FrancophonIA/ELRC3.0 huggingface dataset:
English: Once the PhVWP had received and started its assessment of the data, the working party had further concerns about the medicines, and consequently, on 14 May 2009, the UK medicines regulatory agency asked the CHMP to carry out a full assessment of the benefit-risk balance of modafinilcontaining medicines, and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union.
Danish: Da PhVWP havde modtaget og påbegyndt sin vurdering af dataene, fik arbejdsgruppen yderligere betænkeligheder ved lægemidlerne, og derfor bad lægemiddelkontrolmyndigheden i Det Forende Kongerige den 14. maj 2009 CHMP om at udføre en fuld vurdering af risk/benefit-forholdet for lægemidler indeholdende modafinil og om at komme med en udtalelse om, hvorvidt deres markedsføringstilladelser skulle opretholdes, ændres, suspenderes eller trækkes tilbage i hele EU.
English: In addition the Committee also recommended that modafinil-containing medicines not be used in patients with uncontrolled hypertension or irregular heart beat.
Danish: Derudover anbefalede udvalget, at lægemidler indeholdende modafinil ikke blev anvendt til patienter med ukontrolleret hypertension eller uregelmæssig hjerterytme.
English: The exact way modafinil works is not fully understood, but it most likely interacts with some chemicals in the brain called neurotransmitters such as dopamine and norepinephrine.
Danish: Virkningsmekanismen for modafinil er ikke fuldt klarlagt, men sandsynligvis interagerer stoffet med visse kemiske stoffer i hjernen kaldet neurotransmittere som f.eks. dopamin og noradrenalin.
English: In addition, data on the misuse of modafinil by university students, currently being collected, will be analysed once available.
Danish: Derudover skal data, som er ved at blive indsamlet om universitetsstuderendes misbrug af modafinil, analyseres, når disse data foreligger.
English: Modafinil-containing medicines are used in patients who suffer from excessive sleepiness.
Danish: Lægemidler indeholdende modafinil bruges til patienter, som lider af overdreven søvnighed.
English: These include informing healthcare professional of the changes to the product information triggered by this latest review, and putting in place studies looking at the cardiovascular and skin safety of modafinil.
Danish: Disse omfatter oplysning af sundhedsfaglige personer om de ændringer i produktinformationen, som følger den seneste vurdering, og iværksættelse af undersøgelser, hvor man undersøger den kardiovaskulære og kutane sikkerhed ved modafinil.
English: The CHMP also recommended further changes to the product information to ensure that the medicines are used appropriately, and asked the manufacturers to put in place risk minimisation measures.
Danish: CHMP anbefalede også yderligere ændringer af produktinformationen for at sikre, at lægemidlerne anvendes korrekt, og har bedt producenterne om at etablere risikominimerende foranstaltninger.
English: Looking at the safety data, the Committee noted that modafinil is strongly linked to a risk of serious, life-threatening skin reactions, and this risk appears higher in children.
Danish: Efter en gennemgang af sikkerhedsdataene bemærkede udvalget, at modafinil er tæt forbundet med en risiko for alvorlige, livstruende hudreaktioner, og denne risiko synes at være højere hos børn.
English: • Doctors prescribing modafinil-containing medicines should keep in mind the change in the indication: modafinil is only indicated to treat narcolepsy.
Danish: • Læger, som ordinerer lægemidler indeholdende modafinil, skal være opmærksomme på den ændrede indikation: modafinil er kun indiceret til behandling af narkolepsi.
English: For obstructive sleep apnoea (including in patients with excessive sleepiness despite correctly using a Continuous Positive Airway Pressure machine), shift-work sleep disorder and idiopathic hypersomnia, the CHMP concluded that the data on the effectiveness were not sufficient to outweigh the risks, and that therefore the benefit-risk balance was negative.
Danish: Med hensyn til obstruktiv søvnapnø (herunder patienter med overdreven søvnighed på trods af korrekt anvendelse af et CPAP-apparat (kontinuerlig overtryksbehandling)), søvnforstyrrelse på grund af skifteholdsarbejde og idiopatisk hypersomni konkluderede CHMP, at dataene vedrørende virkning ikke var tilstrækkelige til at opveje risiciene, og at risk/benefit-forholdet derfor var negativt.
