FrancophonIA/ELRC3.0 huggingface dataset:
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Danish: Det virker ligesom naturligt binyrebarkhormon, idet det dæmper immunsystemets aktivitet ved at bindes til receptorer i forskellige typer immunceller.
English: The benefits and risks of Vylaer Spiromax are therefore taken to be the same as those of the reference medicine.
Danish: Fordelene og risiciene ved Vylaer Spiromax antages derfor at være de samme som med referencelægemidlet
English: The reference medicine for Vylaer Spiromax is Symbicort Turbohaler.
Danish: Referencelægemidlet for Vylaer Spiromax er Symbicort Turbohaler.
English: Studies were carried out to show that Vylaer Spiromax is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Danish: Der er udført undersøgelser, der viser, at Vylaer Spiromax frembringer samme mængde aktivt stof i kroppen som referencelægemidlet (dvs. det er bioækvivalent med referencelægemidlet), og at de to lægemidler virker på samme måde.
English: Vylaer Spiromax is a medicine that contains the active substances budesonide and formoterol.
Danish: Vylaer Spiromax er et lægemiddel, der indeholder de to aktive stoffer budesonid og formoterol.
English: Other information about Vylaer Spiromax
Danish: Andre oplysninger om Vylaer Spiromax
English: Vylaer Spiromax is a ‘hybrid medicine'.
Danish: Vylaer Spiromax er et “hybridt lægemiddel”.
English: For more information about treatment with Vylaer Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vylaer Spiromax, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When inhaled it mainly attaches to the receptors in the airways and causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Danish: Ved inhalation bindes det hovedsagelig til disse receptorer i luftvejene og afslapper musklerne, så luftvejene holdes frie, og patienten bedre kan trække vejret.
English: What measures are being taken to ensure the safe and effective use of Vylaer Spiromax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vylaer Spiromax?
English: What is Vylaer Spiromax and what is it used for?
Danish: Hvad er Vylaer Spiromax, og hvad anvendes det til?
English: What are the benefits and risks of Vylaer Spiromax?
Danish: Hvilke fordele og risici er der forbundet med Vylaer Spiromax?
English: For asthma reliever therapy, patients should take a separate ‘reliever inhaler' to relieve their symptoms.
Danish: Mod astmaanfald bør patienten bruge en separat inhalator som anfaldsmedicin til at dæmpe symptomerne.
English: For practical information about using Vylaer Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vylaer Spiromax, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The Committee recommended that Vylaer Spiromax be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Vylaer Spiromax.
English: Why is Vylaer Spiromax approved?
Danish: Hvorfor er Vylaer Spiromax blevet godkendt?
English: It is not intended to provide practical advice on how to use Vylaer Spiromax.
Danish: Det er ikke en praktisk vejledning i, hvordan Vylaer Spiromax bør anvendes.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Danish: Det leveres som et inhalationspulver i en bærbar inhalator.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Danish: Dette mindsker frigivelsen af stoffer såsom histamin, der deltager i inflammationsprocessen.
English: How is Vylaer Spiromax used?
Danish: Hvordan anvendes Vylaer Spiromax?
English: How does Vylaer Spiromax work?
Danish: Hvordan virker Vylaer Spiromax?
English: Date of first authorisation: 8 December 2014 Date of latest renewal: 23 September 2019
Danish: Dato for første markedsføringstilladelse: 8. december 2014 Dato for seneste fornyelse: 23. september 2019
English: Patients over 65 years of age have been represented in the phase III studies.
Danish: Patienter over 65 år var repræsenteret i fase III-studierne.
English: Long-term safety and tolerability
Danish: Langsigtet sikkerhed og tolerance
English: Very Common Common Uncommon Rare
Danish: Meget almindelig Almindelig almindelig Sjælden Ikke kendt
English: 2132NP Hoofddorp The Netherlands
Danish: 2132NP Hoofddorp Holland
English: • if your opioid medicine is to be stopped for more than 24 hours
Danish: • hvis din behandling med opioider skal afbrydes i mere end 24 timer.
English: You should not drink large amounts of grapefruit juice whilst taking Moventig.
Danish: Du bør ikke drikke store mængder grapefrugtjuice, når du tager Moventig.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: • Stir and drink immediately
Danish: • Rør rundt og drik straks vandet
English: Opioid withdrawal symptoms may affect up to 1 in 100 people.
