FrancophonIA/ELRC3.0 huggingface dataset:
English: Ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH): in patients with haemolysis with clinical symptom(s) indicative of high disease activity in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5.1).
Danish: Ultomiris er indiceret til behandling af voksne patienter med paroksystisk nokturn hæmoglobinuri (PNH): hos patienter med hæmolyse med klinisk(e) symptom(er), der tyder på høj sygdomsaktivitet hos patienter, der er klinisk stabile efter behandling med eculizumab i mindst de sidste 6 måneder (se pkt.
English: If patients with PNH discontinue treatment with ravulizumab, they should be closely monitored for signs and symptoms of serious intravascular haemolysis, identified by elevated LDH (lactate dehydrogenase) levels along with sudden decrease in PNH clone size or haemoglobin, or reappearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction.
Danish: Hvis patienter med PNH seponerer behandlingen med ravulizumab, skal de overvåges nøje for tegn og symptomer på alvorlig intravaskulær hæmolyse, identificeret ved forhøjede niveauer af LDH (lactatdehydrogenase) med en pludselig reduktion i PNH-klonstørrelse eller hæmoglobin, eller tilbagevenden af symptomer som udmattelse, hæmoglobinuri, abdominalsmerter, stakåndethed (dyspnø), større vaskulære bivirkninger (herunder trombose), dysfagi eller erektil dysfunktion.
English: The patient information pack should contain: o Package leaflet o A patient guide o A patient alert card
Danish: Informationsmaterialet til patienter skal indeholde: o Indlægsseddel o En patientvejledning o Et patientkort
English: Serious meningococcal infection
Danish: Alvorlig meningokokinfektion
English: Age (years) at PNH diagnosis Mean (SD) Median
Danish: Alder (år) ved PNH-diagnose Gennemsnit (SD)
English: Excipient(s) with known effect: Sodium (5 mmol per vial)
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på: Natrium (5 mmol pr. hætteglas)
English: Meningococcal infection*
Danish: Meningokokinfektion*
English: Non-clinical data reveal no special hazard for humans based on nonclinical studies using a murine surrogate molecule, BB5.1, in mice.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra prækliniske studier med et murint surrogatmolekyle, BB5.1, hos mus.
English: Patients who initiate ravulizumab treatment less than 2 weeks after receiving a meningococcal vaccine, must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.
Danish: Patienter, som påbegynder behandling med ravulizumab mindre end 2 uger efter, at de har fået en meningokokvaccine, skal behandles med passende profylaktisk antibiotika indtil 2 uger efter vaccination.
English: 3- Administration
Danish: 2- Før administration
English: Infections and infestations Upper respiratory tract infection, Nasopharyngitis
Danish: Infektion i de øvre luftveje, Nasofaryngitis
English: After dilution, the medicinal product should be used immediately.
Danish: Lægemidlet skal anvendes straks efter fortynding.
English: Patients should be informed of the signs and symptoms of meningococcal septicaemia and advised to seek medical care immediately.
Danish: Patienter skal informeres om tegn og symptomer på meningokoksepsis og rådes til straks at søge lægehjælp.
English: There were no noteworthy differences in the demographic or baseline characteristics between the ravulizumab and eculizumab treatment groups in either of the Phase 3 studies.
Danish: Der var ingen bemærkelsesværdig forskel i patientdemografi eller baselinekarakteristika mellem grupperne behandlet med ravulizumab og eculizumab i de to fase III-studier.
English: Number of patients with packed red blood cell (pRBC) transfusions within 12 months prior to first dose n (%)
Danish: Antal patienter med transfusioner med pakkede røde blodlegemer (pRBC) inden for 12 måneder før den første dosis n (%)
English: The eculizumab-experienced study was a 26-week, multicentre, open-label, randomised, active-controlled Phase 3 study conducted in 195 patients with PNH who were clinically stable (LDH ≤ 1.5 x ULN) after having been treated with eculizumab for at least the past 6 months.
Danish: Studiet med eculizumab-erfarne patienter var et 26-ugers, åbent, randomiseret, aktivt kontrolleret fase III-multicenterstudie udført på 195 patienter med PNH, som var klinisk stabile (LDH ≤ 1,5 x ULN), efter at de var blevet behandlet med eculizumab i mindst de forudgående 6 måneder.
English: Renal impairment No dose adjustment is required for patients with renal impairment, see section 5.2.
