FrancophonIA/ELRC3.0 huggingface dataset:
English: MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Danish: Multipel sklerose er en sygdom, hvor betændelse beskadiger nerverne og det beskyttende lag omkring dem (demyelinisering).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rebif have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Rebif.
English: It is used when the patient is considered to be at high risk of developing MS. Before using Rebif, doctors need to exclude other causes for the symptoms.
Danish: Før anvendelse af Rebif skal lægen udelukke andre årsager til symptomerne.
English: Rebif has also been studied in patients with secondary progressive MS. Rebif had no significant effect on the progression of disability, but the relapse rate was reduced by about 30%.
Danish: Rebif havde ikke nogen nævneværdig virkning på forværringen af invaliditeten, men tilbagefaldsraten blev reduceret med ca. 30 %.
English: 3 x 30 tablets (multipack)
Danish: 3 x 30 tabletter (multipakni ng)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke Lægemiddelfor m
English: Route of Administration
Danish: Administration Indhold (Koncentra tion)
English: Progressive means that symptoms get steadily worse over time.
Danish: Progressiv betyder, at symptomerne bliver stadig værre over tid.
English: In addition, the Committee was of the opinion that more information was needed about how the medicine is absorbed, modified and removed from the body.
Danish: Desuden var udvalget af den holdning, at det var nødvendigt med yderligere oplysninger om, hvordan lægemidlet absorberes, modificeres og fjernes fra kroppen.
English: Qizenday is a medicine that contains the active substance biotin.
Danish: Qizenday er et lægemiddel, der indeholder det aktive stof biotin.
English: It was to be available as capsules to be taken by mouth.
Danish: Det skulle have været leveret som kapsler, der tages gennem munden.
English: The main measure of effectiveness was improvement in vision.
Danish: Det primære mål for virkningen var forbedring af synet.
English: What is Qizenday?
Danish: Hvad er Qizenday?
English: The first study involved 154 patients with spinal progressive multiple sclerosis.
Danish: I den første undersøgelse deltog 154 patienter med spinal progressiv multipel
English: Three of these enzymes are involved in energy production, while a fourth is believed to be involved in the production of sheaths around the nerve cells.
Danish: Tre af disse enzymer er involveret i energiproduktionen, mens et fjerde menes at være involveret i dannelsen af skeder omkring nervecellerne.
English: What was Qizenday expected to be used for?
Danish: Hvad forventedes Qizenday anvendt til?
English: The main
Danish: sklerose.
English: Withdrawal of the marketing authorisation application for Qizenday (biotin)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Qizenday (biotin)
English: Withdrawal of the marketing authorisation application for Qizenday (biotin) EMA/821654/2017
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Qizenday (biotin) EMA/821654/2017
English: measure of effectiveness was the number of patients whose overall disability decreased and whose ability to walk improved.
Danish: Det primære mål for virkningen var antallet af patienter, hvis samlede invaliditet faldt, og hvis gangevne blev forbedret.
English: The company presented data from two main studies comparing Qizenday with placebo (a dummy treatment).
Danish: Virksomheden fremlagde data fra to hovedundersøgelser, der sammenlignede Qizenday med placebo (ikke-aktivt stof).
English: The CHMP considered that the data on the medicine's effectiveness were not robust enough, and that there were uncertainties regarding the medicine's safety given the small number of patients treated with Qizenday.
Danish: CHMP fandt, at dataene for lægemidlets virkning ikke var solide nok, og at der var usikkerhed med hensyn til sikkerheden ved lægemidlet på grund af det lille antal patienter, der var behandlet med Qizenday.
English: Symptoms include weakness, difficulty walking and problems with vision.
Danish: Symptomerne omfatter svaghed, gangbesvær og synsforstyrrelser.
English: The second study involved 93 patients with multiple sclerosis who had visual loss due to inflammation of the optic nerve.
Danish: Den anden undersøgelse omfattede 93 patienter med multipel sklerose, der havde synstab på grund af betændelse i den optiske nerve.
English: On 13 November 2017, Medday Pharmaceuticals officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Qizenday, for the treatment of progressive multiple sclerosis.
Danish: Den 13. november 2017 meddelte Medday Pharmaceuticals officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Qizenday til behandling af progressiv multipel sklerose.
English: Qizenday was to be used to treat adults with the progressive form of multiple sclerosis, a disease in which the protective sheath around the nerve cells in the brain and spinal cord is damaged, and the nerves progressively degenerate.
