FrancophonIA/ELRC3.0 huggingface dataset:
English: Ravulizumab was non-inferior compared to eculizumab for the primary endpoint, percent change in LDH from baseline to day 183, and for all 4 key secondary endpoints (Figure 2).
Danish: Ravulizumab var non-inferior sammenlignet med eculizumab for det primære endepunkt, procentvis ændring i LDH fra baseline til dag 183, og for alle de 4 vigtigste sekundære endepunkter (figur 2).
English: Body weight at time of treatment.
Danish: Legemsvægt på behandlingstidspunktet.
English: No clear treatment-related effects or adverse effects were observed in the murine surrogate reproductive toxicology studies in mice.
Danish: Der blev ikke observeret nogen klare behandlingsrelaterede virkninger eller bivirkninger i de toksikologiske reproduktionsstudier med murint surrogat hos mus.
English: Do not use if there is evidence of particulate matter or precipitation.
Danish: Må ikke anvendes, hvis der er evidens for partikler eller udfældning.
English: Maintenance doses should be administered at a once every 8-week interval, starting 2 weeks after loading dose administration.
Danish: Vedligeholdelsesdoserne skal administreres i intervaller på én gang hver 8. uge startende 2 uger efter administration af en støddosis.
English: o The importance of meningococcal vaccination prior to treatment and/or to receive antibiotic prophylaxis.
Danish: o Vigtigheden af meningokok-vaccination forud for behandling og/eller at modtage profylaktisk antibiotisk behandling.
English: Rash, Pruritus
Danish: Udslæt, Pruritus
English: Figure 2: Analysis of primary and secondary endpoints - full analysis set (eculizumabexperienced study)
Danish: Figur 2: Analyse af primære og sekundære endepunkter - fuldstændigt analysesæt (studie med eculizumab-erfarne patienter)
English: Ravulizumab must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological disorders.
Danish: Ravulizumab skal administreres af læger og sundhedspersonale og under overvågning af en læge med erfaring i at behandle patienter med hæmatologiske sygdomme.
English: For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses are administered once every 8 weeks, starting 2 weeks after loading dose administration, as shown in Table 1.
Danish: For patienter, der skifter fra eculizumab til ravulizumab, skal en støddosis af ravulizumab administreres 2 uger efter den sidste eculizumab-infusion, hvorefter vedligeholdelsesdoser administreres en gang hver 8. uge startende 2 uger efter administration af en støddosis som vist i tabel 1.
English: Clear to translucent, slight whitish colour, pH 7.0 solution.
Danish: Klar til gennemsigtig, let hvidlig opløsning med en pH på 7,0.
English: Over the studied dose and regimen range, ravulizumab exhibited dose proportional and time linear pharmacokinetics (PK).
Danish: Over det undersøgte dosis- og programinterval udviste ravulizumab dosisproportional og tidslineær farmakokinetik.
English: Due to its mechanism of action, the use of ravulizumab increases the patient's susceptibility to meningococcal infection/sepsis (Neisseria meningitidis).
Danish: Som følge af virkningsmekanismen øger brugen af ravulizumab patientens modtagelighed over for meningokokinfektion/sepsis (Neisseria meningitidis).
English: In clinical trials, some patients with PNH experienced infusion reactions which were mild in severity and transient (e.g., lower back pain and drop in blood pressure).
Danish: I kliniske studier oplevede nogle patienter med PNH infusionsreaktioner, som var af en let sværhedsgrad og forbigående (f.eks. smerter i lænden og blodtryksfald).
English: 5 mg/mL after dilution
Danish: 30 ml 5 mg/ml efter fortynding
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ultomiris in one or more subsets of the paediatric population in paroxysmal nocturnal haemoglobinuria (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Ultomiris i en eller flere undergrupper af den pædiatriske population med paroksystisk nokturn hæmoglobinuri (se pkt.
English: However, based on population-PK assessment no impact of sex, age, race and hepatic or renal function on ravulizumab PK was identified in the studied healthy volunteers subjects and patients with PNH, and as a result, no dosing adjustment is considered necessary.