English: In 2007, the CHMP's Pharmacovigilance Working Party (PhVWP) reviewed the safety of modafinilcontaining medicines because of concerns that the medicines were associated with serious psychiatric disorders (suicidal thoughts, mania and symptoms of psychosis such as delusion) and with skin reactions, including severe reactions such as Stevens-Johnson syndrome, a life-threatening type of allergic reaction affecting the skin and mucous membranes.
Danish: I 2007 vurderede CHMP's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP) sikkerheden ved lægemidler indeholdende modafinil på grund af bekymringer om, at lægemidlerne var forbundet med alvorlige psykiatriske lidelser (selvmordstanker, mani og symptomer på psykose som f.eks. vrangforestillinger) og med hudreaktioner, herunder svære reaktioner som f.eks. Stevens-Johnsons syndrom, en livstruende allergisk reaktion, som påvirker huden og slimhinderne.
English: • Doctors should also be aware of the safety profile of modafinil-containing medicines, and they should monitor their patients appropriately.
Danish: • Lægerne skal være opmærksomme på sikkerhedsprofilen for lægemidler indeholdende modafinil, og de skal monitorere deres patienter omhyggeligt.
English: This can be seen in people who work a shift-pattern or in those who suffer from obstructive sleep apnoea (a condition in which pauses in breathing occur repeatedly during the night, disturbing sleep).
Danish: Dette kan ses hos personer, som arbejder i skiftehold, eller personer, som lider af obstruktiv søvnapnø (en lidelse, hvor der forekommer gentagne vejrtrækningspauser om natten, hvilket forstyrrer søvnen).
English: • Patients who are receiving modafinil-containing medicines should contact their doctors at a convenient time to check that they should continue receiving it.
Danish: • Patienter, som får lægemidler indeholdende modafinil, skal kontakte deres læge på et passende tidspunkt for at få tjekket, at de kan fortsætte med behandlingen.
English: Excessive sleepiness can be caused by narcolepsy, a disease that causes the person to fall asleep during the day, or it can be due to disturbed night-time sleeping patterns leading to daytime sleepiness.
Danish: Overdreven søvnighed kan være forårsaget af narkolepsi, som er en sygdom, hvor patienten falder i søvn om dagen, eller forstyrrelse i det natlige søvnmønster, som medfører søvnighed om dagen.
English: The Committee also noted a link between modafinil and psychiatric adverse reactions, such as suicidal thoughts, depression, psychotic episodes, and between modafinil and cardiovascular adverse reactions, such as hypertension (high blood pressure) and irregular heart beat.
Danish: Udvalget bemærkede også en forbindelse mellem modafinil og psykiatriske bivirkninger som f.eks. selvmordstanker, depression og psykotiske episoder og mellem modafinil og kardiovaskulære bivirkninger som f.eks. hypertension (forhøjet blodtryk) og uregelmæssig hjerterytme.
English: The PhVWP also asked the companies that make modafinil-containing medicines to provide all information they had to assess if further measures were needed.
Danish: PhVWP anmodede også de virksomheder, som fremstiller lægemidler indeholdende modafinil, om at fremlægge alle de oplysninger, som de havde, for at vurdere, om der var behov for yderligere foranstaltninger.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of modafinil-containing medicines continue to outweigh their risks but that their use should be restricted to the treatment of narcolepsy.
Danish: EMA's udvalg for lægemidler til mennesker (CHMP) har konkluderet, at fordelene ved lægemidler indeholdende modafinil fortsat opvejer risiciene, men at brugen af disse skal begrænses til behandling af narkolepsi.
English: The CHMP also reviewed all the side effects reported with modafinil-containing medicines.
Danish: CHMP vurderede også alle bivirkninger, som er rapporteret i forbindelse med lægemidler indeholdende modafinil.
English: Looking at the data from the clinical trials, the Committee noted that the effectiveness of modafinil in narcoleptic patients had been shown.
Danish: Efter en gennemgang af dataene fra de kliniske undersøgelser bemærkede udvalget, at effekten af modafinil til narkoleptiske patienter var blevet påvist.
English: • Modafinil should no longer be used to treat: Obstructive sleep apnoea; Shift work sleep disorder; Idiopathic hypersomnia.
Danish: • Modafinil må ikke længere bruges til behandling af: Obstruktiv søvnapnø, Søvnforstyrrelse på grund af skifteholdsarbejde, Idiopatisk hypersomni.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of modafinil-containing medicines continue to outweigh their risks only in the treatment of narcolepsy.
