FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lucentis have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lucentis.
English: In the second study, patients receiving Lucentis on its own or as an add-on to laser photocoagulation could see after one year an average of 5 letters more than patients receiving laser photocoagulation on its own.
Danish: I det andet studie kunne de patienter, der fik Lucentis alene eller som tillægsbehandling til laserfotokoagulation, efter et år se ca. 5 bogstaver mere end de patienter, der fik laserfotokoagulation alene.
English: How does Lucentis work?
Danish: Hvordan virker Lucentis?
English: Patients were classified as having experienced no significant worsening of vision if the number of letters that they could see increased, stayed the same, or fell by less than 15.
Danish: Hvis det antal bogstaver, patienterne kunne se, var steget, var uændret eller var mindsket med mindre end 15, blev patienternes synsstyrke klassificeret som uden væsentlig forringelse.
English: Lucentis must not be used in patients who may have an infection of the eye or the area around the eye, or who have severe inflammation within the eye. For the full list of restrictions, see the package leaflet.
Danish: Lucentis må ikke anvendes hos patienter med infektion i øjet eller i øjenomgivelserne eller hos patienter med en alvorlig betændelsestilstand inde i øjet.
English: In the first study, lasting one year, patients receiving Lucentis could see about 6 letters more than those receiving sham injections.
Danish: I det første studie, der varede et år, kunne de patienter, der fik Lucentis, se ca. 6 bogstaver mere end dem, der fik skininjektioner.
English: After 2 months of treatment, patients given Lucentis could see around 10 letters more on average than those given sham treatment.
Danish: Efter to måneders behandling kunne de patienter, der fik Lucentis, i gennemsnit se ca. 10 bogstaver mere end dem, der fik skininjektioner.
English: The main measure of effectiveness in both was the change in vision using a standard eye test with a letter chart.
Danish: I begge var det primære mål for virkning ændringen af synet målt ved hjælp af en almindelig synstavle.
English: Diabetic macular oedema
Danish: Diabetisk makulaødem
English: On average over the first 3 months of treatment, patients given Lucentis could see around 8 to 9 letters more than those receiving verteporfin PDT.
Danish: Patienter, der fik Lucentis, kunne efter de første tre måneder i gennemsnit se 8-9 bogstaver mere end dem, der fik fotodynamisk terapi med verteporfin.
English: The vision of patients receiving Lucentis also remained better than the vision of those receiving sham injections in a study in which injections were given less frequently, with injections every month for the first three months and then every three months.
Danish: I de første tre måneder af dette studie blev injektionerne givet hver måned og derefter hver tredje måned.
English: This summary was last updated in 11-2009.
Danish: Dette sammendrag blev sidst ajourført i 11-2009.
English: The dose is adjusted to give the best control.
Danish: Dosis justeres, så der opnås den bedste kontrol.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Krka to Krka, d.d., Novo mesto on 4 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Repaglinid Krka til Krka, d.d., Novo mesto den 4 november 2009.
English: Repaglinide Krka is taken before meals, normally up to 15 minutes before each main meal.
Danish: Repaglinid Krka indtages før måltiderne, normalt op til 15 minutter før hvert hovedmåltid.
English: It is available as round tablets (white: 0.5 mg; yellow: 1 mg; pink: 2 mg).
Danish: Det fås som runde tabletter (hvide: 0,5 mg, gule: 1 mg, lyserøde: 2 mg).
English: This means that Repaglinide Krka is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Danish: Det betyder, at Repaglinid Krka er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder NovoNorm.
English: Repaglinide Krka repaglinide
Danish: Repaglinid Krka repaglinid
English: The full EPAR for Repaglinide Krka can be found here.
Danish: Den fuldstændige EPAR for Repaglinid Krka findes her.
English: Other information about Repaglinide Krka:
Danish: Andre oplysninger om Repaglinid Krka:
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Repaglinide Krka has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Repaglinid Krka er af sammenlignelig kvalitet og er bioækvivalent med NovoNorm.
English: Repaglinide Krka is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Danish: Repaglinid Krka anvendes til patienter, som lider af type 2-diabetes (ikke-insulinkrævende diabetes).
English: Repaglinide Krka is a medicine that contains the active substance repaglinide.
Danish: Repaglinid Krka er et lægemiddel, der indeholder det aktive stof repaglinid.
English: The Committee recommended that Repaglinide Krka be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Repaglinid Krka.
English: Repaglinide Krka is a ‘generic medicine'.
