FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking the tablets with meals will help the medicine to work.
Danish: Medicinen virker bedst, når den tages sammen med et måltid.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til indehaveren af
English: The safety and effectiveness of Fexeric have not been studied in this population.
Danish: Fexerics sikkerhed og virkning er ikke
English: Therefore, patients may need a reduction in
Danish: Det kan derfor være relevant at nedsætte dosis af ESA'er.
English: From in vitro studies, certain antibiotic (doxycycline, cefdinir), anticonvulsant (valproate sodium), antidepressant (sertraline HCl), bisphosphonate (alendronate sodium), anti-parkinsonian (levodopa)
Danish: I in vitro-studier viste visse antibiotika (doxycyclin, cefdinir), antikonvulsiva (valproatnatrium), antidepressiva (sertralin HCl), bisphosphonat (alendronatnatrium), antiparkinson-midler (levodopa) og immunosuppressanter (methotrexat), at de potentielt kan interagere med Fexeric: ethvert af disse eller andre lægemidler, som potentielt kan interagere med Fexeric, skal tages mindst 2 timer før eller efter
English: Package leaflet: Information for the patient Fexeric 1 g film-coated tablets ferric citrate coordination complex This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten Fexeric 1 g filmovertrukne tabletter
English: abdominal pain/discomfort, nausea, vomiting, haemorrhoids, haematochezia, mucous stools, dyspepsia, flatulence, dry mouth
Danish: Diarré, konstipation, misfarvning af fæces Smerter/ubehag i abdomen, kvalme, opkastning, hæmorroider, hæmatokeksi, slimet afføring, dyspepsi, flatulens, tør mund
English: Table 1: Adverse reactions observed during clinical studies in which Fexeric was administered in CKD 5D patients on haemodialysis or peritoneal dialysis.
Danish: Tabel 2 Bivirkninger observeret under kliniske studier, hvor Fexeric blev administreret til Systemorganklasse i henhold til MedDRA Bivirkning
English: In the pivotal non-dialysis study 204, a total of 148 CKD ND patients with hyperphosphatemia and iron deficiency anaemia received treatment with study drug; there were 141 patients in the intent-totreat population (Fexeric: 72 patients; Placebo: 69 patients).
Danish: Der var 141 patienter i intent-to-treat-populationen (Fexeric: 72 patienter; Placebo: 69 patienter).
English: See the end of section 4
Danish: Se sidst i afsnit 4, hvordan du indberetter bivirkninger.
English: In adults with impaired kidney function it is used to lower high blood phosphorus levels.
Danish: Det bruges til at sænke forhøjede niveauer af fosfor i blodet hos voksne med nedsat nyrefunktion.
English: If you take more Fexeric than you should
Danish: Hvis du holder op med at tage Fexeric
English: Adverse Reaction
Danish: Dosistitrering
English: Diarrhoea, constipation, discoloured faeces
Danish: Svimmelhed, hovedpine
English: Pruritus, rash Incontinence
Danish: Palpitationer, dyspnø
English: Reporting of suspected adverse reactions
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER
English: The following side effects have been reported with Fexeric in dialysis patients: Very common side effects (may affect more than 1 in 10 people):
Danish: Følgende bivirkninger med Fexeric er indberettet hos dialysepatienter:
English: Pulmonary oedema, wheezing
Danish: Nyrer og urinveje
English: Clinical consequences are unknown.
Danish: De kliniske følgevirkninger er ukendte.
English: Other body areas
Danish: Andre områder af kroppen
English: <Active substance name (INN)> is a linear GdCA.
Danish: <Aktivt stofnavn (INN)> er en lineær GdCA.
English: <Product name> is approved for use in children above two years of age.
Danish: <Produktnavn> er godkendt til anvendelse hos børn over 2 år.
English: Intravenous gadobenic acid (restriction of the indication - all references to other indications should be removed across the Product Information)
Danish: Intravenøs gadobensyre (restriktion af indikationen - alle henvisninger til andre indikationer skal fjernes i hele produktinformationen) Produktresumé
English: between 40 and 120 minutes following the injection, depending on the individual imaging needs.
Danish: Mellem 40 og 120 minutter efter injektioner, afhængig af det individuelle scanningsbehov.
English: Brain and spine
Danish: Hjerne og rygrad
English: This includes retention in the brain and in other tissues and organs.
Danish: Dette omfatter en tilbageholdelse i hjernen og andet væv og andre organer.
