FrancophonIA/ELRC3.0 huggingface dataset:
English: At week 96, the mean change from baseline in CD4+ cell count was +228 × 10
Danish: I uge 96 var den gennemsnitlige ændring fra baseline i CD4+ celletal +228 x 10 6 celler/l i rilpivirin gruppen og +219 x 10
English: When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily (see section 4.5).
Danish: Ved seponering af rifabutin skal dosis af EDURANT nedsættes til 25 mg 1 gang dagligt (se pkt.
English: nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were, respectively, 21%, 29% and 35% lower as compared to postpartum; during the 3
Danish: Hos kvinder, der fik rilpivirin 25 mg én gang daglig under graviditetens 2. trimester, var de gennemsnitlige intra-individuelle værdier for Cmax, AUC24h og Cmin for total-rilpivirin henholdsvis 21 %, 29 % og 35 % lavere ved sammenligning med postpartum.
English: Virologic outcome in adult subjects in the ECHO and THRIVE trials (pooled data in the week 48 (primary) and week 96 analysis; ITT-TLOVR*) Outcome in the week 48 analysis
Danish: Tabel 4: Virologisk resultat hos voksne forsøgspersoner i studierne ECHO og THRIVE (puljede data i uge 48 (primær analyse) og uge 96; ITT-TLOVR
English: Pregnant women should discuss the use of EDURANT with their doctor.
Danish: Hvis du er gravid, skal du spørge din læge til råds vedrørende brugen af EDURANT.
English: rilpivirine AUC ↑ 49% rilpivirine Cmin ↑ 76% rilpivirine Cmax ↑ 30%
Danish: rilpivirin AUC ↑ 49 % rilpivirin Cmin ↑ 76 % rilpivirin Cmax ↑ 30 %
English: In THRIVE, the BR consisted of 2 investigator-selected N(t)RTIs: tenofovir disoproxil fumarate plus emtricitabine or zidovudine plus lamivudine or abacavir plus lamivudine.
Danish: I THRIVE bestod baggrundsregimet af 2 investigatorvalgte N(t)RTI: tenofovirdisoproxilfumarat plus emtricitabin eller zidovudin plus lamivudin eller abacavir plus lamivudin.
English: rilpivirine AUC ↑ 16%* rilpivirine Cmin ↔* rilpivirine Cmax ↑ 43%*
Danish: rilpivirin AUC ↑ 16 % rilpivirin Cmin ↔* rilpivirin Cmax ↑ 43 %
English: EDURANT should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
Danish: EDURANT skal anvendes med forsigtighed sammen med lægemidler, der er kendt for at indebære en risiko for torsades de pointes.
English: If a patient vomits within 4 hours of taking the medicine, another EDURANT tablet should be taken with a meal.
Danish: I tilfælde af opkastning inden for 4 timer efter indtagelse af lægemidlet skal patienten tage en tablet til i forbindelse med et måltid.
English: please carefully read how to take them in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
Danish: 3 "Vejledning i brug til voksne og unge (fra 12 til under 18 år)".
English: No dose adjustment of rilpivirine is required in patients with mild or moderate renal impairment.
Danish: Der kræves ingen dosisjustering af rilpivirin til patienter med let eller moderat nedsat nyrefunktion.
English: 6 cells/l in patients receiving rilpivirine 25 mg and 160 × 10
Danish: 6 celler/l hos patienter, der fik rilpivirin 25 mg, og 160 x 10 6 celler/l hos patienter, der fik efavirenz.
English: Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
Danish: Almindelige unormale drømme depression søvnforstyrrelser nedsat stemningsleje
English: In the week 96 efficacy analysis, the virologic response rate [confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml)] was evaluated in patients receiving rilpivirine 25 mg once daily in addition to a BR versus patients receiving efavirenz 600 mg once daily in addition to a BR.
Danish: I effektanalysen efter 96 uger blev den virologiske responsrate (konfirmeret udetekterbar viral load (< 50 hiv 1-RNA-kopier/ml)) vurderet hos patienter behandlet med rilpivirin 25 mg x 1 ud over et baggrundsregime versus patienter behandlet med efavirenz 600 mg x 1 ud over et baggrundsregime.
