FrancophonIA/ELRC3.0 huggingface dataset:
English: In order to address the concern of the extended (lengthened ring use) of up to 28 days, which is a deviation from the recommended use that is included in the SmPC of NuvaRing, the applicant provided further information on pharmaceutical quality data between the test and reference medicinal product, in vitro dissolution data which evaluated the rate of release of the test and reference product over 28 days, In Vitro-In Vivo Correlation (IVIVC) for the reference formulation for 28 days and an In Vitro-In Vivo Correlation (IVIVC) for the test formulation for 21 days, and the residual contents in the rings of etonogestrel and ethinyelstradiol at 21 days for test and reference medicinal product.
Danish: Med henblik på at imødegå betænkeligheden ved den forlængede brug af ringen i op til 28 dage, som er en afvigelse fra den anbefalede brug i produktresuméet for NuvaRing, fremlagde ansøgeren yderligere oplysninger om lægemiddelkvaliteten for både det omhandlede produkt og referencelægemidlet, in vitro-opløsningsdata vedrørende frigivelseshastigheden for det omhandlede produkt og referencelægemidlet over 28 dage, data for in vitro-in vivo-korrelation (IVIVC) for referencelægemidlet for 28 dage og data for in vitro-in vivo-korrelation for det omhandlede produkt over 21 dage og data for ringenes restmængder af etonogestrel og ethinylestradiol efter 21 dage for både det omhandlede produkt og referencelægemidlet.
English: The recommended period of use of this product is 21 days; however, according to the summary of product characteristics (SmPC) of the reference medicinal product, even though not the recommended regimen, the contraceptive efficacy of the reference product is maintained for up to 28 days.
Danish: Den anbefalede brugsperiode for dette produkt er 21 dage; i henhold til produktresuméet for referencelægemidlet har referencelægemidlet dog en præventiv virkning i op til 28 dage, selvom dette ikke er det anbefalede regime.
English: To address the issue of extended use up to 28 days, which is included in the SmPC of NuvaRing as a deviation to the recommended use, the applicant has additionally conducted IVIVC modelling to demonstrate that the behaviour of the ring does not change between 21 and 28 days, based on data from the test product for 21 days and from published data on reference product for 28 days.
Danish: For at imødegå problemstillingen med den forlængede brug i op til 28 dage, der fremgår af NuvaRings produktresumé som en afvigelse i forhold til den anbefalede brug, har ansøgeren gennemført en IVIVC-modellering for at påvise, at ringens virkning ikke ændres mellem dag 21 og dag 28, baseret på data for det omhandlede produkt i 21 dage og publicerede data for referencelægemidlet for 28 dage.
English: If you forget a dose, take it as soon as you remember it.
Danish: Hvis du glemmer en dosis, så tag den så snart, du husker det.
English: It shall address the following key elements:
Danish: Det skal indeholde følgende centrale elementer:
English: The tablets should be taken during or just after a meal.
Danish: Tabletterne skal tages under eller lige efter et måltid.
English: 48 tablets
Danish: 48 tabletter
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan påvirke op til 1 af 100 personer
English: It is not usually recommended for use during pregnancy.
Danish: Det anbefales normalt ikke til brug under graviditet.
English: Date of first authorisation: 28 April 2014 Date of latest renewal: 2 April 2019
Danish: Dato for første markedsføringstilladelse: 28 april 2014 Dato for seneste fornyelse: 2 april 2019
English: All missing cultures up to the time of SCC were assumed to be positive cultures in the primary analysis.
Danish: Alle manglende kulturer op til tidspunktet for SCC blev betragtet som positive kulturer i den primære analyse.
English: • Intense lack of energy
Danish: • Intens mangel på energi
English: Frequent ECG monitoring should be performed.
Danish: Hyppig EKG-overvågning bør udføres.
English: Remember to take the pack with you so that it is clear what medicine you have taken.
Danish: Husk at medbringe pakningen, så det er tydeligt, hvilket lægemiddel, du har taget.
English: Liver disorders is categorised as an important potential risk.