Danish: Repaglinid Krka er et ‘generisk lægemiddel'.
English: What are the benefit and risk of Repaglinide Krka?
Danish: Hvilken fordel og risiko er der forbundet med Repaglinid Krka?
English: Repaglinide Krka can also be used for type 2 diabetes patients whose blood glucose levels are usually controlled well on diet, but are experiencing temporary loss of blood glucose control.
Danish: Repaglinid Krka kan også anvendes til patienter med type 2-diabetes, hvis blodglukoseniveau normalt kontrolleres tilfredsstillende med diæt, men hvor blodglukosen midlertidigt ikke er under kontrol.
English: Repaglinide Krka helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Danish: Repaglinid Krka får bugspytkirtlen til at producere mere insulin i forbindelse med måltider og anvendes til at holde type 2- diabetes under kontrol.
English: Because Repaglinide Krka is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Repaglinid Krka er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Because Repaglinide Krka is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, NovoNorm.
Danish: Da Repaglinid Krka er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet NovoNorm.
English: Repaglinide Krka is not recommended for patients below 18 years of age because of a lack of information on safety and effectiveness in this age group.
Danish: Hvis patienten er skiftet fra et andet lægemiddel mod diabetes, er den anbefalede startdosis 1 mg. Repaglinid Krka anbefales ikke til patienter under 18 år på grund af manglende data om sikkerhed og virkning i denne aldersgruppe.
English: Why has Repaglinide Krka been approved?
Danish: Hvorfor blev Repaglinid Krka godkendt?
English: What is Repaglinide Krka?
Danish: Hvad er Repaglinid Krka?
English: How has Repaglinide Krka been studied?
Danish: Hvordan blev Repaglinid Krka undersøgt?
English: What is Repaglinide Krka used for?
Danish: Hvad anvendes Repaglinid Krka til?
English: How is Repaglinide Krka used?
Danish: Hvordan anvendes Repaglinid Krka?
English: How does Repaglinide Krka work?
Danish: Hvordan virker Repaglinid Krka?
English: If you receive more GADOGRAF than you should have received:
Danish: Hvis du får mere GADOGRAF end du burde have fået:
English: Before you receive Gadograf, tell your doctor if any of these applies to you.
Danish: Før du får Gadograf, skal du fortælle din læge, om noget af ovenstående gælder for dig.
English: The usual safety requirements for magnetic resonance imaging, especially the exclusion of ferromagnetic materials, also apply when using Gadograf.
Danish: De sædvanlige sikkerhedskrav for magnetisk resonans scanning, specielt udelukkelsen af ferromagnetisk materiale, gælder også ved brug af Gadograf.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Germany
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Tyskland
English: The passage of Gadograf into breast milk has not been investigated in humans so far.
Danish: Passage af Gadograf til modermælken er hidtil ikke blevet undersøgt hos mennesker.
English: Tell your doctor if you are pregnant or could be pregnant, since Gadograf should not be used during pregnancy unless it is considered absolutely necessary.
Danish: Fortæl det til din læge, hvis du er gravid eller kan være gravid, eftersom Gadograf ikke må anvendes under graviditet med mindre det anses for absolut nødvendigt.
English: - If you are younger than 18, use of Gadograf is not recommended.
Danish: - Hvis du er under 18 år, er brugen af Gadograf ikke anbefalet.
English: Gadograf should not be used in patients with uncorrected hypokalemia.
Danish: Gadograf bør ikke anvendes til patienter med ukorrigeret hypokaliæmi.
English: Like all medicines, Gadograf can cause side effects, although not everybody gets them.
Danish: Gadograf kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Do not use GADOGRAF - if you are allergic (hypersensitive) to gadobutrol or any of the other ingredients of
Danish: Brug ikke GADOGRAF - hvis du er allergisk (overfølsom) over for gadobutrol eller et af de øvrige indholdsstoffer i
English: Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.
Danish: Der er påvist 24 timers kemisk og fysisk stabilitet under brug ved stuetemperatur.
English: Gadograf (see “What Gadograf contains”)
Danish: Gadograf (se “Gadograf indeholder”)
English: Additional side effects which have been reported after the approval of Gadograf:
Danish: Yderligere bivirkninger som er blevet rapporteret efter godkendelsen af Gadograf:
English: - Allergy-like reactions may occur after use of Gadograf.
Danish: - Der kan opstå allergi-lignende reaktioner efter brug af Gadograf.
