FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep turning until the dose counter stops and shows 0.5 mg.
Danish: • Drej dosisvælgeren, indtil den viser 0,5 mg. Bliv ved med at dreje indtil dosistælleren stopper og viser 0,5 mg.
English: Each dose contains 1 mg of semaglutide in 0.74 ml solution.
Danish: Hver dosis indeholder 1 mg semaglutid i 0,74 ml opløsning.
English: Count slowly:
Danish: Tæl langsomt:
English: -3.6 [-4.7, -2.4]a p <0.0001 (2-sided) for superiority
Danish: -3,6 [-4,7; -2,4]a ap <0,0001 (2-sidet) for superioritet
English: Ozempic 1 mg solution for injection in pre-filled pen semaglutide
Danish: Ozempic 1 mg injektionsvæske, opløsning i fyldt pen semaglutid
English: Vomiting
Danish: Ventrikeltømning
English: Flow check symbol
Danish: Klargøringssymbol
English: Ozempic 0.25 mg solution for injection in pre-filled pen semaglutide
Danish: Ozempic 0,25 mg injektionsvæske, opløsning i fyldt pen semaglutid
English: Diabetic retinopathy complicationsb
Danish: Komplikationer ved diabetisk retinopati
English: Semaglutide exposure increased in a dose proportional manner for doses of 0.5 mg and 1 mg.
Danish: Semaglutideksponeringen steg proportionalt med dosis for doser på 0,5 mg og 1 mg. Der blev opnået samme eksponering ved subkutan administration af semaglutid i maven, låret og overarmen.
English: -3.6c [-4.3, -2.8]a p <0.0001 (2-sided) for superiority b
Danish: -3,8 [-4,6; -3,0]a p <0,0001 (2-sidet) for superioritet
English: Each dose contains 0.25 mg of semaglutide in 0.19 ml solution.
Danish: Hver dosis indeholder 0,25 mg semaglutid i 0,19 ml opløsning.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Disodium phosphate dihydrate Propylene glycol
Danish: Dinatriumphosphatdihydrat Propylenglycol
English: Each dose contains 0.5 mg of semaglutide in 0.37 ml solution.
Danish: Hver dosis indeholder 0,5 mg semaglutid i 0,37 ml opløsning.
English: Ozempic 0.5 mg solution for injection in pre-filled pen semaglutide
Danish: Ozempic 0,5 mg injektionsvæske, opløsning i fyldt pen semaglutid
English: Difference from insulin glargine [95% CI] -4.6 [-5.3, -4.0]
Danish: Ændring fra baseline ved uge 40 -4,6 Forskel fra dulaglutid [95% CI]
English: If you use more Ozempic than you should
Danish: Hvis du har brugt for meget Ozempic
English: The dose selector clicks differently when turned forwards, backwards or past 0.25 mg. Do not count the pen clicks.
Danish: Kun dosistælleren og dosismarkøren viser, at du har valgt 0,25 mg. Dosisvælgeren klikker forskelligt, når den drejes frem, tilbage eller forbi 0,25 mg. Tæl ikke antal klik.
English: The dose and number of injections depend on the patient's response.
Danish: Dosis og antal injektioner afhænger af patientens reaktion.
English: Further information on NeuroBloc can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om NeuroBloc findes på agenturets websted ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: NeuroBloc received a marketing authorisation valid throughout the EU on 22 January 2001.
Danish: NeuroBloc fik en markedsføringstilladelse med gyldighed i hele EU den 22. januar 2001.
English: Most patients who had a response to NeuroBloc by the fourth week had returned to their original condition 12 to 16 weeks after the injection.
Danish: De fleste patienter, der reagerede på NeuroBloc efter fjerde uge, var vendt tilbage i deres oprindelige tilstand 12-16 uger efter injektionen.
English: Other information about NeuroBloc
Danish: Andre oplysninger om NeuroBloc
English: The effect of an injection of NeuroBloc gradually wears off over time.
Danish: Virkningen af en injektion af NeuroBloc aftager gradvist med tiden.
English: As for all medicines, data on the use of NeuroBloc are continuously monitored.
Danish: Som for alle lægemidler, er data vedrørende brug af NeuroBloc løbende overvåget.