Danish: Opioidabstinens-symptomer kan forekomme hos op til 1 ud af 100 personer.
English: Moventig is not recommended for use in children and adolescents below 18 years of age because it has not been studied in these age-groups.
Danish: Moventig er ikke anbefalet til brug hos børn og unge under 18 år, fordi det ikke er blevet undersøgt i disse aldersgrupper.
English: In addition, no safety and tolerability concerns were identified in this study up to the highest dose given (150 mg).
Danish: Der blev desuden ikke identificeret nogen sikkerheds- eller toleransproblemer i dette studie op til den højeste anvendte dosis (150 mg).
English: Of the 844 patients who were randomized, 61.1% completed the study (defined as completing the 2-week follow-up visit after the 52-week treatment period).
Danish: Ud af de 844 patienter, der blev randomiseret, afsluttede 61,1 % studiet (defineret som fuldførelse af det opfølgende besøg 2 uger efter behandlingsperioden på 52 uger).
English: They were often reported as having a component of cramping discomfort.
Danish: De blev ofte indberettet med et element af krampende ubehag.
English: Constipation related to opioids can result in symptoms such as:
Danish: Opioid-relateret forstoppelse kan resultere i symptomer, såsom:
English: Northumberland, NE61 3YA United Kingdom
Danish: Northumberland, NE61 3YA Storbritannien
English: Tablets are engraved with “nGL” on one side and the strength of the tablet on the other.
Danish: Tabletterne er præget med ”nGL” på den ene side og tabletstyrken på den anden side.
English: The overall benefit-risk profile for each patient should be taken into account.
Danish: Der skal tages hensyn til den samlede benefit/risk-profil hos hver enkelt patient.
English: Take Moventig in the morning, to avoid bowel movements in the middle of the night.
Danish: Tag Moventig om morgenen for at undgå afføring midt om natten.
English: • If you miss a dose of Moventig, take it as soon as you remember.
Danish: • Hvis du glemmer en dosis af Moventig, skal du tage den, så snart du kommer i tanker om det.
English: Time to first spontaneous bowel movement
Danish: Tid til første spontane afføring
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: It is important to flush the nasogastric tube through with water after administration of the mixture.
Danish: Det er vigtigt at skylle den nasogastriske sonde gennem med vand efter administration af blandingen.
English: Do not take Moventig if you are taking any of the following medicines (see section “Do not take Moventig”):
Danish: Tag ikke Moventig, hvis du tager et eller flere af følgende lægemidler (se afsnittet ”Tag ikke Moventig”):
English: This could be a symptom of damage to the wall of the gut and can be life-threatening.
Danish: Det kan være et symptom på beskadigelse af tarmvæggen, som kan være livstruende.
English: • Do not take a double dose to make up for a missed dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Food effects: A high-fat meal increased the extent and rate of naloxegol absorption.
Danish: Indvirkning af føde: Et måltid med højt fedtindhold øgede omfanget og hastigheden af naloxegolabsorptionen.
English: Do not use Moventig if any of the above applies to you.
Danish: Brug ikke Moventig, hvis noget af ovenstående gælder for dig.
English: According to the ICH E14 Guideline, this is considered a definitively negative thorough QT/QTc study.
Danish: I henhold til ICH E14-vejledningen anses dette studie som et definitivt negativt, grundigt QT-/QTc-studie.
English: Refer to section 6.6 for further information on administration through a nasogastric tube.
Danish: 6.6 for yderligere oplysninger om administration via nasogastrisk sonde.
English: • if you have had a heart attack within the last 6 months, have heart failure with daily shortness of breath or other severe problems with your heart which cause daily symptoms
Danish: • hvis du har haft et hjertetilfælde inden for de sidste 6 måneder, hvis du har hjertesvigt med daglig stakåndethed eller andre alvorlige problemer med hjertet, som forårsager daglige symptomer.
English: Following oral administration, naloxegol is absorbed rapidly, with peak concentrations (Cmax) achieved at less than 2 hours.
Danish: Efter oral administration absorberes naloxegol hurtigt, og de maksimale koncentrationer (Cmax) opnås efter mindre end 2 timer.
