FrancophonIA/ELRC3.0 huggingface dataset:
English: No animal studies have been conducted to evaluate the genotoxic and carcinogenic potential of ravulizumab.
Danish: Der er ikke udført dyrestudier til evaluering af ravulizumabs genotoksicitet og karcinogenicitet .
English: The mean total PNH RBC clone size was 60.05 %, mean total PNH granulocyte clone size was 83.30 %, and the mean total PNH monocyte clone size was 85.86 %.
Danish: Den gennemsnitlige totale PNH RBCklonstørrelse var 60,05 %, gennemsnitlig total PNH granulocyt-klonstørrelse var 83,30 %, og den gennemsnitlige totale PNH-monocyt-klonstørrelse var 85,86 %.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Single use Type I glass vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas af type I-glas til engangsbrug
English: If signs and symptoms of haemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ravulizumab.
Danish: Hvis der opstår tegn og symptomer på hæmolyse efter seponering, herunder forhøjet LDH, bør det overvejes at genstarte behandlingen med ravulizumab.
English: If the patient is being switched from eculizumab treatment, physicians should verify that meningococcal vaccination is current according to national guidelines for vaccination use.
Danish: Hvis patienten skiftes fra eculizumab-behandling skal lægerne verificere, at meningokokvaccinationen stadig dækker, i henhold til de nationale retningslinjer for brug af vacciner.
English: This anti-drug antibody was transient in nature with low titre and did not correlate with clinical response or adverse events.
Danish: Dette antistof mod lægemidlet var af en forbigående art med en lav titer, og det korrelerede ikke med klinisk respons eller bivirkninger.
English: All patients should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics.
Danish: Alle patienter skal overvåges for tidlige tegn på meningokokinfektion og sepsis og straks evalueres, hvis der er mistanke om en infektion, og behandles med passende antibiotika.
English: If you forget an appointment to receive Ultomiris If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Ultomiris”.
Danish: Hvis du har glemt en aftale, hvor du skulle have haft Ultomiris Hvis du har glemt en aftale, skal du straks kontakte lægen for rådgivning og se punktet nedenfor ”Hvis du holder op med at bruge Ultomiris”.
English: Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the body's defence system called the ‘complement system'.
Danish: Ravulizumab er beregnet til at binde sig til C5-komplementproteinet, som er en del af kroppens forsvarssystem, kaldet ”komplementsystemet”.
English: This medicinal product must be administered through a 0.2 µm filter and should not be administered as an intravenous push or bolus injection.
Danish: Dette lægemiddel skal administreres gennem et 0,2 µm filter og må ikke administreres som en hurtig intravenøs injektion eller bolus.
English: Each vial is intended for single use only.
Danish: Hvert hætteglas er kun til engangsbrug.
English: Myelodysplastic syndrome Pregnancy complication Other a a
Danish: Myelodysplastisk syndrom Graviditetskomplikation Andet a a
English: If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor.
Danish: Hvis du oplever et eller flere af symptomerne på meningokokinfektion (se punkt 2 ”Symptomer på meningokokinfektion”), skal du straks fortælle det til lægen.
English: The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
Danish: - Den fortyndede opløsning må ikke opvarmes i en mikrobølgeovn eller med andre varmekilder end den omgivende rumtemperatur.
English: When given the same dose, heavier patients with PNH had lower median serum ravulizumab concentrations compared with lighter patients.
Danish: Ved administration af den samme dosis havde tungere patienter med PNH en lavere median serumkoncentration af ravulizumab sammenlignet med lettere patienter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Etiket på karton
English: If you were previously receiving another medicine for PNH called Soliris, the loading dose should be given 2 weeks after the last Soliris infusion.
Danish: Hvis du tidligere har fået et andet lægemiddel mod PNH kaldet Soliris, skal støddosen gives 2 uger efter den sidste infusion med Soliris.
English: Dosing schedule is allowed to occasionally vary by ± 7 days of the scheduled infusion day (except for the first maintenance dose of ravulizumab) but the subsequent dose should be administered according to the original schedule.
Danish: Det er tilladt lejlighedsvis at variere doseringsplanen med ± 7 dage fra den planlagte infusionsdag (undtagen den første vedligeholdelsesdosis af ravulizumab), men den efterfølgende dosis skal administreres i henhold til den oprindelige plan.
English: Vaccination may not be sufficient to prevent meningococcal infection.
