FrancophonIA/ELRC3.0 huggingface dataset:
English: Other common side effects in cats include diarrhoea and loss of appetite.
Danish: Andre almindelige bivirkninger hos katte omfatter diarré og appetitløshed Den fuldstændige liste over de indberettede bivirkninger ved Comfortis fremgår af indlægssedlen.
English: How does Comfortis work?
Danish: Hvordan virker Comfortis?
English: MedDRA preferred term
Danish: MedDRA foretrukken term
English: Two patients were positive at only a single time point.
Danish: To af patienterne var kun positive på et enkelt tidspunkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1033/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1033/001
English: Children and adults
Danish: Børn og voksne
English: The educational material should contain:
Danish: Undervisningsmaterialet skal indeholde:
English: Each infusion will take approximately 1 to 2 hours.
Danish: Hver infusion tager ca. 1 til 2 timer.
English: The age range at study entry was 1-6 months.
Danish: Aldersspredningen ved indtrædelse i studiet var 1-6 måneder.
English: Based on the limited data currently available the development of ADA seems to occur more frequently in infants.'
Danish: Baseret på de begrænsede data, der foreligger i øjeblikket, synes udvikling af ADA at forekomme hyppigere hos spædbørn.
English: Additional risk minimisation measures
Danish: Yderligere risikominimeringsforanstaltninger
English: These increases have generally occurred within the first 2 to 4 weeks and improved within a further 8 weeks of treatment.
Danish: Disse stigninger er som regel forekommet inden for de første 2 til 4 uger og er bedret inden for yderligere 8 ugers behandling.
English: Final study report expected in July 2019
Danish: Endelig studierapport forventes i juli
English: MedDRA System organ class
Danish: MedDRA systemorganklasse
English: Infants (< 6 months of age)
Danish: Spædbørn (< 6 måneder)
English: Frequency a
Danish: Hyppighed a
English: The Guide for healthcare professionals shall contain the following key elements:
Danish: Vejledningen til sundhedspersonale skal indeholde følgende nøgleelementer:
English: KANUMA should be started at as young an age as possible and is intended for long-term use.
Danish: KANUMA bør påbegyndes i en så tidlig alder som muligt og er beregnet til langtidsbehandling.
English: P-values are from Fisher's exact test for normalisation endpoints and Wilcoxon rank-sum test for all other endpoints.
Danish: P-værdier er fra Fishers eksakte test for normaliseringsendepunkter og Wilcoxon rank-sum test for alle andre endepunkter.
English: Unopened vials: 2 years.
Danish: Uåbnede hætteglas: 2 år.
English: The total volume of the infusion should be administered over approximately 2 hours.
Danish: Det samlede infusionsvolumen skal administreres over ca. 2 timer.
English: P-value d
Danish: P-værdi d
English: With continued treatment beyond 12 months of age, 1 additional patient died at age 15 months.
Danish: Ved fortsat behandling efter 12 måneders alderen døde endnu 1 patient 15 måneder gammel.
English: This is known as an infusion reaction which can sometimes be severe, and may include an allergic reaction.
Danish: Det kaldes en infusionsreaktion, og den kan sommetider være alvorlig og eventuelt omfatte en allergisk reaktion.
English: Elderly population (≥ 65 years old)
Danish: Ældre patienter (≥ 65 år)
English: The majority of reactions occurred during or within 4 hours of the completion of the infusion.
Danish: Hovedparten af reaktionerne forekom under eller inden for 4 timer efter afsluttet infusion.
English: Total infusion volume (ml)
Danish: Samlet infusionsvolumen (ml)
English: Age at first dose: 4 to 58 years e
Danish: Alder ved første dosis: 4 til 58 år e
English: Frequency, type and severity of adverse reactions in children are the same as in adults.
Danish: Bivirkningernes hyppighed, type og alvorlighed hos børn er de samme som hos voksne.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighederne er defineret efter følgende konvention: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The infusion period may be extended in the event of dose escalation.
Danish: Infusionsperioden kan forlænges i tilfælde af dosisstigning.
English: Adverse reactions are listed by System Organ Class and frequency.
Danish: Bivirkningerne er opstillet efter systemorganklasse og hyppighed.
English: The vials should not be left outside the refrigerator longer than 24 hours prior to dilution for infusion.
Danish: Hætteglassene må ikke efterlades uden for køleskab længere end 24 timer før fortynding til infusion.
English: The efficacy objectives are assessment of hepatic function overtime up to 3 years and survival at 12 months.
Danish: Effektmålene er vurdering af leverfunktion over tid op til 3 år og overlevelse ved 12 måneder.
