FrancophonIA/ELRC3.0 huggingface dataset:
English: low blood pressure, airless or collapsed lung.
Danish: Lavt blodtryk, luftmangel i en lunge eller sammenklapning af en lunge.
English: The gas cylinder should be put in an equipped site with appropriate material in order to hold the gas cylinder vertically.
Danish: Gasflasken skal placeres et specialudstyret sted med egnet udstyr til fastholdelse af gasflasken i lodret stilling.
English: What INOmax is and what it is used for What you need to know before you begin a treatment with INOmax How INOmax is given
Danish: Det skal De vide, før De begynder behandling med INOmax Sådan gives INOmax
English: How to store INOmax
Danish: Sådan gives INOmax
English: In the INOT27 trial, 795 preterm infants (GA<29 weeks) with hypoxic respiratory failure were randomised to receive either INOmax (n=395) in a dose of 5 ppm or nitrogen (placebo n=400),
Danish: I INOT27-forsøget blev 795 for tidligt fødte børn (GA<29 uger) med hypoxisk respirationssvigt randomiseret til at få enten INOmax (n=395) i en dosis på 5 ppm eller nitrogen (placebo n=400) med start inden for de første 24 timer efter fødslen og behandlet i mindst 7 dage og op til 21 dage.
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: LÆGEMIDLETS NAVN
English: Nitric oxide is genotoxic in some test systems.. No evidence of a carcinogenic effect was apparent, at inhalation exposures up to the recommended dose (20 ppm), in rats for 20 h/day for up to two years.
Danish: Der var ingen tydelig evidens for en karcinogen virkning efter eksponeringer ved inhalation op til den anbefalede dosis (20 ppm) hos rotter i 20 t/dag i op til to år.
English: If you see any signs or symptoms that may be associated to bleeding you should directly inform the doctor.
Danish: Kontakt straks lægen, hvis De observerer tegn eller symptomer, som kan tyde på blødning.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, even after you or your child leave the hospital, please tell your doctor.
Danish: Dette gælder også, hvis bivirkningerne først optræder efter, at De eller Deres barn har forladt hospitalet.
English: See section 4
Danish: De Keten 7
English: Keep this medicine out of the sight and reach of children
Danish: Opbevar dette lægemiddel utilgængeligt for børn.
English: AUTHORISATION
Danish: Fravænning
English: This will be monitored by blood samples and if required the INOmax dose will be decreased and the administration of medicines such as vitamin C, methylene blue, or eventually blood transfusion, in order to improve the oxygen carrying capacity, may be considered.
Danish: Lægen kan endvidere overveje at give lægemidler såsom ascorbinsyre eller methylenblåt eller eventuel blodtransfusion for at forbedre blodets evne til at transportere ilt.
English: The withdrawal of inhaled nitric oxide therapy should be performed in a stepwise manner.
Danish: Seponering af inhaleret nitrogenoxid bør ske trinvis.
English: Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care.
Danish: Ordinering af nitrogenoxid skal kontrolleres af en læge, der har erfaring i intensivbehandling af neonatale.
English: Methaemoglobi naemiaa
Danish: Methæmoglo binæmia
English: A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
Danish: En 10 liters gascylinder fyldt under et tryk på 155 bar absolut indeholder 1.535 liter gas under et tryk på 1 bar ved 15 oC.
English: INOmax 800 ppm mol/mol inhalation gas Nitric oxide
Danish: INOmax 800 ppm mol/mol inhalationsgas Nitrogenoxid
English: Thrombocytopeniaa
Danish: Trombocytopenia
English: A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15oC.
Danish: En 2 liters gascylinder fyldt under et tryk på 155 bar absolut indeholder 307 liter gas under et tryk på 1 bar ved 15 oC.
English: INOmax 400 ppm mol/mol inhalation gas Nitric oxide
Danish: INOmax 400 ppm mol/mol inhalationsgas Nitrogenoxid
English: The monitoring of Methaemoglobin level
Danish: Kontrol af dannelse af methæmoglobin (MetHb)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 800 ppm mol/mol.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Nitrogenoxid (NO) 800 ppm mol/mol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/003, EU/1/01/194/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/194/003, EU/1/01/194/004
English: STATEMENT OF ACTIVE SUBSTANCE(S) Nitric oxide (NO) 400 ppm mol/mol.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Nitrogenoxid (NO) 400 ppm mol/mol.
