FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of ALPROLIX in previously untreated patients have not yet been established.
Danish: ALPROLIX' sikkerhed og virkning hos tidligere ubehandlede patienter er endnu ikke klarlagt.
English: Pharmacokinetic parameters1
Danish: Farmakokinetiske parametre1
English: Fertility There are no fertility data available.
Danish: Fertilitet Der foreligger ingen data angående fertilitet.
English: No bleeding episodes were experienced in 33% of paediatric subjects.
Danish: Der forekom ikke blødningsepisoder hos 33 % af de pædiatriske forsøgspersoner.
English: An instructional video on how to prepare and administer ALPROLIX is available by scanning the QR code with a smartphone or via the website
Danish: En video med anvisninger i klargøring og administration af ALPROLIX kan ses ved at scanne QR-koden med en smarttelefon eller via websitet
English: The Fc region of human immunoglobulin G1 binds with the neonatal Fc receptor.
Danish: Fc-regionen i humant immunglobulin G1 binder til den neonatale Fc-receptor.
English: • Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive, as there can be several reasons for this.
Danish: • Kontakt lægen, hvis du mener, at din blødning ikke kan kontrolleres med den dosis, du får, da der kan være flere årsager til dette.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor IX levels in your blood.
Danish: Din læge vil tage relevante blodprøver for at være sikker på, at du har et tilstrækkeligt faktor IX-niveau i blodet.
English: The elimination half-life of ALPROLIX (82 hours) is influenced by the Fc region, which in animal models was shown to be mediated by neonatal Fc receptor cycling pathways.
Danish: Eliminationshalveringstiden for ALPROLIX (82 timer) er påvirket af Fc-regionen, som i dyremodeller blev vist at være medieret af neonatale Fc-receptor-cyklusser.
English: ALPROLIX can be used in children and adolescents of all ages.
Danish: ALPROLIX kan bruges til børn og unge i alle aldre.
English: If you are using ALPROLIX to prevent bleeding, your doctor will calculate the dose for you.
Danish: Hvis du bruger ALPROLIX til at forhindre blødning, vil lægen beregne dosis for dig.
English: Table 5 presents the pharmacokinetic parameters calculated from the paediatric data of 35 subjects less than 18 years of age.
Danish: Tabel 5 viser farmakokinetiske parametre beregnet fra pædiatriske data fra 35 forsøgspersoner under 18 år.
English: For extent and age characterisation of the safety database in children see section 5.1.
Danish: For omfanget og alderskarakteriseringen af børn i sikkerhedsdatabasen, se pkt.
English: Factor IX products may increase the risk of unwanted blood clots in your body, especially if you have risk factors for developing blood clots.
Danish: Faktor IX-præparater kan øge risikoen for, at der dannes uønskede blodpropper i din krop, især hvis du har risikofaktorer for at udvikle blodpropper.
English: NA 77.1
Danish: IR 77,1
English: • 100 IU/kg once every 10 days, adjust interval based on individual response.
Danish: • 100 IU/kg én gang hver 10. dag, justér intervallet på basis af individuelt respons.
English: This receptor is expressed throughout life as part of a naturally occurring pathway that protects immunoglobulins from lysosomal degradation by cycling these proteins back into circulation, resulting in their long plasma half-life.
Danish: Denne receptor udtrykkes hele livet igennem som en del af den naturligt forekommende reaktionsvej, der beskytter immunglobuliner mod lysosomal nedbrydning ved at sende disse proteiner tilbage i kredsløbet, hvilket resulterer i deres lange halveringstid i plasma.
English: Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Danish: Derfor bør faktor IX kun anvendes under graviditet og amning, hvis det er absolut nødvendigt.
English: It is a vitamin-K dependent coagulation factor.
Danish: Det er en vitamin Kafhængig koagulationsfaktor.
English: After this time, the prepared ALPROLIX should be discarded.
Danish: Efter denne periode skal det fremstillede ALPROLIX bortskaffes.
English: Of the 35 major surgeries, 28 surgeries (80.0%) required a single pre-operative dose to maintain haemostasis during surgery.
Danish: Ud af de 35 større operationer krævede 28 operationer (80,0 %) en enkelt præoperativ dosis til at opretholde hæmostase under operationen.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Danish: Faktor IX er et enkeltkædet glykoprotein med en molekylvægt på ca. 68.000 Dalton.
