FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on evidence from the literature, it was considered necessary to amend and harmonise the ‘Interaction with other medicinal products' section of the product information.
Danish: På grundlag af evidens fra litteraturen blev det fundet nødvendigt at ændre og harmonisere produktinformationens afsnit om »Interaktion med andre lægemidler«.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for zolpidem-containing medicinal products;
Danish: • PRAC behandlede proceduren i henhold til artikel 31 i direktiv 2001/83/EF på baggrund af lægemiddelovervågningsdata for lægemidler indeholdende zolpidem,
English: However, on a population level, the randomised trials only showed convincing evidence of efficacy of the 10mg dose of zolpidem.
Danish: I de randomiserede undersøgelser var der imidlertid på populationsniveau kun overbevisende evidens for virkning af zolpidem i en dosis af 10 mg.
English: Discrepancies about drug-drug interactions information were observed in different product information of zolpidem containing products, notably on the interaction of zolpidem with CNS depressant.
Danish: Der blev fundet afvigelser mellem oplysningerne om lægemiddelinteraktioner i forskellige produktinformationer for lægemidler indeholdende zolpidem, herunder interaktionen mellem zolpidem og CNS-depressiva.
English: The analysis of the submitted individual case reports of driving ability and somnambulism showed that whatever the age and gender category, most of the cases of impaired driving were reported at a 10mg daily dose for both events.
Danish: Analysen af de forelagte enkelttilfælde vedrørende evnen til at føre motorkøretøj og søvngængeri viste, at størstedelen for begge hændelsers vedkommende var indberettet i forbindelse med en dagsdosis på 10 mg uanset alder og køn.
English: With regards to the effects on the ability to drive and use machines, the PRAC recommended that vehicle drivers and machine operators are warned that in addition to the possible risk of drowsiness, prolonged reaction time and impaired driving the morning after therapy, there is also the possibility of dizziness, sleepiness, blurred/double vision and reduced alertness.
Danish: Vedrørende virkningerne på evnen til at føre motorkøretøj og betjene maskiner anbefalede PRAC, at førere af motorkøretøjer og maskinoperatører advares om, at der ud over den mulige risiko for døsighed, forlænget reaktionstid og nedsat evne til at føre motorkøretøj morgenen efter behandlingen også er mulighed for svimmelhed, søvnighed, sløret syn/dobbeltsyn og nedsat årvågenhed.
English: Amongst the risk factors for impaired driving and somnambulism were, concomitant intake of other CNS depressants, sleep-deprivation and alcohol or illicit drugs consumption.
Danish: Blandt risikofaktorerne for nedsat evne til at føre motorkøretøj og søvngængeri var samtidig indtagelse af andre CNS-depressiva, søvnmangel og alkohol- eller narkotikaindtagelse.
English: • The PRAC also reviewed the available data on the efficacy of zolpidem in order to determine whether amendments to the posology would help to minimise the risks but agreed that the available efficacy data do not provide robust evidence that a lower dose would be effective on a population level;
Danish: • PRAC gennemgik desuden de foreliggende data om virkningen af zolpidem med henblik på at afgøre, om ændringer af doseringen ville medvirke til at mindske risiciene, men fandt, at de foreliggende data om virkning ikke giver fyldestgørende evidens for, at en lavere dosis ville være effektiv på populationsniveau,
English: Considering that the effect of zolpidem may last for at least 8 hours and in view of the above referred risk factors, the PRAC also recommended to include warnings indicating that the risk of impaired driving is increased if zolpidem is taken within less than 8 hours before performing activities that require mental alertness, if zolpidem is taken in a higher than the recommended dose, and/or coadministered with other CNS depressants, and/or alcohol or illicit drugs.
Danish: I betragtning af at virkningen af zolpidem kan vare i mindst otte timer og på baggrund af ovennævnte risikofaktorer, anbefalede PRAC desuden at indsætte advarsler om, at risikoen for nedsat evne til at føre motorkøretøj øges, hvis zolpidem indtages mindre end 8 timer før aktiviteter, der kræver årvågenhed, og hvis zolpidem indtages i højere dosis end den anbefalede og/eller indtages sammen med andre CNS-depressiva og/eller alkohol eller narkotika.
English: It was therefore considered by the PRAC that the dosing recommendation should include instructions that Zolpidem is to be taken in a single intake immediately at bedtime and should not be re-administered during the same night.