Danish: Qizenday forventedes anvendt til behandling af voksne med den progressive form af multipel sklerose, der er en sygdom, hvor den beskyttende skede omkring nervecellerne i hjernen og rygmarven er beskadiget, og nerverne progressivt degenerer.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Qizenday did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Qizenday ikke opvejede risiciene.
English: After the CHMP had assessed the company's responses to the last round of questions, there were still some unresolved issues.
Danish: Efter CHMP's vurdering af virksomhedens svar på den sidste spørgsmålsrunde, var der fortsat visse uafklarede punkter.
English: Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Qizenday could not have been approved for the treatment of progressive multiple sclerosis.
Danish: På baggrund af gennemgangen af dataene og virksomhedens svar på CHMP's lister med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Qizenday ikke kunne være blevet godkendt til behandling af progressiv multipel sklerose.
English: How does Qizenday work?
Danish: Hvordan virker Qizenday?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes using Qizenday.
Danish: Virksomheden har til CHMP oplyst, at der ikke er nogen konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser eller i programmer for anvendelse af Qizenday med særlig udleveringstilladelse.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on the CHMP's opinion that the clinical data presented do not allow the Committee to conclude on a positive benefit-risk balance for Qizenday.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at baggrunden for tilbagetrækningen er CHMP's udtalelse om, at de fremlagte kliniske data ikke sætter udvalget i stand til at konkludere, at benefit/risk-forholdet for Qizenday er positivt.
English: The mechanism of action of Qizenday in multiple sclerosis is not well understood; however, it is thought that the medicine acts on enzymes (known as carboxylases) to increase energy production in the damaged nerves and to help repair the protective sheath around the nerve cells.
Danish: Det menes dog, at lægemidlet får en række enzymer, der hedder carboxylaser, til at øge energiproduktionen i de beskadigede nerver og bidrage til reparationen af den beskyttende skede omkring nervecellerne.
English: These checks may include:
Danish: Disse kontroller kan omfatte:
English: This will show if you still need to take the medicine.
Danish: Dette vil vise, om du stadig har behov for at tage medicinen.
English: • you have fainted recently
Danish: • du for nylig er besvimet
English: • concentrate.
Danish: • koncentrere sig.
English: Take the medicine pack with you and tell them how much you have taken.
Danish: Tag medicinpakningen med dig, og fortæl dem, hvor meget du har taget.
English: • you have thoughts or feelings of suicide
Danish: • du har tanker eller følelser om selvmord
English: Children under 6 years
Danish: Børn under 6 år
English: • Your doctor will start you on 1 mg per day.
Danish: • Din læge vil starte dig på 1 mg dagligt.
English: They can find it hard to behave well at home, at school or in other places.
Danish: De kan have svært med at opføre sig ordentligt hjemme, i skolen og andre steder.
English: Syncope has also been observed.
Danish: Der er også blevet observeret synkope.
English: Fainting has also been reported but is not a common effect.
Danish: Besvimelse er også blevet rapporteret, men det er ikke er almindelig virkning.
English: • your height and weight
Danish: • din højde og vægt
English: • sit still
Danish: • sidde stille
English: Activated charcoal may be useful in limiting the absorption.
Danish: Aktivt kul kan være nyttigt til at begrænse absorptionen.
English: This is because this medicine can make these problems worse.
Danish: Dette lægemiddel kan nemlig forværre disse problemer.
English: The following serious side effects have been reported.
Danish: De følgende alvorlige bivirkninger er blevet rapporteret.
English: • This medicine should be taken once a day either in the morning or evening.
Danish: • Dette lægemiddel bør tages en gang dagligt, enten om morgenen eller aftenen.
English: • This leaflet has been written as though the person taking the medicine is reading it.
Danish: • Denne indlægsseddel er blevet skrevet, som om personen, der tager lægemidlet, læser den.
English: Lactose is a type of sugar.
Danish: Lactose er en type sukker.
English: • seeing or hearing things that are not there (hallucination).
Danish: • se eller høre ting, som ikke eksisterer (hallucinationer).
English: These small changes are not expected to be clinically meaningful.
Danish: Disse små ændringer forventes ikke at have klinisk betydning.
English: If you forget a dose, wait until the next day and take your usual dose.
Danish: Hvis du har glemt en dosis, skal du vente til næste dag og tage din sædvanlige dosis.