Danish: Baseret på en populationsfarmakokinetisk vurdering blev der imidlertid ikke identificeret nogen påvirkning af køn, alder, race og nedsat levereller nyrefunktion på farmakokinetikken for ravulizumab hos de undersøgte raske frivillige og hos patienter med PNH, og som følge heraf anses en dosisjustering ikke at være nødvendig.
English: Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy.
Danish: Kontakt lægen, før du starter med Ultomiris, for at sikre, at du får en vaccination mod Neisseria meningitidis mindst 2 uger før, du begynder behandlingen.
English: Prepare Ultomiris as follows:
Danish: Ultomiris skal klargøres på følgende måde:
English: Meningococcal infection/sepsis
Danish: Meningokokinfektion/sepsis
English: No formal trial of the effect of sex, race, age (geriatric), hepatic or renal impairment on the pharmacokinetics of ravulizumab was conducted.
Danish: Der er ikke udført et formelt studie af virkningen af køn, race, alder (geriatrisk), nedsat lever- eller nyrefunktion på farmakokinetikken for ravulizumab.
English: At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections if you have not previously had one or if your vaccination is outdated.
Danish: Mindst 2 uger før du starter behandlingen med Ultomiris, vil lægen give dig en vaccine mod meningokokinfektioner, hvis du ikke tidligere har fået en sådan, eller hvis din vaccination er for gammel.
English: The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose, see section 4.2.
Danish: Antallet af hætteglas, der skal fortyndes, skal bestemmes ud fra den enkelte patients vægt og den ordinerede dosis, se pkt.
English: Human IgG are known to cross the human placental barrier, and thus ravulizumab may potentially cause terminal complement inhibition in the foetal circulation.
Danish: Humant IgG vides at krydse placentabarrieren hos mennesker, og ravulizumab kan derfor potentielt forårsage terminal komplementhæmning i det føtale kredsløb.
English: Table 3 gives the adverse reactions observed from clinical trials.
Danish: Tabel 3 angiver bivirkninger observeret i kliniske studier.
English: Body weight at time of treatment b
Danish: Legemsvægt på behandlingstidspunktet b
English: 2- Before administration Dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Danish: Fortynding skal udføres i overensstemmelse med reglerne for god praksis, især hvad angår aseptiske teknikker.
English: Key secondary endpoints included the percent change from baseline in LDH levels, change in quality of life (FACITFatigue), the proportion of patients with breakthrough haemolysis and proportion of patients with stabilized haemoglobin.
Danish: De vigtigste sekundære endepunkter omfattede den procentvise ændring fra baseline i LDH-niveauer, ændring i livskvalitet (FACIT-Fatigue), andelen af patienter med gennembrudshæmolyse og andelen af patienter med stabiliseret hæmoglobin.
English: Haematuria or haemoglobinuria Aplastic anaemia Renal failure
Danish: Hæmaturi eller hæmoglobinuri Aplastisk anæmi Nyresvigt
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Secondary endpoints included the proportion of patients with breakthrough haemolysis, quality-of-life (FACITFatigue), transfusion avoidance (TA), and proportion of patients with stabilised haemoglobin.
Danish: Sekundære endepunkter omfattede andelen af patienter med gennembrudshæmolyse, livskvalitet (FACITFatigue), transfusionsundgåelse (TA) og andelen af patienter med stabiliseret hæmoglobin.
English: o The need for patients to be vaccinated against N. meningitidis two weeks prior to receiving ravulizumab and/or to receive antibiotic prophylaxis.
Danish: o Behovet for, at patienterne vaccineres mod N. meningitidis 2 uger før, de modtager ravulizumab, og/eller at de modtager profylaktisk antibiotisk behandling.
English: If you are allergic to ravulizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Ultomiris hvis du er allergisk over for ravulizumab, proteiner udvundet fra mus, andre monoklonale antistoffer eller et af de øvrige indholdsstoffer i Ultomiris (angivet i punkt 6).