English: After opening of the infusion bottle under aseptic conditions Gadograf remains stable for at least 8 hours at room temperature.
Danish: Efter at infusionsflasken er blevet åbnet under aseptiske forhold, holder Gadograf sig stabilt i mindst 8 timer ved stuetemperatur.
English: The actual dosage of Gadograf that is right for you will depend on your body weight and on the region of examination:
Danish: Den faktiske dosis af Gadograf, som passer til dig, afhænger af din kropsvægt og af området, der skal undersøges:
English: Side effects which have been observed in clinical trials before the approval of Gadograf: Uncommon
Danish: Bivirkninger, som er blevet observeret i kliniske undersøgelser før godkendelsen af Gadograf: Usædvanlig
English: Gadograf 1.0 mmol/ml (INN gadobutrol) was approved for “Contrast enhancement in cranial and spinal magnetic resonance imaging” (MRI) in Germany in January 2000 and subsequently in July 2001 in Spain via the mutual recognition procedure.
Danish: Gadograf 1,0 mmol/ml (INN gadobutrol) blev godkendt til indikationen “Kontrastforstærkning ved kraniel og spinal magnetisk resonanstomografi” i Tyskland i januar 2000 og senere i juli 2001 i Spanien i henhold til den gensidige anerkendelsesprocedure.
English: In patients with an allergic disposition the decision to use Gadograf must be made after particularly careful evaluation of the risk-benefit ratio.
Danish: Hos patienter disponeret for allergi må beslutningen om at anvende Gadograf træffes efter særlig omhyggelig vurdering af risk-benefit-forholdet.
English: In patients with severe cardiovascular disease Gadograf should only be administered after careful risk benefit assessment because only limited data are available so far.
Danish: Hos patienter med alvorlig kardiovaskulær lidelse bør Gadograf kun anvendes efter en omhyggelig vurdering af risk-benefit-forholdet , da der indtil videre kun er begrænsede oplysninger tilgængelige.
English: Tissue enhancement generally lasts up to 45 minutes after injection of Gadograf.
Danish: Vævsforstærkningen varer normalt indtil 45 minutter efter injektion af Gadograf.
English: Important information about some of the ingredients of GADOGRAF This medicinal product contains less than 1 mmol sodium (23 mg) per dose (based on the average amount given to a 70 kg person), i.e. essentially ‘sodium-free'.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Gadograf Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis (baseret på den gennemsnitlige mængde givet til en person som vejer 70 kg), dvs. stort set ‘natriumfri'.
English: In particularly severe cases, it is advisable to remove Gadograf from the body by extracorporeal haemodialysis: For removal of the agent from the body, at least 3 dialysis sessions within 5 days of the injection should be performed.
Danish: I særligt alvorlige tilfælde tilrådes det at fjerne Gadograf fra kroppen ved ekstrakorporal hæmodialyse: For at fjerne stoffet fra kroppen bør der foretages dialyse mindst 3 gange inden for 5 dage efter injektionen.
English: With reference to Question 2) the MAH acknowledged that Gadograf has not been adequately studied for any of its approved indications (including the new indication “contrast-enhanced MRI of liver and kidneys”) in patients aged less than 18 years.
Danish: Vedrørende spørgsmål 2) erkendte indehaveren af markedsføringstilladelsen, at Gadograf ikke var blevet tilstrækkelig undersøgt til nogen af de godkendte indikationer (herunder den nye indikation "kontrastforstærket MRI af lever og nyrer") hos patienter under 18 år.
English: Average specificity in a patientbased analysis was 52% and in a lesion-based analysis 82%.
Danish: Den gennemsnitlige specificitet ved patient-baseret analyse var 52 % og ved læsions-baseret analyse 82 %.
English: Gadograf This leaflet was last approved in {MM/YYYY}.
Danish: Gadograf Denne indlægsseddel blev senest godkendt den {{MM/ÅÅÅÅ}.
English: Do not use Gadograf after the expiry date which is stated on the label after EXP.
Danish: Brug ikke Gadograf efter den udløbsdato, der står på pakningen.
English: Gadograf is injected by a doctor via a small needle into a vein.
Danish: Gadograf indsprøjtes af en læge gennem en lille nål i en blodåre.
English: D - 133 42 Berlin, Germany Telephone: +49 30 468-1111
Danish: Telefon: +49 30 468-1111
English: Gadograf should only be administered by physicians experienced in the field of clinical MRI practice.