Danish: Nedsat nyrefunktion Ingen dosisjustering er nødvendig for patienter med nedsat nyrefunktion, se pkt.
English: Following ravulizumab treatment in both complement-inhibitor naïve patients and eculizumab-experienced patients with PNH in Phase 3 studies, immediate and complete inhibition of serum free C5 (concentration of < 0.5 µg/mL) was observed by the end of the first infusion and sustained throughout the entire 26-week treatment period in all patients.
Danish: Efter ravulizumab-behandling blev der hos både patienter, der var naive med hensyn til komplementhæmmer, og eculizumab-erfarne patienter med PNH i fase III-studier observeret umiddelbar og fuldstændig hæmning af serumfrit C5 (koncentration på < 0,5 µg/ml) ved slutningen af den første infusion, hvilket blev opretholdt i løbet af hele den 26-uger lange behandlingsperiode hos alle patienter.Frit C5-niveau på under 0,5 µg/ml korrelerede med maksimal intravaskulær hæmolysekontrol og fuldstændig terminal komplementhæmning.
English: Visually inspect Ultomiris solution for particulate matter and discolouration.
Danish: - Ultomiris-opløsningen skal inspiceres visuelt for partikler og misfarvning.
English: Each vial of Ultomiris contains 300 mg of active substance in 30 mL of product solution.
Danish: 1- Sådan leveres Ultomiris Hvert hætteglas med Ultomiris indeholder 300 mg aktivt stof i en 30 ml præparatopløsning.
English: Alexion Dublin Manufacturing Facility College Business and Technology Park Blanchardstown Rd North Dublin 15 R925
Danish: Alexion Pharma International Operations Unlimited CompanyAlexion Dublin Manufacturing FacilityCollege Business and Technology ParkBlanchardstown Rd NorthDublin 15 R925
English: Vomiting, Nausea, Diarrhoea, Abdominal pain, Dyspepsia
Danish: • opkastning, kvalme, diarré, mavesmerter, fordøjelsesbesvær (dyspepsi)
English: Women of childbearing potential should use effective contraception methods during treatment and up to 8 months after treatment.
Danish: Kvinder i den fertile alder skal anvende sikre kontraceptionsmetoder under behandlingen og i op til 8 måneder efter behandlingen.
English: Immunization
Danish: Immunisering
English: The safety and efficacy of ravulizumab in patients with PNH were assessed in two open-label, randomised, active-controlled Phase 3 trials: a complement-inhibitor naïve study in adult patients with PNH who were naïve to complement inhibitor treatment, an eculizumab -experienced study in patients with PNH who were clinically stable after having been treated with eculizumab for at least the previous 6 months.
Danish: Ravulizumabs sikkerhed og virkning hos patienter med PNH blev vurderet i 2 åbne, randomiserede, aktivt kontrollerede fase III-studier: et studie med voksne patienter med PNH, der var naive med hensyn til behandling med komplementhæmmer, et studie med eclizumab-erfarne PNH-patienter, som var klinisk stabile efter behandling med eculizumab i mindst de forudgående 6 måneder.
English: This medicine when diluted with sodium chloride 9 mg/mL (0.9%) solution for injection for IV administration contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose.
Danish: Når dette lægemiddel er fortyndet med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning til intravenøs administration, indeholder det 2,65 g natrium (hovedkomponent af madlavnings-/bordsalt) pr. 720 ml ved maksimal dosis.
English: • The patient guide shall contain the following key messages: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Danish: • Patientvejledningen skal indeholde de følgende centrale budskaber: o Håndtering af risikoen for meningokokinfektion, alvorlig hæmolyse efter lægemiddelseponering hos patienter med PNH, immunogenicitet, alvorlige infektioner, maligniteter og hæmatologiske anomalier, anvendelse til gravide eller ammende kvinder.
English: The 12-month transfusion history was similar between ravulizumab and eculizumab treatment groups within each of the Phase 3 studies.
Danish: 12-månederstransfusionsanamnesen var sammenlignelig mellem grupperne behandlet med ravulizumab og eculizumab i de to fase III-studier.
English: Table 5 presents the baseline characteristics of the PNH patients enrolled in the eculizumabexperienced study, with no apparent clinically meaningful differences observed between the treatment arms.
Danish: Tabel 5 viser baselinekarakteristika i studiet med eculizumab-erfarne PNH-patienter, hvor der ikke blev observeret nogen åbenbare klinisk betydningsfulde forskelle mellem behandlingsarmene
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ultomiris 300 mg concentrate for solution for infusion.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ultomiris 300 mg koncentrat til infusionsvæske, opløsning.