English: o The need to explain to and ensure understanding of by patients: o the risk of treatment with ravulizumab (including potential risks of serious infections and malignancies and haematologic abnormalities) o the signs and symptoms of meningococcal infection and what action to take o the patient's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with ravulizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the PNH registry o Details of the PNH registry and how to enter patients
Danish: o Behovet for at forklare og sikre, at patienterne har forstået: o risikoen ved behandling med ravulizumab (herunder mulige risici for alvorlige infektioner og maligniteter og hæmatologiske anomalier) o tegn og symptomer på meningokokinfektion og hvilken handling, de skal foretage o patientens vejledninger og disses indhold o behovet for at bære patientkortet på sig og fortælle eventuelt sundhedspersonale, at han/hun modtager behandling med ravulizumab o kravetom vaccinationer/profylaktisk antibiotisk behandling før behandling o indskrivning i PNH-registret o Detaljer omkring PNH-registret, og hvordan man indskriver patienterne
English: The prepared solution should be administered immediately following preparation.
Danish: - Den klargjorte opløsning skal administreres straks efter fortynding.
English: Ravulizumab was non-inferior compared to eculizumab for both coprimary endpoints, avoidance of pRBC transfusion per protocol-specified guidelines and LDH normalisation from day 29 to day 183, and for all 4 key secondary endpoints (Figure 1).
Danish: Ravulizumab var non-inferior sammenlignet med eculizumab for begge co-primære endepunkter, undgåelse af pRBC-transfusion i henhold til protokolspecificerede retningslinjer og LDHnormalisering fra dag 29 til dag 183 og for alle de 4 vigtigste sekundære endepunkter (figur 1).
English: Mean (SD) Median Min, max
Danish: Median Min; maks
English: Gently agitate the infusion bag containing the diluted Ultomiris solution to ensure thorough mixing of the medicinal product and diluent.
Danish: - Infusionsposen med den fortyndede Ultomiris-opløsning blandes forsigtigt for at sikre, at lægemidlet og fortyndingsmidlet blandes grundigt.
English: If you have meningococcal infection.
Danish: hvis du har en meningokokinfektion.
English: Prior to dilution, the solution in the vials should be visually inspected; the solution should be free of any particulate matter or precipitation.
Danish: Før fortynding skal opløsningen i hætteglassene inspiceres visuelt, og opløsningen skal være fri for partikler eller udfældning.
English: If the medicinal product is not used immediately after dilution, storage times must not exceed 24 hours at 2°C - 8°C or 6 hours at room temperature taking into account the expected infusion time.
Danish: Hvis lægemidlet ikke bruges straks efter fortynding, må opbevaringstiderne ikke overskride 24 timer ved 2 °C - 8 °C eller 6 timer ved stuetemperatur, under hensyntagen til den forventede infusionstid.
English: In patients with PNH, the complement system is overactive and attacks their red blood cells, which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing, erectile dysfunction and blood clots.
Danish: Hos patienter med PNH er komplementsystemet overaktivt og angriber de røde blodlegemer, hvilket kan føre til et lavt antal blodlegemer (anæmi), træthed, problemer med at fungere, smerter, mavesmerter, mørk urin, stakåndethed, synkebesvær, rejsningsproblemer og blodpropper.
English: Cases of serious meningococcal infections/sepsis have been reported in patients treated with ravulizumab.
Danish: Tilfælde af alvorlige meningokokinfektioner/sepsis er blevet rapporteret hos patienter i behandling med ravulizumab.
English: Ravulizumab was dosed in accordance with the recommended dosing described in section 4.2 (4 infusions of ravulizumab over 26 weeks) while eculizumab was administered according to the approved dosing regimen of eculizumab of 600 mg every week for the first 4 weeks and 900 mg every 2 weeks (15 infusions over 26 weeks).
Danish: 4.2 (4 infusioner med ravulizumab i løbet af 26 uger), mens eculizumab blev administreret i henhold til det godkendte doseringsprogram for eculizumab med 600 mg hver uge i de første 4 uger og 900 mg hver 2. uge (15 infusioner i løbet af 26 uger).
