FrancophonIA/ELRC3.0 huggingface dataset:
English: At the same weight-based dosing regimen of 240 µg/kg, the plerixafor mean exposure (AUC0-24h) is lower in paediatric patients aged 2 to <6 years (1410 ng.h/mL), 6 to <12 years (2318 ng.h/mL), and 12 to <18 years (2981 ng.h/mL) than in adults (4337 ng.h/mL).
Danish: Ved samme vægtbaserede dosisregime på 240 µg/kg er gennemsnitseksponeringen (AUC0-24t) for plerixafor lavere hos pædiatriske patienter i alderen 2 til < 6 år (1.410 ng.t/ml), 6 til <12 år (2318 ng.t/mL) og 12 til <18 år (2.981 ng.t/ml) end hos voksne (4.337 ng.t/ml).
English: The major route of elimination of plerixafor is urinary.
Danish: Plerixafor elimineres fortrinsvis gennem urinen.
English: After opening the vial, Mozobil should be used immediately.
Danish: Mozobil skal anvendes med det samme, når hætteglasset er åbnet.
English: Rarely, gastrointestinal side effects may be severe (diarrhoea, vomiting, stomach pain and nausea).
Danish: Bivirkninger i mave-tarm-kanalen kan i sjældne tilfælde være kraftige (diaré, opkastning, mavepine og kvalme).
English: Adverse reactions occurring more frequently with Mozobil than placebo and considered related to Mozobil during mobilisation and apheresis in phase III studies
Danish: Bivirkninger, der under mobilisering og aferese i fase III-studier opstod hyppigere ved behandling med Mozobil end med placebo, og som anses for at være relaterede til Mozobil
English: If you have moderate or severe kidney problems, your doctor will reduce the dose.
Danish: Din læge vil reducere dosis, hvis du har moderate eller svære nyreproblemer.
English: • diarrhoea, nausea (feeling sick), injection site redness or irritation
Danish: • diaré, kvalme, rødmen eller irritation på injektionsstedet
English: Clear type I glass 2 ml vial with a chlorobutyl/butyl rubber stopper and aluminium seal with a plastic flip-off cap. Each vial contains 1.2 ml solution.
Danish: Gennemsigtige 2 ml type I-glas med en gummiprop af chlorobutyl/butyl og en aluminiumsforsegling med en flip-off-hætte af plast.
English: Hydrochloric acid, concentrated (pH adjustment) Sodium hydroxide (pH adjustment) Water for injections
Danish: Saltsyre, koncentreret (pH-justering) Natriumhydroxid (pH-justering) Vand til injektionsvæsker
English: Additionally, two female oncology patients in the compassionate use programme experienced myocardial infarction following haematopoietic stem cell mobilisation with plerixafor and G-CSF.
Danish: Desuden fik to kvindelige kræftpatienter i compassionate useprogrammet (på udleveringstilladelser) myokardieinfarkt efter mobilisering af hæmatopoietiske stamceller med plerixafor og G-CSF.
English: How much Mozobil is given?
Danish: Hvor meget Mozobil skal du have?
English: The adverse reactions reported in patients with lymphoma and multiple myeloma who received Mozobil in the controlled Phase III studies and uncontrolled studies, including a Phase II study of Mozobil as monotherapy for haematopoietic stem cell mobilisation, are similar.
Danish: De indberettede bivirkninger for patienter med lymfom og multipelt myelom, som fik Mozobil i de kontrollerede fase III-studier og i ikke-kontrollerede studier, herunder et fase II-studie med Mozobil som monoterapi til mobilisering af hæmatopoietiske stamceller, er ens. Der blev ikke observeret nogen signifikante forskelle i forekomsten af bivirkninger hos onkologiske patienter med hensyn til sygdom, alder eller køn.
English: Study AMD3100-3102 efficacy results - CD34+ cell mobilisation in multiple myeloma patients
Danish: Effektresultater fra studie AMD3100-3102 - CD34+ celle-mobilisering hos patienter med multipelt myelom
English: This leaflet was last approved in.
Danish: Denne indlægsseddel blev senest ændret
English: Excipients: sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Danish: Hjælpestoffer: natriumchlorid, saltsyre (koncentreret) og natriumhydroxid til pH-justering og vand til injektionsvæsker.
English: If you want to know more about G-CSF ask your doctor and read the corresponding package leaflet.
Danish: Spørg lægen og læs den medfølgende indlægsseddel, hvis du vil vide mere om G-CSF.