Danish: Leversygdom er klassificeret som en væsentlig potentiel risiko.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Danish: Det er vigtigt, at du fortæller det til din læge, hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid.
English: DO NOT stop taking the tablets unless your doctor tells you to.
Danish: Stop ikke med at tage tabletterne, med mindre din læge giver dig besked på det.
English: 80636 München Germany
Danish: 80636 München Tyskland
English: This prolongation increases slowly over time in the first 6-10 weeks of treatment and remains stable therafter.
Danish: Denne forlængelse steg langsomt over tid i de første 6-10 uger af behandling og forblev derefter stabil.
English: • Hearing a persistent sound in your ear when no sound exists (tinnitus)
Danish: • En vedvarende lyd i øret, når en sådan lyd ikke findes (tinnitus)
English: These four patients were only receiving two other medicinal products in addition to delamanid.
Danish: Disse fire patienter fik kun to andre lægemidler i tillæg til delamanid.
English: Your doctor may also perform a blood test to check the concentration of some minerals and proteins which are important for the function of your heart.
Danish: Din læge vil måske også tage en blodprøve for at kontrollere koncentrationen af visse mineraler og proteiner, der er vigtige for dit hjertes funktion.
English: Deltyba is not suitable for children under age 18.
Danish: Deltyba er ikke egnet til børn under 18 år.
English: Concentrations of the identified metabolites progressively increase to steady state after 6 to 10 weeks.
Danish: De identificerede metabolitters koncentrationer stiger progressivt til steady state efter 6 til 10 uger.
English: The frequency of the side effects listed below is defined using the following definitions: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people
Danish: Hyppigheden af de bivirkninger, der er anført herunder, defineres ved hjælp af følgende definitioner: Meget almindelige: kan påvirke mere end 1 af 10 personer Almindelige: kan påvirke op til 1 af 10 personer
English: You may be more at risk for dangerous changes of the heart rhythm.
Danish: Du kan være mere udsat for farlige ændringer af hjerterytmen.
English: Delamanid should be taken with food.
Danish: Delamanid bør indtages sammen med mad.
English: However, if it is nearly time for the next dose, just skip the missed dose.
Danish: Men hvis det næsten er tid til at tage den næste dosis, så spring den manglende dosis over.
English: Deltyba may cause harm to an unborn baby.
Danish: Deltyba kan eventuelt skade et ufødt barn.
English: Film coating Hypromellose Macrogol 8000
Danish: Filmovertræk Hypromellose Macrogol 8000
English: Elderly patients (≥ 65 years) No patients of ≥ 65 years of age were included in clinical trials.
Danish: Ældre patienter (≥ 65 år) Ingen patienter på ≥ 65 år deltog i de kliniske forsøg.
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP:”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken eller blisteren efter "EXP:".
English: Aluminium/Aluminium blister: 48 tablets.
Danish: Aluminium/Aluminiumblister: 48 tabletter.
English: Elimination Delamanid disappears from plasma with a t1/2 of 30-38 hours.
Danish: Elimination Delamanid forsvinder fra plasma med t1/2 på 30-38 timer.
English: Delamanid highly binds to all plasma proteins with a binding to total proteins of ≥99.5%.
Danish: Delamanid binder i høj grad til alle plasmaproteiner med en binding til samlede proteiner på ≥99,5 %.
English: Gamma-glutamyltransferase increased*
Danish: Gamma-glutamyltransferase forøget*
English: Delamanid plasma exposure increases less than proportionally with increasing dose.
Danish: Delamanid plasma-eksponering stiger mindre end proportionalt med stigende dosis.
English: • Itchy or red skin including around the hair roots.
Danish: • Kløende eller rød hud, bl.a. omkring hårrødderne
English: The safety and efficacy of delamanid in children and adolescents below 18 years has not yet been established.
Danish: Delamanids sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at du lider af intolerans over for visse sukkerarter, skal du kontakte lægen, før du tager dette lægemiddel.
English: Your doctor will weigh up the benefits to you against the risks to your baby of taking Deltyba whilst you are pregnant.
