FrancophonIA/ELRC3.0 huggingface dataset:
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Danish: Selv om effektiv virussuppression med antiretroviral behandling har vist sig væsentligt at reducere risikoen for seksuel overførsel, kan en resterende risiko ikke udelukkes.
English: More than one vial of Trogarzo will be needed to get the required dose.
Danish: Det er nødvendigt med mere end et hætteglas med Trogarzo for at få den nødvendige dosis.
English: The results of the primary endpoint analysis are shown in Table 2 below.
Danish: Resultaterne af den primære endepunktsanalyse er vist i Tabel 2 nedenfor.
English: Allergic reaction (hypersensivity).
Danish: • Allergiske reaktioner (overfølsomhed).
English: Dizziness, nausea, fatigue and headache have been reported during treatment with ibalizumab (see section 4.8).
Danish: Svimmelhed, kvalme, træthed og hovedpine er rapporteret under behandling med ibalizumab (se afsnit 4.8).
English: In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Danish: For at undgå overførsel af hiv til spædbarnet anbefales det, at hiv-inficerede kvinder under ingen omstændigheder ammer deres spædbørn.
English: The most frequently reported adverse reactions were rash (9.2%), diarrhoea (3.9%), dizziness (3.9%), headache (3.9%), nausea (3.9%), fatigue (2.0%) and vomiting (2.0%).
Danish: De hyppigst rapporterede bivirkninger var udslæt (9,2 %), diarré (3,9 %), svimmelhed (3,9 %), hovedpine (3,9 %), kvalme (3,9 %), træthed (2,0 %) og opkast (2,0 %).
English: Trogarzo has a low sodium content
Danish: Trogarzo har et lavt natriumindhold
English: Date of first authorisation: {DD month YYYY}
Danish: Dato for første markedsføringstilladelse: {DD måned ÅÅÅÅ}>
English: Subjects must have been treated with antiretrovirals for at least 6 months and be failing or had recently failed therapy (i.e., in the last 8 weeks).
Danish: Forsøgspersoner skulle have været behandlet med antiretrovirale lægemidler i mindst 6 måneder, hvor behandlingen var svigtende eller havde svigtet (dvs. i de sidste 8 uger).
English: This dose was administered as it is at least 10-fold the estimated free clinical AUC and Cmax for the 800 mg Q2W dose.
Danish: Denne dosis blev indgivet, da den er mindst 10 gange den estimerede frie kliniske AUC og Cmax for 800 mg Q2W-dosis.
English: It is also active against HIV-1 resistant to currently approved antiretroviral medicinal products and exhibits antiretroviral activity against R5-tropic, X4-tropic, and dual-tropic HIV-1.
Danish: Det er også aktivt mod hiv-1-resistens over for nuværende godkendte antiretrovirale lægemidler og udviser antiretroviral aktivitet mod R5-tropisk, X4-tropisk og dobbelt-tropisk hiv-1.
English: However, the effect is unlikely to impact virologic outcome and does not warrant a dose adjustment.
Danish: Imidlertid er det usandsynligt, at effekten påvirker det virologiske resultat hvilket ikke berettiger en dosisjustering.
English: However, CD4+ cells in infants of treated females were temporarily suppressed from BD14-91 compared to control, but there was no further impact on immunocompetence of the infants.
Danish: CD4+-celler i spædbørn hos behandlede hunner blev imidlertid supresseret af BD14-91 sammenlignet med kontrol, men der var ingen yderligere indflydelse på spædbørnernes immunkompetence.
English: Prophylactic medication is not warranted prior to each infusion.
Danish: Det er ikke nødvendigt at give et profylaktisk lægemiddel forud for hver infusion.
English: The results suggest that ibalizumab concentration decreases as body weight increases.
Danish: Resultaterne antyder, at koncentrationen af ibalizumab falder, når kropsvægten øges.
English: This behaviour is characteristic of saturable (capacity-limited) elimination kinetics.
Danish: Denne opførsel er karakteristisk for mættelig (kapacitetsbegrænset) elimineringskinetik.
English: Pharmacotherapeutic group: Antivirals for systemic use, other antivirals.
Danish: Farmakoterapeutisk klassifikation: Antivirale lægemidler til systemisk brug, andre antivirale lægemidler.
English: This period was to establish the safety and durability of virologic suppression of ibalizumab when used in combination with an optimized background regimen.
Danish: Denne periode skulle fastlægge sikkerheden og holdbarheden af ibalizumabs virologiske suppression, når det blev brugt i kombination med et optimeret baggrundsregime.