English: The European Medicines Agency decided that NeuroBloc's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur afgjorde, at fordelene ved NeuroBloc opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Effectiveness was measured by looking at the change in symptoms (severity, pain and disability) after four weeks, measured using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
Danish: Virkningen blev målt på ændringen i symptomer (sværhedsgrad, smerte og invaliditet) efter fire uger, målt på bedømmelsesskalaen Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).
English: NeuroBloc (botulinum toxin type B) EMA/356522/2018
Danish: NeuroBloc (botulinum type B toxin) EMA/356522/2018
English: Side effects reported with NeuroBloc are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for NeuroBloc vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of NeuroBloc?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af NeuroBloc?
English: For more information about using NeuroBloc, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om anvendelsen af af NeuroBloc,kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: NeuroBloc was more effective than placebo (a dummy treatment) at improving symptoms of cervical dystonia in four studies involving a total of 392 adults.
Danish: NeuroBloc var mere effektivt end virkningsløs behandling (placebo) til at give bedring i symptomerne på cervikal dystoni i fire studier med i alt 392 voksne.
English: An overview of NeuroBloc and why it is authorised in the EU
Danish: En oversigt over NeuroBloc og hvorfor det er godkendt i EU
English: NeuroBloc treatment starts with 10,000 U, divided into equal doses and injected directly into the two to four muscles in the neck and shoulders that are most affected.
Danish: Behandlingen med NeuroBloc begynder med 10.000 E, der fordeles på lige store doser og injiceres direkte i de to til fire muskler i nakke og skuldre, der er stærkest angrebet.
English: It is only used in hospitals, by a doctor who has experience in the treatment of cervical dystonia and in the use of botulinum toxins.
Danish: Det anvendes kun på hospitaler af læger med erfaring i behandling af cervikal dystoni og i anvendelse af botulinumtoxiner.
English: The toxin is the cause of a type of food poisoning called botulism, where patients suffer from muscle weakness and paralysis.
Danish: Dette toxin er årsag til en form for fødevareforgiftning, der betegnes botulisme, hvor patienterne får muskelsvaghed og -lammelse.
English: What is NeuroBloc and what is it used for?
Danish: Hvad er NeuroBloc, og hvad anvendes det til?
English: Three of the studies included patients who had stopped responding to type A botulinum toxin (another type of botulinum toxin that may also be used to treat cervical dystonia), and the fourth only included patients who did respond to type A toxin.
Danish: Tre af studierne omfattede patienter, der ikke længere reagerede på botulinum type A toxin (en anden type botulinumtoxin, der også kan anvendes til behandling af cervikal dystoni), mens det fjerde kun omfattede patienter, der reagerede på type A toxin.
English: Why is NeuroBloc authorised in the EU?
Danish: Hvorfor blev NeuroBloc godkendt i EU?
English: NeuroBloc must not be used in patients with other neuromuscular (nerve and muscle) disorders.
Danish: NeuroBloc må ikke anvendes hos patienter med andre nerve- og muskellidelser.
English: When injected directly into a muscle it reduces the release of acetylcholine and muscle contraction in the affected neck or shoulder muscles, thereby relieving the patient's symptoms.
Danish: Når det injiceres direkte i en muskel, mindskes frigivelsen af acetylcholin og muskelsammentrækningen i de berørte hals- eller skuldermuskler, hvorved patientens symptomer lettes.
English: Cervical dystonia, which is also known as torticollis, is a disorder when the neck muscles contract, causing abnormal movement and twisting of the neck and unusual positioning of the head.
Danish: Cervikal dystoni, der også kaldes torticollis, er en lidelse, hvor halsmusklerne trækker sig sammen og forårsager unormal bevægelse og vridning af halsen og en usædvanlig stilling af hovedet.
English: Acetylcholine is needed to transfer electrical impulses from the nerves to the muscles in order for the muscles to contract.
Danish: Acetylcholin er nødvendigt til at overføre de elektriske impulser fra nerverne til musklerne, så musklerne trækker sig sammen.
English: NeuroBloc is available as a solution for injection (5,000 units [U] per millilitre) and it can only be obtained with a prescription.
Danish: NeuroBloc fås som injektionsvæske, opløsning (5.000 enheder [E] pr. ml), og udleveres kun på recept.
English: The toxin reduces the release of acetylcholine from the nerve endings.
Danish: Toxinet mindsker frigivelsen af acetylcholin fra nerveenderne.
English: The most common side effects with NeuroBloc (which may affect more than 1 in 10 people) are dry mouth, headache (in patients new to treatment with botulinum toxins), dysphagia (difficulty swallowing) and pain at the site of the injection.