English: Therefore, EDURANT is not recommended in patients with severe hepatic impairment (see section 5.2).
Danish: EDURANT anbefales derfor ikke til patienter med svært nedsat leverfunktion (se pkt.
English: Blood and lymphatic system disorders common decreased white blood cell count decreased haemoglobin decreased platelet count
Danish: Blod og lymfesystem Almindelige fald i leukocyttal fald i hæmoglobin fald i trombocyttal
English: (inhibition of CYP3A enzymes)
Danish: (hæmning af CYP3A enzymer)
English: Famotidine* 40 mg single dose taken 2 hours before rilpivirine rilpivirine AUC ↓ 76% rilpivirine Cmin NA rilpivirine Cmax ↓ 85%
Danish: 40 mg enkeltdosis taget 2 timer før rilpivirin rilpivirin AUC ↓ 76 % rilpivirin Cmin IR rilpivirin Cmax ↓ 85 %
English: Resistance to emtricitabine/lamivudine % (n/N)
Danish: Behandling med efavirenz Resistens over for emtricitabin/lamivudin % (n/N)
English: Didanosine*
Danish: Norethindron*
English: How to take EDURANT
Danish: Sådan skal du tage EDURANT
English: HIV Integrase Strand Transfer Inhibitors Raltegravir*
Danish: Hiv-integrasehæmmere Raltegravir*
English: Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine.
Danish: Der er observeret nedsat plasmakoncentration af rilpivirin ved samtidig indgift af rilpivirin og lægemidler, der inducerer CYP3A, hvilket kan reducere den terapeutiske effekt af rilpivirin.
English: Rilpivirine should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Danish: Rilpivirin bør ikke anvendes i kombination med systemisk dexamethason (undtagen som en enkeltdosis), da samtidig indgift kan medføre tab af terapeutisk effekt af rilpivirin (se pkt.
English: Throughout co-administration of rilpivirine with rifabutin, the rilpivirine dose should be increased from 25 mg once daily to 50 mg once daily.
Danish: Ved samtidig administration af rilpivirin og rifabutin skal dosis af rilpivirin øges fra 25 mg x 1 til 50 mg x 1.
English: Study TMC278-C204 was a randomised, active-controlled, Phase IIb trial in antiretroviral treatment-naïve HIV-1 infected adult patients consisting of 2 parts: an initial partially blinded dose-finding part [(rilpivirine) doses blinded] up to 96 weeks, followed by a long-term, open label part.
Danish: Studie TMC278-C204 var et randomiseret, aktivt kontrolleret, fase IIb-studie antiretroviralnaive hiv 1-inficerede voksne patienter bestående af 2 dele: en indledende delvist blindet dosisbestemmende del [doserne af (rilpivirin) er blindede] på op til 96 uger, efterfulgt af en langvarig, åben del. I den åbne del af studiet blev patienter, der oprindeligt var randomiseret til en af de tre doser af rilpivirin, alle behandlet med rilpivirin 25 mg x 1 som tillæg til BR, efter at dosis til fase III-studierne var valgt.
English: ORAL CONTRACEPTIVES Ethinylestradiol* 0.035 mg once daily Norethindrone* 1 mg once daily ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17% norethindrone AUC ↔ norethindrone Cmin ↔ norethindrone Cmax ↔ rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Danish: ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17 % norethindron AUC ↔ norethindron Cmin↔ norethindron Cmax ↔ rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * baseret på historiske kontroller
English: 40 mg once daily atorvastatin AUC ↔ atorvastatin Cmin ↓ 15% atorvastatin Cmax ↑ 35% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↓ 9%
Danish: atorvastatin AUC ↔ atorvastatin Cmin ↓ 15 % atorvastatin Cmax ↑ 35 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↓ 9 %
English: EDURANT must be taken with a meal (see section 5.2).
Danish: EDURANT skal indtages i forbindelse med et måltid (se pkt.