English: The risks and benefits of re-administering sebelipase alfa following a severe reaction should be considered.
Danish: Risici og fordele ved genadministration af sebelipase alfa efter en alvorlig reaktion skal overvejes.
English: You should not be given KANUMA if you are pregnant unless clearly necessary.
Danish: Graviditet og amning Du må ikke få KANUMA, hvis du er gravid, medmindre det er helt nødvendigt.
English: Pre-treatment with antipyretics and/or antihistamines may prevent subsequent reactions in those cases where symptomatic treatment was required.
Danish: Forbehandling med antipyretika og/eller antihistaminer kan forbygge efterfølgende reaktioner i de tilfælde, hvor der var behov for symptomatisk behandling.
English: Table 3: Primary and secondary efficacy endpoints in LAL-CL02 Endpoint
Danish: Tabel 3: Primære og sekundære effektendepunkter i LAL-CL02
English: In the absence of more clinical data, this dose is not recommended.
Danish: Da der ikke foreligger flere kliniske data, frarådes denne dosis.
English: For patients who have experienced allergic reactions during infusion, caution should be exercised upon re-administration.
Danish: Hos patienter, der har oplevet allergiske reaktioner under infusion, skal der udvises forsigtighed ved genadministration.
English: 4-11 years old N=24
Danish: 4-11 år n=24
English: 12-17 years old N=23
Danish: 12-17 år n=23
English: Prior to launch of Kanuma in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational material including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Kanuma lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen aftale indhold og format for undervisningsmateriale, herunder kommunikationsmedier, distributions modaliteter og andre af programmets aspekter, med den relevante nationale myndighed.
English: A 1-hour infusion may be considered after patient tolerability is established.
Danish: Infusion over 1 time kan overvejes, når patienttolerabiliteten er klarlagt.
English: The vials should not be frozen, heated or microwaved and should be protected from light.
Danish: Hætteglassene må ikke nedfryses, varmes eller opvarmes i mikrobølgeovn og skal beskyttes mod lys.
English: Study LAL-CL02 - Children and Adults 1 mg/kg once every other week
Danish: Studie LAL-CL02 - børn og voksne 1 mg/kg én gang hver anden uge
English: Posology It is important to initiate treatment as early as possible after diagnosis of LAL deficiency.
Danish: Dosering Det er vigtigt, at behandlingen initieres så hurtigt som muligt efter diagnosticering af LAL-mangel.
English: This medicinal product may contain traces of egg proteins.
Danish: Dette lægemiddel kan indeholde spor af æggeproteiner.
English: Side effects were seen while patients were being given the medicine or shortly after (infusion reactions).
Danish: Der er set bivirkninger, mens patienterne fik medicinen eller kort tid efter (infusionsreaktioner).
English: You can help by reporting any side effects you or your child may get.
Danish: Du kan hjælpe ved at indberette alle de bivirkninger, du eller dit barn får.
English: Of the 32 patients who had a liver biopsy at study entry, 100% had fibrosis and 31% had cirrhosis.
Danish: Af de 32 patienter, som havde fået foretaget leverbiopsi ved indtrædelse i studiet, havde 100 % fibrose, og 31 % havde cirrhose.
English: For study entry, patients were required to have ALT levels of ≥1.5 X upper limit of normal (ULN).
Danish: For at indtræde i studiet skulle patienterne have ALAT-niveauer ≥ 1,5 X den øvre normalgrænse (ULN).
English: The age range at randomisation was 4-58 years old (71% were < 18 years old).
Danish: Aldersspredningen ved randomisering var 4-58 år (71 % var < 18 år gamle).
English: In cases of severe infusion reactions and in cases of lack or loss of effect, patients should be tested for the presence of antibodies.
Danish: I tilfælde af alvorlige infusionsreaktioner og i tilfælde af mangel på eller tab af effekt skal patienten testes for tilstedeværelse af antistoffer.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Der skal tages hensyn til dette hos patienter, der er på natriumreduceret diæt.
English: Sebelipase alfa has not been investigated in patients 2 to 4 years of age or patients aged 65 years or older.
Danish: Sebelipase alfa er ikke undersøgt hos patienter i alderen 2 til 4 år og hos patienter på 65 år og derover.
English: * The infusion volume should be based on the prescribed dose and should be prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.
Danish: * Infusionsvolumenet skal baseres på den ordinerede dosis og skal fremstilles, så den endelige sebelipase alfa-koncentration bliver 0,1-1,5 mg/ml.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Kun til engangsbrug.
English: If interrupted, the infusion may be resumed at a slower rate with increases as tolerated.