Danish: De hyppigste bivirkninger med NeuroBloc (som kan forekomme hos mere end 1 ud af 10 personer) er mundtørhed, hovedpine (hos patienter, der ikke før er behandlet med botulinumtoxiner), synkebesvær (dysfagi) og smerter på injektionsstedet.
English: NeuroBloc is a medicine used to treat cervical dystonia in adults.
Danish: NeuroBloc er et lægemiddel, der anvendes til behandling af cervikal dystoni hos voksne.
English: What are the risks associated with NeuroBloc?
Danish: Hvilke risici er der forbundet med NeuroBloc?
English: The active substance in NeuroBloc, botulinum toxin type B, is a well-known toxic substance produced by the bacterium Clostridium botulinum.
Danish: Det aktive stof i NeuroBloc, botulinum type B toxin, er et velkendt giftstof, der produceres af bakterien Clostridium botulinum.
English: In NeuroBloc, the toxin is used as a muscle relaxant.
Danish: I NeuroBloc anvendes toxinet som muskelafslappende middel.
English: NeuroBloc (botulinum toxin type B)
Danish: NeuroBloc (botulinum type B toxin)
English: For the full list of side effects reported with NeuroBloc, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med NeuroBloc fremgår af indlægssedlen.
English: The medicine improved the TWSTRS score of the non-responders to type A botulinum toxin as well as the score of the responders.
Danish: Lægemidlet forbedrede TWSTRS-score både hos patienter, der ikke reagerede på botulinum type A toxin, og hos dem, der gjorde det.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NeuroBloc 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 NeuroBloc.
English: NeuroBloc contains the active substance botulinum toxin type B.
Danish: NeuroBloc indeholder det aktive stof botulinum type B toxin.
English: How is NeuroBloc used?
Danish: Hvordan anvendes NeuroBloc?
English: How does NeuroBloc work?
Danish: Hvordan virker NeuroBloc?
English: What benefits of Neurobloc have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved NeuroBloc?
English: London, 26 April 2007 Doc.
Danish: London, den 26. april 2007 Ref.dok.
English: In the study, 27 children (aged 3 to 15 years) have been receiving IPLEX for up to one year.
Danish: I undersøgelsen har 27 børn (i alderen 3 til 15 år) fået IPLEX i indtil ét år.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING AUTHORISATION APPLICATION for IPLEX
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNING AF ANSØGNINGEN OM MARKEDSFØRINGSTILLADELSE for IPLEX
English: Patients had also not been treated for long enough to show that the medicine's effect continues when used for longer than one year.
Danish: Patienterne var desuden ikke blevet behandlet tilstrækkeligt længe til at vise, at lægemidlets virkning holder sig, når det bruges længere end ét år.
English: International non-proprietary name (INN): mecasermin rinfabate
Danish: Internationalt fællesnavn (INN): mecasermin rinfabat
English: The effects of IPLEX were first tested in experimental models before being studied in humans.
Danish: Virkningerne af IPLEX blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The application was at day 120 when the company withdrew.
Danish: Ansøgningen var på dag 120, da firmaet trak den tilbage.
English: What is IPLEX?
Danish: Hvad er IPLEX?
English: Its effectiveness has been studied in one clinical trial, which is still ongoing.
Danish: Virkningerne er undersøgt i én klinisk undersøgelse, der stadig er i gang.
English: The main measure of effectiveness was based on the speed of growth during the study, compared to that in the year before the study began.
Danish: Behandlingens virkning blev hovedsagelig bedømt på væksthastigheden i undersøgelsesperioden sammenlignet med væksthastigheden i året forud for undersøgelsen.
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to them.
Danish: CHMP havde opstillet en række spørgsmål, som firmaet skulle besvare, hvilket endnu ikke var sket.
English: In the body, natural growth hormone promotes growth in children by stimulating the body to produce IGF-I. IGF-I then stimulates the bones to grow.
Danish: I kroppen styrker det naturlige væksthormon væksten hos børn ved at stimulere organismen til at producere IGF-I. IGF-I stimulerer derefter knoglevæksten.
English: This may allow IGF-I to circulate in the body at higher levels and for longer periods than unbound IGF-I.
Danish: Derved kan IGF-I cirkulere i organismen i højere koncentration og længere tid ad gangen end ubundet IGF-I.