English: • Control period (Day 0 to Day 6): Subjects were either monitored on their current failing therapy or received no therapy if they had failed and discontinued treatment within the 8 weeks preceding screening.
Danish: • Kontrolperiode (dag 0 til dag 6): Forsøgspersoner blev enten monitoreret for deres nuværende mislykkede behandling eller modtog ingen behandling, hvis denne var mislykkedes og ophørt inden for de 8 uger, der foregik inden screeningen.
English: Rashes were common.
Danish: Udslæt var almindeligt forekommende.
English: End of control period End of functional monotherapy period
Danish: Afslutning på kontrolperioden Afslutning på funktionel monoterapiperiode
English: The majority of subjects in Trial TMB-301 were male (85%), white (55%) and between 23 and 65 years of age (mean [SD] age: 50.5 [11.0] years).
Danish: Størstedelen af forsøgspersoner i forsøg TMB-301 var mænd (85 %), hvide (55 %) og mellem 23 og 65 år (gennemsnitlig [SD] alder: 50.5 [11.0] år).
English: Human immunoglobulin (IgG) is known to cross the placental barrier.
Danish: Humant immunoglobulin (IgG) vides at krydse placentabarrieren.
English: As an example, an OSS of 2 would indicate that the HIV-1 isolate tested was fully susceptible to two drugs in the OBR.
Danish: Som et eksempel kunne en OSS på 2 indikere, at hiv-1isolatet, der var testet, var fuldt følsomt for to lægemidler i OBR.
English: abnormal results on tests of the heart's electrical activity (electrocardiogram)
Danish: • unormale resultater ved test af hjertets elektriske aktivitet (elektrokardiogram)
English: • Maintenance period (Day 14 to Week 25): On Day 14 of the treatment period, viral load was assessed for the primary endpoint, and thereafter the background regimen was optimized to include at least one drug to which the subject's virus was susceptible.
Danish: • Vedligeholdelsesperiode (dag 14 til dag 25): På dag 14 i behandlingsperioden blev virusmængde vurderet for det primære endepunkt, og derefter blev baggrundsregimet optimeret til at omfatte mindst et lægemiddel, som forsøgspersonens virus var modtagelig over for.
English: The use of an investigational drug as a component of the optimized background regimen was allowed.
Danish: Brug af et andet forsøgsprodukt til behandling af hiv, som komponent i det optimerede baggrundsregime, blev tilladt.
English: This helps your body to increase the CD4 cell count in your blood.
Danish: Dette hjælper din krop med at øge CD4-celletallet i dit blod.
English: Sodium chloride Polysorbate 80
Danish: Natriumchlorid Polysorbat 80
English: 4 vials (5.32 mL)
Danish: 4 hætteglas (5,32 ml)
English: The subject had no adverse reactions associated with the positive immunogenicity result.
Danish: Forsøgspersonen havde ingen bivirkninger forbundet med det positive immunogenicitetsresultat.
English: The volume of distribution of ibalizumab is approximately 4.8 L, which is comparable with vascular space, based on the performed population pharmacokinetics analysis.
Danish: Fordelingsvolumen for ibalizumab er ca. 4,8 l, hvilket er sammenligneligt med vaskulært rum, baseret på den udførte farmakokinetiske populationsanalyse.
English: Trogarzo is used in adults to treat HIV infection that has not responded to a number of HIV treatments in the past.
Danish: Trogarzo bruges til behandling af hiv-infektion hos voksne, der ikke tidligere har reageret på en række hiv-behandlinger.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe er bivirkningerne opstillet efter aftagende alvorlighed.
English: Specific metabolism studies were not conducted because ibalizumab is a protein.
Danish: Specifikke studier i metabolisme blev ikke udført, da ibalizumab er et protein.
English: One subject out of 153 was reported to have hypersensitivity (allergic reaction) on Day 21 (i.e. 7 days after the 2nd infusion of ibalizumab).
Danish: En forsøgsperson ud af 153 blev rapporteret at have overfølsomhed (allergisk reaktion) på dag 21 (dvs. syv dage efter den anden infusion af ibalizumab).
English: HIV-RNA (copies/mL)
Danish: Hiv-RNA (kopier/ml)
English: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Ireland
Danish: MIAS Pharma Limited Suite 2 Stafford House, Strand Road, Portmarnock, Co. Dublin, D13 H525 Irland
English: There were no ibalizumab-related adverse effects (maternal, foetal, or infant) at 110 mg/kg (No-Observed-Adverse-Effect Level, NOAEL).