Danish: Hvis en infusion afbrydes, kan den genoptages ved en lavere hastighed, som kan øges, hvis det tolereres.
English: Store in a refrigerator Do not freeze.
Danish: Opbevares i køleskab Må ikke nedfryses.
English: This medicine may contain egg proteins.
Danish: Dette lægemiddel kan indeholde æggeproteiner.
English: Patients also had rapidly progressive liver disease and severe hepatosplenomegaly.
Danish: Patienterne havde også hurtigt progredierende leversygdom og svær hepatosplenomegali.
English: Proportion of patients who achieved normalisation defined as 34-59 U/l, depending on age and gender.
Danish: Andel af patienter, der opnåede normalisering defineret som 34-59 E/l afhængigt af alder og køn.
English: Twenty-four patients were aged 411 years, 23 were aged 12-17 years, and 18 were aged ≥ 18 years (Table 4).
Danish: Fireogtyve patienter var 4-11 år, 23 var 1217 år, og 18 var ≥ 18 år (tabel 4).
English: The age range of patients with biopsy evidence of cirrhosis was 4-21 years old.
Danish: Aldersspredningen for patienter med biopsiverificeret cirrhose var 4-21 år.
English: Common side effects reported in children and adolescents (4 to 18 years old) and adults are: severe allergic reaction (anaphylactic reaction)
Danish: Almindelige bivirkninger, som er indberettet hos børn og unge (4 til 18 år gamle) og voksne, er: alvorlig allergisk reaktion (anafylaktisk reaktion)
English: a. The number of vials to be diluted for infusion should be determined based on the patient's weight and prescribed dose.
Danish: a. Antallet af hætteglas, der skal fortyndes til infusion, skal bestemmes ud fra patientens vægt og den ordinerede dosis.
English: The medicine will be diluted before being given to you or your child.
Danish: Medicinen skal fortyndes, før du eller dit barn får den.
English: Patients with known egg allergies were excluded from clinical studies (see section 4.3).
Danish: Patienter med kendt allergi over for æg blev udelukket fra de kliniske studier (se pkt.
English: A statistically significant improvement in multiple endpoints was observed in the sebelipase alfatreated group as compared to the placebo group at the completion of the 20-week double-blind period of the study, as shown in Table 3.
Danish: Der blev observeret en statistisk signifikant forbedring i flere endepunkter i gruppen, der blev behandlet med sebelipase alfa, sammenlignet med placebogruppen ved afslutningen af studiets 20 uger lange dobbeltblinde periode, som vist i tabel 3.
English: • Information on the ongoing LAL Deficiency Registry, including the importance of enrolling patients, also those not treated with Kanuma, and the modalities for participation.
Danish: • Information om det løbende LAL-mangel-register, herunder vigtigheden af at indskrive patienter, også dem, der ikke behandles med Kanuma, og modaliteterne til at deltage.
English: Method of administration KANUMA is for intravenous use only.
Danish: Administration KANUMA er kun til intravenøs administration.
English: The absolute reduction in mean ALT level was -57.9 U/l (-53%) in the sebelipase alfa-treated group and -6.7 U/l (-6%) in the placebo group.
Danish: Det absolutte fald i middel-ALAT var -57,9 E/l (53 %) i sebelipase alfa-gruppen, og -6,7 E/l (-6 %) i placebogruppen.
English: Patients have developed anti-drug antibodies (ADA) to sebelipase alfa.
Danish: Patienter har udviklet antistoffer (anti-drug antibodies (ADA)) mod sebelipase alfa.
English: Following the first sebelipase alfa infusion, including the first infusion after a dose escalation, patients should be observed for 1 hour in order to monitor for any signs or symptoms of anaphylaxis or a severe hypersensitivity reaction.
Danish: Efter første infusion af sebelipase alfa, herunder første infusion efter en dosisstigning, skal patienterne overvåges i 1 time for eventuelle tegn eller symptomer på anafylaksi eller en alvorlig overfølsomhedsreaktion.
English: Therefore, appropriate medical support must be readily available when sebelipase alfa is administered.
Danish: Relevante nødhjælpsforanstaltninger skal derfor være umiddelbart tilgængelig, når sebelipase alfa administreres.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Enzymes; ATC code: not yet assigned
Danish: Farmakoterapeutisk klassifikation: Andre midler til fordøjelsesorganer og stofskifte, Enzymer; ATCkode: endnu ikke tildelt
English: Most patients who developed ADA did so within the first 2 months of exposure.
Danish: De fleste patienter, der udviklede ADA, gjorde det inden for de første 2 måneder efter eksponering.