English: Dizziness c a: Identified from the clinical trial b: Identified from Post-Marketing experience c: Identified from Post-Marketing experience, experienced by healthcare personnel following accidental exposure d: Post Marketing Safety Surveillance (PMSS) data, effects associated with acute withdrawal of the medicinal product, and /or delivery system failures.
Danish: d: Data fra sikkerhedsovervågning efter markedsføring (PMSS), symptomer associeret med akut seponering af lægemidlet og/eller fejl i tilførselssystemet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001, EU/1/01/194/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/194/001, EU/1/01/194/002.
English: - If you have any further questions, ask your doctor - If you get any side effects, talk to your doctor.
Danish: - Tal med lægen, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: The active substance in INOmax is nitric oxide 800 ppm mol/mol.
Danish: Aktivt stof: nitrogenoxid 800 ppm mol/mol.
English: The active substance in INOmax is nitric oxide 400 ppm mol/mol.
Danish: Aktivt stof: nitrogenoxid 400 ppm mol/mol.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/194/004
English: Low platelet count.
Danish: Lavt antal blodplader.
English: Dyspnoeac Chest Discomfortc Dry throat c
Danish: Hypoxiab,d Dyspnøc Ubehag i brystetc Tør halsc
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/194/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/01/194/003
English: NAME OF THE MEDICINAL PRODUCT INOmax 800 ppm mol/mol inhalation gas
Danish: LÆGEMIDLETS NAVN INOmax, 800 ppm mol/mol inhalationsgas.
English: 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15 at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15oC.
Danish: En 10 l gasflaske fyldt ved 155 bar absolut tryk giver 1535 liter gas under tryk på 1 bar ved 15 °C.
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Danish: En 10 liters aluminiumsgascylinder (mærket med akvamarinfarvet skulder og hvid flaske) fyldt under et tryk på 155 bar, udstyret med en trykreduktionsventil af rustfrit stål med en specifik tilslutning og et håndhjul til en ventil udstyret med INOmeter.
English: A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.
Danish: En 2 liters aluminiumsgascylinder (mærket med akvamarinfarvet skulder og hvid flaske) fyldt under et tryk på 155 bar, udstyret med en trykreduktionsventil af rustfrit stål med en specifik tilslutning og et håndhjul til en ventil udstyret med INOmeter.
English: NAME OF THE MEDICINAL PRODUCT INOmax 400 ppm mol/mol inhalation gas
Danish: LÆGEMIDLETS NAVN INOmax, 400 ppm mol/mol inhalationsgas.
English: A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Danish: En 10 liters aluminiumsgascylinder (mærket med akvamarinfarvet skulder og hvid flaske) fyldt under et tryk på 155 bar, udstyret med en trykreduktionsventil af rustfrit stål med en specifik tilslutning og et håndhjul til standardventil.
English: A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.
Danish: En 2 liters aluminiumsgascylinder (mærket med akvamarinfarvet skulder og hvid flaske) fyldt under et tryk på 155 bar, udstyret med en trykreduktionsventil af rustfrit stål med en specifik tilslutning og et håndhjul til standardventil.
English: Side effects that may be seen, but uncommonly (affects between 1 user in 100 and 1 user in 1000) are: increase in methaemoglobin, thus reduced oxygen carrying capacity.
Danish: Ikke almindelige bivirkninger (forekommer hos mellem 1 ud af 100 brugere og 1 ud af 1.000 brugere):
English: d
Danish: Hjerte
English: Weaning
Danish: Dosering
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26 January 2018
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom26.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Danish: To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen, og de forventes derfor at have samme effekt.
English: What consequences does this withdrawal have for patients in clinical trials?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske studier?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would be unable to provide the required additional data in the time available.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at den ikke ville være i stand til at fremskaffe de krævede supplerende data inden for den fastsatte tidsramme.