Danish: På baggrund af vurderingen af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende modafinil fortsat kun opvejer risiciene i forbindelse med behandling af narkolepsi.
English: The Committee looked at all the data from the clinical trials of modafinil in narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and at articles from the published literature.
Danish: Udvalget gennemgik alle data fra kliniske undersøgelser af modafinil til behandling af narkolepsi, obstruktiv søvnapnø, søvnforstyrrelse på grund af skifteholdsarbejde og idiopatisk hypersomni samt artikler fra den publicerede litteratur.
English: The Committee also noted the increased risk of serious life-threatening skin reactions with modafinil in children and advised against its use in children.
Danish: Udvalget bemærkede også den øgede risiko for alvorlige livstruende hudreaktioner med modafinil til børn og frarådede brug af stoffet til børn.
English: Because the Committee noted in its review that modafinil has often been used for conditions for which it is not indicated, the companies have also been asked to carry out further studies, including a ‘drug utilisation study' to look at why family doctors prescribe the medicines.
Danish: Da udvalget i sin vurdering bemærkede, at modafinil ofte er blevet brugt til lidelser, til hvilke det ikke er indiceret, er virksomhederne også blevet bedt om at udføre yderligere undersøgelser, herunder en
English: The CHMP has also asked the companies that make modafinil-containing medicines to put in place measures to minimise the risks.
Danish: CHMP har også anmodet de virksomheder, som producerer lægemidler indeholdende modafinil, om at tage risikominimerende forholdsregler.
English: This plan should address the following:
Danish: Denne plan skal omhandle følgende:
English: Training for the patients will be via a healthcare professional.
Danish: Patientens træning vil blive foretaget af sundhedspersonalet.
English: ¾ The Member States must ensure that the education plans for health care professionals and patients contain the measures to minimise the risks as detailed below,
Danish: Medlems landene skal sikre, at uddannelsesplanen for sundhedspersonale og patienter indeholder parametere der har til formål at minimerer de risici der er specificeret herunder.
English: • An educational plan for patients, which is aimed at risk minimisation and to support safe and effective use for the product.
Danish: • En uddannelsesplan for patienter, som har til formål at minimere risikoen ved og understøtte sikker og effektiv anvendelse af produktet.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE ADDRESSED TO THE MEMBER STATES
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET SOM SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: • An educational plan for physicians and health care providers, which is aimed at risk minimisation and to support safe and effective use for the product.
Danish: • En uddannelsesplan for læger og sundhedspersonale, som har til formål at minimere risikoen ved og understøtte sikker og effektiv anvendelse af produktet.
English: Use in patients with a history of drug abuse
Danish: Anvendelse til patienter med tidligere misbrug Bortskaffelse iht.
English: EU/1/09/600/001
Danish: EU/1/09/600/001 Zutectra
English: Pre-filled syringe (glass) 1 ml
Danish: 500 IU Injektionsvæske, opløsning Subkutan anvendelse Fyldt injektionssprøjte (glas) 1 ml
English: Zutectra
Danish: Indgivelsesvej
English: Before you start
Danish: Inden du starter
English: No specific measures are usually required.
Danish: Der kræves normalt ingen særlige forholdsregler.
English: Lay out everything you need on a clean surface:
Danish: Læg alt, hvad du skal bruge, på en ren overflade:
English: Do not use any other sort of water.
Danish: Brug ikke andre former for vand.
English: Your doctor will tell you the exact date and time.
Danish: Din læge vil oplyse dig om den præcise dato og tidspunkt.
English: You can choose to inject every morning or every evening.
Danish: Du kan vælge at indsprøjte hver morgen eller hver aften.
English: Wash your hands • It is important that your hands and the things you use are as clean as possible.
Danish: • Det er vigtigt, at dine hænder og de ting, du bruger, er så rene som muligt.
English: • Your doctor must supervise your first injection.
Danish: • Din læge skal overvåge din første injektion.
English: • This medicine is only for you - do not let anyone else use it.
Danish: • Denne medicin er kun beregnet til dig - lad aldrig andre tage den.
English: It is best to use the medicine at the same time each day, leaving 24 hours between each dose.
Danish: Det er bedst at bruge medicinen på samme tidspunkt hver dag med 24 timer mellem hver dosis.