English: Mozobil 20 mg/ml solution for injection Plerixafor
Danish: Mozobil 20 mg/ml injektionsvæske, opløsning Plerixafor
English: 9/L or greater were observed, on the day prior to or any day of apheresis, in 7% patients receiving Mozobil and in 1% patients receiving placebo in the Phase III studies.
Danish: I fase III-studierne var antallet af hvide blodlegemer100 x 109/L eller derover dagen inden eller dagen for aferese hos 7 % af de patienter, der fik Mozobil, og hos 1 % af de patienter, der fik placebo.
English: • dizziness, feeling tired or unwell
Danish: • svimmelhed, træthed eller utilpashed
English: What you need to know before you use Mozobil
Danish: Det skal du vide, før du begynder at bruge Mozobil Brug ikke Mozobil
English: Each vial contains 1.2 ml solution.
Danish: Hvert hætteglas indeholder 1,2 ml opløsning.
English: Tumour cell mobilisation in patients with lymphoma and multiple myeloma When Mozobil is used in conjunction with G-CSF for haematopoietic stem cell mobilisation in patients with lymphoma or multiple myeloma‚ tumour cells may be released from the marrow and subsequently collected in the leukapheresis product.
Danish: Når Mozobil anvendes i forbindelse med G-CSF til mobilisering af hæmatopoietiske stamceller hos patienter med lymfom eller multipelt myelom, frigives der muligvis tumorceller fra knoglemarven, som efterfølgende opsamles i leukaferese-produktet.
English: Patients received daily morning doses of G-CSF 10 μg/kg for 4 days prior to the first dose of plerixafor or placebo and on each morning prior to apheresis.
Danish: Patienterne fik hver morgen doser af G-CSF 10 μg/kg i 4 dage inden den første dosis plerixafor eller placebo og hver morgen inden aferese.
English: What Mozobil looks like and contents of the pack Mozobil is supplied as a clear colourless or pale yellow solution for injection in a glass vial with a non-latex rubber stopper.
Danish: Mozobil leveres som en gennemsigtig, farveløs eller lysegul injektionsvæske, opløsning, i et hætteglas med en latexfri gummiprop.
English: How to use Mozobil
Danish: Sådan skal du bruge Mozobil
English: The pharmacist will throw away medicines you no longer use.
Danish: Apoteket vil bortskaffe medicinrester.
English: One ml of solution contains 20 mg plerixafor.
Danish: En ml opløsning indeholder 20 mg plerixafor.
English: Patients received daily morning doses of G-CSF 10 g/kg for 4 days prior to the first dose of plerixafor or placebo and on each morning prior to apheresis.
Danish: Patienterne fik hver morgen doser af G-CSF 10 µg/kg i 4 dage inden den første dosis plerixafor eller placebo og hver morgen inden aferese.
English: Heart attacks
Danish: Hjerteanfald
English: cells/kg in ≤ 2 apheresis days and successful engraftment p-value calculated using Cochran-Mantel-Haenszel statistic blocked by baseline platelet count Statistically significantly more patients achieved ≥ 6 x 10
Danish: Patienter, der opnår ≥ 6 x 106 celler/kg inden for ≤ 2 aferesedage og vellykket transplantation a p-værdien er beregnet med anvendelse af Cochran-Mantel-Haenszel-statistik med blokke af trombocytter ved baseline b Statistisk signifikant flere patienter opnåede ≥ 6 x 106 celler/kg inden for ≤ 2 aferesedage med Mozobil og G-CSF (n=106;
English: Some patients have experienced dizziness, fatigue or vasovagal reactions; therefore caution is advised when driving or operating machines.
Danish: Nogle patienter har oplevet svimmelhed, træthed eller vasovagale reaktioner.
English: In general, care should be taken in dose selection for elderly patients due to the greater frequency of decreased renal function with advanced age.
Danish: På grund af den øgede hyppighed af nedsat nyrefunktion i takt med stigende alder skal der generelt udvises forsigtighed i forbindelse med valg af dosis til ældre personer.
English: Adverse reactions that occurred more frequently with Mozobil and G-CSF than placebo and G-CSF and were reported as related in ≥1% of the patients who received Mozobil, during haematopoietic stem cell mobilisation and apheresis and prior to chemotherapy/ablative treatment in preparation for transplantation are shown in Table 1.
Danish: Bivirkningerne blev indberettet som relaterede hændelser hos ≥1 % af de patienter, der fik Mozobil, under mobilisering af hæmatopoietiske stamceller og aferese og inden kemoterapi/ablativ behandling som forberedelse til transplantation.
English: However, these effects do not seem to occur more frequently when you use Mozobil.
Danish: Brugen af Mozobil synes dog ikke at påvirke denne hyppighed.