English: None of the metabolites were present in > 10% of the plasma concentrations of parent or total parent and metabolite related material.
Danish: Ingen af metabolitterne var til stede med >10 % af plasmakoncentrationen af moderstoffet eller det totale moderstof- og metabolitrelaterede materiale.
English: Patients should be advised to promptly report severe, persistent or worsening symptoms to their physician.
Danish: Patienter skal rådes til omgående at indberette svære, vedvarende eller forværrede symptomer til deres læge.
English: The observed neoplastic changes are well known hormonal and centrally mediated effects in the rat which are not relevant for humans.
Danish: De observerede neoplastiske forandringer er velkendte hormonelle og centralt medierede virkninger hos rotter, som ikke er relevante for mennesker.
English: • recurrent or advanced ovarian cancer
Danish: • tilbagevendende eller fremskreden ovariecancer
English: The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Danish: Naloxegols sikkerhed og virkning hos børn i alderen <18 år er endnu ikke klarlagt.
English: Do not take Moventig if any of the above apply to you.
Danish: Tag ikke Moventig, hvis noget af ovenstående gælder for dig.
English: All these effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Danish: Alle disse virkninger blev kun set ved eksponeringer, der blev vurderet at være tilstrækkeligt højere end den maksimale humane eksponering, hvilket tyder på, at de er af ringe relevans i klinisk brug.
English: Tell your doctor what opioid pain medicines you are taking and the dose of them.
Danish: Fortæl lægen, hvilke smertestillende opioider, du tager, og i hvilken dosis.
English: If you have trouble swallowing the tablet you can crush it and mix with water as follows:
Danish: Hvis du har problemer med at synke tabletten, kan du knuse den og blande den med vand på denne måde:
English: These metabolites represented more than 32% of the administered dose and were formed via N-dealkylation, O-demethylation, oxidation and partial loss of the PEG chain.
Danish: Disse metabolitter repræsenterede over 32 % af den administrerede dosis og blev dannet via Ndealkylering, O-demetylering, oxidering og delvist tab af PEG-kæden.
English: Moventig with drink
Danish: Brug af Moventig sammen med drikke
English: In a mass balance study in humans, a total of 6 metabolites were identified in plasma, urine and faeces.
Danish: I et massebalancestudie hos mennesker blev der identificeret i alt 6 metabolitter i plasma, urin og fæces.
English: Opioid withdrawal syndrome typically develops within minutes to several days following administration of an opioid antagonist.
Danish: Opioidabstinenssyndrom udvikles typisk i løbet af nogle minutter til adskillige dage efter administration af en opioidantagonist.
English: This was observed in a higher proportion of patients taking methadone than those not taking methadone.
Danish: Dette blev set hos en større andel af de patienter, der tog methadon, end hos de patienter, der ikke tog methadon.
English: Most such reports were observed shortly after initial administration with the medicinal product and were mild or moderate in intensity.
Danish: De fleste af disse tilfælde blev observeret kort tid efter den første administration af lægemidlet og var af mild eller moderat sværhedsgrad.
English: SBM was defined as a bowel movement without rescue laxative taken within the past 24 hours.
Danish: SBM var defineret som afføring uden indtagelse af nødlaksantia inden for de sidste 24 timer.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and fertility.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og fertilitet.
English: In all treatment groups, including placebo, improvements in PAC-SYM domains observed in Kodiac 4 were maintained for patients continuing in Kodiac 7.
Danish: I alle behandlingsgrupper, herunder placebo, blev de forbedringer i PAC-SYM, der blev set i Kodiac 4, fastholdt hos de patienter, der fortsatte i Kodiac 7.
English: Pharmacotherapeutic group: Drugs for constipation, peripheral opioid receptor antagonists ATC code: A06AH03
Danish: Farmakoterapeutisk klassifikation: Lægemidler mod obstipation, perifere opioidreceptorantagonister, ATC-kode: A06AH03
English: Other possible side effects: Very common (may affect more than 1 in 10 people):
Danish: Andre bivirkninger: Meget almindelige (kan forekomme hos flere end 1 ud af 10 behandlede):
English: If you have trouble swallowing the tablet
Danish: Hvis du har problemer med at synke tabletten
English: Moventig should be taken on an empty stomach at least 30 minutes prior to the first meal of the day or 2 hours after the first meal of the day.