Danish: PRAC fandt derfor, at doseringsanbefalingerne skal indeholde anvisninger om, at zolpidem skal tages som en enkelt dosis umiddelbart før sengetid, og at indtagelsen ikke må gentages samme nat.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of zolpidem containing medicinal products for which the amendments to the product information are set out in annex III.
Danish: Efter at have gennemgået PRAC's anbefaling af 6. marts 2014 i medfør af artikel 107k, stk. 1 og 2, i direktiv 2001/83/EF tog CMD(h) stilling til ændring af markedsføringstilladelserne for lægemidler indeholdende zolpidem, for hvilke ændringerne af produktinformationen fremgår af bilag III.
English: Based on the totality of the data available on the safety and the efficacy of zolpidem, and considering all the risk minimisation measures proposed during assessment, the PRAC concluded that the benefitrisk balance of zolpidem-containing medicinal products remains favourable subject to changes to the product information.
Danish: På grundlag af samtlige foreliggende data om sikkerheden og virkningen af zolpidem og i betragtning af de risikominimeringsforanstaltninger, der blev foreslået under vurderingen, konkluderede PRAC, at benefit/risk-forholdet for lægemidler indeholdende zolpidem fortsat er gunstigt under forudsætning af ændringer af produktinformationen.
English: Following this, the PRAC requested the MAH of the reference medicinal product for zolpidem to submit a cumulative review of spontaneous cases, clinical studies and published literature of ‘impaired driving ability', ‘Road traffic accidents' and ‘Somnambulism' associated with zolpidem.
Danish: PRAC anmodede herefter indehaveren af markedsføringstilladelsen for referencelægemidlet for zolpidem om at forelægge en kumulativ gennemgang af spontane indberetninger, kliniske undersøgelser og publiceret litteratur vedrørende »nedsat evne til at føre motorkøretøj«, »trafikuheld« og »søvngængeri« forbundet med zolpidem.
English: • The PRAC considered that the data from post-marketing spontaneous case reports, clinical trials, published literature and other available information have shown that the use of zolpidemcontaining products is associated with an increased risk of impaired driving and somnambulism;
Danish: • PRAC fandt, at data fra spontane indberetninger efter markedsføring, kliniske undersøgelser, den publicerede litteratur og andre foreliggende oplysninger har vist, at anvendelse af lægemidler indeholdende zolpidem er forbundet med øget risiko for nedsat evne til at føre motorkøretøj og søvngængeri,
English: In light of the data provided in the cumulative review performed by the MAH, and taking into consideration the recent Food and Drug Administration (FDA) approved label changes specifying new dosing recommendations for zolpidem-containing medicinal products, AIFA considered that it was in the interest of the EU to refer the matter to the PRAC for a benefit-risk review of zolpidem-containing medicinal products.
Danish: På baggrund af oplysningerne fra den kumulative gennemgang foretaget af indehaveren af markedsføringstilladelsen og de ændringer af produktinformationen med nye dosisanbefalinger for lægemidler indeholdende zolpidem, der for nylig var godkendt af FDA (Food and Drug Administration), fandt AIFA det i EU's interesse at indbringe sagen for PRAC med henblik på en benefit/risk-vurdering af lægemidler indeholdende zolpidem.
English: • The PRAC considered that the above-mentioned risks of impaired driving ability and somnambulism could be mitigated by changes to the product information of zolpidem-containing medicines, in particular that zolpidem should be taken as a single intake immediately at bedtime and not exceed the recommended dose, without being re-administered during the same night, as well as highlighting the risks regarding impaired driving and somnambulism, warnings and precautions aimed at decreasing this risk and also the risks of co-administration with CNS depressants and alcohol, and/ or illicit drugs;
Danish: • PRAC fandt, at ovennævnte risici for nedsat evne til at føre motorkøretøj og søvngængeri kan afbødes gennem ændringer af produktinformationen for lægemidler indeholdende zolpidem, herunder at zolpidem bør indtages som en enkelt dosis umiddelbart før sengetid, at den anbefalede dosis ikke må overskrides, at der ikke må indtages en ny dosis samme nat, og at det er nødvendigt at fremhæve risiciene for nedsat evne til at føre motorkøretøj og søvngængeri, advarslerne og sikkerhedsforanstaltningerne til mindskelse af denne risiko samt risiciene ved samtidig administration med CNS-depressiva og alkohol og/eller narkotika, konkluderede PRAC, at benefit/risk-forholdet for de i bilag I nævnte lægemidler indeholdende zolpidem fortsat er positivt under forudsætning af de i bilag III angivne ændringer af produktinformationen.