Danish: Din læge vil afveje fordelene for dig med risikoen for dit barn ved at tage Deltyba, mens du er gravid.
English: Less than 5% of an oral dose of delamanid is recovered from urine.
Danish: Mindre end 5 % af en oral dosis delamanid udskilles i urinen.
English: However, since the concentrations in the gut can potentially be much greater than these multiples of the Cmax, there is a potential for delamanid to have an effect on these transporters.
Danish: Men da koncentrationer i maven potentielt kan være meget højere end disse multipler af Cmax, er det muligt, at delamanid kan have en virkning på disse transportører.
English: The finding was shown to be partially reversible; the clinical relevance of this finding is unknown.
Danish: Resultatet var delvist reversibelt; kliniske relevans af dette fund er ukendt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendix V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: • Difficulties with falling or staying asleep
Danish: • Problemer med at falde i søvn eller med at sove
English: There are no data on treatment with delamanid for more than 24 consecutive weeks.
Danish: Der foreligger ingen data om behandling med delamanid i mere end 24 på hinanden følgende uger.
English: • Changes found in investigations (electrocardiogram, ECG) of the heart
Danish: • Ændringer, der konstateres under undersøgelser (elektrokardiogram, EKG) af hjertet
English: Before you start taking Deltyba, and during the treatment, your doctor may check your heart's electrical activity using an ECG (electrocardiogram) machine (electrical recording of the heart).
Danish: Før du begynder at tage Deltyba og under behandlingen, vil din læge måske kontrollere dit hjertes elektriske aktivitet ved hjælp af en EKG-maskine (elektrokardiogram) (en elektrisk registrering af hjertet).
English: However, patients should be advised not to drive or use machines if they experience any adverse reaction with a potential impact on the ability to perform these activities (e.g. headache and tremor are very common).
Danish: Patienterne bør imidlertid rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de oplever bivirkninger med potentiel virkning på evnen til at udføre disse aktiviteter (f.eks. er hovedpine og tremormeget almindelige).
English: Delamanid has a large apparent volume of distribution (Vz/F of 2,100 L).
Danish: Delamanid har stor, tilsyneladende distributionsvolumen (Vz/F på 2.100 l).
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirkninger, der ikke er medtaget i denne indlægsseddel.
English: Therefore the potential for drug-drug interactions of clinical significance to occur with delamanid and the possible consequences, including the total effect on the QTc interval, cannot be predicted with confidence.
Danish: Derfor kan potentialet for, at der vil forekomme lægemiddelinteraktioner af klinisk betydning med delamanid og de mulige konsekvenser, herunder den samlede effekt på QTc-intervallet, ikke forudses med sikkerhed.
English: Hereford, HR3 5PG United Kingdom
Danish: Hereford, HR3 5PG Storbritannien
English: • Increased need to urinate at night
Danish: • Øget behov for vandladning om natten
English: There are very limited data from the use of delamanid in pregnant women.
Danish: Der findes meget begrænsede data vedrørende brugen af delamanid hos gravide.
English: If a QTcF >500 ms is observed either before the first dose of delamanid or during delamanid treatment, treatment with delamanid should either not be started or should be discontinued.
Danish: Hvis QTcF > 500 ms observeres enten før første dosis delamanid eller under delamanid-behandlingen, skal behandling med delamanid enten ikke påbegyndes eller afbrydes.
English: Resistance to delamanid
Danish: Resistens over for delamanid
English: Pharmacotherapeutic group: Antimycobacterials, antibiotics, ATC code: J04AK06.
Danish: Farmakoterapeutisk gruppe: Antimykobakterielle antibiotika, ATC-kode: J04AK06.
English: Treatment with an appropriate combination regimen should continue after completion of the 24-week delamanid treatment period according to WHO guidelines.
Danish: Behandling med en hensigtsmæssig kombinationsbehandling skal fortsætte efter den 24-ugers delamanid behandlingsperiode i henhold til WHO-retningslinjerne.
English: Two sensitivity analyses were conducted - a last-observation-carried-forward (LOCF) analysis and an analysis using “bookending” methodology (which required that the previous and subsequent cultures were both observed negative cultures to impute a negative result, otherwise a positive result was imputed).