English: Administration in the morning
Danish: Administration om morgenen
English: DATE OF REVISION OF THE TEXT {DD/MM/YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {DD/MM/ÅÅÅÅ}
English: The effect of the medicine will last for longer.
Danish: Medicinen vil virke længere.
English: Do not use Cetrotide if any of the above applies to you.
Danish: Brug ikke Cetrotide, hvis et eller flere af ovenstående punkter gælder for dig.
English: The adverse reactions reported below are classified according to frequency of occurrence as follows: 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).
Danish: Bivirkningerne rapporteret herunder er klassificeret efter hvor ofte, de forekommer: 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).
English: • Do not inject a double dose to make up for a forgotten dose.
Danish: • Du må ikke indsprøjte en dobbeltdosis som erstatning for den glemte dosis.
English: Uncommon: Severe OHSS (WHO grade III)
Danish: Ikke almindelig: Alvorlig OHSS (WHO grad III)
English: Your doctor or nurse will show you how to prepare and inject the medicine.
Danish: Din læge eller sygeplejerske vil vise dig, hvordan du skal klargøre og indsprøjte medicinen.
English: Vigorous shaking with bubble formation should be avoided.
Danish: Kraftig rysten med dannelse af bobler bør undgås.
English: Based on your ovarian response, your doctor may decide to start on another day.
Danish: Baseret på responset fra dine æggestokke, kan lægen beslutte at starte på en anden dag.
English: Unopened vial: 2 years
Danish: Uåbnet hætteglas: 2 år.
English: Administration in the evening
Danish: Administration om aftenen
English: You may be having a possible serious, life-threatening allergic reaction to the medicine.
Danish: Du kan have fået en mulig alvorlig, livstruende allergisk reaktion over for medicinen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/100/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/99/100/001
English: The onset of suppression is virtually immediate and is maintained by continuous treatment, without initial stimulatory effect.
Danish: Starten på undertrykkelsen er næsten øjeblikkelig og opretholdes ved kontinuert behandling uden indledende stimulerende virkning.
English: Overdosage in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects.
Danish: Overdosering hos mennesker kan medføre forlænget indvirkningsvarighed, men kan sandsynligvis ikke forbindes med akut toksiske virkninger.
English: Inversely, severe OHSS remains uncommon.
Danish: Derimod er alvorlig OHSS ikke almindeligt.
English: Do not use this medicine if you notice that the white powder in the vial has changed in appearance.
Danish: Brug ikke lægemidlet, hvis du bemærker, at det hvide pulver i hætteglasset har skiftet udseende.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 April 1999
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 13. april 1999 Dato for seneste fornyelse: 13. april 2009
English: Distribution The volume of distribution (Vd) is 1.1 L x kg
Danish: Fordeling Fordelingsvoluminet (Vd) er 1,1 l x kg
English: Cetrotide is one of the medicines used during ‘assisted reproductive techniques' to help you get pregnant.
Danish: Cetrotide er et af de lægemidler, der anvendes i forbindelse med 'assisteret reproduktionsteknik' som hjælp til at blive gravid.
English: No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.
Danish: Der forekom ingen teratogene virkninger, når lægemidlet blev indgivet under den følsomme gestationsfase.
English: Therefore, cetrorelix should be used in repeated cycles only after a careful benefit/risk evaluation.
Danish: Cetrorelix bør derfor kun anvendes ved gentagne cykluser efter en grundig vurdering af benefit/risk-forholdet.
English: Repeated ovarian stimulation procedure
Danish: Gentagen ovariestimulationsprocedure
English: • If you forget a dose, inject it as soon as you remember and talk to your doctor.
Danish: • Hvis du har glemt en dosis, skal du indsprøjte den, så snart du kommer i tanker om det, og kontakte lægen.
English: Pharmacotherapeutic group: anti-gonadotropin-releasing hormones, ATC code: H01CC02.
Danish: Farmakoterapeutisk klassifikation: Anti-gonadotropin-releasing hormoner, ATC-kode: H01CC02.
English: During or after you receive these medicines, you may develop OHSS.
Danish: Mens du får, eller efter at du har fået disse lægemidler, kan du eventuelt udvikle OHSS.
English: However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.
Danish: Muligheden for interaktioner med gonadotropiner eller lægemidler, der kan fremkalde frigivelse af histamin i modtagelige personer, kan imidlertid ikke helt udelukkes.