English: o The need for effective contraception in women of childbearing potential during and up to eight months after treatment, and that breast-feeding should be discontinued during and up to eight months after treatment.
Danish: o Behovet for sikker kontraception for kvinder i den fertile alder under og i op til 8 måneder efter behandlingen, og at amning skal ophøre under og i op til 8 måneder efter behandlingen.
English: The complement-inhibitor naïve study was a 26-week, multicentre, open-label, randomised, active-controlled, Phase 3 study conducted in 246 patients who were naïve to complement inhibitor treatment prior to study entry.
Danish: Studiet med patienter, der var naive med hensyn til komplementhæmmer, var et 26-ugers, åbent, randomiseret, aktivt kontrolleret fase III-multicenterstudie, som blev udført hos 246 patienter, der var naive med hensyn til behandling med komplementhæmmer, før de indgik i studiet.
English: When maternal exposure to the antibody occurred during organogenesis, two cases of retinal dysplasia and one case of umbilical hernia were observed among 230 offspring born to mothers exposed to the higher antibody dose (approximately 4 times the maximum recommended human ravulizumab dose, based on a body weight comparison); however, the exposure did not increase foetal loss or neonatal death.
Danish: Når moderdyret blev eksponeret for antistoffet under organogenese, blev der observeret to tilfælde af retinal dysplasi og et tilfælde af navlebrok blandt 230 afkom fra moderdyr, der blev eksponeret for den højeste antistofdosis (ca.
English: The calculated volume of medicinal product is withdrawn from the appropriate number of vials and diluted in an infusion bag using sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Danish: Det beregnede volumen af lægemidlet trækkes op fra det relevante antal hætteglas og fortyndes i en infusionspose med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning som fortyndingsmiddel.
English: Ultomiris must be diluted to a final concentration of 5 mg/mL.
Danish: Ultomiris skal fortyndes til en endelig koncentration på 5 mg/ml.
English: Breast-feeding should be discontinued during and up to eight months after treatment.
Danish: Amning skal seponeres under og i op til 8 måneder efter behandlingen.
English: How to use Ultomiris
Danish: Sådan skal du bruge Ultomiris
English: After dilution, the final concentration of the solution to be infused is 5 mg/mL.
Danish: Efter fortynding er den endelige koncentration, der skal infunderes, 5 mg/ml.
English: Study in complement-inhibitor naïve patients with PNH
Danish: Studie med patienter med PNH, der var naive med hensyn til komplementhæmmer
English: Volume of NaCl diluent b
Danish: Volumen af NaClfortyndingsmiddel b
English: Withdraw the required amount of Ultomiris from the vial(s) using a sterile syringe.
Danish: - Træk den påkrævede mængde Ultomiris op fra hætteglasset/hætteglassene med en steril sprøjte.
English: How to store Ultomiris 6.
Danish: Sådan skal du bruge Ultomiris 4.
English: Patients with unresolved Neisseria meningitidis infection at treatment initiation (see section Patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section
Danish: Patienter, som ikke aktuelt er vaccineret mod Neisseria meningitidis, medmindre de får profylaktisk behandling med passende antibiotika indtil 2 uger efter vaccinationen (se pkt.
English: What Ultomiris looks like and contents of the pack Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial - pack size of 1).
Danish: Ultomiris fås som et koncentrat til injektionsvæske, opløsning (30 ml i et hætteglaspakningsstørrelse på 1).
English: Table 2: Maintenance dose administration reference table
Danish: Tabel 2: Referencetabel for administration af vedligeholdelsesdosis
English: Number of patients with pRBC/whole blood transfusions within 12 months prior to first dose n (%)
Danish: Antal patienter med transfusioner med pRBC/fuldblod inden for 12 måneder før den første dosis n (%)
English: Pre-treatment LDH levels
Danish: LDH-niveauer før behandling Gennemsnit (SD)
English: Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Ultomiris Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Treatment discontinuation
Danish: Behandlingsseponering
English: Ravulizumab blocks terminal complement activation; therefore patients may have increased susceptibility to infections caused by Neisseria species and encapsulated bacteria.
Danish: Derfor kan patienterne have en øget modtagelighed for infektioner forårsaget af Neisseria-arter og indkapslede bakterier.