Danish: Det kan være, at en vaccination ikke er tilstrækkelig til at forebygge en meningokokinfektion.
English: One vial of 30 mL contains 300 mg of ravulizumab, produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology.
Danish: Et hætteglas med 30 ml indeholder 300 mg ravulizumab fremstillet i en cellekultur fra kinesiske hamsterovarier (CHO) ved hjælp af rekombinant dna-teknologi.
English: Since many medicinal products and immunoglobulins are secreted into human milk, and because of the potential for serious adverse reactions in nursing infants, breast-feeding should be discontinued during treatment with ravulizumab and up to 8 months after treatment.
Danish: Da mange lægemidler og immunglobuliner udskilles i human mælk og på grund af potentialet for alvorlige bivirkninger hos ammede spædbørn, skal amning ophøre under behandling med ravulizumab og i op til 8 måneder efter behandlingen.
English: The mean (standard deviation [SD]) volume of distribution at steady state for patients with PNH on the studied weight-based dose regimen was 5.34 (0.92) L.
Danish: Det gennemsnitlige (standardafvigelse [SD]) fordelingsvolumen ved steady-state for patienter med PNH på det undersøgte vægtbaserede dosisprogram var 5,34 (0,92) l.
English: The product should be mixed gently.
Danish: Præparatet skal blandes forsigtigt.
English: The educational and controlled distribution programme is aimed at education and instruction of healthcare professionals/patients about the detection, careful monitoring, and/or proper management of selected safety concerns associated with Ultomiris.
Danish: Uddannelsesprogrammet og det kontrollerede udleveringsprogram er udviklet med henblik på uddannelse og anvisninger til læger og sundhedspersonale/patienter om detektion, nøje overvågning og/eller korrekt behandling af udvalgte sikkerhedsmæssige betænkeligheder forbundet med Ultomiris.
English: Total volume (mL)
Danish: Totalt volumen (ml)
English: Ravulizumab therapy should be administered with caution to patients with active systemic infections.
Danish: Ravulizumab-behandlingen skal administreres med forsigtighed hos patienter med aktive systemiske infektioner.
English: Refer to the administration reference tables below.
Danish: Se referencetabellen for administration nedenfor.
English: If you have not been vaccinated against meningococcal infection.
Danish: hvis du ikke er blevet vaccineret mod meningokokinfektion.
English: Physicians should provide patients with a patient information brochure and a patient safety card.
Danish: Læger skal udlevere en patientinformationsbrochure og et patientkort til patienter.
English: Instructions for proper use Ultomiris is given by infusion (drip) into a vein.
Danish: Anvisninger i korrekt brug Ultomiris gives ved infusion (drop) i en vene.
English: The mean (SD) values for terminal elimination half-life and clearance of ravulizumab in patients with PNH are 49.7 (8.9) days and 0.003 (0.001) L/h, respectively.
Danish: Gennemsnitlige (SD) værdier for terminal eliminationshalveringstid og clearance af ravulizumab hos patienter med PNH er hhv. 49,7 (8,9) dage og 0,003 (0,001) l/t.
English: “Other” as specified on case report form included thrombocytopenia, chronic kidney disease, and pancytopenia, as well as a number of other conditions.
Danish: ”Andet” som specificeret på case report formularen omfattede trombocytopeni, kronisk nyresygdom og pancytopeni samt flere andre tilstande.
English: When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain.
Danish: Når Ultomiris gives, kan du opleve reaktioner mod infusionen (droppet), såsom hovedpine, smerter i lænden og infusionsrelaterede smerter.
English: Myelodysplastic syndrome Pregnancy complication Other b a
Danish: Myelodysplastisk syndrom Graviditetskomplikation Andet b a
English: “Other” category included neutropenia, renal dysfunction, and thrombopenia, as well as a number of other conditions.
Danish: ”Andet”-kategorien omfattede neutropeni, nyredysfunktion og trombopeni samt flere andre tilstande
English: Your dose will be worked out by your doctor, based on your body weight, as shown in Table 1.
Danish: Lægen vil beregne din dosis, baseret på din legemsvægt som vist i tabel 1.
English: Any patient who discontinues ravulizumab should be monitored for at least 16 weeks to detect haemolysis and other reactions.
Danish: Alle patienter, der seponerer ravulizumab skal overvåges i mindst 16 uger for at detektere hæmolyse og andre reaktioner.