English: Do not use Cetrotide
Danish: Brug ikke Cetrotide
English: Remove from the refrigerator approximately 30 minutes before use.
Danish: Fjern fra køleskabet ca. 30 minutter før brug.
English: This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins
Danish: Dette må dog betragtes som en væsentlig risiko ved stimulationsprocessen med gonadotropiner.
English: - The other ingredients are:
Danish: • Øvrige indholdsstoffer:
English: • This section tells you how to mix the powder and the sterile water (solvent) together and then how to inject your medicine.
Danish: • I dette afsnit beskrives, hvordan du blander pulveret og det sterile vand (solvens), og derefter hvordan du indsprøjter medicinen.
English: • During pregnancy and lactation.
Danish: • Under graviditet og amning.
English: In clinical trials, these effects were observed with a frequency of 9.4% following multiple injections of Cetrotide 0.25 mg.
Danish: I kliniske undersøgelser blev disse virkninger observeret med en frekvens på 9,4% efter flere injektioner med Cetrotide 0,25 mg.
English: Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Danish: Efter første indgivelse, anbefales det, at patienten holdes under opsyn af en medicinsk kyndig person i 30 minutter, for at sikre, at der ikke opstår en allergisk/pseudoallergisk reaktion på injektionen.
English: The starting day of Cetrotide is depending on the ovarian response, i.e. the number and size of growing follicles and/or the amount of circulating oestradiol.
Danish: Opstartsdagen for Cetrotide afhænger af ovarieresponset, det vil sige antallet og størrelse af voksende follikler og/eller niveauet af cirkulerende østradiol.
English: If blood appears:
Danish: Hvis der kommer blod
English: The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the medicinal product in a slow rate to facilitate the progressive absorption of the medicinal product.
Danish: Reaktioner på injektionsstedet kan minimeres ved at skifte mellem injektionsstederne, udsætte injektion på samme sted og injicere lægemidlet langsomt for at fremme den progressive absorption af lægemidlet.
English: • You start by using another medicine on day 1 of your treatment cycle.
Danish: • Du begynder med at tage et andet lægemiddel den 1. dag i din behandlingscyklus.
English: EXP After reconstitution, use immediately.
Danish: EXP Efter rekonstitution, anvendes umiddelbart.
English: Children and adolescents Cetrotide is not indicated for the use in children and adolescents.
Danish: Børn og unge Cetrotide er ikke indiceret til børn og unge.
English: Cetrorelix is not to be used in the presence of any of the conditions listed below:
Danish: Cetrorelix må ikke anvendes, hvis nogle af de nedenfor anførte tilstande er til stede:
English: Additionally, for each vial the pack contains:
Danish: For hvert hætteglas indeholder pakningen desuden:
English: The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple's infertility or the ART procedures.
Danish: Forekomsten af medfødte anomalier efter anvendelsen af assisteret reproduktionsteknik (ART) sammen med eller uden GnRH-antagonister kan være en smule højere end efter spontan konception, selvom det er uklart, om dette er relateret til nogle af de faktorer, der forårsager parrets infertilitet eller til ART-procedurerne.
English: In animals as well as in humans, the antagonistic hormonal effects of cetrorelix were fully reversible after termination of treatment.
Danish: Hos såvel dyr som mennesker var de antagonistiske hormonelle virkninger af cetrorelix fuldt reversible efter afsluttet behandling.
English: In case you pulled out the plunger with the plunger stopper by mistake, make sure to discard the dose as sterility will be lost, and prepare a new dose (and restart from step 1).
Danish: Hvis du ved en fejltagelse trækker stemplet med stempelproppen ud, skal du smide dosen ud, da den ikke længere vil være steril, og du skal forberede en ny dosis (og starte igen fra trin 1).
English: This is when your follicles develop too much and become large cysts.
Danish: Dette indebærer, at folliklerne overudvikles og bliver til store cyster.
English: Absorption The absolute bioavailability of cetrorelix after subcutaneous administration is about 85%.
Danish: Absorption Den absolutte biotilgængelighed for cetrorelix efter subkutan indgivelse er cirka 85%.
English: It should be removed from the refrigerator approximately 30 minutes before use.
Danish: Det skal tages ud af køleskabet ca. 30 minutter før brug.