English: Studies to investigate genotoxicity, carcinogenicity, toxicity to reproduction or embryo-foetal development have not been conducted.
Danish: Der er ikke udført studier af genotoksicitet, karcinogenicitet, reproduktionstoksicitet eller embryoføtal udviklingstoksicitet.
English: • if you are allergic to eftrenonacog alfa or any other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for eftrenonacog alfa eller et af de øvrige indholdsstoffer i ALPROLIX (angivet i punkt 6).
English: Once you have prepared ALPROLIX it should be used right away.
Danish: Når du har fremstillet ALPROLIX, skal det straks anvendes.
English: Post Marketing Experience
Danish: Erfaring efter markedsføring
English: • 50 IU/kg once weekly, adjust dose based on individual response or
Danish: • 50 IU/kg én gang ugentligt, justér dosis på basis af individuelt respons, eller
English: NA 2.86
Danish: IR 2,86
English: Talk to your doctor, pharmacist or nurse before using ALPROLIX.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger ALPROLIX.
English: Check the expiry date on the ALPROLIX carton.
Danish: Kontroller udløbsdatoen på kartonen med ALPROLIX.
English: This product is for single use only.
Danish: Dette præparat er kun til engangsbrug.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated injections.
Danish: Under behandlingen tilrådes passende bestemmelse af faktor IX-niveauet som guide for den dosis, der skal administreres, og hyppigheden af gentagne injektioner.
English: The dose of ALPROLIX is calculated depending on your body weight and the factor IX levels to be achieved.
Danish: Dosis af ALPROLIX beregnes ud fra din legemsvægt og det faktor IX-niveau, der skal opnås.
English: Factor IX level required (%) (IU/dL)
Danish: Nødvendigt faktor IXniveau (%) (IU/dl)
English: A single large luer lock syringe may be used to draw back the prepared contents of each of the individual vials.
Danish: En enkelt stor luer-lock-sprøjte kan anvendes til at trække indholdet i de enkelte hætteglas op.
English: The estimate of CL of ALPROLIX for a typical 70 kg adult is 2.30 dL/h and steady-state volume of distribution of ALPROLIX is 194.8 dL, respectively.
Danish: Estimatet for CL for ALPROLIX for en typisk voksen på 70 kg er 2,30 dl/t, og fordelingsvoluminet ved steady state for ALPROLIX er 194,8 dl.
English: The product should not be used beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.
Danish: Præparatet må ikke anvendes efter den udløbsdato, som er trykt på hætteglasset, eller 6 måneder efter kartonen er taget ud af køleskab, hvis det er tidligere.
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing, then therapy at least for another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL).
Danish: Injektionen gentages hver 8. til 24. time efter behov indtil tilstrækkelig sårheling, og derefter fortsættes behandling i mindst 7 dage for at opretholde en faktor IX-aktivitet på 30 % til 60 % (IU/dl).
English: All patients received treatment with ALPROLIX and were followed for up to 52 weeks.
Danish: Alle patienter fik behandling med ALPROLIX, og de blev fulgt i op til 52 uger.
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Det rekonstituerede lægemiddel skal inspiceres visuelt for partikler og misfarvning før administration.
English: Factor IX is a protein produced naturally in the body necessary for the blood to form clots and stop bleeding.
Danish: Faktor IX er et protein, der dannes naturligt i kroppen, og som er nødvendigt for at blodet kan størkne og blødninger stoppe.
English: If preferred, you may use one of the plasters (G) provided in the pack to hold the plastic wings of the needle in place at the injection site.
Danish: Hvis du foretrækker det, kan du anvende et af de plastre (G), der fulgte med pakningen, til at holde plastikvingerne på kanylen på plads på injektionsstedet.
English: Only the provided infusion set should be used because treatment failure can occur as a consequence of coagulation factor IX adsorption to the internal surfaces of some injection equipment.
Danish: Kun det medfølgende infusionssæt må anvendes, da der kan opstå behandlingssvigt på grund af adsorption af koagulationsfaktor IX på de indre overflader af nogle former for injektionsudstyr.
English: The total number of exposure days was 26,106 with a median of 165 (range 1-528) exposure days persubject.