English: To reduce this risk of infection, all patients must be vaccinated against meningococcal infections at least two weeks prior to initiating ravulizumab unless the risk of delaying ravulizumab therapy outweighs the risk of developing a meningococcal infection.
Danish: For at nedsætte denne infektionsrisiko skal alle patienter vaccineres mod meningokokinfektioner mindst to uger før, ravulizumab-behandlingen påbegyndes, medmindre risikoen ved at forsinke ravulizumab-behandling opvejer risikoen for at udvikle en meningokokinfektion.
English: Patients with any PNH conditions a prior to informed consent n (%)
Danish: Patienter med en PNH-tilstand a før det informerede samtykke n (%)
English: Serious infections with Neisseria species (other than Neisseria meningitidis), including disseminated gonococcal infections, have been reported in patients treated with other terminal complement inhibitors.
Danish: Alvorlige infektioner med Neisseria-arter (ud over Neisseria meningitidis), herunder disseminerede gonokokinfektioner, er blevet rapporteret hos patienter i behandling med andre terminale komplementhæmmere.
English: Refer to the administration reference tables below for minimum infusion duration.
Danish: Se referencetabellerne for administration nedenfor for den korteste infusionsvarighed.
English: Meningococcal and other Neisseria infections symptoms Because the medicine blocks the complement system, which is part of the body's defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis.
Danish: Symptomer på meningokok- og andre Neisseria-infektioner Da lægemidlet blokerer komplementsystemet, som er en del af kroppens forsvar mod infektion, øger brugen af Ultomiris din risiko for en meningokokinfektion (som skyldes Neisseria meningitidis).
English: The primary endpoint was haemolysis as measured by LDH percent change from baseline.
Danish: Det primære endepunkt var hæmolyse målt ved LDH procentvis ændring fra baseline.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmside: http://www.ema.europa.eu.
English: The active substance is ravulizumab (300 mg/30 mL in a vial corresponding to 10 mg/mL).
Danish: − Aktivt stof: ravulizumab (300 mg/30 ml i et hætteglas svarende til 10 mg/ml).
English: The recommended dosing regimen for adult patients (≥ 18 years of age) with PNH consists of a loading dose followed by maintenance dosing, administered by intravenous infusion.
Danish: Det anbefalede dosisprogram for voksne patienter (≥ 18 år) med PNH består af en støddosis efterfulgt af vedligeholdelsesdosering administreret via intravenøs infusion.
English: Based on medical history.
Danish: Baseret på anamnese.
English: The doses to be administered are based on the patient's body weight, as shown in Table 1.
Danish: Doserne, der skal administreres, er baseret på patientens legemsvægt som vist i tabel 1.
English: Store in a refrigerator (2°C-8°C) Do not freeze.
Danish: Opbevares i køleskab (2 °C-8 °C) Må ikke nedfryses.
English: Ultomiris has no or negligible influence on the ability to drive and use machines.
Danish: Ultomiris påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: If an adverse event occurs during the administration of Ultomiris, the infusion may be slowed or stopped at the discretion of the physician.
Danish: Hvis der opstår en bivirkning under administrationen af Ultomiris, kan infusionshastigheden sænkes eller infusionen stoppes efter lægens vurdering.
English: As an immunoglobulin gamma (IgG) monoclonal antibody, ravulizumab is expected to be metabolized in the same manner as any endogenous IgG (degraded into small peptides and amino acids via catabolic pathways), and is subject to similar elimination.
Danish: Som et immunglobulin-gamma (IgG)-monoklonalt antistof forventes ravulizumab at blive metaboliseret på samme måde som alle endogene IgG'er (nedbrydes til små peptider og aminosyrer via kataboliske veje), og det gennemgår en tilsvarende elimination.
English: o The risk of immunogenicity with ravulizumab, including anaphylaxis, and the need for clinical monitoring post-infusion.
Danish: o Risikoen for immunogenicitet med ravulizumab, herunder anafylaksi, og behovet for klinisk monitorering efter infusion.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedsgruppering er bivirkningerne opstillet efter hvor alvorlige de er.
English: The coprimary endpoints were transfusion avoidance, and haemolysis as directly measured by normalisation of LDH levels (LDH levels ≤ 1 × ULN; the ULN for LDH is 246 U/L).