English: - The other ingredients are sodium chloride, hydrochloric acid (concentrated) and sodium hydroxide for pH adjustment and water for injections.
Danish: - Øvrige indholdsstoffer: natriumchlorid, saltsyre og natriumhydroxid til pH-justering, vand til injektionsvæsker.
English: Mozobil and G-CSF (n = 150)
Danish: Mozobil og G-CSF (n = 150)
English: Placebo and G-CSF (n = 154)
Danish: Placebo og G-CSF (n = 154)
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Danish: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: Each ml solution for injection contains 20 mg plerixafor.
Danish: Hver ml injektionsvæske, opløsning indeholder 20 mg plerixafor.
English: • In children age 1 to less than 18 years of age with lymphoma or solid tumours.
Danish: • Hos børn i alderen 1 - under 18 år, der har lymfom eller solide tumorer (tumor der udgår fra de solide organer som f.eks. lunger, mave-tarm, hoved-hals, lever osv.).
English: Placebo and G-CSF (n = 148)
Danish: Placebo og G-CSF (n = 148)
English: Mozobil and G-CSF (n = 148)
Danish: Mozobil og G-CSF (n = 148)
English: Pins and needles and numbness
Danish: Snurren og prikken og følelsesløshed
English: Thirty patients were treated with 0.24 mg/kg of Mozobil in an open label, multicenter, controlled study (DFI 12860) (see section 5.1).
Danish: I et kontrolleret, åbent, multicenterstudie (DFI 12860) blev tredive patienter behandlet med 0,24 mg/kg Mozobil (se pkt.
English: cells/kg in ≤ 4 apheresis days and successful engraftment a p-value calculated using Pearson's Chi-Squared test Statistically significantly more patients achieved ≥ 5 x 10
Danish: Patienter, der opnår ≥ 5 x 106 celler/kg inden for ≤ 4 aferesedage og vellykket transplantation Patienter, der opnår ≥ 2 x 106 celler/kg inden for ≤ 4 aferesedage og vellykket transplantation a p-værdi beregnet med anvendelse af Pearsons chi-kvadrattest bStatistisk signifikant flere patienter opnåede ≥ 5 x 106 celler/kg inden for ≤ 4 aferesedage med Mozobil og G-CSF (n=89;
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=141; 95.3%) than with placebo and G-CSF (n=136; 88.3%), p=0.031.
Danish: 51,3 %), p < 0,001; statistisk signifikant flere patienter opnåede ≥ 2 x 106 celler/kg inden for ≤ 4 aferesedage med Mozobil og G-CSF (n=141; 95,3 %) end med placebo og G-CSF (n=136; 88,3 %), p=0,031.
English: What Mozobil contains - The active substance is plerixafor.
Danish: - Aktivt stof: plerixafor.
English: What Mozobil is and what it is used for What you need to know before you use Mozobil How to use Mozobil
Danish: Det skal du vide, før du begynder at bruge Mozobil Sådan skal du bruge Mozobil Bivirkninger
English: Of these patients, 55 % (34 out of 62) mobilised ≥ 2 x10
Danish: Ud af disse patienter mobiliserede 55 % (34 ud af 62) ≥ 2 x106/kg CD34+ celler og gennemgik transplantation med vellykket resultat.
English: Study AMD3100-3102 - Proportion of patients who achieved ≥ 6 x 10
Danish: Studie AMD3100-3102 - procentdel patienter med multipelt myelom, der opnåede ≥
English: • flatulence, constipation, indigestion, vomiting
Danish: • luft i maven, forstoppelse, fordøjelsesbesvær, opkastning
English: Or Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Danish: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Irland Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Any unused solution should be discarded.
Danish: Ikke anvendt injektionsvæske skal kasseres.
English: 6/kg CD34+ cells and had successful engraftment.
Danish: 6 x 106 CD34+ celler/kg efter et antal aferesedage Dage
English: cells/kg by apheresis day in multiple myeloma patients
Danish: Mobilisering af tumorceller hos patienter med lymfom og multipelt myelom
English: Sanofi AB
Danish: SANOFI BULGARIA EOOD
English: cells/kg) numbers of CD34+ cells/kg within a given number of days, as well as the primary composite endpoints which incorporated successful engraftment are presented in Tables 3 and 5; the proportion of patients reaching optimal numbers of CD34+ cells/kg by apheresis day are presented in Tables 4 and 6.
Danish: I tabel 4 og 6 ses procentdelen af patienter, der opnåede det optimale antal CD34+ celler/kg efter et bestemt antal aferesedage.
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=130; 86.7%) than with placebo and G-CSF (n=70; 47.3%), p<0.001.