English: • The patient alert card shall contain the following key messages: o Signs and symptoms of meningococcal infection o Warning to seek immediate medical care if above are present o Statement that the patient is receiving ravulizumab o Contact details where a healthcare professional can receive further information
Danish: • Patientkortet skal indeholde de følgende centrale budskaber: o Tegn og symptomer på meningokokinfektion o Advarsel om straks at søge lægehjælp, hvis ovenstående er til stede o Meddelelse om, at patienten er i behandling med ravulizumab o Kontaktinformation, hvor sundhedspersonale kan modtage yderligere informationer
English: *Meningococcal infection includes preferred terms of meningococcal infection and meningococcal sepsis
Danish: Asteni *Meningokokinfektion omfatter de foretrukne termer meningokokinfektion og meningokoksepsis
English: Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with other terminal complement inhibitors.
Danish: Tilfælde af alvorlige eller dødelige meningokokinfektioner/sepsis er blevet rapporteret hos patienter i behandling med andre terminale komplementhæmmere.
English: After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the medicine should be used immediately, or within 24 hours if refrigerated or within 6 hours at room temperature.
Danish: Efter fortynding med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning skal lægemidlet bruges straks eller inden for 24 timer, hvis det er i køleskab, eller inden for 6 timer ved stuetemperatur.
English: Patients were vaccinated against meningococcal infection prior to or at the time of initiating treatment with ravulizumab or eculizumab, or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
Danish: Patienterne blev vaccineret mod meningokokinfektion før eller ved påbegyndelsen af behandlingen med ravulizumab eller eculizumab, eller de fik profylaktisk behandling med passende antibiotika indtil 2 uger efter vaccinationen.
English: In clinical trials, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ravulizumab; all 3 had been vaccinated.
Danish: I kliniske studier udviklede 3 ud af 261 PNH-patienter alvorlig meningokokinfektion/sepsis, mens de blev behandlet med ravulizumab.
English: Table 5: Baseline characteristics in the eculizumab-experienced study Parameter
Danish: Tabel 5: Baselinekarakteristika i studiet med eculizumab-erfarne patienter Parameter
English: PNH medical history was similar between ravulizumab and eculizumab treatment groups.
Danish: PNH-anamnesen var sammenlignelig mellem behandlingsgrupperne med ravulizumab og eculizumab.
English: Discard any unused portion left in a vial as the medicinal product contains no preservatives.
Danish: - Eventuel ubrugt opløsning i hætteglasset skal bortskaffes, da lægemidlet ikke indeholder nogen konserveringsmidler.
English: The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals
Danish: Uddannelsesmaterialet til lægerne skal indeholde: o Produktresumé o En vejledning til læger og sundhedspersonale
English: Treatment for meningococcal infection while travelling If you are travelling in a region where you are unable to contact your doctor or will be temporarily unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis to bring with you.
Danish: Hvis du rejser til et sted, hvor du ikke kan kontakte lægen eller i perioder ikke kan få medicinsk behandling, kan lægen udskrive en recept på et antibiotikum mod Neisseria meningitidis, som du kan tage med dig.
English: Meningococcal infection symptoms Because of the importance of rapidly identifying and treating meningococcal infection in patients who receive Ultomiris, you will be provided a ‘patient safety card' to carry with you at all times, listing relevant signs and symptoms of meningococcal infection/sepsis.
Danish: Da det er vigtigt hurtigt at identificere og behandle en meningokokinfektion hos patienter, der får Ultomiris, vil du få et patientkort, som du hele tiden skal have på dig, med en liste over relevante tegn og symptomer på meningokokinfektion/sepsis.
English: What you need to know before you use Ultomiris 3.
Danish: Det skal du vide, før du begynder at bruge Ultomiris 3.
English: Do not administer as an intravenous push or bolus injection.
Danish: Må ikke administreres som en hurtig intravenøs injektion eller bolus.
English: This medicinal product when diluted with sodium chloride 9 mg/mL (0.9 %) solution for injection contains 2.65 g sodium per 720 mL at the maximal dose, equivalent to 133 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Når dette lægemiddel fortyndes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning indeholder det 2,65 g natrium pr. 720 ml ved den maksimale dosis, svarende til 133 % af den WHOanbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: No specific non-clinical study on fertility has been conducted with ravulizumab.
Danish: Der er ikke udført specifikke prækliniske studier af fertiliteten med ravulizumab.
English: Driving and using machines This medicine has no or negligible influence on the ability to drive and use machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Pack size of one vial.