Danish: De co-primære endepunkter var transfusionsundgåelse og hæmolyse målt direkte ved normalisering af LDH-niveauer (LDH-niveauer ≤ 1 × ULN, ULN for LDH er 246 E/l).
English: The diluted solution should be allowed to warm to room temperature (18°C-25°C) prior to administration by exposure to ambient air during approximately 30 min.
Danish: - Den fortyndede opløsning skal have tid til at nå stuetemperatur (18 °C - 25 °C) før administration ved eksponering for omgivende luft i ca. 30 minutter.
English: The safety and efficacy of ravulizumab have not been studied in patients with hepatic impairment; however pharmacokinetic data suggest that no dose adjustment is required in patients with hepatic impairment.
Danish: Ravulizumabs sikkerhed og virkning er ikke blevet undersøgt hos patienter med nedsat leverfunktion, men farmakokinetiske data tyder på, at dosisjustering ikke er nødvendig hos patienter med nedsat leverfunktion.
English: The most common adverse drug reactions are upper respiratory tract infection (very common), nasopharyngitis (very common) and headache (very common).
Danish: De mest almindelige bivirkninger er infektion i de øvre luftveje (meget almindelig), nasofaryngitis (meget almindelig) og hovedpine (meget almindelig).
English: Talk to your doctor before using Ultomiris.
Danish: Kontakt lægen, før du bruger Ultomiris.
English: The MAH shall send annually to prescribers or pharmacists who prescribe/dispense ravulizumab, a reminder in order that prescriber/pharmacist checks if a (re)-vaccination against Neisseria meningitidis is needed for his/her patients on ravulizumab.
Danish: Indehaveren af markedsføringstilladelsen skal årligt sende en påmindelse til læger eller farmaceuter, som ordinerer/udleverer ravulizumab, så læger/farmaceuter kontrollerer, om en (re)-vaccination imod Neisseria meningitidis er nødvendig for de patienter, som de har i behandling med ravulizumab.
English: o No clinical data on exposed pregnancies is available.
Danish: o Der findes ingen kliniske data om eksponerede graviditeter.
English: Ravulizumab has not been studied in patients with PNH who weigh less than 40 kg.
Danish: Ravulizumab er ikke blevet undersøgt hos patienter med PNH, der vejer under 40 kg.
English: The MAH shall ensure that in each Member State where Ultomiris is marketed, a system aimed to control distribution of Ultomiris beyond the level of routine risk minimisation measures is in place.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at der er et system på plads i hvert medlemsland, hvor Ultomiris markedsføres, der kontrollerer udleveringen af Ultomiris, og at det går ud over niveauet for rutinemæssige risikominimimeringsforanstaltninger.
English: The 12-month transfusion history was similar between ravulizumab and eculizumab treatment groups and more than 87 % of patients in both treatment groups had not received a transfusion within 12 months of study entry.
Danish: 12-måneders transfusionsanamnesen var sammenlignelig mellem behandlingsgrupperne med ravulizumab og eculizumab, og over 87 % af patienterne i begge behandlingsgrupper havde ikke fået en transfusion inden for 12 måneder, før de indgik i studiet.
English: Infections Before starting Ultomiris, inform your doctor if you have any infections.
Danish: Infektioner Før du begynder med Ultomiris, skal du fortælle det til lægen, hvis du har en eller flere infektioner.
English: Age (years) at PNH diagnosis
Danish: Alder (år) ved PNH-diagnose
English: Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Ultomiris bør ikke anvendes under graviditeten og til kvinder i den fødedygtige alder, som ikke anvender sikker prævention.
English: If you experience any of the following symptoms, you should immediately inform your doctor: headache with nausea or vomiting headache and fever headache with a stiff neck or stiff back fever fever and rash confusion muscle aches with flu-like symptoms eyes sensitive to light
Danish: Hvis du får et eller flere af følgende symptomer, skal du straks informere lægen: hovedpine med kvalme eller opkastning hovedpine og feber hovedpine med stiv nakke eller stiv ryg feber feber og udslæt forvirring muskelsmerter med influenzalignende symptomer lysfølsomme øjne
English: The MAH shall ensure that in each Member State where Ultomiris is marketed, all healthcare professionals and patients who are expected to prescribe, dispense and use Ultomiris have access to/are provided with the following educational package to be disseminated through professional bodies:
Danish: Indehaveren af markedsføringstilladelsen skal, i hvert medlandsland hvor Ultomiris markedsføres, sikre, at alle læger og sundhedspersonale og patienter, som forventes at ordinere, udlevere eller anvende Ultomiris, har adgang til/har fået følgende uddannelsespakke udleveret via professionelle kanaler:
English: o Risk of serious haemolysis following ravulizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management.
