FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients studied were Caucasian.
Danish: Hovedparten af patienterne i studierne var kaukasiske.
English: Instructions for preparation of the medicinal product before administration
Danish: Instruktioner til klargøring af lægemidlet før administration
English: 6Nominal p value
Danish: 6Nominel p-værdi
English: For persistent elevated urinary protein, further evaluation should be considered.
Danish: Ved vedvarende forhøjet urinprotein bør yderligere evaluering overvejes.
English: Date of first authorisation: 30 May 2017
Danish: Dato for første markedsføringstilladelse: 30. maj 2017
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke bestemmes ud fra de tilgængelige data)
English: The frequency of these reactions is not known as they have been reported from the post marketing setting.
Danish: Hyppigheden af disse reaktioner er ikke kendt, da de er blevet indberettet efter markedsføring.
English: Ninety-eight of these were considered not or unlikely related to nusinersen.
Danish: Otteoghalvfems af disse blev vurderet til ikke, eller sandsynligvis ikke, at være relateret til nusinersen.
English: Patients were assessed over a 3 year treatment period.
Danish: Patienterne blev vurderet i løbet af en 3-års behandlingsperiode.
English: If you or your child misses an injection
Danish: Hvis du eller dit barn har sprunget over en injektion
English: Clear and colourless solution with pH of approximately 7.2.
Danish: Klar og farveløs opløsning med en pH på ca. 7,2.
English: It is unknown whether nusinersen/metabolites are excreted in human milk.
Danish: Det er ukendt, om nusinersen/metabolitter udskilles i human mælk.
English: You or your child may also be given a medicine to make you relax or sleep during the procedure.
Danish: Du eller dit barn kan også få et lægemiddel, der får dig/dit barn til at slappe af eller sove under proceduren.
English: There are no or limited amount of data from the use of nusinersen in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af nusinersen til gravide kvinder.
English: A cumulative search of postmarketing data identified 37 possible hypersensitivity events; 20 medically confirmed.
Danish: En kumulativ søgning i postmarketing-data identificerede 37 mulige overfølsomhedshændelser; 20 blev medicinsk bekræftet.
English: In Part 1 of the study, patients were followed for a median of 302 days.
Danish: I del 1 af dette studie blev patienterne fulgt i en medianperiode på 302 dage.
English: There were no reports of a patient discontinuing treatment due to these events.
Danish: Der var ingen rapporter om patienter, der fik seponeret behandlingen på grund af disse hændelser.
English: 6Based on log-rank test stratified by disease duration
Danish: 6Baseret på log-rank-test stratificeret efter sygdomsvarighed
English: The recommended dosage is 12 mg (5 ml) per administration.
Danish: Den anbefalede dosering er 12 mg (5 ml) pr. administration.
English: The mean terminal elimination half-life in CSF is estimated at 135 to 177 days.
Danish: Den gennemsnitlige terminale eliminationshalveringstid i CSF er estimeret til at være 135 til 177 dage.
English: - The active substance is nusinersen.
Danish: - Aktivt stof: nusinersen.
English: It may also weaken the muscles used for breathing and swallowing.
Danish: Det kan også svække de muskler, der anvendes for at trække vejret og synke.
English: There are no data available on the potential effects on fertility in humans.
Danish: Der foreligger ingen data for den mulige virkning på fertiliteten hos mennesker.
English: By binding, the ASO displaces splicing factors, which normally suppress splicing.
Danish: Ved bindingen fortrænger ASO splejsningsfaktorer, som normalt undertrykker splejsning.
English: These effects were observed within several hours post-dose and generally resolved within 48 hours.
Danish: Disse virkninger blev observeret i løbet af flere timer efter dosis og gik normalt væk i løbet af 48 timer.
English: Time to onset was reported in 11 of these 20, and ranged from directly following the injection to 1 week after the injection.
Danish: Tiden til indtræden blev rapporteret for 11 ud af disse 20 hændelser og varierede fra direkte efter injektionen til 1 uge efter injektionen.
English: CS3B was designed to assess the effect of Spinraza on motor function and survival.
Danish: CS3B var designet til at vurdere virkningen af Spinraza på den motoriske funktion og overlevelse.
English: Two events, angioedema and serum sickness, were considered serious and related.
Danish: To hændelser, angioødem og serumsygdom, blev vurderet til at være alvorlige og relaterede.
English: The incidence and severity of these events were consistent with events expected to occur with lumbar puncture.