English: Some studies showed an association between impaired driving performance on the next morning and middle of the night intake of zolpidem.
Danish: Nogle undersøgelser viste sammenhæng mellem indtagelse af zolpidem midt om natten og nedsat evne til at føre motorkøretøj den påfølgende morgen.
English: The PRAC reviewed the safety and efficacy data relating to the risk of impaired driving and somnambulism following treatment with zolpidem.
Danish: PRAC gennemgik oplysningerne om sikkerhed og virkning vedrørende risikoen for nedsat evne til at føre motorkøretøj og søvngængeri efter behandling med zolpidem.
English: In February 2013, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed the results of the search in EudraVigilance (EV) of cases of impaired driving ability as well as road traffic accidents associated with zolpidem, performed by the Italian Competent Authority (AIFA).
Danish: I februar 2013 drøftede PRAC resultaterne af en søgning i EudraVigilance vedrørende tilfælde af nedsat evne til at føre motorkøretøj samt trafikuheld i forbindelse med zolpidem.
English: The provided data did not consistently show that a lower dose would be effective or that a lower dose would significantly reduce the risk of impaired driving and somnambulism, and it was considered that reducing the daily recommended dose would likely result in in-effective doses being used, in turn resulting in additional doses being taken in the middle of the night and in an increased risk of accidents the following day.
Danish: Desuden forventedes det, at en nedsættelse af den anbefalede dagsdosis sandsynligvis ville medføre anvendelse af ineffektive doser, som til gengæld ville føre til indtagelse af supplerende doser midt om natten og øget risiko for uheld den påfølgende dag.
English: • The PRAC reviewed all available data provided by the MAHs on the safety and efficacy of zolpidemcontaining medicines with regards the risk of impaired driving ability and somnambulism following treatment with zolpidem;
Danish: • PRAC gennemgik alle de data om virkning og sikkerhed, der var forelagt af indehaverne af markedsføringstilladelserne vedrørende risikoen for nedsat evne til at føre motorkøretøj og søvngængeri efter behandling med zolpidem,
English: Finally and in view of further minimising the risks of impaired driving and somnambulism, a potential lowering of the recommended dose for adults was discussed by the PRAC.
Danish: Endelig drøftede PRAC en eventuel nedsættelse af den anbefalede dosis til voksne med henblik på yderligere at minimere risiciene for nedsat evne til at føre motorkøretøj og søvngængeri.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 with regards to zolpidem-containing medicinal products, agrees with the recommendation therein as stated below:
Danish: CMD(h) (koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker) har gennemgået anbefalingen fra PRAC (Det Rådgivende Udvalg for Risikovurdering inden for Lægemiddelvurdering) af 6. marts 2014 for lægemidler indeholdende zolpidem, og CMD(h) tilslutter sig anbefalingen, således som det fremgår af følgende:
English: This will take about one hour.
Danish: Det tager ca. 1 time.
English: Date of first authorisation: 20 November 2018
Danish: Dato for første markedsføringstilladelse: 20. november 2018
English: You will be observed closely during treatment:
Danish: Du vil blive fulgt tæt under behandlingen:
English: • regular blood tests to ensure it is safe for you to continue treatment
Danish: • regelmæssige blodprøver for at tjekke, at det er sikkert for dig at fortsætte med behandlingen
English: Number at risk
Danish: Antal med risiko
English: In the event of an overdose, the patient should be closely monitored.
Danish: I tilfælde af overdosering skal patienten overvåges tæt.
English: Protect from direct and/or bright light throughout the preparation process.
Danish: Skal beskyttes mod direkte og/eller kraftigt lys under hele klargøringsprocessen.
English: Additional experience from clinical studies
Danish: Yderligere erfaringer fra kliniske studier
English: EXP After reconstitution: use immediately.
Danish: EXP Efter rekonstitution: anvendes straks.
English: • multi-organ failure which can lead to death
Danish: • multiorgansvigt, der kan medføre døden
English: Patients 65 years and older
Danish: Patienter i alderen 65 år og derover
English: Non-Caucasian patients
Danish: Ikke-kaukasiske patienter
English: Thus, the distribution phase is essentially complete at 2 hours after the end of infusion.
Danish: Således er fordelingsfasen i det væsentlige komplet 2 timer efter infusionens afslutning.
English: The reconstituted product should not be diluted.
Danish: Det rekonstituerede produkt må ikke fortyndes.