English: 20 mg once daily omeprazole AUC ↓ 14% omeprazole Cmin NA omeprazole Cmax ↓ 14% rilpivirine AUC ↓ 40% rilpivirine Cmin ↓ 33% rilpivirine Cmax ↓ 40%
Danish: omeprazol AUC ↓ 14 % omeprazol Cmin IR omeprazol Cmax ↓ 14 % rilpivirin AUC ↓ 40 % rilpivirin Cmin ↓ 33 % rilpivirin Cmax ↓ 40 %
English: Rifampicin* 600 mg once daily rifampicin AUC ↔ rifampicin Cmin NA rifampicin Cmax ↔ 25-desacetyl-rifampicin AUC ↓ 9% 25-desacetyl-rifampicin Cmin NA 25-desacetyl-rifampicin Cmax ↔ rilpivirine AUC ↓ 80% rilpivirine Cmin ↓ 89% rilpivirine Cmax ↓ 69%
Danish: rifampicin AUC ↔ rifampicin Cmin IR rifampicin Cmax ↔ 25-desacetylrifampicin AUC ↓ 9 % 25-desacetylrifampicin Cmin IR 25-desacetylrifampicin Cmax ↔ rilpivirin AUC ↓ 80 % rilpivirin Cmin ↓ 89 % rilpivirin Cmax ↓ 69 %
English: See package leaflet for further information.
Danish: Se yderligere oplysninger i indlægssedlen.
English: Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Danish: 4.5): - følgende antiepileptika: carbamazepin, oxcarbazepin, phenobarbital, phenytoin - følgende antibiotika med virkning på mykobakterier: rifampicin, rifapentin - syrepumpehæmmere, f.eks. omeprazol, esomeprazol, lansoprazol, pantoprazol, rabeprazol - det systemiske glukokortikoid dexamethason (undtagen som enkeltdosis) - perikon (Hypericum perforatum)
English: 300 mg once daily tenofovir AUC ↑ 23% tenofovir Cmin ↑ 24% tenofovir Cmax ↑ 19% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Danish: tenofovir AUC ↑ 23 % tenofovir Cmin ↑ 24 % tenofovir Cmax ↑ 19 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
English: The bottle comes with a child resistant cap.
Danish: Beholderen er forsynet med et børnesikret låg.
English: 800/100 mg once daily darunavir AUC ↔ darunavir Cmin ↓ 11% darunavir Cmax ↔ rilpivirine AUC ↑ 130% rilpivirine Cmin ↑ 178% rilpivirine Cmax ↑ 79%
Danish: darunavir AUC ↔ darunavir Cmin ↓ 11 % darunavir Cmax ↔ rilpivirin AUC ↑ 130 % rilpivirin Cmin ↑ 178 % rilpivirin Cmax ↑ 79 %
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Danish: Der er ikke behov for dosisjustering til patienter med let eller moderat nedsat nyrefunktion.
English: Gastrointestinal disorders very common nausea increased pancreatic amylase common abdominal pain vomiting increased lipase abdominal discomfort dry mouth
Danish: Almindelige abdominalsmerter opkastning forhøjet lipase abdominalgener mundtørhed
English: The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
Danish: Doseringsanbefalingen gælder for den anbefalede dosis af rilpivirin på 25 mg x 1
English: Famotidine* 40 mg single dose taken 4 hours after rilpivirine rilpivirine AUC ↑ 13% rilpivirine Cmin NA rilpivirine Cmax ↑ 21%
Danish: 40 mg enkeltdosis taget 4 timer efter rilpivirin rilpivirin AUC ↑ 13 % rilpivirin Cmin IR rilpivirin Cmax ↑ 21 %
English: (inhibition of intestinal P-gp)
Danish: (hæmning af P-gp i tarmen).
English: - low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood
Danish: - sløvhed - nedsat appetit - søvnforstyrrelser - mavegener - dårligt humør - mundtørhed - lavt antal hvide blodlegemer og/eller blodplader, fald i blodets indhold af hæmoglobin, stigning i blodets indhold af triglycerider, lipase og/eller bilirubin
English: The list of rilpivirine resistance-associated mutations presented in section 5.1 should only guide the use of EDURANT in the treatment-naïve population.
Danish: 5.1 er kun beregnet som vejledning til brug af EDURANT hos den behandlingsnaive population.
English: In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
Danish: I analysen i uge 48 havde 31 ud af 62 forsøgspersoner med virologisk svigt af rilpivirin samtidig RAM forbundet med NNRTI og NRTI.