Danish: Forekomsten og sværhedsgraden af disse hændelser var i overensstemmelse med hændelser, der forventes at opstå med lumbalpunktur.
English: There is no accumulation in plasma exposure measures (Cmax and AUC) after multiple doses.
Danish: Der er ingen akkumulation i målinger af plasmaeksponering (Cmax og AUC) efter flere doser.
English: Of the 28 patients, 3 were at least 18 years of age at their last study visit.
Danish: Ud af de 28 patienter var 3 mindst 18 år på tidspunktet for deres sidste studiebesøg.
English: This reduces the loss of nerve cells and so may improve muscle strength.
Danish: Dette nedsætter tabet af nerveceller og kan forbedre muskelstyrken.
English: The studies enrolled patients who were between 2 to 15 years of age at first dose.
Danish: Studierne inkluderede patienter, der var fra 2 til 15 år ved den første dosis.
English: Read all of this leaflet carefully before you or your child receives this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn får dette lægemiddel, da den indeholder vigtige oplysninger.
English: A second gene SMN2, located near SMN1, is responsible for a small amount of SMN protein production.
Danish: Et andet gen SMN2, der er placeret tæt på SMN1, er ansvarlig for produktion af en lille mængde SMN-protein.
English: If clinically indicated, urine protein testing (preferably using a first morning urine specimen) is recommended.
Danish: Hvis det er klinisk indiceret, anbefales urinproteinanalyse (fortrinsvis ved anvendelse af en første morgenurinprøve).
English: The majority of these are reported within 72 hours of the procedure.
Danish: Størstedelen af disse er indberettet inden for 72 timer efter proceduren.
English: However, individual safety data for the treatment-emergent ADA-positive cases were reviewed, and no AEs of interest were identified.
Danish: De individuelle sikkerhedsdata for de ADA-positive tilfælde, der opstod under behandlingen, blev dog gennemgået, og der blev ikke fundet bivirkninger af interesse.
English: Proportion of patients who achieved new motor milestones at 15 months4
Danish: Andelen af patienter, der opnåede nye motoriske milepæle ved 15 måneder4
English: The length of treatment ranged from 74 to 474 days (median 250 days) at the time of the interim analysis.
Danish: Behandlingslængden varierede fra 74 til 474 dage (median 250 dage) på tidspunktet for interimanalysen.
English: An analysis of the subset of patients in the ITT population who had observed values at Month 15 demonstrated consistent, statistically significant results.
Danish: En analyse af en undergruppe af patienter i ITT-populationen med værdier observeret ved måned 15 viste konsistente, statistisk signifikante resultater.
English: Information on long term efficacy of this medicinal product is not available.
Danish: Der forefindes ingen oplysninger om langtidsvirkningen af dette lægemiddel.
English: Characteristics in specific patient populations
Danish: Karakteristika i specifikke patientpopulationer
English: Four patients met the criteria for permanent ventilation and five patients died during the study.
Danish: 4 patienter opfyldte kriterierne for permanent ventilering, og 5 patienter døde i løbet af studiet.
English: Sham-control Patients
Danish: Sham-kontrolpatienter
English: Prevention and treatment will be managed by routine clinical practice and no additional risk minimization measures or evaluations are required as part of the pharmacovigilance plan.
Danish: Forebyggelse og behandling håndteres i henhold til klinisk standardpraksis, og yderligere risikominimeringsforanstaltninger eller evalueringer er ikke påkrævet som en del af lægemiddelovervågningsplanen.
English: In the event of an overdose, supportive medical care should be provided including consulting with a healthcare professional and close observation of the clinical status of the patient.
Danish: I tilfælde af en overdosering skal der gives støttende medicinsk behandling, herunder konsultation med sundhedspersonale og nøje observation af patientens kliniske status.
English: Spinraza treatment should be initiated as early as possible after diagnosis with 4 loading doses on Days 0, 14, 28 and 63.
Danish: Behandlingen med Spinraza bør påbegyndes snarest muligt efter diagnosen med 4 støddoser på dag 0, 14, 28 og 63.
English: WHO motor milestones
Danish: WHO motoriske milepæle
English: A maintenance dose should be administered once every 4 months thereafter.
Danish: Derefter indgives en vedligeholdelsesdosis hver 4. måned.
English: Proportion of patients who achieved at least a 3 point improvement from baseline to month 152
Danish: Andelen af patienter, der opnåede en forbedring på mindst 3 point fra baseline til måned 152,
English: Of the 346 patients who received Spinraza up to a maximum of 5 years, 258 patients received treatment for at least 1 year.