Danish: To følsomhedsanalyser blev gennemført (en last-observation-carried-forward-analyse (LOCF) og en bookending-analyse (som krævede, at både tidligere og efterfølgende kulturer var observerede negative kulturer for at kunne betragte et resultat som negativt; ellers blev resultatet betragtet som positivt).
English: • Papules (small skin elevations)
Danish: • Papeller (små forhøjelser i huden)
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Deltyba are provided with educational material.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, der er involveret i at ordinere, udlevere, håndtere eller administrere Deltyba, er forsynet med undervisningsmateriale.
English: Delamanid is primarily metabolised in plasma by albumin and to a lesser extent by CYP3A4.
Danish: Delamanid metaboliseres primært i plasma ved albumin og i mindre udstrækning ved CYP3A4.
English: - Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
Danish: - Elektrolytforstyrrelser, især hypokalæmi, hypokalcæmi eller hypomagnesæmi.
English: Data from clinical studies
Danish: Data fra kliniske forsøg
English: • Decreased tolerability of the eyes for bright light
Danish: • Reduceret tolerance for skarpt lys
English: Investigations Electrocardiogram ST segment depression
Danish: Elektrokardiogram ST segment depression
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppe præsenteres bivirkningerne efter faldende alvor.
English: Deltyba contains lactose monohydrate.
Danish: Deltyba indeholder laktose monohydrat.
English: Within each System Organ Class, adverse reactions are listed under frequency categories of 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: Inden for hver systemorganklasse er bivirkningerne anført under hyppighedskategorierne: 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 PRAC requests a cumulative review of this risk in next PSUR, using appropriate PT terms, in order to assess whether an update of the risk is needed.
Danish: PRAC ønsker en kumulativ gennemgang af denne risiko i den næste PSUR under anvendelse af de foretrukne termer, så det kan vurderes, om det er nødvendigt at opdatere bivirkningsrisikoen.
English: If you experience side effects that might affect your ability to concentrate and react, do not drive or use machines.
Danish: Hvis du oplever bivirkninger, der kan påvirke din koncentrations- og reaktionsevne, så undlad at føre motorkøretøj og betjene maskiner.
English: Non-clinical data reveal no specific hazard for humans based on conventional studies for genotoxicity and carcinogenic potential.
Danish: Prækliniske data viser ingen specifik risiko for mennesker vurderet ud fra konventionelle studier for genotoksicitet og karcinogenicitet.
English: Albeit, some reactions were observed at a higher frequency and the rate of QT prolongation increased in a dose-related manner.
Danish: Nogle reaktioner blev dog observeret med større hyppighed, og graden af QTforlængelse steg dosisrelateret.
English: Anaemia* Eosinophilia*
Danish: Anæmi* Eosinophilia*
English: Deltyba is not recommended in pregnant women or in women of childbearing potential unless they are using a reliable form of contraception.
Danish: Deltyba anbefales ikke til gravide kvinder og til kvinderi den fødedygtige alder medmindre de anvender en sikker form for prævention.
English: Treatment with delamanid should not be initiated in patients with the following risk factors unless the possible benefit of delamanid is considerd to outweigh the potential risks.
Danish: Behandling med delamanid må ikke påbegyndes hos patienter med følgende risikofaktorer, medmindre delamanids mulige fordel opvejer de potentielle risici.
English: Deltyba is not expected to have an influence on your ability to drive and use machines.
Danish: Deltyba forventes ikke at påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside www.ema.europa.eu.
English: General recommendations
Danish: Generelle anbefalinger
English: Round, yellow, film-coated tablet.
Danish: Rund, gul, filmovertrukket tablet.
English: • Feeling of emotional and mental discomfort
Danish: • Fornemmelse af emotionelt og mentalt ubehag
English: In-vitro studies showed that delamanid did not inhibit CYP450 isozymes.
Danish: In-vitro forsøg har vist, at delamanid ikke hæmmer CYP450-isozymer.
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority and implement it prior to launch.
