over 65 years of age.
Danish: Ældre: Enfuvirtids farmakokinetik er ikke formelt undersøgt hos ældre patienter over 65 år.
English: • Do not inject into areas that could become irritated by your belt or the waistline of your clothes.
Danish: • Giv ikke indsprøjtningen steder, der kan blive generet af et bælte eller en linning i tøjet.
English: Log Change from baseline (log10 copies/ml)*
Danish: Log ændring fra baseline (log10 kopier/ml)*
English: Refrigerated reconstituted solution should be brought to room temperature before injection.
Danish: Afkølet rekonstitueret opløsning skal bringes til stuetemperatur før injektion.
English: OB alone regimen Per 100 patient years n (Total Exposure patient years) ALAT Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN) Haemoglobin Gr. 3 (6.5-7.9 g/dL) Gr. 4 (<6.5 g/dL) Creatinine phosphokinase Gr. 3 (>5-10 x ULN) Gr. 4 (>10 x ULN)
Danish: OB alene pr. 100 patientår n (Total patienteksponeringsår) ALAT Gr. 3 (> 5-10 x ULN) Gr. 4 (> 10 x ULN) Hæmoglobin Gr. 3 (6,5-7,9 g/dl) Gr. 4 (< 6,5 g/dl) Kreatininphosphokinase Gr. 3 (> 5-10 x ULN) Gr. 4 (> 10 x ULN)
English: If you are preparing both of your daily doses at one time, make sure to use new syringes, Water for Injections, and Fuzeon for each dose.
Danish: Hvis du klargør begge dine daglige doser på samme tid, skal du sørge for at bruge nye sprøjter, et nyt hætteglas med vand til injektionsvæsker og et nyt hætteglas med Fuzeon til hver dosis.
English: Date of latest renewal:
Danish: Dato for seneste fornyelse af tilladelsen:
English: No clinically significant pharmacokinetic interactions are expected between enfuvirtide and concomitantly given medicinal products metabolised by CYP450 enzymes.
Danish: Der forventes ingen klinisk signifikante farmakokinetiske interaktioner mellem enfuvirtid og samtidigt indgivne lægemidler, som metaboliseres af CYP450-enzymer.
English: If you have any of these reactions do not stop using Fuzeon, but talk to your doctor about any concerns you have.
Danish: Hvis du får én eller flere af disse reaktioner, skal du ikke holde op med at tage Fuzeon, men tale med lægen, hvis du er bekymret.
English: Nervous system disorders Very common Common
Danish: Nervesystemet Meget almindelig Almindelig
English: Events included rash, fever, nausea and vomiting, chills, rigors, low blood pressure and elevated serum liver transaminases in various combinations, and possibly primary immune complex reaction, respiratory distress and glomerulonephritis.
Danish: De omfatter udslæt, feber, kvalme og opkastning, kulderystelser, stivhed, lavt blodtryk og forhøjede serum-levertransaminaser i forskellige kombinationer og muligvis primært immunkompleksreaktioner, respirationsbesvær og glomerulonefritis.
English: If the reconstituted solution cannot be injected immediately, it must be kept refrigerated until use and used within 24 hours.
Danish: Hvis den rekonstituerede opløsning ikke skal injiceres med det samme, skal den holdes afkølet og anvendes inden for 24 timer.
English: Autoimmune disorders may occur many months after the start of treatment.
Danish: Autoimmune lidelser kan opstå mange måneder efter, du er påbegyndt behandling.
English: • feeling anxious or irritated
Danish: • angst eller irritation
English: Race: Analysis of plasma concentration data from patients in clinical trials indicated that the clearance of enfuvirtide was not different in Afro-Americans compared to Caucasians.
Danish: Race: Analyser af plasmakoncentrationsdata fra patienter i kliniske forsøg tyder på, at der ikke er forskel på enfuvirtid-clearance hos afro-amerikanere sammenlignet med kaukasere.
English: • Fuzeon is not a cure for HIV infection.
Danish: • Fuzeon helbreder ikke hiv.
English: The following is a basic, step-by-step guide to injecting your medicine.
Danish: Følgende er en trinvis vejledning i, hvordan du indsprøjter medicinen.
English: Section 7 tells you how to prepare Fuzeon and how to give yourself an injection.
Danish: I afsnit 7 forklares det, hvordan du skal klargøre Fuzeon, og hvordan du giver dig selv indsprøjtningen.
English: Your doctor should discuss this with you at that time.
Danish: Hvis det sker, vil lægen diskutere det med dig.
English: Data is limited in patients with moderate to severe renal impairment, and in patients maintained on dialysis.