Danish: 59,3 %) end med placebo og G-CSF (n=29; 19,6 %), p < 0,001; statistisk signifikant flere patienter opnåede ≥ 2 x 106 celler/kg inden for ≤ 4 aferesedage med Mozobil og G-CSF (n=130; 86,7 %) end med placebo og G-CSF (n=70; 47,3 %), p<0,001.
English: cells/kg in ≤ 4 apheresis days with Mozobil and G-CSF (n=112; 75.7%) than with placebo and G-CSF (n=79; 51.3%), p<0.001; statistically significantly more patients achieved ≥ 2 x 10
Danish: 71,6 %) end med placebo og G-CSF (n=53; 34,4 %), p < 0,001; statistisk signifikant flere patienter opnåede ≥ 6 x 106 celler/kg inden for ≤ 4 aferesedage med Mozobil og G-CSF (n=112; 75,7 %) end med placebo og G-CSF (n=79;
English: Common Hyperhidrosis, erythema Musculoskeletal and connective tissue disorders Common Arthralgia, musculoskeletal pain General disorders and administration site conditions Very common Injection and infusion site reactions Common Fatigue, malaise
Danish: Meget almindelig Reaktioner på injektions- og infusionssted Almindelig Træthed, utilpashed
English: Median
Danish: Dosering
English: Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 1600
Danish: Τηλ: +30 210 900 1600
English: • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er)
English: Proportion a in Mozobil and G-CSF (n=147
Danish: Mozobil og G-CSF Procentdela (n=147b)
English: Proportion a in Placebo and G-CSF (n=142
Danish: Placebo og G-CSF Procentdela (n=142b)
English: OUTER CARTON
Danish: Effektendepunktb
English: Proportion a in Placebo and G-CSF (n=150
Danish: Placebo og G-CSF Procentdela (n=150b)
English: Proportion a in Mozobil and G-CSF (n=144
Danish: Mozobil og G-CSF Procentdela (n=144b)
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: The main measure of effectiveness was based on an assessment of how well the treatment worked.
Danish: Det primære mål for virkning var baseret på en vurdering af, hvor godt behandlingen virkede.
English: Further information on Veyvondi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Veyvondi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: As for all medicines, data on the use of Veyvondi are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Veyvondi løbende overvåget.
English: The dose and frequency of treatment depend on the type and seriousness of the bleeding episode or extent of the surgery, and the patient's condition and body weight.
Danish: Dosis og hyppighed af injektionerne afhænger af blødningsepisodens art og sværhedsgrad eller operationens omfang samt patientens tilstand og legemsvægt.
English: For more information about using Veyvondi, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Veyvondi, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Other information about Veyvondi
Danish: Andre oplysninger om Veyvondi
English: The European Medicines Agency decided that Veyvondi's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Veyvondi opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Veyvondi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Veyvondi?
English: It replaces the missing protein, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Danish: Det erstatter det manglende protein og medvirker derved til blodets størkning, så der opnås midlertidig kontrol med blødningsforstyrrelsen.
English: Side effects reported with Veyvondi are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Veyvondi vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: The side effects with Veyvondi were considered typical for this type of medicine.
Danish: Bivirkningerne ved Veyvondi vurderes at være typiske for denne slags medicin.
English: Veyvondi contains the active substance vonicog alfa.
Danish: Veyvondi indeholder det aktive stof vonicog alfa.
English: Veyvondi must not be used in patients who have had allergic reactions to mouse or hamster proteins.
Danish: Veyvondi må ikke gives til patienter, der har haft allergiske reaktioner over for muse- eller hamsterproteiner.
English: An overview of Veyvondi and why it is authorised in the EU
Danish: En oversigt over Veyvondi, og hvorfor det er godkendt i EU
English: The most common side effects with Veyvondi (which may affect up to 1 in 10 patients) are dizziness, vertigo (a spinning sensation), dysgeusia (taste disturbances), tremor, rapid heartbeat, deep venous thrombosis (blood clot in a deep vein, usually in the leg), hypertension (high blood pressure), hot flush, vomiting, nausea (feeling sick), pruritus (itching), chest discomfort, sensations like numbness, tingling, pins and needles at the site of infusion, and an abnormal reading on the electrocardiogram (ECG).
Danish: De hyppigste bivirkninger ved Veyvondi (der kan forekomme hos op til 1 ud af 10 patienter) er svimmelhed, ørhed, smagsforstyrrelser, skælven, hurtig hjerterytme, dyb venetrombose (blodprop i en dyb vene, typisk i benet), forhøjet blodtryk, hedeture, opkastning, kvalme, kløe, ubehag i brystet, følelsesløshed, prikkende/stikkende fornemmelse på infusionsstedet og unormalt EKG (hjertediagram).