English: General disorders and administration site conditions common fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet
English: By baseline CD4 count (× 10
Danish: Inddelt efter CD4+ celletal (x 10
English: When rifabutin co-administration is stopped, the rilpivirine dose should be decreased to 25 mg once daily.
Danish: Ved seponering af rifabutin skal dosis af rilpivirin nedsættes til 25 mg x 1.
English: Cardiovascular
Danish: Tabletovertræk
English: No dose adjustment of EDURANT is required in patients with mild or moderate hepatic impairment.
Danish: Der kræves ingen dosisjustering af EDURANT til patienter med let eller moderat nedsat leverfunktion.
English: When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Danish: Ved undersøgelse af supraterapeutiske doser på 75 mg x 1 og 300 mg x 1 af rilpivirin til raske voksne var de højeste gennemsnitlige tidsmæssigt afstemte (95 % øvre konfidensgrænse) forskelle i QTcFinterval i forhold til placebo efter baselinekorrektion henholdsvis 10,7 (15,3) og 23,3 (28,4) ms. Steady state-indgift af rilpivirin 75 mg x 1 og 300 mg x 1 resulterede i et gennemsnitligt Cmax på henholdsvis ca. 2,6 og 6,7 gange højere end det gennemsnitlige Cmax ved steady state, der blev observeret med den anbefalede dosis på 25 mg x 1 af rilpivirin.
English: EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole,
Danish: Tag ikke EDURANT i kombination med et af følgende lægemidler, da de kan påvirke virkningen af EDURANT eller den anden medicin: - carbamazepin, oxcarbazepin, phenobarbital, phenytoin (medicin til behandling af epilepsi og til forebyggelse af krampeanfald).
English: Hepatobiliary disorders very common increased transaminases common increased bilirubin
Danish: Lever og galdeveje meget almindelige forhøjede aminotransferaser
English: At the recommended dose of 25 mg once daily, no dose adjustment is required when rilpivirine is co-administered with ketoconazole.
Danish: Dosisjustering er ikke nødvendig, når rilpivirin (i den anbefalede dosis på 25 mg x 1) indgives sammen med ketoconazol.
English: What EDURANT is and what it is used for What you need to know before you take EDURANT How to take EDURANT
Danish: Det skal du vide, før du begynder at tage EDURANT Sådan skal du tage EDURANT Bivirkninger
English: ANTICOAGULANTS Dabigatran etexilate
Danish: Andre antivirale midler Ribavirin
English: Tabulated summary of adverse reactions
Danish: Liste i tabelform over bivirkninger
English: Resistance to efavirenz % (n/N) * The number of patients with virologic failure and paired genotypes (baseline and failure) were 71, 11, and 4 for rilpivirine and 30, 10,
Danish: Antallet af patienter med virologisk svigt og parrede genotyper (ved baseline og svigt) var henholdsvis 71, 11 og 4 i rilpivirin-gruppen og 30, 10 og 2 i efavirenz-gruppen for regimerne tenofovir/emtricitabin, zidovudin/lamivudin og abacavir/lamivudin.
English: Rilpivirine must not be used in combination with these anticonvulsants as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Danish: Rilpivirin må ikke anvendes i kombination med disse antiepileptika, da samtidig indgift kan medføre tab af terapeutisk effekt af rilpivirin (se pkt.
English: - methadone (used to treat narcotic withdrawal and dependence) - dabigatran etexilate (anticoagulant).
Danish: - produkter, som indeholder perikon (Hypericum perforatum) (et naturlægemiddel, som anvendes mod depression).
English: Renal impairment
Danish: Almindelige træthed
English: Co-administration of rilpivirine and medicinal products that inhibit CYP3A has been observed to increase the plasma concentrations of rilpivirine.
Danish: Der er observeret øget plasmakoncentration af rilpivirin ved samtidig indgift af rilpivirin og lægemidler, der hæmmer CYP3A.
English: Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Danish: Rilpivirin må ikke anvendes i kombination med rifampicin, da samtidig indgift sandsynligvis vil medføre tab af terapeutisk effekt af rilpivirin (se pkt.
English: If you take these medicines,
Danish: Hvis du tager disse former for medicin, skal du omhyggeligt læse, hvordan du skal tage dem, i pkt.
English: If you take more EDURANT than you should Contact your doctor or pharmacist immediately.