Danish: Moventig skal tages på tom mave mindst 30 minutter før dagens første måltid eller 2 timer efter dagens første måltid.
English: In cases of known or suspected overdose of naloxegol, symptomatic treatment as well as monitoring of vital functions should be performed.
Danish: I tilfælde af kendt eller mistænkt overdosering af naloxegol, skal der iværksættes symptomatisk behandling og overvågning af de vitale funktioner.
English: Consideration may be given to lowering the dose to 12.5mg in patients experiencing severe gastrointestinal adverse events depending upon the response and tolerability of individual patients.
Danish: Det kan overvejes at nedsætte dosen til 12,5 mg hos patienter, der oplever svære gastrointestinale bivirkninger afhængigt af den individuelle patients respons og tolerance.
English: As there are additional data from the use of this medicine in pregnant women, the use of Moventig during pregnancy is not recommended.
Danish: Da der er yderligere data fra anvendelsen af dette lægemiddel til gravide kvinder, frarådes det at bruge Moventig under graviditeten.
English: The mean apparent volume of distribution during the terminal phase (Vz/F) in healthy volunteers ranged from 968 to 2,140 L across dosing groups and studies.
Danish: Det gennemsnitlige, tilsyneladende distributionsvolumen i den terminale fase (Vz/F) hos raske frivillige rangerede fra 968 til 2.140 liter på tværs af doseringsgrupper og studier.
English: Definition of laxative inadequate responder
Danish: Definition af utilstrækkeligt respons på laksantia
English: The Cmax and area under the plasma concentration-time curve (AUC) were increased by approximately 30% and 45%, respectively.
Danish: Cmax og arealet under plasmakoncentrations-/tidskurven (AUC) steg med hhv. cirka 30 % og 45 %.
English: 12 hours until your next dose, skip the missed dose.
Danish: Hvis der er mindre end 12 timer til din næste dosis, skal du dog springe den glemte dosis over.
English: • allergic reaction • gastrointestinal perforation (a hole developing in the bowel wall)
Danish: • allergisk reaktion • gastrointestinal perforation (der udvikles et hul i tarmvæggen)
English: • if you are allergic to naloxegol or similar medicines or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for naloxegol eller lignende lægemidler eller et af de øvrige indholdsstoffer i Moventig (angivet i afsnit 6).
English: Following oral administration of radiolabelled naloxegol, 68% and 16% of total administered dose were recovered in the faeces and urine, respectively.
Danish: Efter oral administration af radioaktivt mærket naloxegol blev hhv. 68 % og 16 % af den totale administrerede dosis genfundet i fæces og urin.
English: • hard stools (stools which are hard “like a rock”)
Danish: • hård afføring (afføringer, der er ”hårde som sten”)
English: If you forget to take Moventig
Danish: Hvis du har glemt at tage Moventig
English: Thus renal excretion is a minor clearance pathway for naloxegol.
Danish: Renal udskillelse er dermed en mindre udskillelsesvej for naloxegol.
English: Pregnancy There are limited data from the use of naloxegol in pregnant women.
Danish: Graviditet Der er begrænsede data vedrørende brug af naloxegol hos gravide kvinder.
English: Less than 20% decrease in AUC and 10% decrease in Cmax were observed in patients with mild and moderate hepatic impairment (Child-Pugh Class A and B).
Danish: Der blev set et fald på under 20 % i AUC og et fald på 10 % i Cmax hos patienter med mild og moderat leverinsufficiens (Child-Pugh-klasse A og B).
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 behandlede):
English: If side effects impacting tolerability occur, naloxegol should be discontinued.
Danish: Hvis der opstår bivirkninger med indvirkning på tolerancen, bør naloxegol seponeres.
English: Your doctor may tell you to take a lower dose of 12.5 mg
Danish: Din læge vil eventuelt anvise en lavere dosis på 12,5 mg
English: Gastrointestinal obstruction
Danish: Gastrointestinal obstruktion
English: Patients with moderate or severe hepatic insufficiency (Child's-Pugh Class B or C) were excluded from the Phase III studies (Kodiac 4 and 5).