English: ADHD can cause problems with everyday life.
Danish: ADHD kan give problemer i hverdagen.
English: This medicine belongs to a group of medicines which affects brain activity.
Danish: Dette lægemiddel tilhører en gruppe lægemidler, som påvirker hjerneaktiviteten.
English: The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10)
Danish: Følgende definitioner gælder for den herefter anvendte terminologi for hyppighed: Meget almindelig (≥1/10)
English: Adolescent subjects must weigh at least 34 kg.
Danish: Unge skal veje mindst 34 kg.
English: ADHD does not affect the intelligence of a child or young person.
Danish: ADHD påvirker ikke intelligensen hos et barn eller en ung person.
English: This medicine can help improve your attention, concentration and make you less impulsive and hyperactive.
Danish: Dette lægemiddel kan hjælpe dig med at forbedre din opmærksomhed og gør dig mindre impulsiv og hyperaktiv.
English: Children (under 6 years old) and adults (18 years and over)
Danish: Børn (under 6 år) og voksne (18 år og derover)
English: Treatment is recommended only for children who are able to swallow the tablet whole without problems.
Danish: Behandlingen anbefales kun for børn, der er i stand til at sluge tabletten hel uden problemer.
English: The medicine is given as part of a treatment programme, which usually includes the following:
Danish: Medicinen gives som en del af et behandlingsprogram, der normalt omfatter:
English: Formal pharmacokinetic studies for race have not been conducted.
Danish: Formelle farmakokinetik-studier af race er ikke blevet udført.
English: Difference from placebo (95%CI)
Danish: Forskel fra placebo (95 % CI)
English: Tel + 44 (0) 1256 894 959 e-mail medinfoEMEA@shire.com
Danish: Tlf. + 44 (0) 1256 894 959 e-mail medinfoEMEA@shire.com
English: This is because Intuniv and some other medicines can affect each other.
Danish: Intuniv og nogle andre lægemidler kan nemlig påvirke hinanden.
English: • you suffer from any other psychiatric conditions
Danish: • du lider af andre psykiske sygdomme
English: Weight Group a
Danish: Vægtgruppe a
English: Used to control epilepsy.
Danish: Bruges til at kontrollere epilepsi.
English: Depending on how you respond to treatment your doctor may increase your dose more slowly.
Danish: Afhængigt af, hvordan du reagerer på behandlingen, kan din læge øge dosis mere langsomt.
English: Results of the secondary endpoints were consistent with that of the primary endpoint.
Danish: Resultaterne for de sekundære endepunkter var i overensstemmelse med resultaterne for det primære endepunkt.
English: Dose should be individualised according to the patient's response and tolerability.
Danish: Dosis bør justeres individuelt i henhold til patientens respons og tolerabilitet.
English: Date of first authorisation: 17/09/2015
Danish: Dato for første markedsføringstilladelse: 17. september 2015
English: Treatment of an underlying psychiatric condition may be necessary and consideration should be given to a possible change in the ADHD treatment programme.
Danish: Behandling af en underliggende psykisk sygdom kan være nødvendig, og en mulig ændring i behandlingsprogrammet for ADHD bør overvejes.
English: • sleeping more than normal (hypersomnia)
Danish: • sover mere end normalt (hypersomni)
English: People with ADHD find it hard to:
Danish: Personer med ADHD har besvær med at:
English: The elimination half-life of guanfacine is approximately 18 hours.
Danish: Eliminationshalveringstiden for guanfacin er ca. 18 timer.
English: An apparent increase in mean QTc was observed for both doses.
Danish: En tilsyneladende forhøjelse i gennemsnitlig QTc blev observeret for begge doser.
English: Intuniv with food, drinks and alcohol
Danish: Brug af Intuniv sammen med mad, drikke og alkohol
English: Before you start taking this medicine your doctor will check to make sure this medicine is safe for you and that it will help you.
Danish: Før du begynder at tage dette lægemiddel vil din læge kontrollere, at dette lægemiddel er sikkert for dig, og at det vil hjælpe dig.
English: Children and young people with ADHD may have difficulty learning and doing homework.
Danish: Børn og unge personer med ADHD kan have problemer med indlæring og med at lave lektier.
English: Patients should not drink alcohol whilst taking Intuniv.
Danish: Patienter må ikke drikke alkohol, mens de tager Intuniv.