Danish: Data er begrænset for patienter med moderat til svær nyreinsufficiens, og for patienter i dialyse.
English: Sinusitis, skin papilloma, influenza, pneumonia, ear infection
Danish: Sinusitis, hudpapillom, influenza, pneumoni, øreinfektion
English: Appetite decreased, anorexia, hypertriglyceridaemia, blood triglycerides increased, diabetes mellitus
Danish: Nedsat appetit, anoreksi, hypertriglyceridæmi, forhøjede triglycerider i blodet, diabetes mellitus
English: Total prior ARVs >
Danish: Total tidligere ARL
English: - After the dose is fully delivered, remove the needle from the skin.
Danish: • Når hele dosis er givet, trækkes nålen ud af huden.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: • This step may be repeated until the correct amount of Water for Injections is in the syringe.
Danish: • Dette trin kan gentages, indtil du har den rigtige mængde vand til injektionsvæsker i sprøjten.
English: It is an inhibitor of the structural rearrangement of HIV-1 gp41 and functions by specifically binding to this virus protein extracellularly thereby blocking fusion between the viral cell membrane and the target cell membrane, preventing the viral RNA from entering into the target cell.
Danish: Det er en hæmmer af den strukturelle ændring af hiv-1-gp41 og virker ved specifikt at binde sig ekstracellulært til dette virusprotein, hvilket blokerer fusionen af virus- og målcelle-cellemembranerne og hindrer dermed virus i at komme ind i cellen.
English: Combination studies of enfuvirtide with representative members of the various antiretroviral classes exhibited additive to synergistic antiviral activities and an absence of antagonism.
Danish: Studier af en kombination af enfuvirtid og repræsentative lægemidler fra forskellige antiretrovirale lægemiddelgrupper viste additiv til synergistisk antiviral aktivitet og ingen antagonisme.
English: • flu or ‘flu-like' symptoms
Danish: • influenza eller influenza-lignende symptomer
English: In in vitro human microsomal and hepatocyte studies, hydrolysis of the amide group of the C-terminus amino acid, phenylalanine results in a deamidated metabolite and the formation of this metabolite is not NADPH dependent.
Danish: I humane in vitro mikrosomale og hepatocyt-studier, resulterer hydrolyse af amidgruppen i den C-terminale aminosyre, phenylalanin, i en deamineret metabolit, og dannelsen af denne metabolit er ikke NADPH-afhængig.
English: If you stop and there is a gap in your treatment this may speed up the chances of the HIV in your blood becoming resistant to Fuzeon.
Danish: Hvis du stopper, vil der opstå en pause i din behandling, og dette kan øge risikoen for at hiv-virus i blodet ikke længere reagere på (bliver resistent over for) Fuzeon.
English: The vast majority of ISRs occurred within the first week of Fuzeon administration and were associated with mild to moderate pain or discomfort at the injection site without limitation of usual activities.
Danish: Langt defleste reaktioner på injektionsstedet opstod inden for den første uge efter administration af Fuzeon og var ledsaget af let til middelsvær smerte eller ubehag på injektionsstedet uden begrænsning i sædvanlige aktiviteter.
English: Biotransformation: As a peptide, enfuvirtide is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acids in the body pool.
Danish: Biotransformation: Som peptid forventes enfuvirtid at blive nedbrudt til de aminosyrer, som det består af, med efterfølgende genanvendelse i kroppen.
English: Risk factors that may predict the occurrence or severity of hypersensitivity to enfuvirtide have not been identified.
Danish: Der er ikke fundet risikofaktorer, som kan forudsige forekomst eller sværhedsgrad af hypersensitivitet overfor enfuvirtid.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
English: The pharmacokinetic properties of enfuvirtide have been evaluated in HIV-1-infected adult and paediatric patients.
Danish: Enfuvirtids farmakokinetiske egenskaber er undersøgt hos hiv-1-smittede voksne og børn.
English: Fuzeon must only be reconstituted with 1.1 ml of Water for Injections.
Danish: Fuzeon må kun rekonstitueres med 1,1 ml vand til injektionsvæsker.
English: Conversely, mutations in aa 36-45 of gp41 which give resistance to enfuvirtide would not be expected to give cross resistance to other classes of antiretrovirals.
Danish: Omvendt forventes det ikke, at mutationer i gp41 aminosyrerne 36-45, som forårsager resistens over for enfuvirtid, vil forårsage resistens over for andre antiretrovirale lægemiddelgrupper.
English: If you accidentally touch the rubber stopper, make sure to clean it again with a new alcohol swab
Danish: Hvis du ved et uheld kommer til at røre ved gummiproppen, er det vigtigt at rengøre den igen med en ny spritserviet
English: The highest dose administered to 12 patients in a clinical trial was 180 mg as a single dose subcutaneously.