Danish: Der var ingen ibalizumab-relaterede bivirkninger (mor, foster eller spædbarn) ved 110 mg/kg (No-Observed-Adverse-Effect Level, NOAEL).
English: Patients in Arm A and B arm who experienced virologic failure had the option of switching to a new OBR.
Danish: Patienter der oplevede virologisk svigt i arm A og B, havde muligheden for at skifte til en ny OBR.
English: The HIV virus infects cells in your blood called ‘CD4' or ‘T-cells'.
Danish: Hiv-viruset inficerer celler i dit blod kaldet CD4- eller T-celler.
English: This will reduce the amount of virus in your body, and keeps it at a low level.
Danish: Dette mindsker mængden af hiv i blodet og holder det på et lavt niveau.
English: When this is stably kept at undetectable levels, the chances that you can still pass on HIV to your sexual partners become negligible.
Danish: Når mængden holdes stabilt på niveauer, der ikke kan spores, er risikoen for, at du stadig kan videregive hiv til dine seksuelle partnere, ubetydelig.
English: - The other excipients are sucrose, sodium chloride (see section 2 ‘Trogarzo has a low sodium content'), polysorbate 80, histidine, hydrochloric acid, water for injections.
Danish: - De andre hjælpestoffer er saccharose, natriumchlorid (se afsnit 2 'Trogarzo har et lavt natriumindhold'), polysorbat 80, histidin, saltsyre, vand til injektionsvæsker.
English: This was an observational period to establish baseline HIV viral load.
Danish: Formålet med denne observationsperiode var at etablere en baseline hiv-virusmængde.
English: Trogarzo attaches to the CD4 receptor and blocks HIV from entering and infecting your blood cells.
Danish: Trogarzo fastgøres til CD4-receptoren og blokerer hiv fra at komme ind og inficere dine blodceller.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør indledes af en læge med erfaring i behandling af hiv-infektion.
English: Laboratory abnormalities
Danish: Laboratorie abnormiteter
English: If you stop having Trogarzo Keep having Trogarzo infusions until your doctor tells you to stop.
Danish: Du skal fortsætte med at få Trogarzo-infusioner, indtil din læge siger, at du skal stoppe.
English: The safety and efficacy of ibalizumab in children under the age of 18 years have not yet been established.
Danish: Ibalizumabs sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: No relevant remaining effect of ibalizumab is expected in cases of resistance development.
Danish: Der forventes ingen relevant resterende effekt af ibalizumab i tilfælde af resistensudvikling.
English: Genotoxicity, carcinogenic potential
Danish: Genotoksicitet, carcinogenspotientiale
English: Subjects were required to have a viral load greater than 1,000 copies/mL and documented resistance to at least one antiretroviral medication from three classes of antiretroviral medications as measured by resistance testing.
Danish: Forsøgspersonerne skulle have en virusmængde på mere end 1.000 kopier/ml og dokumenteret resistens over for mindst et antiretroviralt lægemiddel fra tre klasser af antiretrovirale lægemidler, som målt ved resistensforsøg.
English: Maintenance dose of 800 mg
Danish: Vedligeholdelsesdosis på 800 mg
English: Instructions on dilution of ibalizumab before use
Danish: Instruktioner om fortynding af ibalizumab før brug
English: Ibalizumab is expected to degrade to small peptides and individual amino acids.
Danish: Ibalizumab forventes at nedbrydes til små peptider og individuelle aminosyrer.
English: Ibalizumab is produced in murine myeloma non-secreting (NS0) cells by recombinant DNA technology.
Danish: Ibalizumab produceres i murine myeloma ikke-udskillende celler (NS0) ved hjælp af rekombinant DNA-teknologi.
English: This medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Dette lægemiddel skal inspiceres visuelt for partikler og misfarvning inden administration.
English: decrease in viral load N=40
Danish: log10-fald i virusmængde N=40
English: 10 vials (13.3 mL)
Danish: 10 hætteglas (13,3 ml)
English: An increase in the mean number of CD4+ T-cells of 62 cells/mm3 was observed from Baseline to Week 25 (Intent-To-Treat (ITT) analysis).
Danish: En stigning i det gennemsnitlige antal CD4+ T-celler på 62 celler/mm3 blev observeret fra baseline til uge 25 (Intent-ToTreat (ITT) analyse).
English: * Frequency was calculated based on 24 weeks of safety data from 153 subjects enrolled in Phase 2b study TMB-202 (n = 113) and Phase 3 study TMB-301 (n=40), as well as on at least 48 weeks of safety data from 27 subjects from TMB-301 that rolled-over into expanded access study TMB-311.