English: Mecasermin rinfabate is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce it.
Danish: Mecasermin rinfabat fremstilles ved "rekombinant DNAteknologi": Det produceres af en bakterie, der har fået indsat et gen (dna), som gør den i stand til at producere stoffet.
English: They also had major concerns regarding the way in which the medicine's effectiveness had been assessed, especially regarding the type of patients that have been included in the clinical trial.
Danish: Udvalget havde desuden betænkeligheder vedrørende den måde, lægemidlets virkning blev bedømt på, især hvad angår den type patienter, der deltog i den kliniske undersøgelse.
English: In IPLEX, IGF-I is bound to IGFBP-3 because this mimics the way in which IGF-1 is carried in the body.
Danish: I IPLEX er IGF-I bundet til IGFBP-3, fordi dette svarer til den måde, IGF-1 bliver transporteret på i kroppen.
English: What were the reasons given by the company to withdraw the application?
Danish: Hvilke begrundelser angav firmaet for tilbagetrækningen af ansøgningen?
English: IPLEX was to be used in children with short stature whose bodies have problems handling growth hormone because:
Danish: IPLEX skulle anvendes til børn med væksthæmning, hvis krop har vanskeligt ved at håndtere væksthormon, fordi:
English: Ref. EMEA/111199/2007
Danish: EMEA/231335/2007
English: Because the number of patients with these diseases is low, they are considered ‘rare', and mecasermin rinfabate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 June 2006.
Danish: Da der kun findes få patienter med disse sygdomme, blev mecasermin rinfabat udpeget som lægemiddel til sjældne sygdomme den 20. juni 2006.
English: What was IPLEX expected to be used for?
Danish: Hvad forventedes IPLEX anvendt til?
English: The active substance in IPLEX, mecasermin rinfabate, is a binary protein made up of two proteins that are normally produced by the body: insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3).
Danish: Det aktive stof i IPLEX, mecasermin rinfabat, er et dobbeltprotein bestående af to proteiner, som normalt produceres af kroppen: insulin-lignende vækstfaktor I (IGF-I) og bindingsprotein 3 for insulin-lignende vækstfaktor (IGFBP-3).
English: What documentation did the company present to support its application to the CHMP?
Danish: Hvilken dokumentation fremlagde firmaet i forbindelse med ansøgningen til CHMP?
English: • they are not able to make growth hormone and have received growth hormone in the past, but have developed neutralising antibodies, special proteins than can prevent injected growth hormone from having an effect.
Danish: • de ikke kan producere væksthormon og tidligere er blevet behandlet med væksthormon, men har udviklet neutraliserende antistoffer, der er særlige proteiner, som kan forhindre indsprøjtet væksthormon i at virke.
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefit of IPLEX had not been sufficiently demonstrated and did not outweigh the identified risks.
Danish: På tilbagetrækningstidspunktet var det derfor CHMP's opfattelse, at fordelene ved IPLEX ikke var godtgjort tilfredsstillende og ikke opvejede de fundne risici.
English: How is IPLEX expected to work?
Danish: Hvordan forventes IPLEX at virke?
English: IPLEX is a solution for injection containing 60 mg/ml mecasermin rinfabate as the active substance.
Danish: IPLEX er en injektionsvæske (opløsning), der indeholder 60 mg/ml af det aktive stof, mecasermin rinfabat.
English: The company informed the CHMP that the withdrawal will have no impact on the ongoing clinical study of the safety and efficacy of IPLEX in the treatment of Growth Hormone Insensitivity Syndrome.
Danish: Firmaet meddelte CHMP, at tilbagetrækningen ikke ville få konsekvenser for den igangværende kliniske undersøgelse af sikkerheden og virkningen af IPLEX til behandling af syndromet nedsat følsomhed for væksthormon.
English: What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with IPLEX?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med IPLEX eller i programmer for anvendelse med særlig udleveringstilladelse?
English: The CHMP had major concerns regarding the way the medicine is manufactured, and they were unsure that the medicine that would have been marketed would have been comparable to the one used in the clinical trial.
Danish: CHMP havde især betænkeligheder vedrørende fremstillingsmetoden for lægemidlet og var ikke overbevist om, at det lægemiddel, der ville blive markedsført, ville svare til det, der blev anvendt i den kliniske undersøgelse.