English: Weight-based dosing is proposed in section 4.2, Table
Danish: Vægtbaseret dosering foreslås i pkt.
English: Table 1: Ultomiris weight-based dosing regimen
Danish: Tabel 1: Ultomiris vægtbaseret doseringsprogram Legemsvægtinterval (kg)
English: Pyrexia, Influenza like illness, Fatigue, Chills, Asthenia
Danish: • feber (pyreksi), influenzalignende sygdom, kulderystelser, træthedsfølelse (udmattelse, asteni)
English: Units of pRBC transfused within 12 months prior to first dose
Danish: Enheder af transfusioner med pRBC inden for 12 måneder før den første dosis
English: The need for effective contraception in women of childbearing potential during and up to eight months after treatment.
Danish: Behovet for sikker kontraception hos kvinder i den fertile alder under og i op til 8 måneder efter behandlingen.
English: Body weight range (kg)
Danish: Legemsvægtinterval (kg)
English: Animal reproductive toxicology studies have not been conducted with ravulizumab, but were conducted in mice with a murine surrogate complement inhibitory antibody, BB5.1.
Danish: Der er ikke udført toksikologiske reproduktionsstudier hos dyr med ravulizumab, men der er udført toksikologiske reproduktionsstudier hos mus med et murint surrogat-komplementhæmmende antistof, BB5.1.
English: What Ultomiris contains
Danish: Ultomiris indeholder:
English: Ultomiris 300 mg concentrate for solution for infusion ravulizumab
Danish: Ultomiris 300 mg koncentrat til infusionsvæske, opløsning ravulizumab
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Table 4 presents the baseline characteristics of the PNH patients enrolled in the complement-inhibitor naïve study, with no apparent clinically meaningful differences observed between the treatment arms.
Danish: Tabel 4 viser baselinekarakteristika for PNH-patienterne, der indgik i studiet, hvor patienterne var naive med hensyn til komplementhæmmer, uden at der blev observeret nogen åbenbare klinisk betydningsfulde forskelle mellem behandlingsarmene.
English: Mean (SD) Median
Danish: Gennemsnit (SD)
English: Nonclinical reproductive toxicology studies conducted in mice with a murine surrogate molecule (BB5.1) identified no adverse effect on fertility of the treated females or males.
Danish: Prækliniske studier af reproduktionstoksiciteten udført hos mus med det murine surrogatmolekyle BB5.1 identificerede ingen bivirkning på fertiliteten af de behandlede hunner eller hanner.
English: Back pain, Arthralgia, Myalgia, Muscle spasms
Danish: Rygsmerter, Artralgi, Myalgi,
English: Meningococcal infections in patients treated with ravulizumab presented as meningococcal sepsis.
Danish: Meningokokinfektioner hos patienter i behandling med ravulizumab viste sig som meningokoksepsis.
English: Male Female
Danish: Kvinde
English: o Risk of severe haemolysis following discontinuation/postponement of ravulizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing ravulizumab administrations o Potential risks of severe, non-neisserial infections and malignancies and haematologic abnormalities in PNH patients treated with ravulizumab.
Danish: o Risikoen for alvorlig hæmolyse efter seponering/udsættelse af administration af ravulizumab, tegn og symptomer herpå og anbefaling om at konsultere den ordinerende læge før seponering/udsættelse af administration af ravulizumab.
English: Table 6: Loading dose administration reference table Body weight range (kg)a
Danish: Tabel 6: Referencetabel for administration af støddosis Legemsvægt interval (kg)a
English: Pregnancy, breast-feeding, and fertility
Danish: Graviditet, amning og frugtbarhed
English: Loading dose (mg)
Danish: Støddosis (mg)
English: Units of pRBC/whole blood transfused within 12 months prior to first dose
Danish: Enheder af transfusioner med pRBC/fuldblod inden for 12 måneder før den første dosis
English: Table 1: Loading dose administration reference table
Danish: Tabel 1: Referencetabel for administration af støddosis
English: Pregnancy/ Breast-feeding
Danish: Graviditet/amning
English: Nonclinical reproductive toxicology studies conducted in mice with the murine surrogate molecule BB5.1 identified no adverse effect to pups resulting from consuming milk from treated dams.
Danish: Nonkliniske studier af reproduktionstoksiciteten udført hos mus med det murine surrogatmolekyle BB5.1 identificerede ingen bivirkninger på afkommet, der stammede fra behandlede moderdyrs diegivning.