Danish: * Hyppigheden blev beregnet på basis af 24 ugers sikkerhedsdata fra 153 forsøgspersoner, der deltog i fase 2b-studie TMB202 (n = 113) og fase 3-studie TMB-301 (n = 40), samt på mindst 48 ugers sikkerhedsdata fra 27 forsøgspersoner fra TMB301, der deltog til udvidet adgangsstudie TMB-311.
English: Uncommon (may affect up to 1 in 100 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 patienter):
English: You must not be given Trogarzo: - if you are allergic to ibalizumab or any of the other ingredients of this medicine (listed in section
Danish: Du må ikke få Trogarzo: - hvis du er allergisk over for ibalizumab eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Virologic response at week 25 by baseline CD4 cell count, integrase inhibitor resistance and Overall Susceptibility Score (OSS)* for study TMB-301
Danish: Virologisk respons i uge 25 ved basislinje af CD4-celletal, integraseinhibitorresistens og Overall Susceptibility Score (OSS)* for studie TMB-301
English: Ibalizumab is not recommended during pregnancy.
Danish: Ibalizumab anbefales ikke under graviditet.
English: The duration of the first infusion (loading dose) should be no less than 30 minutes.
Danish: Varigheden af den første infusion (initialdosis) skal være mindst 30 minutter.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and given appropriate symptomatic treatment.
Danish: I tilfælde af overdosering anbefales det, at patienten overvåges for tegn eller symptomer på bivirkninger og får passende symptomatisk behandling.
English: Ibalizumab was generally well tolerated in pregnant monkeys and in their offspring, when evaluated through 180 ± 2 days postpartum.
Danish: Ibalizumab tolereredes generelt godt hos gravide aber og hos deres afkom, da de blev vurderet gennem 180 ± 2 dage efter fødslen.
English: If you miss a dose of Trogarzo
Danish: Hvis du har glemt en dosis Trogarzo
English: • itchy skin, or skin damage bruising abnormal heartbeat high blood pressure or frequent changes in blood pressure Seen in tests:
Danish: • højt blodtryk eller hyppige ændringer i blodtrykket Set i forsøg:
English: Headache, feeling dizzy, feeling sick (nausea) or feeling tired are common side effects of Trogarzo and can affect your ability to drive or use machines.
Danish: Hovedpine, svimmelhedsfølelse, kvalme eller træthed er almindelige bivirkninger af Trogarzo og kan påvirke din evne til at føre motorkøretøj eller betjene maskiner.
English: No action was taken with ibalizumab in response to these events.
Danish: Der blev ikke truffet nogle foranstaltninger med ibalizumab i forhold til disse begivenheder.
English: Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Danish: Kvinder, der er hivpositive, må ikke amme, da hivinfektion kan overføres til spædbørn via modermælken.
English: A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates (age, body weight, sex, baseline CD4+ cell count) on ibalizumab pharmacokinetics.
Danish: En populationsfarmakokinetisk analyse blev udført for at undersøge de potentielle virkninger af udvalgte covariater (alder, kropsvægt, køn, basislinje CD4+ celletal) på ibalizumabs farmakokinetik.
English: • feeling dizzy, faint or light headed when standing up
Danish: • svimmelhed, besvimelse eller svimmel når du rejser dig op
English: The pack size is 2 glass vials per carton.
Danish: Pakningsstørrelsen er 2 hætteglas pr. æske.
English: Virologic response CD4 cell counts (cells/ mm3)
Danish: Virologisk respons CD4-celletal (celler/ mm
English: Ibalizumab pharmacokinetics in geriatric patients (≥ 65 years of age) is limited (n = 5).
Danish: Farmakokinetikken for Ibalizumab hos geriatriske patienter (≥ 65 år) er begrænset (n = 5).
English: Study TNX-355.03 was a multicenter, randomized, double-blinded, placebo-controlled, multi-dose, 3arm safety and efficacy study in 82 subjects with HIV-1 and who were failing or had failed highly active antiretroviral therapy.
Danish: Studie TNX-355.03 var et multicenter, randomiseret, dobbeltblindet, placebokontrolleret, multidosis, 3-arms sikkerheds- og effektivitetsstudie hos 82 forsøgspersoner med hiv-1, hvor højaktiv antiretroviral behandling fejlede eller havde fejlet.
English: Ibalizumab has a minor influence on the ability to drive and use machines.
Danish: Ibalizumab påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you are breast-feeding, or thinking about breast-feeding:
Danish: Hvis du ammer eller påtænker at amme:
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end de, der er oplistet i pkt.