Danish: o Risikoen for alvorlig hæmolyse efter seponering og udsættelse af administration af ravulizumab, kriterier forbundet hermed, den påkrævede monitorering efter behandlingen og den foreslåede håndtering heraf.
English: Note: The black triangle indicates the non-inferiority margins, and grey dot indicates point estimates.
Danish: Bemærk: Den sorte trekant indikerer non-inferioritetsmarginer, og de grå prikker indikerer punktestimater.
English: Sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, and water for injections.
Danish: Natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat, natriumchlorid, polysorbat 80 og vand til injektionsvæsker.
English: Ultomiris volume (mL)
Danish: Ultomirisvolumen (ml)
English: 30 mL of sterile concentrate in a vial (Type I glass) with a stopper and a seal.
Danish: 30 ml sterilt koncentrat i et hætteglas (type 1-glas) med en prop og en forsegling.
English: Ultomiris is used to treat adult patients with a disease called Paroxysmal Nocturnal Haemoglobinuria (PNH).
Danish: Ultomiris anvendes til at behandle voksne patienter med en sygdom, der kaldes paroksystisk nokturn hæmoglobinuri (PNH).
English: Chronic intravenous human immunoglobulin (IVIg) treatment may interfere with the endosomal neonatal Fc receptor (FcRn) recycling mechanism of monoclonal antibodies such as ravulizumab and thereby decrease serum ravulizumab concentrations.
Danish: Gentagne intravenøse behandlinger med humant immunglobulin (IVIg) kan påvirke den endosomale neonatale Fc-receptors (FcRn)-recirkuleringsmekanisme for monoklonale antistoffer, såsom ravulizumab, og dermed nedsætte ravulizumab-koncentrationerne i serum.
English: o The patient alert card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with ravulizumab.
Danish: o Patientkortet og behovet for, at patienterne bærer dette på sig og informerer eventuelt behandlende sundhedspersonale om, at de er i behandling med ravulizumab.
English: Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution.
Danish: Ultomiris er en klar til gennemsigtig opløsning med let hvidlig farve stort set fri for partikler.
English: In PNH patient studies (N = 261), only 1 (0.38 %) case with development of treatment-emergent anti-drug antibody has been reported with ravulizumab.
Danish: I PNHpatientstudier (N = 261) er der kun blevet rapporteret 1 (0,38 %) tilfælde med udvikling af antistof mod lægemidlet, der opstod under behandlingen med ravulizumab.
English: Ultomiris should only be administered via intravenous infusion.
Danish: - Ultomiris må kun administreres via en intravenøs infusion.
English: Ultomiris should be prepared for administration by a qualified healthcare professional using aseptic technique.
Danish: Ultomiris skal klargøres til administration af kvalificerede læger eller sundhedspersonale ved anvendelse af aseptisk teknik.
English: Study in PNH patients previously treated with eculizumab
Danish: Studie med PNH-patienter tidligere behandlet med eculizumab
English: Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately.
Danish: Patienterne skal informeres om disse tegn og symptomer, og der skal straks søges lægehjælp.
English: The majority of the complement-inhibitor naïve study population was highly haemolytic at baseline; 86.2 % of enrolled patients presented with elevated LDH ≥ 3 × ULN, which is a direct measurement of intravascular haemolysis, in the setting of PNH.
Danish: Hovedparten af studiepopulationen, som var naive med hensyn til komplementhæmmer, var meget hæmolytiske ved baseline, 86,2 % af de inkluderede patienter havde forhøjet LDH ≥ 3 × ULN, hvilket er en direkte måling af den intravaskulære hæmolyse, i præsentationen med PNH.
English: o Signs and symptoms of meningococcal infection and the need to obtain urgent medical care.
Danish: o Tegn og symptomer på meningokokinfektion og behovet for at modtage akut lægehjælp.
English: The following information is intended for healthcare professionals only: Instructions for Use for Healthcare Professionals Handling Ultomiris
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Brugsanvisning for læger og sundhedspersonale Håndtering af Ultomiris
English: Maintenance dose (mg)
Danish: Vedligeholdelsesdosis (mg)