Danish: Ud af de 346 patienter, der fik Spinraza i maksimalt 5 år, fik 258 patienter behandlingen i mindst 1 år.
English: In vitro studies indicate that the likelihood for interactions with nusinersen due to competition for plasma protein binding, or competition with or inhibition of transporters is low.
Danish: In vitro-studier indikerer, at sandsynligheden for interaktioner med nusinersen, der skyldes konkurrence om plasmaproteinbinding eller konkurrence med eller hæmning af transportere, er lav.
English: 5 Based on logistic regression with treatment effect and adjustment for each subject's age at screening and HFMSE score at baseline
Danish: 5Baseret på logistisk regression med behandlingseffekt og justering for hver forsøgspersons alder ved screeningen og HFMSE-score ved baseline
English: The 6MWT (six-minute walk test) was conducted for ambulatory patients only.
Danish: 6MWT (6 minutters gangtest) blev kun udført for patienter der kunne gå.
English: Symptomatic patients
Danish: Symptomatiske patienter
English: The usual dose of Spinraza is 12 mg.
Danish: Den almindelige dosis af Spinraza er 12 mg.
English: Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards.
Danish: Bivirkninger, der er forbundet med lumbalpunkturen, kan forekomme, mens Spinraza gives eller senere.
English: These events can be considered manifestations of post-lumbar puncture syndrome.
Danish: Disse hændelser kan betragtes som manifestationer af post-lumbalpunktursyndrom.
English: • Hydrocephalus (a build-up of too much fluid around the brain)
Danish: • Hydrocephalus (en ophobning af for meget væske omkring hjernen)
English: These results are supported by 2 open label studies (study CS2 and study CS12).
Danish: Disse resultater støttes af 2 åbne studier (studie CS2 og studie CS12).
English: Nusinersen is not a substrate or inhibitor of human BCRP, P-gp, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, or BSEP transporters.
Danish: Nusinersen er ikke et substrat for eller en hæmmer af humane BCRP-, P-gp-, OAT1-, OAT3-, OCT1-, OCT2-, OATP1B1-, OATP1B3- eller BSEP-transportere.
English: The remaining 2 events (rash and eosinophil count increased, both nonserious) were possibly related to nusinersen.
Danish: De resterende 2 hændelser (udslæt og øget eosinofiltal, begge ikke-alvorlige) var muligvis relateret til nusinersen.
English: SMA is a progressive neuromuscular disease resulting from mutations in chromosome 5q in the SMN1 gene.
Danish: SMA er en progressiv neuromuskulær sygdom, der skyldes mutationer i kromosom 5q i SMN1-genet.
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 being given 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 eller apotekspersonalet til råds, før du får dette lægemiddel.
English: Patients achieved milestones unexpected in Type I or II SMA and more consistent with normal development.
Danish: Patienterne opnåede milepæle, der var uventede for type I eller II SMA, og mere i overensstemmelse med normal udvikling.
English: • If you or your child are allergic to nusinersen or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis du eller dit barn er allergisk over for nusinersen eller et af de øvrige indholdsstoffer i Spinraza (angivet i punkt 6).
English: Don't stop treatment with Spinraza unless your doctor tells you to.
Danish: Hold ikke op med Spinrazabehandlingen, medmindre lægen fortæller dig det.
English: Additional side effects not seen in clinical trials:
Danish: Yderligere bivirkninger, der ikke er set i kliniske studier:
English: Displacement of these factors leads to retention of exon 7 in the SMN2 mRNA and hence when SMN2 mRNA is produced, it can be translated into the functional full length SMN protein.
Danish: Fortrængningen af disse faktorer fører til retention af exon 7 i SMN2-mRNA, og når SMN2-mRNA dannes, kan det dermed translateres til det funktionelle SMN-protein i fuld længde.
English: If you notice any symptoms of increase in head size, decreased consciousness, persistent nausea, vomiting or headache; or other symptoms that cause you concern, please inform your or your child's doctor to seek necessary treatment.
Danish: Hvis du bemærker symptomer som øget hovedstørrelse, nedsat bevidsthedsniveau, vedvarende kvalme, opkastning eller hovedpine eller andre symptomer, der gør dig bekymret, skal du informere din eller dit barns læge for at få den nødvendige behandling.