Danish: Patienter med moderat eller svær leverinsufficiens (Child-Pughklasse B eller C) blev udelukket fra fase III-studierne (Kodiac 4 og 5).
English: • Crush the tablet to a powder
Danish: • Knus tabletten til pulver
English: Parent naloxegol excreted in the urine accounted for less than 6% of the total administered dose.
Danish: Udskillelsen af moderstoffet naloxegol i urinen udgjorde mindre end 6 % af den totale administrerede dosis.
English: • clarithromycin or telithromycin - antibiotics
Danish: • clarithromycin eller telithromycin - antibiotika
English: • methadone
Danish: • methadon
English: There is a small effect of age on the pharmacokinetics of naloxegol (approximately 0.7% increase in AUC for every year increase in age).
Danish: Alder har en lille indvirkning på farmakokinetikken af naloxegol (stigning i AUC på cirka 0,7 % for hvert års aldersstigning).
English: What you need to know before you take Moventig Do not take Moventig:
Danish: Det skal du vide, før du begynder at tage Moventig Tag ikke Moventig:
English: In clinical pharmacology studies, the half-life of naloxegol at therapeutic dose ranged from 6-11 hours.
Danish: I kliniske farmakologistudier var halveringstiden af naloxegol i terapeutiske doser 6 til 11 timer.
English: Moventig is not expected to affect you being able to drive a car or use any tools or machines.
Danish: Moventig forventes ikke at påvirke din evne til at køre bil og betjene værktøj og maskiner.
English: Grapefruit juice has been classified as a potent CYP3A4 inhibitor when consumed in large quantities.
Danish: Grapefrugtjuice er klassificeret som en potent CYP3A4-hæmmer, når det indtages i store mængder.
English: • if you experience symptoms of opioid withdrawal syndrome (see section 4 below).
Danish: • hvis du får symptomer på opioidabstinens (se afsnit 4 nedenfor).
English: The primary objective was to assess long-term safety and tolerability for naloxegol 25 mg and to compare with usual care treatment using descriptive statistics.
Danish: Det primære formål var at vurdere den langsigtede sikkerhed af og tolerance over for naloxegol 25 mg og at sammenligne med sædvanlig behandling ved hjælp af deskriptiv statistik.
English: The majority of gastrointestinal adverse reactions were graded as mild to moderate, occurred early in treatment and resolved with continued treatment.
Danish: Størstedelen af de gastrointestinale bivirkninger blev karakteriseret som milde til moderate, indtrådte tidligt i behandlingen og forsvandt ved fortsat behandling.
English: The primary objective was to compare safety and tolerability among the three treatment groups for an additional 12 weeks (beyond that observed in Kodiac 4) using descriptive statistics.
Danish: Det primære formål var at sammenligne sikkerheden og tolerancen blandt de tre behandlingsgrupper i yderligere 12 uger (udover observationerne i Kodiac 4) ved hjælp af deskriptiv statistik.
English: Embryo-foetal development studies were conducted in rats and rabbits.
Danish: Der blev udført studier af den embryoføtale udvikling hos rotter og kaniner.
English: At therapeutic doses, most opioids (e.g. morphine, meperidine, methadone) are excreted into breast milk in minimal amounts.
Danish: Ved brug af terapeutiske doser udskilles de fleste opioider (f.eks. morfin, meperidin, methadon) i modermælken i minimale mængder.
English: It is unknown whether naloxegol is excreted in human milk.
Danish: Det er ukendt, om naloxegol udskilles i human mælk.
English: Paediatric population Interaction studies have only been performed in adults.
Danish: Pædiatrisk population Der er kun udført interaktionsstudier hos voksne.
English: • ritonavir, indinavir or saquinavir - to treat HIV
Danish: • ritonavir, indinavir eller saquinavir - til behandling af hiv
English: Studies in animals have shown reproductive toxicity where systemic exposures were several times above the therapeutic exposure level (see section 5.3).
Danish: Dyrestudier har påvist reproduktionstoksicitet ved systemiske eksponeringer, der var flere gange højere end de terapeutiske eksponeringsniveauer (se pkt.
English: • if you have cancer-related pain
Danish: • hvis du har kræftrelaterede smerter.
English: Moventig has no or negligible influence on the ability to drive and use machines.
Danish: Moventig påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.