Danish: Det totale antal eksponeringsdage var 26,106 med en median på 165 (interval 1-528) eksponeringsdage pr. person.
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Danish: På grund af den sjældne forekomst af hæmofili B hos kvinder foreligger der ikke data angående anvendelse af faktor IX under graviditet og amning.
English: MRT (h) Vss (mL/kg) Time to 1% (days)2
Danish: MRT (t) Vss (ml/kg) Tid til 1 % (dage)2
English: The frequencies in the table below were observed in a total of 153 patients with severe haemophilia B in phase III clinical studies and an extension study.
Danish: Hyppighederne i tabellen nedenfor blev observeret hos i alt 153 patienter med svær hæmofili B i kliniske fase III-studier og et forlængelsesstudie.
English: Do not increase the total dose of ALPROLIX to control your bleed without talking to your doctor.
Danish: Du må ikke øge den totale dosis af ALPROLIX for at kontrollere din blødning uden at kontakte lægen.
English: Dosing intervals and factor consumption remained similar in Study III compared to Study II.
Danish: Doseringsintervaller og faktorforbrug vedblev med at være tilsvarende i studie III, sammenlignet med studie II.
English: After preparation, ALPROLIX can be stored at room temperature for up to 6 hours before administration.
Danish: Efter fremstilling kan ALPROLIX opbevares ved stuetemperatur i op til 6 timer før administration.
English: Do not stop using ALPROLIX without consulting your doctor.
Danish: Du må ikke holde op med at bruge ALPROLIX uden at kontakte din læge.
English: All patients received treatment with ALPROLIX and were followed for up to 77 weeks.
Danish: Alle patienter fik behandling med ALPROLIX og blev fulgt i op til 77 uger.
English: The safety, efficacy, and pharmacokinetics of ALPROLIX were evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study in adults and adolescents, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Danish: ALPROLIX' sikkerhed, virkning og farmakokinetik er blevet evalueret i to multinationale, åbne pivotale studier: et fase III-studie hos voksne og unge, der omtales som studie I, og et pædiatrisk fase III-studie, der omtales som studie II (se Pædiatrisk population).
English: If a repeat dose is required to control the bleed, the prolonged half-life of ALPROLIX should be taken into account (see section 5.2).
Danish: Hvis der er behov for en gentagen dosis for at kontrollere blødningen, skal ALPROLIX' langvarige halveringstid tages i betragtning (se pkt.
English: Please safely dispose of the used needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Danish: Bortskaf den brugte kanyle, al ikke brugt injektionsvæske, sprøjten og det tomme hætteglas på sikker vis i en dertil beregnet beholder til medicinsk affald, da disse materialer kan skade andre, hvis de ikke bortskaffes korrekt.
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Danish: Der er en potentiel risiko for tromboemboliske episoder efter administration af faktor IX-præparater, med en større risiko for præparater med lav renhed.
English: Following a washout period of at least 120 hours (5 days), the subjects received a single dose of 50 IU/kg of ALPROLIX.
Danish: Efter en udvaskningsperiode på mindst 120 timer (5 dage) fik forsøgspersonerne en enkelt dosis på 50 IU/kg ALPROLIX.
English: Pharmacokinetic properties were evaluated in 22 subjects (≥19 years) receiving ALPROLIX (rFIXFc).
Danish: De farmakokinetiske egenskaber blev evalueret hos 22 forsøgspersoner (≥19 år), der fik ALPROLIX (rFIXFc).
English: If ALPROLIX has been stored in a refrigerator, allow the vial of ALPROLIX (A) and the syringe with solvent (B) to reach room temperature before use.
Danish: Hvis ALPROLIX er blevet opbevaret i køleskab, skal hætteglasset med ALPROLIX (A) og sprøjten med solvens (B) have tid at opnå stuetemperatur før anvendelse.
English: The median dosing interval overall was 6.99 day (interquartile range, 6.94 to 7.03) with no difference in the median dosing interval between age cohorts.
Danish: Det overordnede mediane doseringsinterval var 6,99 dage (interkvartilt interval 6,94 til 7,03) uden forskel i det mediane doseringsinterval mellem alderskohorterne.
English: Adverse events were monitored for a total of 561 subject years.
Danish: Der blev overvåget for bivirkninger i 561 forsøgspersonår i alt.