Danish: Den højeste dosis, som blev givet til 12 patienter i et klinisk forsøg, var en enkelt subkutan dosis på 180 mg subkutant.
English:  Risk factors for developing this disease include: how long you have been taking anti-HIV medicines, whether you take corticosteroids, how much alcohol you drink, how well your immune system works and being overweight.
Danish: • Risikofaktorer for udvikling af denne sygdom omfatter: Hvor længe du har fået HIV-medicin, om du får binyrebarkhormon (steroid), hvor meget alkohol du indtager, hvor godt dit immunforsvar er, og om du er overvægtig.
English: Subcutaneous use
Danish: Anvendes subkutant
English:  Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: • Tegn på osteonekrose er stive led, ledsmerter (særligt i hofte, knæ og skulder) og bevægelsesbesvær.
English: Fuzeon must be taken as part of a combination regimen.
Danish: Fuzeon gives som led i en kombinationsbehandling.
English: Also do not use the Water for Injections if you see any particles in the vial or if the water is cloudy.
Danish: Brug heller ikke vandet til injektionsvæsker, hvis du ser partikler i hætteglasset, eller hvis vandet er uklart.
English: Most adverse reactions were of mild or moderate intensity.
Danish: Intensiteten af de fleste bivirkninger var for det meste let eller moderat.
English: The syringes supplied with this medicine have a coloured needle protector.
Danish: De sprøjter, der udleveres sammen med denne medicin, har en farvet hætte over nålen.
English: Fuzeon should be used with caution in these populations (see sections 4.2 and 5.2).
Danish: Fuzeon skal anvendes med forsigtighed til disse populationer (se pkt.
English: • Your doctor has prescribed Fuzeon to help control your HIV infection.
Danish: • Lægen har ordineret Fuzeon til behandling af din hiv-smitte.
English: There is no evidence that enfuvirtide may alter the patient's ability to drive and use machines, however, the adverse event profile of enfuvirtide should be taken into account (see section 4.8).
Danish: Det er ikke bevist at enfuvirtid påvirker evnen til at føre motorkøretøj eller betjene maskiner, men enfuvirtids bivirkningsprofil skal dog tages i betragtning (se pkt.
English: 1Discontinuations or virological failures considered as failures.
Danish: 1Behandlingsstop eller virologisk svigt betragtes som behandlingssvigt.
English: However, if it is less than 6 hours before the next regular dose, the missed dose should be skipped
Danish: Er der mindre end 6 timer til næste dosis, skal den glemte dosis dog springes over.
English: Patients should be instructed on the use and administration of Fuzeon by a healthcare professional before using for the first time.
Danish: En sundhedsfaglig kompetent person skal instruere patienten i anvendelse og administration af Fuzeon inden første behandling.
English: 11.0 to 15.5
Danish: 11,0 til 15,5
English: Adults and adolescents ≥ 16 years: The recommended dose of Fuzeon is 90 mg twice daily injected subcutaneously into the upper arm, anterior thigh or abdomen.
Danish: Voksne og unge ≥ 16 år: Den anbefalede dosis er 90 mg Fuzeon to gange dagligt, injiceret subkutant i overarmen, på lårets forside eller i abdomen.
English: Weight decreased Influenza like illness, asthenia c. Description of selected adverse reactions
Danish: Vægttab Influenzalignende sygdom, asteni c. Beskrivelse af udvalgte bivirkninger
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget for krav om brailleskrift
English: ● pain, feeling sore or tender These reactions can appear in the first week of treatment and usually only last for up to 7 days.
Danish: Disse reaktioner kan opstå i løbet af den første uge, hvor du får behandlingen, men varer som regel kun i op til 7 dage.
English: METHOD OF ADMINISTRATION Read the package leaflet before use
Danish: ADMINISTRATIONSMETODE Læs indlægssedlen inden brug.
English: Signs of autoimmune disorders
Danish: Tegn på autoimmun sygdom
English: • you have chronic hepatitis B or C or another liver disease - you are more likely to get serious liver problems while using this medicine
Danish: • du har kronisk hepatitis B eller C eller anden leversygdom - det vil øge risikoen for, at du får alvorlige leverproblemer under behandlingen med denne medicin.
English: Please also refer to the respective summary of product characteristics of the other antiretroviral medicinal products used in the combination.
Danish: Der henvises til de respektive produktresuméer for de øvrige antiretrovirale lægemidler, der anvendes i behandlingen.
English: Breast-feeding: It is not known whether enfuvirtide is secreted in human milk.