English: Your doctor will routinely monitor you to see how this medicine affects you.
Danish: Din læge vil overvåge dig rutinemæssigt for at se, hvordan lægemidlet påvirker dig.
English: Guanfacine is not dialysable in clinically significant amounts (2.4%).
Danish: Guanfacin kan ikke dialyseres i klinisk signifikante mængder (2,4 %).
English: Intuniv is taken once daily either morning or evening.
Danish: Intuniv tages en gang dagligt enten om morgenen eller om aftenen.
English: Active renal secretion is mediated via OCT2 transporter.
Danish: Den aktive nyresecernering medieres via OCT2-transporteren.
English: Co-administration with Psychostimulants
Danish: Administration sammen med psykostimulantia
English: • Swallow the tablet whole with a drink of water or other liquid (but not grapefruit juice).
Danish: • Slug tabletten hel sammen med vand eller anden væske (men ikke grapefrugtjuice).
English: Therefore, a risk on the breast-fed infant cannot be excluded.
Danish: Derfor kan en risiko for det ammede spædbarn ikke udelukkes.
English: The results with respect to the primary endpoint study are presented in Table 5.
Danish: Resultaterne med hensyn til studiet af det primære endepunkt vises i tabel 5.
English: If this happens do not drive, cycle, use any tools or machines or participate in activities that could cause injury until you know how this medicine affects you.
Danish: Hvis dette forekommer, må du ikke føre motorkøretøj, cykle, betjene værktøj eller maskiner eller deltage i aktiviteter, der kan forårsage personskade, indtil du ved, hvordan lægemidlet påvirker dig.
English: If you feel unwell in any way while you are taking your medicine please tell an adult straight away.
Danish: Hvis du på en eller anden måde føler dig utilpas, mens du tager din medicin, bedes du straks fortælle det til en voksen.
English: • difficulty to get or keep an erection (erectile dysfunction).
Danish: • problemer med at få eller holde en rejsning (erektil dysfunktion).
English: However, individuals may have larger increases than reflected by the mean changes.
Danish: Den enkelte patient kan imidlertid opleve en større stigning end det, som de gennemsnitlige ændringer viser.
English: Switching from other formulations of guanfacine
Danish: Skift fra andre guanfacin-formuleringer
English: Cancer.
Danish: Kræft.
English: • Do not take this medicine if you are pregnant or you are not using contraception.
Danish: • Tag ikke lægemidlet, hvis du er gravid, eller hvis du ikke bruger prævention.
English: Summary of primary efficacy for study SPD503-316: ADHD-RS-IV
Danish: Oversigt over primær virkning for studie SPD503-316: ADHD-RS-IV
English: Your doctor may want to review your treatment.
Danish: Det kan være, at lægen gerne vil justere din behandling.
English: Pre-treatment screening:
Danish: Screening før behandling:
English: The recommended dose titration for children and adolescents is provided below (see tables 1 and 2).
Danish: Den anbefalede dosistitrering for børn og unge er anført nedenfor (se tabel 1 og 2).
English: Patients with emergent suicidal ideation or behaviour during treatment for ADHD should be evaluated immediately by their physician.
Danish: Patienter, der får selvmordstanker eller oplever selvmordsadfærd under behandlingen af ADHD, bør straks evalueres af deres læge.
English: If you need to take Intuniv for more than a year your doctor will monitor your response to treatment and your doctor may stop the medicine for a short time; this may happen during a school holiday.
Danish: Hvis det er nødvendigt, at du tager Intuniv i over et år, vil lægen overvåge din behandlingsreaktion, og din læge kan afbryde lægemidlet i en kort periode, dette kan finde sted i løbet af skoleferien.
English: Patients should be advised to drink plenty of fluid.
Danish: Patienterne skal rådes til at drikke rigeligt med væske.
English: No age differences were observed with respect to response to the ADHD-RS-IV.
Danish: Der blev ikke observeret nogen aldersforskel med hensyn til responset på ADHD-RS-IV.
English: As part of your treatment your doctor will closely monitor how Intuniv is affecting you during initial dosing and/or dose adjustments.
Danish: Som en del af din behandling vil din læge nøje overvåge, hvordan Intuniv påvirker dig i løbet af den indledende dosering og/eller dosisjusteringer.
English: • your response to treatment, in particular if it makes you sleepy or drowsy
Danish: • din reaktion på behandlingen, især hvis den gør dig søvnig eller døsig
English: The blisters are contained in cardboard cartons.