English: Table 4: Mean Population Pharmacokinetic Parameters
Danish: Tabel 4: Gennemsnitlige populationsfarmakokinetiske parametre
English: KANUMA should be administered through a 0.2 μm filter (see section 6.6).
Danish: KANUMA skal administreres gennem et 0,2 μm filter (se pkt.
English: The safety and efficacy of KANUMA in overweight patients have not been thoroughly evaluated and therefore no alternative dose regimens can be recommended for these patients at this time.
Danish: KANUMAs sikkerhed og virkning hos overvægtige patienter er ikke grundigt evalueret, og alternative dosisregimer for disse patienter kan derfor ikke anbefales på nuværende tidspunkt.
English: Human serum albumin
Danish: Humant serumalbumin
English: For instructions on the preventive measures and monitoring of hypersensitivity reactions, see section 4.4.
Danish: For instruktioner i forebyggende foranstaltninger og monitorering af overfølsomhedsreaktioner, se pkt.
English: KANUMA should be administered by a trained healthcare professional who can manage medical emergencies.
Danish: KANUMA skal administreres af uddannet sundhedspersonale, som kan håndtere akutte kliniske situationer.
English: Anaphylaxis occurred during the infusion as late as 1 year after treatment initiation.
Danish: Anafylaksi forekom under infusionen så sent som 1 år efter behandlingsinitiering.
English: *Sebelipase alfa is produced in egg white of transgenic Gallus by recombinant DNA (rDNA) technology.
Danish: *Sebelipase alfa produceres i æggehvide fra transgene Gallus ved rekombinant DNA (rDNA)teknologi.
English: The majority of patients (58%) had LDLcholesterol > 190 mg/dl at study entry, and 24% of patients with LDL-cholesterol > 190 mg/dl were on lipid lowering medicinal products.
Danish: Hovedparten af patienterne (58 %) havde LDL-kolesterol > 190 mg/dl ved indtrædelse i studiet, og 24 % af patienterne med LDL-kolesterol > 190 mg/dl fik lipidsænkende lægemidler.
English: If severe reactions occur, the sebelipase alfa infusion should be immediately stopped and appropriate medical treatment should be initiated.
Danish: Hvis der forekommer alvorlige reaktioner, skal infusion af sebelipase alfa straks standses og relevant behandling initieres.
English: The most serious adverse reactions experienced by 3% of patients in clinical studies were signs and symptoms consistent with anaphylaxis.
Danish: De alvorligste bivirkninger, som forekom hos 3 % af patienterne i kliniske studier, var tegn og symptomer på anafylaksi.
English: Improvement in growth occurs as a result of substrate reduction in the intestine.
Danish: Forbedring i væksten sker som følge af substratreduktion i tarmen.
English: Those patients who developed ADA did so within the first 3 months of exposure.
Danish: De patienter, der udviklede ADA, gjorde det inden for de første 3 måneder efter eksponering.
English: The association between the development of ADA to sebelipase alfa and reductions in treatment effect or the occurrence of adverse reactions has not been determined.
Danish: Sammenhængen mellem udvikling af ADA mod sebelipase alfa og fald i behandlingseffekt eller forekomst af bivirkninger er ikke blevet klarlagt.
English: Of patients with paired liver biopsies, 63% (10/16) of KANUMA-treated patients had improvement in hepatic steatosis (at least ≥ 5% reduction) as measured by morphometry compared to 40% (4/10) of placebo patients.
Danish: Af patienter med parrede leverbiopsier havde 63 % (10/16) af de KANUMA-behandlede patienter forbedring i hepatisk steatose (et fald på mindst 5 %) målt ved morfometri sammenlignet med 40 % (4/10) af placebo-patienterne.
English: In clinical studies, doses of sebelipase alfa were explored up to 5 mg/kg once weekly and no specific signs or symptoms were identified following the higher doses.
Danish: I kliniske studier blev sebelipase alfa-doser på op til 5 mg/kg én gang ugentligt undersøgt, og der blev ikke identificeret specifikke tegn eller symptomer efter de højeste doser.
English: Consistent with its known mechanism of action, asymptomatic increases in circulating cholesterol and triglycerides have been observed following initiation of treatment.
Danish: I overensstemmelse med dets kendte virkningsmekanisme er der blevet observeret asymptomatiske stigninger i cirkulerende kolesterol og triglycerider efter behandlingsinitiering.
English: Body temperature increased b,c
Danish: Almindelig Forhøjet kropstemperatur b,c
English: LAL deficiency presenting in infants is a medical emergency with rapid disease progression over a period of weeks that is typically fatal within the first 6 months of life.