English: Table 4: Baseline characteristics in the complement-inhibitor naïve study Parameter
Danish: Tabel 4: Baselinekarakteristika i studiet med patienter, der var naive med hensyn til komplementhæmmer
English: Do not administer Ultomiris as an intravenous push or bolus injection.
Danish: 3- Administration - Ultomiris må ikke administreres som en hurtig intravenøs injektion eller bolusinjektion.
English: Adverse reactions MedDRA System Organ Class
Danish: MedDRAsystemorganklasse
English: If you receive more Ultomiris than you should
Danish: Hvis du har fået for meget Ultomiris
English: Table 2: Dose administration rate Body weight range (kg)
Danish: Tabel 2: Dosis administrationshastighed Legemsvægtinterval (kg)
English: NAME OF THE MEDICINAL PRODUCT Ultomiris 300 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Ultomiris 300 mg koncentrat til infusionsvæske, opløsning
English: • The Guide for healthcare professionals shall contain the following key elements: o To address the risks of meningococcal infection, serious haemolysis after drug discontinuation in PNH patients, immunogenicity, serious infections, malignancies and haematological abnormalities, use in pregnant and breast-feeding women.
Danish: • Vejledningen til læger og sundhedspersonale skal indeholde de følgende nøgleelementer: o Håndtering af risikoen for meningokokinfektion, alvorlig hæmolyse efter lægemiddelseponering hos patienter med PNH, immunogenicitet, alvorlige infektioner,
English: What you need to know before you use Ultomiris Do not use Ultomiris:
Danish: Det skal du vide, før du begynder at bruge Ultomiris
English: Nonclinical reproductive toxicology studies were not conducted with ravulizumab (see section 5.3).
Danish: Der er ikke udført prækliniske studier af reproduktionstoksikologi med ravulizumab (se pkt.
English: One vial of 30 mL contains 300 mg of ravulizumab.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas med 30 ml indeholder 300 mg ravulizumab.
English: What Ultomiris is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: The diluted solution of Ultomiris should be administered by intravenous infusion over approximately 2 hours using a syringe-type pump or an infusion pump.
Danish: 2 timer ved brug af en pumpe af sprøjtetypen eller en infusionspumpe.
English: Hepatic impairment
Danish: Influenzalignende sygdom,
English: Dilution should only use sodium chloride 9 mg/mL (0.9 %) solution for injection as diluent.
Danish: Fortynding må kun udføres med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning som fortyndingsmiddel.
English: Ravulizumab weight-based dosing regimen Body weight range (kg)
Danish: Ravulizumab vægtbaseret doseringsprogram Legemsvægtinterval (kg)
English: Table 7: Maintenance dose administration reference table Body weight range (kg)
Danish: Tabel 7: Referencetabel for administration af vedligeholdelsesdosis Legemsvægtinterval (kg)
English: Therefore, effective contraception during treatment and up to 8 months after treatment should be used in women who are able to get pregnant.
Danish: Derfor bør kvinder, som kan blive gravide, bruge sikker prævention i løbet af behandlingen og i 8 måneder efter behandlingen.
English: Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection
Danish: Ultomiris må kun fortyndes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning
English: Dilute Ultomiris to a final concentration of 5 mg/mL (initial concentration divided by 2) by adding the appropriate amount of sodium chloride 9 mg/mL (0.9%) solution for injection to the infusion as per the instructions provided in table below.
Danish: ved at tilsætte den passende mængde natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning til infusionen i henhold til anvisningerne anført i tabellen nedenfor.
English: Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection.
Danish: Ultomiris må kun fortyndes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: - Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: A significant fall in your red blood cell counts (anaemia), Confusion or change in how alert you are,
Danish: Risiciene ved at stoppe Ultomiris omfatter en øget nedbrydning af dine røde blodlegemer, hvilket kan forårsage: Et betydeligt fald i dit antal af røde blodlegemer (anæmi), Forvirring eller ændret opmærksomhedsniveau, Brystsmerter eller angina, En forhøjelse i niveauet af serum-kreatinin (problemer med nyrerne) eller Trombose (blodprop).
English: Packaging Content Package size
Danish: Emballage Indhold
English: Antigenic mass ELISA units.
Danish: (stamme Gr-01-005) 1 Antigen masse ELISA-enheder.
English: 1 vial
Danish: Indgivelsesvej
English: - L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)
Danish: (stamme Ca-12-000) - L. interogans serogruppe Icterohaemorrhagiae serovar