Danish: Gadograf må kun indgives af læger med erfaring inden for klinisk MRI.
English: If you have any further questions, please ask your doctor or the person giving you Gadograf (the radiologist) or the hospital/MRI-centre personnel.
Danish: Spørg lægen eller personen, som giver dig Gadograf (radiologen), eller hospitalets/MRI-centrets personale, hvis der er mere du vil vide.
English: The CHMP has recommended the variation (extension of indication) of the Marketing Authorisation in accordance with the Summary of Product Characteristics set out in Annex III for Gadograf (see Annex I).
Danish: Anbefalede CHMP en ændring (indikationsudvidelse) af markedsføringstilladelsen i overensstemmelse med produktresuméet, der er gengivet i bilag III for Gadograf og tilknyttede navne (se bilag I).
English: the Committee considered the referral made under Article 36(1) of Directive 2001/83/EC, as amended for Gadograf detailed in Annex I;
Danish: Udvalget behandlede indbringelsen i henhold til artikel 36, stk. 1, i direktiv 2001/83/EF, med senere ændringer, for Gadograf og tilknyttede navne som anført i bilag I.
English: Further information regarding the administration and handling of Gadograf is given at the end of the leaflet.
Danish: Du finder yderligere oplysninger vedrørende indgivelse og håndtering af Gadograf i slutningen af indlægssedlen.
English: A single injection of 0.1 millilitre Gadograf per kg body weight is generally sufficient (this means for a person weighing 70 kg the dose would be 7 millilitres).
Danish: En enkelt injektion af 0,1 ml Gadograf pr. kg kropsvægt er generelt tilstrækkelig (dette betyder at dosis for en person, som vejer 70 kg, er 7 ml).
English: QT syndrome) - if you have had changes to the rhythm or rate of your heartbeat after taking medicines - you suffer from brain conditions with seizures or from other diseases of the nervous system
Danish: syndrom) - hvis du har oplevet ændringer i rytmen eller frekvensen af dit hjerteslag efter at have taget medicin - hvis du lider af hjernesygdomme med krampeanfald eller af andre sygdomme i nervesystemet
English: In case of an overdose, Gadograf can be removed from the body by extracorporeal dialysis.
Danish: I tilfælde af overdosering kan Gadograf fjernes fra kroppen ved ekstrakorporal dialyse.
English: A label extension to the indication “Contrastenhanced Magnetic resonance angiography” (CE-MRA) followed in November 2003.
Danish: En udvidelse af indikationen “Kontrastforstærkning ved magnetisk resonansangiografi (CE-MRA) fulgte i november 2003.
English: Optimal opacification is observed during arterial first pass for CE-MRA and within a period of about 15 minutes after injection of Gadograf for CNS indications (time depending on type of lesion/tissue).
Danish: Optimal kontrast ses under arteriel første passage ved kontrastforstærket MRA og inden for et tidsrum af ca. 15 minutter efter injektion af Gadograf ved CNS-indikationer (tiden afhænger af læsion/vævstype).
English: Gadograf should not be used during pregnancy unless clearly necessary.
Danish: Gadograf bør ikke anvendes under graviditet, med mindre det er strengt nødvendigt.
English: Physico-chemical properties:
Danish: Fysisk-kemiske egenskaber
English: The possibility that Gadograf may cause torsade de pointes arrhythmias in an individual patient cannot be excluded (see section 5.3 Preclinical safety data).
Danish: Det kan ikke udelukkes, at Gadograf kan forårsage torsade de pointes-arytmier hos enkelte patienter (se afsnit 5.3 Prækliniske oplysninger).
English: On paravascular injection Gadograf may cause tissue pain lasting up to several minutes.
Danish: Ved paravaskulær injektion kan Gadograf give anledning til vævssmerter, der kan vare indtil flere minutter.
English: Hypersensitivity reactions, as have been reported for other contrast media containing gadolinium, have also been observed after administration of Gadograf.
Danish: Der er rapporteret om hypersensitive reaktioner ved anvendelse af andre kontraststoffer, der indeholder gadolinium, og det er også observeret efter administration af Gadograf.
English: Gadograf contains gadobutrol, a neutral macrocyclic gadolinium complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Danish: Gadograf indeholder gadobutrol, et neutralt, makrocyklisk gadoliniumkompleks med kontrastforstærkende egenskaber, der anvendes til magnetisk resonans imaging (MRI).
English: Delayed allergy-like reactions, hours to several days after the administration of Gadograf, have been observed in rare cases.