Danish: Kontakt straks lægen eller apoteket.
English: Rilpivirine must not be used in combination with products containing St John's wort as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Danish: Rilpivirin må ikke anvendes i kombination med produkter, der indeholder perikon, da samtidig indgift kan medføre tab af terapeutisk effekt af rilpivirin (se pkt.
English: Rilpivirine must not be used in combination with rifapentine as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Danish: Rilpivirin må ikke anvendes i kombination med rifapentin, da samtidig indgift sandsynligvis vil medføre tab af terapeutisk effekt af rilpivirin (se pkt.
English: 6 cells/l (range: 25 to 983 × 10
Danish: 6 celler/l (interval 25 til
English: Rilpivirine must not be used in combination with proton pump inhibitors as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Danish: Rilpivirin må ikke anvendes i kombination med syrepumpehæmmere, da samtidig indgift sandsynligvis vil medføre tab af terapeutisk effekt af rilpivirin (se pkt.
English: Lopinavir/ritonavir (soft gel capsule)* 400/100 mg twice daily lopinavir AUC ↔ lopinavir Cmin ↓ 11% lopinavir Cmax ↔ rilpivirine AUC ↑ 52% rilpivirine Cmin ↑ 74% rilpivirine Cmax ↑ 29%
Danish: lopinavir AUC ↔ lopinavir Cmin ↓ 11 % lopinavir Cmax ↔ rilpivirin AUC ↑ 52 % rilpivirin Cmin ↑ 74 % rilpivirin Cmax ↑ 29 %
English: Most ADRs occurred in the first 48 weeks of treatment.
Danish: De fleste tilfælde af virologisk svigt opstod dog i løbet af de første 48 behandlingsuger.
English: Discontinued for non-AE reason
Danish: Udtrådt af anden årsag end bivirkning/uønsket hændelse
English: This is a summary of the European public assessment report (EPAR) for Idelvion.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Idelvion.
English: It must also not be used in patients allergic to hamster proteins.
Danish: Det må heller ikke gives til patienter med allergi over for hamsterproteiner.
English: Other information about Idelvion
Danish: Andre oplysninger om Idelvion
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Idelvion's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Idelvion opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Idelvion is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Idelvion anvendes så sikkert som muligt.
English: Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Idelvion was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 February 2010.
Danish: Da antallet af patienter med hæmofili er lavt, betragtes sygdommen som "sjælden", og Idelvion blev udpeget som "lægemiddel til sjældne sygdomme" den 4. februar 2010.
English: Idelvion must not be used in patients who are hypersensitive (allergic) to the active substance or other ingredients of the medicine.
Danish: Idelvion må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for det aktive stof eller andre af indholdsstofferne.
English: In a study in 80 adults and adolescents and another study in 27 children aged less than 12 years, Idelvion was effective at preventing bleeding, with most patients experiencing no bleeding while on preventive treatment.
Danish: I en undersøgelse med 80 voksne og unge og i en undersøgelse med 27 børn under 12 år var Idelvion effektivt til forebyggelse af blødning; de fleste af patienterne ikke oplevede nogen blødning, mens de var i forebyggende behandling.
English: The full EPAR for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Idelvion findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Idelvion?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Idelvion?
English: Idelvion can only be obtained with a prescription, and treatment should be supervised by a doctor with experience in treating haemophilia.
Danish: Idelvion udleveres kun efter recept, og behandlingen bør overvåges af en læge med erfaring i behandling af hæmofili.
English: The active substance in Idelvion, albutrepenonacog alfa, works in the body in the same way as human factor IX.
Danish: Det aktive stof i Idelvion, albutrepenonacog alfa, virker på samme måde i kroppen som kroppens egen faktor IX.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Idelvion, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Idelvion, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The dose and the frequency of the injections depend on the patient's bodyweight and whether Idelvion is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health.
Danish: Dosis og hyppighed af indsprøjtningerne afhænger af patientens legemsvægt og af, om Idelvion skal anvendes til at behandle eller forebygge blødning, og desuden af, hvor alvorlig patientens mangel på faktor IX er, blødningens omfang og beliggenhed samt patientens
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Idelvion findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Idelvion approved?
Danish: Hvorfor blev Idelvion godkendt?