English: Instructions for preparation and administration
Danish: Anvisninger til klargøring og administration
English: ALPROLIX pack contains:
Danish: ALPROLIX-pakningen indeholder:
English: Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Danish: Da der er en risiko for allergiske reaktioner med faktor IX-præparater, skal de indledende administrationer af faktor IX, i henhold til den behandlende læges bedømmelse, udføres under overvågning af en læge, hvor den korrekte behandling af allergiske reaktioner kan gives.
English: Prophylaxis fixed weekly and individualised intervals:
Danish: Fast ugentlig profylakse og individuelle intervaller:
English: Individual patients may vary in their response to factor IX, demonstrating different half-lives and recoveries.
Danish: Den enkelte patient kan have variationer i responset på faktor IX og udvise forskellige halveringstider og genfinding.
English: The dose will depend on your individual needs for replacement factor IX therapy and on whether it is used for prevention or treatment of bleeding.
Danish: Dosis vil afhænge af dit behov for erstatningbehandling med faktor IX, og om det anvendes til forebyggelse eller behandling af blødning.
English: Allergic type hypersensitivity reactions have been reported with ALPROLIX.
Danish: Allergiske overfølsomhedsreaktioner er blevet indberettet med ALPROLIX.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Danish: Der har været litteraturrapporter, som viste en korrelation mellem fremkomsten af faktor IX-inhibitor og allergiske reaktioner.
English: It is strongly recommended that every time that ALPROLIX is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Danish: Det anbefales på det kraftigste, at præparatets navn og batchnummer registreres hver gang, ALPROLIX administreres til en patient, for at bibeholde en forbindelse mellem patienten og den pågældende batch af lægemidlet.
English: Non-clinical data reveal no special hazard for humans based on thrombogenicity test in rabbits (Wessler stasis model) and repeated dose toxicity studies (which included assessment of local toxicity, male reproductive organs and electrocardiographic parameters) in rats and monkeys.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra trombogenicitetstests hos kaniner (Wessler-stasemodel) og studier af toksicitet efter gentagne doser (hvilket omfattede vurdering af lokal toksicitet, hanners reproduktionsorganer og elektrokardiografiske parametre) hos rotter og aber.
English: Out of 123 subjects who completed Study I, 93 were enrolled in Study III (extension study) with median total follow-up time of 6.5 years.
Danish: Ud af 123 forsøgspersoner, som gennemførte studie I, indgik 93 i studie III (forlængelsesstudie) med en median total opfølgningstid på 6,5 år.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Danish: Især i tilfælde af større kirurgiske indgreb er det afgørende at monitorere substitutionsbehandlingen meget nøje ved hjælp af koagulationsanalyse (faktor IX-aktivitet i plasma).
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip.
Danish: Bemærk: Hvis injektionsvæsken ikke straks skal bruges, skal hætten forsigtigt sættes tilbage på sprøjtespidsen.
English: Note: If you use more than one vial of ALPROLIX per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place.
Danish: Bemærk: Hvis du anvender mere end et hætteglas med ALPROLIX pr. injektion, skal hvert hætteglas tilberedes separat i henhold til anvisningerne ovenfor (trin 1 til 13), og sprøjten med solvens skal fjernes med hætteglasadapteren siddende på plads.
English: Study I
Danish: Studie I
English: It is a high purity factor product produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line, without the addition of any exogenous human- or animal-derived protein in the cell culture, purification or final formulation.
Danish: Det er et faktorpræparat af høj renhed, fremstillet ved hjælp af dna-teknologi i en cellelinje fra en human embryonisk nyre (HEK) uden tilsætning af eksogene proteiner fra mennesker eller dyr i cellekulturen, oprensningen eller den endelige formulering.
English: No interactions of ALPROLIX with other medicinal products have been reported.
Danish: Der er ikke rapporteret interaktioner mellem ALPROLIX og andre lægemidler.
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Danish: Efter gentagen behandling med humane koagulationsfaktor IX-præparater bør patienten overvåges for udvikling af neutraliserende antistoffer (inhibitorer), som skal kvantificeres i Bethesda-enheder (BE) ved hjælp af passende biologisk testing.
English: ALPROLIX is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Danish: ALPROLIX fremstilles ved hjælp af rekombinant teknologi uden tilsætning af stoffer fra mennesker eller dyr i fremstillingsprocessen.