English: Patients with von Willebrand disease lack von Willebrand factor, a protein needed for normal clotting of the blood, and as a result, they bleed readily.
Danish: Patienter med von Willebrands sygdom mangler von Willebrand-faktor, et protein, der er nødvendigt for blodets normale størkning; derfor får de let blødninger.
English: Why is Veyvondi authorised in the EU?
Danish: Hvorfor blev Veyvondi godkendt i EU?
English: A total of 193 bleeding episodes were recorded, and Veyvondi was rated ‘excellent' or ‘good' at treating around 98% of bleedings.
Danish: Der blev registreret i alt 193 blødningsepisoder, og Veyvondi blev vurderet som fremragende eller godt til behandling af blødning i ca. 98 % af tilfældene.
English: The active substance in Veyvondi, vonicog alfa, works in the body in the same way as natural von Willebrand factor.
Danish: Det aktive stof i Veyvondi, vonicog alfa, virker på samme måde i kroppen som kroppens egen von Willebrand-faktor.
English: The second study involved 15 patients who were given Veyvondi to prevent bleeding during surgery, including major surgery such as knee replacement.
Danish: Det andet studie omfattede 15 patienter, der fik Veyvondi til forebyggelse af blødning under operation, herunder større operative indgreb som f.eks. udskiftning af knæ.
English: Veyvondi can only be obtained with a prescription and treatment should be supervised by a doctor experienced in treating patients with bleeding disorders.
Danish: Veyvondi udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i behandling af patienter med blødersygdomme.
English: What is Veyvondi and what is it used for?
Danish: Hvad er Veyvondi, og hvad anvendes det til?
English: In the 15 major and minor surgeries that occurred during the study, Veyvondi was rated as excellent or good at preventing bleeding episodes for all 15 surgeries.
Danish: Ved 15 større og mindre operative indgreb, der fandt sted i løbet af studiet, blev Veyvondi vurderet som fremragende eller godt til forebyggelse af blødningsepisoder i alle 15 tilfælde.
English: The first study involved 37 patients who were given Veyvondi for the treatment of bleeding episodes.
Danish: Det første studie omfattede 37 patienter, der fik Veyvondi til behandling af blødningsepisoder.
English: Veyvondi was also effective for preventing and treating bleeding related to surgery.
Danish: Veyvondi er også effektivt til at forebygge og behandle operationsrelateret blødning.
English: It is used ‘on demand' to treat bleeding episodes and is also used to prevent and treat bleeding during surgery.
Danish: Det anvendes efter behov til behandling af blødningsepisoder og bruges også til forebyggelse og behandling af blødning under operative indgreb.
English: The following side effects may occur during treatment with Veyvondi: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control.
Danish: Følgende bivirkninger kan forekomme under behandling med Veyvondi: overfølsomhed (allergiske reaktioner), tromboemboliske hændelser (problemer i forbindelse med blodpropdannelse i blodkarrene), udvikling af antistoffer mod von Willebrand-faktor, hvorved medicinen holder op med at virke og kontrollen med blødningerne forringes.
English: What are the risks associated with Veyvondi?
Danish: Hvilke risici er der forbundet med Veyvondi?
English: The benefits of Veyvondi in controlling bleeding have been shown in two main studies involving 52 patients with von Willebrand disease.
Danish: Veyvondis gavnlige effekt til kontrol af blødning er påvist i to hovedstudier af 52 patienter med von Willebrands sygdom.
English: However EMA decided that, as for similar medicines, Veyvondi should be used only when desmopressin (the main treatment for von Willebrand disease) cannot be used or is not working well enough.
Danish: Det Europæiske Lægemiddelagentur har dog vurderet, at Veyvondi som anden lignende medicin kun bør anvendes, når desmopressin (standardbehandlingen ved von Willebrands sygdom) ikke kan anvendes eller ikke virker tilstrækkeligt.
English: Veyvondi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Danish: Veyvondi fås som pulver og solvens, der blandes sammen til en injektionsvæske, som indgives i en vene.
English: Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective.
Danish: Veyvondi er et lægemiddel til kontrol af blødning hos patienter med von Willebrands sygdom (en arvelig blødersygdom), der ikke kan behandles med lægemidlet desmopressin, eller hos hvem desmopressin ikke virker.
English: Treatment with Veyvondi was successful in 95% of patients (20 out of 22).
Danish: 95 % af patienterne (20 ud af 22) havde gavn af behandling med Veyvondi.