English: Thus, only about 1% of the paclitaxel in the body is located in plasma during the elimination phase.
Danish: Det er således kun ca. 1 % af paclitaxelet i kroppen, der genfindes i plasma i eliminationsfasen.
English: There was no statistically significant difference in PFS or OS between the two treatment arms.
Danish: Der var ingen statistisk signifikant forskel i PFS eller OS mellem de to behandlingsgrupper.
English: • an allergic reaction
Danish: • en allergisk reaktion
English: However, compatibility with DEHP-containing administration sets has not been demonstrated.
Danish: Kompatibilitet med DEHP-holdige administrationssæt er imidlertid ikke påvist.
English: This is equivalent to 80% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 80 % af det anbefalede maksimale daglige indtag af natrium for en voksen.
English: There was no marked difference in overall tolerability between the 65-74 age group and younger patients.
Danish: Der var ingen markant forskel i overordnet tolerabilitet mellem gruppen af 65-74-årige og yngre patienter.
English: The average time to onset was 53 days from the first dose.
Danish: Den gennemsnitlige tid til debut var 53 dage fra første dosis.
English: Tel +46 18 50 54 40
Danish: Tlf. +46 18 50 54 40
English: H2 antagonists
Danish: H2-antagonister
English: Patients should be advised not to drive or use machines if they feel tired or dizzy.
Danish: Patienterne bør rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de føler sig trætte eller svimle.
English: The dose is based on your body surface area (worked out from your height and weight) and blood test results.
Danish: Dosen baseres på din legemsoverflade (beregnet ud fra højde og vægt) og dine blodprøveresultater.
English: Patients Events
Danish: Patienter Hændelser
English: • allergic reactions to other medicines, such as penicillin
Danish: • allergiske reaktioner over for andre lægemidler, f.eks. penicillin
English: Steps 3 to 6 should not be more than 30 minutes.
Danish: Trin 3 til 6 må ikke vare mere end 30 minutter.
English: The following information is intended for healthcare professionals only: Administration precautions
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Forsigtighedsregler i forbindelse med administration
English: Apealea is not recommended for children and adolescents under 18 years, because it has not been studied in this age group.
Danish: Apealea anbefales ikke til børn og unge under 18 år, da det ikke er undersøgt i denne aldersgruppe.
English: Probability of progression-free survival
Danish: Sandsynlighed for progressionsfri overlevelse
English: PFS and OS results in the PP population are summarised in Figures 3 and 4.
Danish: PFS- og OS-resultater hos PP-populationen er opsummeret i figur 3 og 4.
English: Tel +46 18 50 54 40 e-mail: med-info@oasmia.com
Danish: Tlf. +46 18 50 54 40 e-mail: med-info@oasmia.com
English: • epileptic fit lasting longer than five minutes or more than one fit within five minutes
Danish: • epileptisk anfald, der varer mere end fem minutter, eller mere end ét anfald inden for fem minutter
English: If neuropathy is observed, follow dose reduction recommendations in Table 1.
Danish: Hvis der observeres neuropati, følges anbefalingerne vedrørende dosisreduktion i tabel 1.
English: The principle measures of efficacy were progression-free survival (PFS) and overall survival (OS).
Danish: De vigtigste effektmål var progressionsfri overlevelse (PFS) og samlet overlevelse (OS).
English: The use of gloves, goggles and protective clothing is recommended.
Danish: Det anbefales at anvende beskyttelseshandsker, beskyttelsesbriller og beskyttelsestøj.
English: Therefore, frequent complete blood cell counts should be performed during treatment with Apealea.
Danish: Derfor bør der hyppigt udføres komplet blodtælling under behandling med Apealea.
English: These reactions are more common on the first infusion and may be improved by slowing the rate of infusion.
Danish: Disse reaktioner ses hyppigst ved den første infusion og kan afhjælpes ved at sænke infusionshastigheden.
English: Cytotoxic: handle with caution.
Danish: Cytotoksisk: håndteres med forsigtighed.
English: Probability of survival
Danish: Sandsynlighed for overlevelse
English: Frequency Preferred term
Danish: Foretrukken term
English: Number of deaths, n (%)
Danish: Antal dødsfald, n (%)
English: Contact your doctor immediately, if during treatment you develop:
Danish: Kontakt lægen med det samme, hvis du under behandlingen oplever:
English: Only a few patients had ECOG performance status of 2.
Danish: Kun få patienter havde en ECOG-performancescore på 2.
English: Do not drive or use machines if you have these symptoms.