English: Spinraza has no or negligible influence on the ability to drive and use machines.
Danish: Spinraza påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The primary route of elimination is expected via urinary excretion of nusinersen and its metabolites.
Danish: Den primære eliminationsvej forventes at være via udskillelse af nusinersen og dens metabolitter i urinen.
English: The extent of improvement in CHOP INTEND is shown in Figure 1 (change from baseline score for each subject).
Danish: Graden af forbedring i CHOP INTEND er vist på figur 1 (ændring fra baseline-score for hver forsøgsperson).
English: Median plasma Tmax values ranged from 1.7 to 6.0 hours.
Danish: Mediane Tmax-værdier i plasma var i intervallet fra 1,7 til 6,0 timer.
English: Spinraza must not be diluted.
Danish: Spinraza må ikke fortyndes.
English: The injection must not be administered in areas of the skin where there are signs of infection or inflammation.
Danish: Injektionen må ikke administreres på hudområder med tegn på infektion eller inflammation.
English: In addition, no patients in the Spinraza or shamcontrol group required the use of permanent ventilation.
Danish: Derudover havde ingen af patienterne i hverken Spinraza- eller sham-kontrolgruppen brug for permanent ventilering.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for nusinersen, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for nusinersen er CHMP nået frem til følgende videnskabelige konklusioner:
English: Intrathecal use.
Danish: Intratekal anvendelse.
English: As of 19 October 2018, 100 AEs of hypersensitivity due to the administration of nusinersen were identified from the clinical trial database.
Danish: Pr. 19. oktober 2018 var 100 uønskede hændelser i form af overfølsomhed på grund af administration af nusinersen identificeret i den kliniske forsøgsdatabase.
English: The median age when patients received their first dose was 164.5 days for treated patients, and 205 days for sham-control.
Danish: Medianalderen, da patienterne fik deres første dosis, var 164,5 dage for behandlede patienter og 205 dage for sham-kontrol.
English: Tell your doctor if you or your child are taking, have recently taken any, or might take any other medicines in future.
Danish: Fortæl det altid til lægen, hvis du eller dit barn tager anden medicin, har gjort det for nylig eller måske vil gøre det i fremtiden.
English: If particles are observed and/or the liquid in the vial is not clear and colourless, the vial must not be used.
Danish: Hvis der observeres partikler, og/eller væsken i hætteglasset ikke er klar og farveløs, må hætteglasset ikke bruges.
English: Proportion achieving pre-defined motor milestone responder criteria (HINE section 2)4,5
Danish: Andel, der opnåede prædefinerede kriterier for motorisk milepæl-respons (HINE afsnit 2) 4,5
English: If you or your child miss a dose of Spinraza, speak with your doctor so that Spinraza can be given as soon as possible.
Danish: Hvis du eller dit barn har sprunget over en dosis Spinraza, skal du tale med lægen, så Spinraza kan gives snarest muligt.
English: Secondary endpoints including functional measures and WHO motor milestone achievement were formally statistically tested and are described in Table 3.
Danish: De sekundære endepunkter, omfattedende funktionelle målinger og WHO motoriske milepæl-resultater, blev formelt statistisk testet og er beskrevet i tabel 3.
English: The need for continuation of therapy should be reviewed regularly and considered on an individual basis depending on the patient's clinical presentation and response to the therapy.
Danish: Behovet for fortsættelse af behandling bør revurderes regelmæssigt og overvejes individuelt afhængig af patientens kliniske billede og respons på behandlingen.
English: The majority of these side effects are reported within 72 hours of the procedure.
Danish: Størstedelen af disse bivirkninger indberettes inden for 72 timer efter proceduren.
English: The vial should be taken out of the refrigerator and allowed to warm to room temperature (25°C) without using external heat sources, prior to administration.
Danish: Hætteglasset skal tages ud af køleskabet og nå stuetemperatur (25 °C) uden at anvende eksterne varmekilder før administration.
English: Motor function Motor milestones3
Danish: Motorisk funktion Motoriske milepæle3
English: At the time of interim analysis, 22 out of 24 patients (92%) were alive.
Danish: På tidspunktet for interimanalyse var 22 ud af 24 patienter (92 %) i live.
English: Patients with profound hypotonia and respiratory failure at birth, where Spinraza has not been studied, may not experience a clinically meaningful benefit due to severe SMN protein deficiency.