English: The Committee was also concerned that the studies on how the patch sticks to the skin had only been done in young adults.
Danish: Udvalget var også betænkelig ved, at plastrets klæbning til huden kun var undersøgt hos unge voksne.
English: Since Parkinson's disease usually occurs in people over 60 years, studies in older people would be required because the skin structure changes due to aging.
Danish: Da Parkinsons sygdom typisk forekommer hos personer over 60 år, er det nødvendigt at gennemføre studier hos ældre, idet hudens struktur ændres som følge af aldring.
English: It was to be available as transdermal patches (patches that deliver a medicine across the skin).
Danish: Det skulle markedsføres som transdermalt plaster (et plaster, der leverer lægemidlet gennem huden).
English: The CHMP was concerned that insufficient data had been provided on the quality of the medicine and its manufacturing process.
Danish: CHMP var betænkelig ved, at de fremlagte data om lægemidlets kvalitet og fremstillingsprocessen var utilstrækkelige.
English: In patients with Parkinson's disease, the cells that produce dopamine die and the amount of dopamine in the brain decreases.
Danish: Hos patienter med Parkinsons sygdom dør de celler, der danner dopamin, og mængden af dopamin i hjernen falder.
English: This means that Rotigotine Mylan contains the same active substance and was intended to work in the same way as a ‘reference medicine' already authorised in the European Union called Neupro.
Danish: Det betyder, at Rotigotine Mylan indeholder det samme aktive stof og skulle virke på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union, og som hedder Neupro.
English: Dopamine is a messenger substance in the parts of the brain that control movement and coordination.
Danish: Dopamin virker som signalstof i de dele af hjernen, der styrer bevægelser og koordinering.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Neupro, and did not need to be repeated for Rotigotine Mylan.
Danish: Der er allerede gennemført studier af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Neupro, og det er ikke nødvendigt at gentage disse med Rotigotine Mylan.
English: Rotigotine Mylan was developed as a ‘generic medicine'.
Danish: Rotigotine Mylan blev udviklet som et "generisk lægemiddel".
English: Rotigotine stimulates the brain as dopamine would, so that patients can control their movement and have fewer of the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Danish: Rotigotin stimulerer hjernen på samme måde som dopamin, så patienten kan styre sine bevægelser og har færre tegn og symptomer på Parkinsons sygdom som f.eks. stivhed og langsomme bevægelser.
English: On 22 December 2017, Mylan SAS officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Rotigotine Mylan, for the treatment of Parkinson's disease and restless-leg syndrome.
Danish: Den 22. december 2017 meddelte Mylan SAS officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Rotigotine Mylan til behandling af Parkinsons sygdom og restless legs-syndrom (uro i benene).
English: Rotigotine Mylan was expected to be used to treat adults with Parkinson's disease and adults with restless-leg syndrome (a disorder where the patient has uncontrollable urges to move the legs to stop uncomfortable, painful or odd sensations in the body, usually at night).
Danish: Rotigotine Mylan skulle anvendes til behandling af voksne patienter med Parkinsons sygdom eller Restless Legs Syndrome, som er en lidelse, hvor patienten har en uimodståelig trang til at bevæge lemmerne for at standse ubehagelige, smertefulde eller underlige fornemmelser i kroppen, sædvanligvis om natten).
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Rotigotine Mylan did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Rotigotine Mylan ikke opvejede risiciene.
English: As for every medicine, the company provided studies on the quality of Rotigotine Mylan, including studies on how the patch sticks to the skin.
Danish: Som for alle lægemidler fremlagde virksomheden studier af kvaliteten af Rotigotine Mylan, herunder studier af, hvordan plastret klæber til huden.
English: The company also carried out studies to investigate whether Rotigotine Mylan is ‘bioequivalent' to the reference medicine.
Danish: Virksomheden gennemførte også studier af, om Rotigotine Mylan er "bioækvivalent" med referencelægemidlet.