Danish: Du må ikke føre motorkøretøj og betjene maskiner, hvis du oplever disse symptomer.
English: The risk of myelosuppression is increased due to the combination use with carboplatin.
Danish: Risikoen for myelosuppression er øget på grund af kombinationen med carboplatin.
English: Paclitaxel should not be used during pregnancy unless the clinical condition requires this treatment.
Danish: Paclitaxel bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver denne behandling.
English: Paraesthesia and hypoaesthesia were the most common ones.
Danish: Paræstesi og hypoæstesi var de hyppigste.
English: Paclitaxel causes myelosuppression (primarily neutropenia).
Danish: Paclitaxel forårsager myelosuppression (fortrinsvis neutropeni).
English: SE-752 28 Uppsala Sweden
Danish: SE-752 28 Uppsala Sverige
English: Intravenous administration
Danish: Intravenøs administration
English: There were no differences in Eastern Cooperative Oncology Group (ECOG) performance score between the two study groups at any time during or after treatment (mainly score 0 or 1).
Danish: Der var ingen forskelle i ECOG-performancescoren (Eastern Cooperative Oncology Group-scoren) mellem de to grupper på noget tidspunkt under eller efter behandling (hovedsageligt score 0 og score 1).
English: Your doctor may wish to delay further treatment with Apealea or reduce the dose.
Danish: Det kan være, lægen vil udskyde den videre behandling med Apealea eller reducere dosen.
English: Apealea should be administered first, then carboplatin.
Danish: Apealea bør administreres først, og derefter carboplatin.
English: Apealea should be reconstituted using either one of the three suitable solutions for reconstitution and according to the following steps:
Danish: Apealea skal rekonstitueres ved brug af en af de tre egnede rekonstitutionsopløsninger og i overensstemmelse med følgende trin:
English: Range (mmol/L)
Danish: Interval (mmol/l)
English: Patients were stratified based on relapse (first or second) and CA125 values.
Danish: Patienterne blev stratificeret baseret på recidiv (første eller andet) og CA125-værdier.
English: In some of the cases, the patients had previously been exposed to cardiotoxic medicinal products such as doxorubicin or had underlying cardiac history.
Danish: I nogle af tilfældene havde patienterne tidligere været eksponeret for kardiotoksiske lægemidler, f.eks. doxorubicin, eller havde underliggende hjerteproblemer.
English: This amounted to a 14% decline in an 86-year-old patient compared to one aged 56.
Danish: Det svarer til et fald på 14 % hos en 86-årig patient sammenholdt med en 56-årig patient.
English: Steps c and to f should not be more than 30 minutes.
Danish: Trin c til f må ikke vare mere end 30 minutter.
English: In both groups, the majority of the serious adverse events were haematological toxicities.
Danish: I begge grupper var størstedelen af de alvorlige bivirkninger hæmatologiske toksiciteter.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstid og opbevaringsforhold fra anbrud til anvendelse brugerens ansvar.
English: Hazard ratio (95% CI) a Primary population in non-inferiority analysis was predefined as the PP population
Danish: Hazard ratio (95 %-KI) a Primær population i noninferioritetsanalyse blev foruddefineret som PP-populationen
English: The mean age was 56 years of age in both treatment groups (range 26-81).
Danish: Gennemsnitsalderen var 56 år i begge behandlingsgrupper (interval 26-81).
English: Approximately 86% of patients experienced adverse reactions.
Danish: Ca. 86 % af patienterne oplevede bivirkninger.
English: Patients with low neutrophil count should be made aware of the increased risk of infections.
Danish: Patienter med lavt neutrofiltal skal gøres opmærksomme på den øgede risiko for infektioner.
English: There are very limited data on the use of paclitaxel in pregnant women.
Danish: Der foreligger kun meget begrænsede data fra anvendelse af paclitaxel hos gravide kvinder.
English: Dose-linearity could not be ascertained since a large inter-individual variability was observed.
Danish: Dosislinearitet kunne ikke fastslås, eftersom der sås stor variabilitet mellem individerne.
English: It can have a marked impact on the patients' self-image and quality of life and patients should be counselled about the likelihood of this adverse effect and on what measures might be available to mitigate it, for example the use of cold caps.
Danish: Det kan få stor indflydelse på patientens selvbillede og livskvalitet, og patienterne skal underrettes om sandsynligheden for denne bivirkning og om, hvad de kan gøre for at lindre den, f.eks. anvende kølehætter.