Danish: LAL-mangel hos spædbørn er en akut medicinsk situation med hurtig sygdomsprogression over en periode på uger, som typisk er dødelig inden for de første 6 levemåneder.
English: In the historical cohort, 0 of 21 patients survived beyond 8 months of age (0% 12-month survival, 95% CI: 0% to
Danish: I den historiske kohorte overlevede 0 ud af 21 patienter længere end til 8-måneders alderen (0 % 12-måneders overlevelse, 95 % CI: 0 % til
English: Interim reports expected yearly
Danish: Interimrapporter forventes årligt
English: A further dose escalation to 5 mg/kg once weekly was allowed.
Danish: Yderligere optrapning af dosis til 5 mg/kg én gang ugentligt var tilladt.
English: • Information to healthcare professionals that it is the responsibility of the MAH to provide the test for the monitoring of ADA positive patients including the modalities for requesting the test.
Danish: • Information til sundhedspersonale om, at indehaveren af markedsføringstilladelsen har ansvaret for tilvejebringelse af testen til monitorering af ADA-positive patienter, herunder modaliteter til rekvirering af testen.
English: c. The vials should not be shaken.
Danish: c. Hætteglassene må ikke omrystes.
English: In addition to liver disease, patients with LAL deficiency experience increased risk for cardiovascular disease and accelerated atherosclerosis.
Danish: Foruden leversygdom oplever patienter med LAL-mangel en øget risiko for hjerte-karsygdomme og accelereret aterosklerose.
English: From baseline to week 48, mean weight-for-age percentile improved from 12.74% to 29.83% and mean serum albumin levels increased from 26.7 g/l to 38.7 g/l.
Danish: Fra baseline til uge 48 forbedredes middelpercentilen for vægt i forhold til alder fra 12,74 % til 29,83 % og middelværdierne for serumalbumin fra 26,7 g/l til 38,7 g/l.
English: Sebelipase alfa is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Danish: Sebelipase alfa er et protein og forventes at blive metaboliseret gennem peptidhydrolyse.
English: Administration of KANUMA to infants with confirmed multiple-organ failure should be at the discretion of the treating physician.
Danish: Administration af KANUMA til spædbørn med bekræftet multiorgansvigt bør finde sted efter den behandlende læges skøn.
English: It also improves blood levels of fats, including elevated LDL (bad cholesterol) and triglycerides.
Danish: Den forbedrer også fedtindholdet i blodet, herunder forhøjet LDL (dårligt kolesterol) og triglycerider.
English: LAL-CL02 was a multicentre, double-blind, placebo-controlled study in 66 children and adults with LAL deficiency.
Danish: LAL-CL02 var et dobbeltblindt, placebokontrolleret multicenterstudie hos 66 børn og voksne med LAL-mangel.
English: Pharmacokinetic Parameter
Danish: Farmakokinetisk parameter
English: One infant was treated with 5 mg/kg once weekly in LAL-CL03; no new adverse reactions were reported at this dose.
Danish: Ét spædbarn blev behandlet med 5 mg/kg én gang ugentligt i LAL-CL03; der blev ikke indberettet nye bivirkninger ved denne dosis.
English: From a microbiological point of view, the diluted solution should be used immediately.
Danish: Af mikrobiologiske hensyn bør den fortyndede infusionsvæske anvendes straks.
English: Reported in ≥ 2 patients receiving KANUMA
Danish: Indberettet for ≥ 2 patienter, der fik KANUMA
English: b. It is recommended to allow KANUMA vials to reach a temperature between 15°C and 25°C prior to reconstitution to minimize the potential for the formation of sebelipase alfa protein particles in solution.
Danish: b. Det anbefales at lade hætteglassene med KANUMA opnå en temperatur på mellem 15 ºC og 25 ºC før rekonstitution for at minimere eventuel dannelse af sebelipase alfa-proteinpartikler i opløsningen.
English: If you have any further questions, ask your doctor.
Danish: Spørg lægen, hvis der er mere, du vil vide.
English: Sebelipase alfa binds to cell surface receptors via glycans expressed on the protein and is subsequently internalized into lysosomes.
Danish: Sebelipase alfa bindes til receptorer på celleoverfladen via glykaner, som udtrykkes på proteinet, hvorefter det internaliseres i lysosomerne.
English: Paired liver biopsies at baseline and week 20 were available in a subset of patients (n = 26).
Danish: Parrede leverbiopsier ved baseline og uge 20 var tilgængelige for en delgruppe af patienterne (n=26).