English: The active substance in Rotigotine Mylan, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Danish: Det aktive stof i Rotigotine Mylan, rotigotin, er en dopaminagonist, hvilket betyder, at det efterligner virkningen af dopamin.
English: Rotigotine Mylan is a medicine that contains the active substance rotigotine.
Danish: Rotigotine Mylan er et lægemiddel, der indeholder det aktive stof rotigotin.
English: What was Rotigotine Mylan expected to be used for?
Danish: Hvad forventedes Rotigotine Mylan anvendt til?
English: EMA/43037/2018
Danish: januar 2018
English: What is Rotigotine Mylan?
Danish: Hvad er Rotigotine Mylan?
English: The company informed the CHMP that there are no ongoing clinical trials with Rotigotine Mylan.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske studier af Rotigotine Mylan.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Rotigotine Mylan could not have been approved for the treatment Parkinson's disease and restless-leg syndrome.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP haft visse betænkeligheder og var af den foreløbige opfattelse, at Rotigotine Mylan ikke kunne være blevet godkendt til behandling af Parkinsons sygdom og restless legs-syndrom.
English: How does Rotigotine Mylan work?
Danish: Hvordan virker Rotigotine Mylan?
English: The syndrome is thought to be caused by problems in the way dopamine works in the brain, which may be improved by rotigotine.
Danish: Lidelsen menes at skyldes problemer med den måde, som dopamin virker på i hjernen.
English: The way rotigotine works in restless-legs syndrome is not fully understood.
Danish: Det vides endnu ikke med nøjagtighed, hvordan rotigotin virker mod uro i benene.
English: This is particularly important for the following medicines:
Danish: Dette er særlig vigtigt for følgende lægemidler:
English: 26 May 2016
Danish: 26. maj 2016
English: Both components contributed to the risk reduction.
Danish: Begge komponenter havde indflydelse på risikoreduktionen.
English: No significant interaction
Danish: Ingen signifikant interaktion
English: Amyloid content was not, however, measured quantitatively in this study.
Danish: Dog blev indholdet af amyloid ikke målt kvantitativt i dette studie.
English: It is advisable to take your medicine at the same time each day.
Danish: Det anbefales, at tage medicinen på samme tidspunkt hver dag.
English: Relative risk reduction p-value ***
Danish: Relativ risikoreduktion p-værdi ***
English: Some side effects may be serious.
Danish: Nogle bivirkninger kan være alvorlige.
English: Symptomatic treatment should be provided.
Danish: Der bør iværksættes symptomatisk behandling.
English: Component of a multipack.
Danish: Del af multipakning.
English: Do not take Neparvis:
Danish: Tag ikke Neparvis:
English: It may be necessary to change the dose, to take other precautions, or even to stop taking one of the medicines.
Danish: Det kan være nødvendigt at ændre dosis, tage andre forholdsregler eller endda stoppe brugen af et af lægemidlerne.
English: This medicine is not for use in children (aged below 18 years).
Danish: Dette lægemiddel bør ikke bruges til børn (under 18 år).
English: Time since randomisation (days)
Danish: Tid efter randomisering (dage)
English: This effect was observed early and was sustained throughout the duration of the study (see Figure 1).
Danish: Denne virkning sås tidligt og varede ved gennem hele studieperioden (se Figur 1).
English: Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Neparvis affects you.
Danish: Før du kører bil, bruger værktøj eller betjener maskiner eller udfører andre aktiviteter, som kræver koncentration, skal du sikre dig, at du ved, hvordan Neparvis påvirker dig.
English: KM estimate of cumulative failure rate (%)
Danish: KM estimat for den kumulative rate af hændelser (%)
English: Limited data are available with regard to overdose in humans.
Danish: Der foreligger begrænsede data vedrørende overdosering hos mennesker.
English: Do not take a double dose to make up for a forgotten tablet.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: If you feel dizzy or very tired while taking this medicine, do not drive a vehicle, cycle or use any tools or machines.
Danish: Hvis du føler dig svimmel eller meget træt, mens du tager dette lægemiddel, må du ikke køre bil, cykle eller bruge noget værktøj eller maskiner.