English: In general, rashes had an early onset (i.e. within 1 to 3 weeks of the first dose of ibalizumab), were mild to moderate in intensity, and resolved within 1-3 weeks with continued ibalizumab administration.
Danish: Generelt havde udslæt et tidligt indtræden (dvs. inden for 1 til 3 uger efter den første dosis af ibalizumab), var milde til moderate i intensitet og væk inden for 1-3 uger med fortsat ibalizumab-administration.
English: Common tremor
Danish: Almindelig tremor
English: If you could get pregnant while taking Trogarzo, you need to use a reliable method of barrier contraception (for example, a condom) with other methods of contraception including oral contraceptive (the pill) or other hormonal contraceptives (for example, implants or injections), to prevent pregnancy.
Danish: Hvis du kan blive gravid, mens du får Trogarzo, skal du bruge sikker prævention i form af en barrieremetode (f.eks. kondom) sammen med en anden præventionsmetode, herunder p-piller eller andre hormonelle præventionsmidler (for eksempel implantat eller injektion) for at undgå graviditet.
English: Such non-linear effects in clearance are common for monoclonal antibodies targeting cell surface molecules, such as CD4.
Danish: Sådanne ikkelineære effekter i clearance er almindelige for monoklonale antistoffer, der er målrettet mod celleoverflademolekyler, såsom CD4.
English: If you are not sure, talk to your doctor or nurse before being given Trogarzo.
Danish: Hvis du er i tvivl, så spørg lægen eller sundhedspersonalet, før du får Trogarzo.
English: Trial TNX-355.03
Danish: Forsøg TMB-355,03
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: (se bilag 1: Produktresumé, pkt.
English: • Discard partially used vials or empty vials of ibalizumab and any unused portion of the diluted ibalizumab solution in accordance with local requirements.
Danish: • Kasser delvist anvendte hætteglas eller tomme hætteglas med ibalizumab og enhver ubrugt del af den fortyndede ibalizumab-opløsning i overensstemmelse med lokale krav.
English: It is unknown whether ibalizumab/metabolites are excreted in human milk.
Danish: Det er ukendt, om ibalizumab/metabolitter udskilles i human mælk.
English: If the treating physician determines there is no additional clinical benefit for the patient in terms of viral load reduction, discontinuation of ibalizumab treatment should be considered, see section 5.1.
Danish: Hvis den behandlende læge konstaterer, at der ikke er nogen yderligere klinisk fordel for patienten med hensyn til reduktion af virusmængde, bør seponering af ibalizumab-behandlingen overvejes, se pkt.
English: What you need to know before you use Trogarzo 3.
Danish: Det skal du vide, før du begynder at bruge Trogarzo 3.
English: • Functional monotherapy period (Day 7 to Day 13): All subjects received a 2,000 mg loading dose of ibalizumab on Day 7.
Danish: • Funktionel monoterapiperiode (dag 7 til dag 13): Alle forsøgspersoner modtog en initialdosis på 2.000 mg ibalizumab på dag 7.
English: Ibalizumab, a humanized monoclonal antibody of immunoglobulin G type 4 (IgG4), is a CD4 domain 2-directed HIV-1 inhibitor.
Danish: Ibalizumab, et humaniseret monoklonalt antistof af immunoglobulin G type 4 (IgG4), er en hiv-1hæmmer målrettet CD4-domæne 2.
English: Skin and subcutaneous tissue disorders rash**, dermatitis, dry skin
Danish: Hud og subkutane væv udslæt**, dermatitis, tør hud
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (cART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af multiterapi (combination antiretroviral therapy, cART) opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Following administration of ibalizumab, at the clinically relevant dose rage of 800-2,000 mg, the maximum serum concentration (Cmax) increased dose proportionally, whereas the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner.
Danish: Efter indgivelse af ibalizumab, ved den klinisk relevante dosis på 800-2.000 mg, steg den maksimale serumkoncentration (Cmax) dosis proportionalt, medens området under koncentrationstidskurven (AUC) steg på en større måde end dosis-proportional.
English: At Baseline, median [Min - Max] viral load and CD4+ T cell counts were 35,350 [304 - 743,000] copies/mL and 73 [0 - 676] cells/mm3, respectively.
Danish: Ved baseline, var den mediane [Min - Max] virusmængde og CD4+ T celletal henholdsvis 35.350 [304 - 743.000] kopier/ml og 73 [0 - 676] celler/mm3.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trogarzo in one or more subsets of the paediatric population in the treatment of HIV-1 infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af undersøgelser med Trogarzo hos en eller flere undergrupper af den pædiatriske population ved behandling af hiv-1 infektion (se pkt.