Danish: I hver medlemsstat skal indehaveren af markedsføringstilladelsen opnå accept af indholdet og formatet af undervisningsmaterialet hos den nationale kompetente myndighed og implementere det forud for lanceringen.
English: Mutation in one of the 5 coenzyme F420 genes is suggested as the mechanism for resistance against delamanid in mycobacteria.
Danish: Mutation i ét ud af de 5 coenzym F420-gener foreslås som mekanismen for mykobakteriers resistens over for delamanid.
English: - if you are taking HIV-medicines containing lopinavir/ritonavir, or saquinavir.
Danish: - hvis du tager HIV-medicin, der indeholder lopinavir/ritonavir eller saquinavir.
English: • Shaking (tremor)
Danish: • Rysten (tremor)
English: The recommended dose is two 50 mg tablets taken twice a day (morning and evening) as advised by your doctor.
Danish: Den anbefalede dosis er to 50 mg tabletter to gange dagligt (morgen og aften) i henhold til lægens anvisning.
English: Package leaflet: Information for the patient Deltyba 50 mg film-coated tablets delamanid This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Deltyba 50 mg filmovertrukne tabletter delamanid Dette lægemiddel er underlagt supplerende overvågning.
English: The identified metabolites do not show anti-mycobacterial activity but some contribute to QTc prolongation, mainly DM6705.
Danish: De identificerede metabolitter viser ikke antimykobakteriel aktivitet, men nogle bidrager til QTc-forlængelse, især DM-6705.
English: This leaflet was last revised in <{MM/YYYY}>.
Danish: Denne indlægsseddel blev senest revideret <{MM/ÅÅÅÅ}>.
English: • Drug use during pregnancy
Danish: • Anvendelse af lægemidlet under graviditet
English: QTc prolongation is very closely correlated with the major delamanid metabolite DM-6705.
Danish: QTc-forlængelse er meget tæt forbundet med den største delamanid-metabolit DM-6705.
English: The adverse drug reactions are listed by MedDRA System Organ Class and Preferred Term.
Danish: Bivirkningerne er anført efter MedDRA's systemorganklasse og foretrukket betegnelse.
English: Talk to your doctor, pharmacist or nurse before taking Deltyba.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Deltyba .
English: If the QTc interval duration exceeds 450/470 ms for male/female patients during delamanid treatment, these patients should be administered more frequent ECG monitoring.
Danish: Hvis QTc-intervallets varighed overstiger 450/470 ms for mandlige/kvindelige patienter under delamanidbehandlingen, skal disse patienter have hyppigere EKG-overvågning.
English: On the basis of the scientific conclusions for delamanid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing delamanid is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for delamanid er CHMP af den opfattelse, at benefit/riskforholdet for det lægemiddel/de lægemidler, der indeholder delamanid, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne, arvelige problemer med intolerans over for galaktose, Lapp-laktaseinsufficiens eller dårlig optagelse af glukose-galaktose bør ikke tage dette lægemiddel.
English: It is also recommended that serum electrolytes, e.g. potassium, are obtained at baseline and corrected if abnormal.
Danish: Det anbefales desuden, at serumelektrolytter, f.eks. kalium, måles ved baseline og korrigeres, hvis værdien er unormal.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for delamanid, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for delamanid er CHMP nået frem til følgende videnskabelige konklusioner:
English: The analyses of SCC were conducted on the modified intent to treat population which included patients who had positive cultures at baseline and the isolate was resistant to both isoniazid and rifampicin, i.e., had MDR TB.
Danish: Analyserne af sputumkultur-konvertering (SCC) blev gennemført på grundlag af den modificerede intent-to-treat-population, der omfattede patienter, som havde positive kulturer ved baseline, og isolatet var resistent over for både isoniazid og rifampicin, dvs. de havde MDR TB.
English: Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.
Danish: Deltyba indeholder det aktive stof delamanid, et antibiotikum til behandling af tuberkulose i lungerne på grund af bakterier, der ikke dræbes af de fleste almindeligt anvendte antibiotika, der bruges til at behandle tuberkulose.