Danish: Pakningsstørrelse på ét hætteglas.
English: The most serious adverse reactions in patients in clinical trials are meningococcal infection and meningococcal sepsis (see section 4.4).
Danish: De mest alvorlige bivirkninger hos patienter i kliniske studier er meningokokinfektion og meningokoksepsis (se pkt.
English: The most serious side effect was meningococcal infection/sepsis.
Danish: Den mest alvorlige bivirkning var meningokokinfektion/sepsis (blodforgiftning).
English: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret FRANCE
Danish: Alexion Europe SAS 103-105 rue Anatole France 92300 Levallois-Perret Frankrig
English: INFORMATION IN BRAILLE Justification for not including braille accepted.
Danish: INFORMATION I BRAILLESKRIFT Fritaget fra krav om brailleskrift.
English: Figure 1: Analysis of coprimary and secondary endpoints - Full analysis set (complementinhibitor naïve study)
Danish: Figur 1: Analyse af co-primære og sekundære endepunkter - fuldstændigt analysesæt (studie med patienter, der var naive med hensyn til komplementhæmmer)
English: If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Danish: Hvis du ikke kan vaccineres 2 uger før, vil lægen udskrive en recept på antibiotika for at nedsætte infektionsrisikoen indtil 2 uger efter, at du er blevet vaccineret.
English: Eligible patients to enter this trial had to demonstrate high disease activity, defined as LDH level ≥ 1.5 × upper limit of normal (ULN) at screening along with the presence of 1 or more of the following PNH-related signs or symptoms within 3 months of screening: fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), anaemia (haemoglobin < 10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cell (pRBC) transfusion due to PNH.
Danish: Egnede patienter, der kunne indgå i dette studie, skulle vise en høj sygdomsaktivitet defineret som et LDH-niveau ≥ 1,5 × øvre normalgrænse (ULN) ved screening samt tilstedeværelse af 1 eller flere af de følgende PNH-relaterede tegn og symptomer inden for 3 måneder fra screening: udmattelse, hæmoglobinuri, abdominalsmerter, stakåndethed (dyspnø), anæmi (hæmoglobin < 10 g/dl), en større vaskulær hændelse i anamnesen (herunder trombose), dysfagi eller erektil dysfunktion, eller en transfusion med pakkede røde blodlegemer (pRBC) på grund af PNH i anamnesen.
English: After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the final concentration of the solution is 5 mg/mL.
Danish: Efter fortynding med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning er den endelige koncentration af opløsningen 5 mg/ml.
English: If you cannot be vaccinated at least 2 weeks before you start treatment with Ultomiris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Danish: Hvis du ikke kan blive vaccineret mindst 2 uger før, du starter behandlingen med Ultomiris, vil lægen ordinere antibiotika for at nedsætte risikoen for infektion indtil 2 uger efter, du er blevet vaccineret.
English: If stored at 2-8°C, allow the diluted solution to warm to room temperature prior to administration.
Danish: Hvis den fortyndede opløsning opbevares ved 2 - 8 °C, skal den opnå stuetemperatur før administration.
English: The other ingredients are: - sodium dihydrogen phosphate dihydrate - disodium phosphate dihydrate - sodium chloride - polysorbate 80 Solvent: water for injections
Danish: − Øvrige indholdsstoffer: - natriumdihydrogenphosphatdihydrat - dinatriumphosphatdihydrat - natriumchlorid - polysorbat 80
English: PNH is a chronic disease and treatment with ravulizumab is recommended to continue for the patient's lifetime, unless the discontinuation of ravulizumab is clinically indicated (see section 4.4).
Danish: PNH er en kronisk sygdom, og det anbefales, at behandlingen med ravulizumab fortsætter i hele patientens liv, medmindre en seponering af ravulizumab er klinisk indiceret (se pkt.
English: Reproductive toxicology studies were conducted in mice using the murine surrogate molecule BB5.1, which assessed effect of C5 blockade on the reproductive system.
Danish: Der er udført studier af reproduktionstoksikologi hos mus med det murine surrogatmolekyle BB5.1, som vurderede virkningen af C5-blokade på reproduktionssystemet.