Danish: Amning: Det vides ikke, om enfuvirtid udskilles i modermælk.
English: The relationship between the in vitro susceptibility of HIV-1 to enfuvirtide and inhibition of HIV-1 replication in humans has not been established.
Danish: Der er ikke påvist sammenhæng mellem følsomhed af hiv-1 over for enfuvirtid in vitro og hæmning af hiv-1replikation hos mennesker.
English: There you will find instructions on how to prepare Fuzeon and how to give yourself an injection.
Danish: Du vil her finde instruktioner i, hvordan du blander Fuzeon, og hvordan du giver dig selv indsprøjtningen.
English: In vitro human microsomal studies and in in vivo studies indicate that enfuvirtide is not an inhibitor of CYP450 enzymes.
Danish: Humane mikrosomale in vitro-studier og in vivostudier tyder på, at enfuvirtid ikke hæmmer CYP450-enzymer.
English: The mean CD4 cell count increase was greater in patients on the Fuzeon + OB regimen than in patients on OB regimen only (see Table 5).
Danish: Middelstigningen i CD4-celletallet var større hos patienter i Fuzeon + OB-gruppen end i OB-gruppen (se tabel 5).
English: Blood and lymphatic system disorders Common
Danish: Blod og lymfesystem Almindelig
English: Therapy with enfuvirtide should not be restarted following systemic signs and symptoms consistent with a hypersensitivity reaction considered related to enfuvirtide.
Danish: Behandlingen med enfuvirtid bør ikke genoptages efter systemiske kliniske fund og symptomer, der er i overensstemmelse med en overfølsomhedsreaktion, og som anses for relateret til enfuvirtid.
English: België/Belgique/Belgien N.V. Roche S.A.
Danish: België/Belgique/Belgien N.V.
English: Mechanism of Action: Enfuvirtide is a member of the therapeutic class called fusion inhibitors.
Danish: Virkningsmekanisme: Enfuvirtid tilhører en terapeutisk gruppe, som kaldes fusionshæmmere.
English: It may be difficult at first to inject in some places, such as the upper arms.
Danish: I starten kan det være svært at give indsprøjtningen nogle bestemte steder, fx i overarmen.
English: Fuzeon has not been tested for its effect on your ability to drive a car or use tools or machines.
Danish: Fuzeon er ikke testet for, om det påvirker din evne til at køre bil, motorcykel eller cykel eller betjene værktøj og maskiner.
English: Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic).
Danish: Det er påvist, at Fuzeon ikke påvirker virkningen af anden hiv-medicin, som du anvender eller af rifampicin (et antibiotikum).
English: Metabolism and nutrition disorders Common
Danish: Metabolisme og ernæring Almindelig
English: If you feel dizzy while using Fuzeon do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel mens du tager Fuzeon, må du ikke køre bil, motorcykel eller cykel eller betjene værktøj og maskiner.
English: Talk to your doctor, pharmacist or nurse before using Fuzeon if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Fuzeon, hvis
English: All patients received an optimised background (OB) regimen consisting of 3 to 5 antiretroviral agents selected on the basis of the patient's prior treatment history, as well as baseline genotypic and phenotypic viral resistance measurements.
Danish: Alle patienter fik en optimal baggrundsbehandling (OB) omfattende 3 til 5 antiretrovirale stoffer, som var valgt ud fra patienternes tidligere behandling og genotypisk og fænotypisk viral resistensbestemmelse ved baseline.
English: Cleansing the injection site
Danish: Rengøring af indsprøjtningsstedet
English: If you notice any of these signs please inform your doctor.
Danish: Hvis du bemærker et eller flere af disse tegn, skal du kontakte lægen.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: • Do not breast-feed if you have HIV because HIV may be passed on to the baby.
Danish: • Hvis du er hiv-smittet, må du ikke amme, da smitten kan overføres til barnet.
English: However if it is less than 6 hours before you are going to take your next regular dose, skip the missed dose.
Danish: Hvis der er mindre end 6 timer til, du skal tage den næste dosis, skal du dog springe den glemte dosis over.
English: Patients developing signs/symptoms of a systemic hypersensitivity reaction should discontinue enfuvirtide treatment and should seek medical evaluation immediately.
Danish: Patienter, som udvikler kliniske fund/symptomer på en systemisk hypersensitivitetsreaktion skal straks stoppe behandlingen med enfuvirtid og søge læge.
English: Draw back 1.1 ml of air.
Danish: Træk 1,1 ml luft op.
English: • hold the plastic cap under the needle protector
Danish: • holde fast i plastikhætten under beskyttelseshætten