English: The mean age of the population studied was 64 years of age and 19% were 75 years of age or older.
Danish: Studiepopulationens gennemsnitsalder var 64 år, og 19 % var 75 år eller ældre.
English: PVC/PVDC/Aluminium blisters.
Danish: PVC/PVDC/Aluminium blistre.
English: Your doctor will decide your exact starting dose based on which medicines you have been taking previously.
Danish: Din læge vil bestemme din nøjagtige startdosis baseret på, hvilken medicin du tidligere har taget.
English: This type of heart failure occurs when the heart is weak and cannot pump enough blood to the lungs and the rest of the body.
Danish: Denne type hjertesvigt opstår, når hjertet er svagt og ikke kan pumpe nok blod til lungerne og resten af kroppen.
English: Your doctor will then adjust the dose depending on how you respond to the treatment until the best dose for you is found.
Danish: Din læge vil derefter justere dosis afhængigt af, hvordan du reagerer på behandlingen, indtil den bedste dosis for dig er fundet.
English: Candesartan 32 * These limits are not applicable for batches where more than one of the above N-nitrosamines has been identified simultaneously; such batches should be rejected.
Danish: Candesartan 32 * Disse grænseværdier gælder ikke batcher, hvor mere end ét af ovenstående N-nitrosaminer er identificeret samtidigt; sådanne batcher bør afvises.
English: Fertility, reproduction and development
Danish: Fertilitet, reproduktion og udvikling
English: If a diuretic is also used, the risk of lithium toxicity may be increased further.
Danish: Hvis der også gives et diuretikum, kan risikoen for lithiumtoksicitet være yderligere øget.
English: Do not use any Neparvis pack that is damaged or shows signs of tampering.
Danish: Brug ikke en Neparvis-pakning, som er beskadiget eller viser tegn på at have været åbnet.
English: ***One-sided p-value
Danish: ***En-sidet p-værdi
English: Do not stop taking your medicine unless your doctor tells you to.
Danish: Stop ikke med at tage din medicin, med mindre din læge har bedt dig om det.
English: The tablets must be swallowed with a glass of water.
Danish: Tabletterne skal synkes med et glas vand.
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Neparvis.
Danish: Din læge vil normalt råde dig til at stoppe med at tage denne medicin, før du bliver gravid, eller så snart du ved, at du er gravid og vil råde dig til at tage en anden medicin end Neparvis.
English: • medicines that increase the amount of potassium in the blood.
Danish: • lægemidler, som øger mængden af kalium i blodet.
English: The safety and efficacy of Neparvis in children and adolescents aged below 18 years have not been established.
Danish: Neparvis' sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Treatment should not be initiated unless SBP is ≥100 mmHg.
Danish: Behandling må ikke initieres, medmindre SBT er ≥100 mmHg.
English: This medicine is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if it is used after the third month of pregnancy.
Danish: Denne medicin bør ikke bruges i den tidlige fase af graviditeten, og den må ikke tages, når du er mere end 3 måneder henne i graviditeten, da det kan føre til alvorlig skade på din baby, hvis den bruges efter tredje måned i graviditetsforløbet.
English: This is because it has not been studied in this age group.
Danish: Grunden er, at der ikke er gennemført forsøg for denne aldersgruppe.
English: If this happens, your doctor may reduce the dose of any other medicine you are taking, temporarily reduce your Neparvis dose, or stop your Neparvis treatment completely.
Danish: Hvis dette sker, kan din læge vælge at nedsætte dosis af eventuel anden medicin, du tager, nedsætte dosis af Neparvis midlertidigt, eller fuldstændigt stoppe din behandling med Neparvis.
English: When driving vehicles or operating machines it should be taken into account that occasionally dizziness or fatigue may occur.
Danish: Ved bilkørsel eller betjening af maskiner skal der tages hensyn til, at der lejlighedsvis kan opstå svimmelhed eller træthed.
English: The median follow-up duration was 27 months and patients were treated for up to 4.3 years.
Danish: Den gennemsnitlige opfølgningsperiode var 27 måneder, og patienterne blev behandlet i op til 4,3 år.