Danish: Patienter med svær hypotoni og respirationsinsufficiens ved fødslen, hvor Spinraza ikke er blevet undersøgt, oplever muligvis ingen klinisk signifikant fordel på grund af svær SMN-proteinmangel.
English: Nusinersen demonstrated no evidence of genotoxicity.
Danish: Nusinersen viste ikke evidens for genotoksicitet.
English: *Adverse events considered related to the lumbar puncture procedure.
Danish: *Bivirkninger, der betragtes som relateret til lumbalpunkturproceduren.
English: The exception was an acute, transient deficit in lower spinal reflexes which occurred at the highest dose levels in each study (3 or 4 mg per dose; equivalent to 30 or 40 mg per intrathecal dose in patients).
Danish: Undtagelsen var en akut, forbigående mangel på reflekser i den nedre spinale region, som opstod ved de højeste dosisniveauer i hvert studie (3 eller 4 mg pr. dosis svarende til 30 eller 40 mg pr. intratekal dosis hos patienterne).
English: Following intrathecal administration trough plasma concentrations of nusinersen were relatively low compared to the trough CSF concentration.
Danish: Efter intratekal administration var minimale plasmakoncentrationer af nusinersen relativt lave sammenlignet med den minimale CSFkoncentration.
English: Spinal muscular atrophy is caused by a shortage of a protein called survival motor neuron (SMN) in the body.
Danish: Spinal muskelatrofi forårsages af mangel på et protein, der kaldes survival motor neuron (SMN) i kroppen.
English: The decision to treat should be based on an individualised expert evaluation of the expected benefits of treatment for that individual, balanced against the potential risk of treatment with Spinraza.
Danish: Beslutningen om at behandle skal baseres på en individuel ekspertvurdering af de forventede fordele ved behandling for personen afvejet mod den potentielle risiko ved behandling med nusinersen.
English: The median time to death or permanent ventilation was 50.9 weeks after initiation of Spinraza treatment in Study CS11.
Danish: Mediantiden til død eller permanent ventilering var 50,9 uger efter opstart af behandling med Spinraza i studie CS11.
English: There may also be difficulties with giving a medicine by this method in very young patients and those with scoliosis (twisted and curved spine).
Danish: Der kan også være vanskeligheder ved at give en medicin ved hjælp af denne metode hos meget unge patienter og hos patienter med skoliose (skæv eller krum rygsøjle).
English: Among patients treated with Spinraza by lumbar puncture, serious infection, such as meningitis, has been observed.
Danish: Blandt patienter behandlet med Spinraza ved lumbalpunktur er der blevet observeret alvorlig infektion, såsom meningitis.
English: Long-term studies in animals to evaluate the carcinogenic potential of nusinersen have not been performed.
Danish: Der er ikke udført langvarige dyrestudier for at evaluere karcinogeniciteten af nusinersen.
English: In Study CS11 all patients received Spinraza, with the length of treatment ranging from 65 to 592 days (median 289 days) at the time of interim analysis.
Danish: I studie CS11 fik alle patienterne Spinraza med en behandlingslængde, der varierede fra 65 til 592 dage (median 289 dage) på tidspunktet for interimanalysen.
English: Proportion achieving a 4-point worsening
Danish: Andel, der opnåede en forværring på 4 point
English: In the 53-week intrathecal dosing study in cynomolgus monkeys no toxicity effects were seen at levels up to 14-fold the recommended annual clinical maintenance dose.
Danish: I det 53-ugers studie med intratekal dosering blev der ikke observeret nogen toksicitetsvirkning hos cynomolgus-aber ved niveauer op til 14 gange den anbefalede, årlige kliniske vedligeholdelsesdosis.
English: Spinraza contains the active substance nusinersen which belongs to a group of medicines known as antisense oligonucleotides.
Danish: Spinraza indeholder det aktive stof nusinersen, som tilhører en gruppe lægemidler kaldet antisenseoligonukleotider.
English: On the basis of the scientific conclusions for nusinersen the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing nusinersen is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for nusinersen er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder nusinersen, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: There is a risk of side effects occuring after Spinraza is given by a lumbar puncture procedure (see section 3).
Danish: Der er en risiko for, at der kan forekomme bivirkninger efter indgivelse af Spinraza ved en lumbalpunkturprocedure (se punkt 3).
English: Overall survival2
Danish: Samlet overlevelse2
English: This may not be required every time you or your child are given Spinraza.
Danish: Dette er muligvis ikke nødvendigt, hver gang du eller dit barn får Spinraza.