Danish: Forsinkede allergi-lignende reaktioner, som opstår timer eller adskillige dage efter indgivelsen af Gadograf, er blevet observeret i sjældne tilfælde.
English: Gadograf may cause local pain lasting up to several minutes if it is injected beside the vein.
Danish: Gadograf kan forårsage lokale smerter som varer op til adskillige minutter, hvis produktet indsprøjtes ved siden af blodåren.
English: Cardiovascular safety pharmacology studies as well as clinical phase I studies gave indication for a potential of Gadograf to block cardiac potassium channels and an effect on cardiac repolarization when administered in doses 3 to 8fold higher than normally administered to patients.
Danish: Kardiovaskulære, farmakologiske sikkerhedsstudier samt kliniske fase I-studier indikerede, at Gadograf potentielt kan blokere for de kardielle kaliumkanaler og indvirke på den kardielle repolarisering, når det gives i doser, der er 3-8 gange højere end de doser, der normalt gives til patienter.
English: Moreover, the wording of the indication should also reflect the clinical context for which Gadograf has demonstrated to have the same diagnostic accuracy than its comparator, that is to correctly localise at least one malignant lesion of liver or kidney in an individual patient using combined pre- and post-contrast MR images.
Danish: Desuden bør ordlyden af indikationen også afspejle den kliniske sammenhæng, i hvilken Gadograf er påvist at have samme diagnostiske præcision som sammenligningspræparatet, dvs. ved anvendelse til korrekt lokalisering af mindst én ondartet forandring i lever eller nyrer hos den pågældende patient ved kombination af MR-billeder optaget før og efter kontrastindgift.
English: Gadograf was the first paramagnetic contrast agent developed in a 1.0 molar solution thus requiring a smaller application volume in a higher dosage.
Danish: Gadograf var det første paramagnetiske kontraststof, der blev udviklet i 1,0 molær opløsning, og kan derfor gives i højere dosis med mindre injiceret volumen.
English: The following applies to the use of the infusion bottle containing 65 ml:
Danish: Følgende gælder for brug af infusionsflasken, der indeholder 65 ml:
English: Gadograf should not be used in case of severe discoloration, the occurrence of particulate matter or a defective container.
Danish: Gadograf må ikke anvendes i tilfælde af kraftig misfarvning, forekomst af partikler eller en defekt beholder.
English: Gadograf will be administered immediately before your MRI examination.
Danish: Gadograf gives lige inden din MRIundersøgelse.
English: Gadograf is a contrast medium for magnetic resonance imaging (MRI) of the brain, spine, vessels, liver and kidneys.
Danish: Gadograf er et kontrastmiddel til magnetisk resonansscanning (MR-scanning) af hjernen, rygraden, kar, leveren og nyrerne.
English: Therefore, the possibility that Gadograf may cause torsade de pointes arrhythmias in an individual patient can not be excluded.
Danish: Derfor kan det ikke udelukkes, at Gadograf kan medføre torsade de pointes- arytmier hos enkelte patienter.
English: METHOD AND ROUTE OF ADMINISTRATION Intravenous use
Danish: ANVENDELSESMÅDE OG ADMINiSTRATIONSVEJ Intravenøs anvendelse
English: Since the issue of clinical utility was satisfactorily addressed and the MAH agreed to the proposed wording, the CHMP is of the opinion that the data provided allow the conclusion that, on basis of the pivotal clinical studies comparing Gadograf-enhanced with Magnevist-enhanced MRI, diagnostic efficacy of Gadograf for the classification of focal liver or renal lesions as benign or malignant, as well as clinical safety of Gadograf has been adequately established.
Danish: Eftersom spørgsmålet om den kliniske værdi er tilfredsstillende belyst, og indehaveren af markedsføringstilladelsen har tilsluttet sig den foreslåede ordlyd, er det CHMP's opfattelse, at de forelagte oplysninger giver grundlag for at konkludere, at den diagnostiske effektivitet, baseret på de kliniske hovedundersøgelser med sammenligning af Gadograf-forstærket og Magnevist-forstærket MRI til klassificering af fokale forandringer i lever og nyrer som benigne eller maligne, såvel som den kliniske sikkerhed af Gadograf, er tilfredsstillende godtgjort.
English: WHAT GADOGRAF IS AND WHAT IT IS USED FOR
Danish: GADOGRAFS VIRKNING OG HVAD DU SKAL BRUGE DET TIL