English: Some patients who are well-controlled on a once every 10 days regimen might be treated on an interval of 14 days or longer.
Danish: der er velkontrollerede på et behandlingsprogram med dosering én gang hver 10. dag, kan behandles med et interval på 14 dage eller længere.
English: Please see package leaflet, for additional information on reconstitution and administration.
Danish: Se indlægssedlen for yderligere oplysninger om rekonstitution og administration.
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dL) x {reciprocal of observed recovery (IU/kg per IU/dL)}
Danish: Påkrævede enheder = legemsvægt (kg) x ønsket faktor IX-stigning (%) (IU/dl) x {den reciprokke værdi af observeret genfinding (IU/kg pr. IU/dl)}
English: ALPROLIX is given as an injection into a vein.
Danish: ALPROLIX gives som en injektion i en vene.
English: Table 2: Adverse reactions reported for ALPROLIX in clinical trials
Danish: Tabel 2: Bivirkninger rapporteret for ALPROLIX i kliniske studier
English: NA 36.7
Danish: IR 36,7
English: Treatment with ALPROLIX will be started by a doctor who is experienced in the care of patients with haemophilia.
Danish: Behandlingen med ALPROLIX vil blive iværksat af en læge med erfaring i behandling af patienter med hæmofili.
English: Repeat injection after 24 hours, as needed until healing is achieved1.
Danish: Injektionen gentages efter 24 timer efter behov, indtil heling er opnået1.
English: There was a lower proportion of subjects in individualised interval prophylaxis with ≥1 target joint at baseline than in weekly prophylaxis (27.6% and 57.1%, respectively).
Danish: En mindre andel af forsøgspersonerne i gruppen med profylakse med individuelt interval end i gruppen med ugentlig profylakse havde ≥1 målled ved baseline (hhv. 27,6 % og 57,1 %).
English: Out of 30 patients having completed Study II, 27 enrolled to Study III (extension study).
Danish: Ud af 30 patienter, der havde gennemført studie II, indgik 27 i studie III (forlængelsesstudie).
English: With the exception of one patient whose last prescribed dose was 100 IU/kg every 5 days, the other 29 patients last prescribed doses were up to 70 IU/kg every 7 days.
Danish: Med undtagelse af en patient, hvor den sidste ordinerede dosis var 100 IU/kg hver 5. dag, var den sidste ordinerede dosis for de andre 29 patienter op til 70 IU/kg hver 7. dag.
English: If you cannot use the prepared ALPROLIX solution immediately, it should be used within 6 hours when stored at room temperature.
Danish: Hvis du ikke straks kan anvende den fremstillede ALPROLIX-injektionsvæske, skal den bruges inden for 6 timer og opbevares ved stuetemperatur.
English: Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive.
Danish: Kontakt lægen, hvis du mener, at din blødning ikke kan kontrolleres med den dosis, du får.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Danish: I nogle tilfælde blev disse reaktioner forværret til svær anafylaksi, og de opstod tidsmæssigt tæt på udviklingen af faktor IX-inhibitorer (se også pkt.
English: ALPROLIX should be injected intravenously over several minutes.
Danish: ALPROLIX bør injiceres intravenøst i løbet af flere minutter.
English: Study I compared the efficacy of each of 2 prophylactic treatment regimens (fixed weekly interval with dosing of 50 IU/kg, and individualised interval with 100 IU/kg starting every 10 days) to on demand treatment.
Danish: Studie I sammenlignede virkningen af to profylaktiske behandlingsprogrammer (fast ugentligt interval med en dosering på 50 IU/kg, og individuelt interval med 100 IU/kg startende hver 10. dag) med behovsbehandling.
English: ALPROLIX should be administered using the infusion set (E) provided in this pack.
Danish: ALPROLIX skal administreres med det infusionssæt (E), der lå i pakningen.
English: A total of 35 major surgical procedures were performed and assessed in 22 subjects (21 adults and adolescents, and 1 paediatric patient <12 years of age) in Study I and Study III.
Danish: Der blev udført og evalueret i alt 35 større kirurgiske indgreb hos 22 forsøgspersoner (21 voksne og unge og 1 pædiatrisk patient <12 år) i studie I og studie III.