Danish: Disse blistre er sat ind i kartonæsker.
English: Guanfacine is a non-stimulant.
Danish: Guanfacin er ikke et stimulerende middel.
English: Used to treat
Danish: Bruges til at behandle
English: Patients should be warned of these possible effects and be advised that if affected, they should avoid these activities (see section 4.4).
Danish: Patienterne bør advares om disse mulige virkninger og rådes til at undgå disse aktiviteter, hvis de er påvirket (se pkt.
English: Do not use this medicine if the tablets or blister pack look damaged.
Danish: Brug ikke lægemidlet, hvis tabletterne eller blisterpakningen ser beskadiget ud.
English: Dose reduction may be required in patients with different degrees of hepatic impairment.
Danish: Det kan være nødvendigt at reducere dosis hos patienter med forskellige grader af nedsat leverfunktion.
English: Monitoring during titration
Danish: Overvågning under titreringen
English: Do not chew, divide or crush.
Danish: Må ikke tygges, deles eller knuses.
English: Management of Intuniv overdose should include monitoring for and treatment of these signs and symptoms.
Danish: Behandling af en overdosering med Intuniv bør omfatte overvågning for og behandling af disse tegn og symptomer.
English: Intuniv is a prolonged-release tablet which means that the active substance is released from the tablet over a period of time.
Danish: Intuniv er en depottablet, hvilket betyder, at det aktive stof frigives fra tabletten over en tidsperiode.
English: ADHD with Oppositional Symptoms Study
Danish: Studie af ADHD med oppositionssymptomer
English: All drug-drug interaction studies have been performed in adults, however, the outcome is expected to be similar in the indicated paediatric age range.
Danish: Alle lægemiddelinteraktionsstudier er blevet udført hos voksne, men udfaldet forventes at svare til i det indicerede pædiatriske aldersinterval.
English: N Baseline ADHD-RS-IV (SD)
Danish: N Baseline ADHDRS-IV (SD)
English: Tell your doctor if you cannot swallow the tablet whole.
Danish: Fortæl det til lægen, hvis du ikke kan sluge tabletten hel.
English: Due to variability in interaction effect, further dose titration may be needed (see above).
Danish: Grundet variabiliteten i virkningen hvad angår interaktion, kan det være nødvendigt med yderligere dosistitrering (se ovenfor).
English: Is a medicine that promotes alertness and is used to treat sleep disorders.
Danish: Er et lægemiddel, der fremmer opmærksomhed og bruges til at behandle søvnforstyrrelser.
English: During the first year of treatment, the patient should be assessed at least every 3 months for:
Danish: Løbende overvågning I løbet af det første års behandling bør patienten vurderes mindst hver 3. måned for:
English: You should talk to your doctor if you do not feel better or if you feel worse and very sleepy or drowsy after taking this medicine for around 6 weeks.
Danish: Kontakt lægen, hvis du får det værre, eller hvis du ikke får det bedre og føler dig meget søvnig eller døsig, efter du har taget lægemidlet i omtrent 6 uger.
English: • medicines for mental health problems (benzodiazepines, barbiturates and antipsychotics)
Danish: • lægemidler mod psykiske problemer (benzodiazepiner, barbiturater og antipsykotika)
English: • Your daily dose will be between 1 and 7 mg depending on your age and how you respond to Intuniv, but not more that 7 mg.
Danish: • Din daglige dosis vil være fra 1 til 7 mg afhængigt af din alder, og hvordan du reagerer på Intuniv, men den vil ikke være over 7 mg.
English: This medicine should not be used in children under 6 years of age and adults 18 years and over because it is not known if it works or is safe.
Danish: Dette lægemiddel må ikke anvendes af børn under 6 år og af voksne på 18 år og derover, da det er ukendt, om det virker eller er sikkert.
English: Thorough QT /QTc study
Danish: Grundigt QT /QTc-studie
English: Studies SPD503-301 and SPD503-304 were 8 and 9 weeks in duration, respectively, both conducted in the United States.
Danish: Studierne SPD503301 og SPD503-304 var af hhv. 8 og 9 ugers varighed, begge udført i USA.
English: Systemic exposure to guanfacine is similar for men and women given the same mg/kg dose.
Danish: Systemisk eksponering over for guanfacin er tilsvarende for mænd og kvinder, der får den samme mg/kg dosis.