English: On 26 March 2007, Insmed Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for IPLEX, for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Danish: Den 26 marts 2007 meddelte Insmed Europe Ltd officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at firmaet ønskede at trække sin ansøgning om markedsføringstilladelse tilbage for IPLEX til behandling af patienter med primær nedsat følsomhed for væksthormon og behandling af patienter, som har gendeletion for væksthormon og har dannet neutraliserende antistoffer mod væksthormon.
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 IPLEX could not have been approved for the treatment of patients with primary growth hormone insensitivity and of patients with growth hormone gene deletion who have developed neutralising antibodies to growth hormone.
Danish: Efter gennemgang af de oplysninger, der forelå på tilbagetrækningstidspunktet, var der i CHMP visse betænkeligheder, og udvalgets foreløbige standpunkt var, at IPLEX ikke kunne godkendes til behandling af patienter med primær nedsat følsomhed for væksthormon og patienter, som har gendeletion for væksthormon og har dannet neutraliserende antistoffer mod væksthormon.
English: • they have primary insensitivity to the hormone, so that injected growth hormone has no effect.
Danish: • de lider af primær nedsat følsomhed for hormonet og derfor ikke kan hjælpes med indsprøjtninger af væksthormon; med "primær" menes, at årsagen til denne nedsatte følsomhed er ukendt
English: IPLEX provides IGF-I directly, as part of the binary protein, and this allows bone growth while bypassing the need for growth hormone itself.
Danish: IPLEX tilfører IGF-I direkte som en del af dobbeltproteinet.
English: Tolperisone exerts its action at 3 levels:
Danish: Tolperison virker på tre niveauer:
English: On 15 July 2011, Germany triggered a referral under Article 31 of Directive 2001/83/EC.
Danish: Den 15. juli 2011 indbragte Tyskland en sag i henhold til artikel 31 i direktiv 2001/83/EF.
English: Tolperisone-containing products are currently approved in the following EU countries: Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovak Republic.
Danish: Lægemidler, der indeholder tolperison, er på nuværende tidspunkt godkendt i følgende EU-lande: Bulgarien, Cypern, Tjekkiet, Tyskland, Ungarn, Letland, Litauen, Polen, Rumænien og Slovakiet.
English: This effect is well demonstrated in several animal models.
Danish: Denne effekt er veldokumenteret i flere dyremodeller.
English: Therefore, in accordance with Article 32(4)(d) of Directive 2001/83/EC, the CHMP recommended:
Danish: I overensstemmelse med artikel 32, stk. 4, litra d), i direktiv 2001/83/EF, anbefalede CHMP derfor:
English: It is well known that the safety profile of a product may vary depending on the formulation.
Danish: Det er en velkendt kendsgerning, at et produkts sikkerhedsprofil kan variere afhængig af formuleringen.
English: The following indications have been approved in at least one Member State (specific wording of the indication may vary from product to product):
Danish: Følgende indikationer er godkendt i mindst én medlemsstat (indikationens specifikke ordlyd kan variere fra lægemiddel til lægemiddel):
English: There are a few studies where a parenteral formulation was used.
Danish: Der findes få undersøgelser, hvor der er anvendt en parenteral formulering.
English: In addition, the improvement in PPT was not accompanied by a corresponding improvement in the mobility of patients.
Danish: Derudover blev forbedringen i PPT ikke ledsaget af en tilsvarende forbedring af patienternes mobilitet.
English: In addition, all patients started by receiving doses above the approved dose.
Danish: Desuden fik alle patienter først højere doser end den godkendte dosis.
English: Overall summary of the scientific evaluation of tolperisone-containing products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af lægemidler, der indeholder tolperison (se bilag I)
English: This indication is mainly supported by the Stamenova (2005) study, which is of acceptable quality.
Danish: Denne indikation støttes hovedsagelig af Stamenova-undersøgelsen (2005), der er af acceptabel kvalitet.
English: Parenteral formulation
Danish: Parenteral formulering
English: The divergent positions are appended to this opinion.
Danish: De afvigende holdninger er vedlagt som bilag til denne udtalelse.
English: The precise mechanism of action is not fully known.
Danish: Den præcise virkningsmekanisme er ikke fuldstændigt beskrevet.
English: The Struck 2004 study also failed to demonstrate a significant improvement in the primary endpoint.
Danish: Struckundersøgelsen (2004) påviste heller ikke nogen signifikant forbedring i det primære endepunkt.