English: The amount in millilitre you will be injected depends on how much you weigh in kilogram of body weight.
Danish: Injektionsmængden angivet i milliliter afhænger af, hvor meget du vejer i kilo legemsvægt.
English: Signal intensity increases and non-clinical data show that gadolinium is released from linear GdCAs.
Danish: Signalintensiteten stiger, og ikke-kliniske data viser, at gadolinium frigives fra lineære GdCA'er.
English: This has not been seen following the small amounts given with injections into the joint.
Danish: Dette er ikke blevet observeret, efter små mængder blev givet ved injektioner i leddet.
English: Prior to administration of <Product name>, it is recommended that all patients are screened for renal dysfunction by obtaining laboratory tests.
Danish: Inden administration af <Produktnavn> anbefales det, at alle patienter bliver screenet for nedsat nyrefunktion ved hjælp af laboratorieprøver.
English: o Accumulation in the body <Product name> works because it contains a metal called gadolinium.
Danish: o Ophobning i kroppen <Produktnavn> virker, da det indeholder et metal, der kaldes gadolinium.
English: <Product name> is injected into a vein, usually in your arm just before the MRI scan.
Danish: <Produktnavn> indsprøjtes i en åre, normalt i armen, lige før MR-scanningen.
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Danish: Patienter, der skal have foretaget levertransplantation, er i en særlig risikogruppe, da hyppigheden af akut nyresvigt er høj hos denne gruppe.
English: Retention of gadolinium in the brain has not been identified for intra-articular administration.
Danish: Tilbageholdelsen af gadolinium i hjernen er ikke blevet identificeret ved intraartikulær administration.
English: The dose should be calculated based on the patient's body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.
Danish: Dosis skal beregnes baseret på patientens legemsvægt, og den må ikke overskride den anbefalede dosis pr. kg legemsvægt, som beskrives i dette pkt.
English: • part for healthcare professionals: Post-contrast imaging acquisition:
Danish: • del tiltænkt læger og sundhedspersonale: Optagelse af post-kontrast scanning:
English: • Specific applications in the heart include measurement of myocardial perfusion under pharmacological stress conditions and viability diagnostics ("delayed enhancement").
Danish: • Specifikke undersøgelser af hjertet omfatter måling af myokardieperfusion under farmakologisk stress og viabilitet ("forsinket forstærkning").
English: • Section 3 How to use <Product name>
Danish: • Punkt 3 Sådan skal du bruge <Produktnavn>
English: Studies have shown that small amounts of gadolinium can remain in the body, including the brain.
Danish: Studier har vist, at små mængder gadolinium kan blive tilbage i kroppen, herunder i hjernen.
English: The lowest dose that provides sufficient enhancement for diagnostic purposes should be used.
Danish: Der skal anvendes den laveste dosis, som giver en tilstrækkelig forstærkning til diagnostiske formål.
English: Because of the lack of information on repeated administration, <Product name> injections should not be repeated unless the interval between injections is at least 7 days.
Danish: På baggrund af manglende information om gentagne doseringer må injektioner med <Produktnavn> kun gentages med mindst 7 dages interval.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR< 30ml/min /1.73 m2).
Danish: Der foreligger rapporter om nefrogen systemisk fibrose (NSF) relateret til brug af nogle gadoliniumholdige kontrastmidler hos patienter med akut eller kronisk alvorligt nedsat nyrefunktion (GFR<30 ml/min/1,73 m2).
English: • Section 2: What you need to know before you are given <product name>
Danish: • Punkt 2: Det skal du vide, før du begynder at få <produktnavn>
English: T1-weighted sequences to be acquired as either dynamic or static delayed imaging.
Danish: T1-vægtede sekvenser, der skal udføres som enten dynamisk eller statisk forsinket billeddannelse.
English: The possible diagnostic advantages of using <active substance name (INN)> in patients who will require repeated scans should be weighed against the potential for deposition of gadolinium in the brain and other tissues.
Danish: De mulige diagnostiske fordele ved at bruge <aktivt stofnavn (INN)> til patienter, der har behov for at få foretaget gentagne scanninger, skal opvejes mod risikoen for at aflejre gadolinium i hjernen og andet væv.
English: • Assessment of myocardial perfusion
Danish: • Undersøgelse af myokardieperfusion
English: It helps your doctor to identify any abnormalities of your liver brain/spine, arteries or other parts of your body.
Danish: Det hjælper lægen til at identificere eventuelle forandringer i din lever, hjerne/rygsøjle, arterier eller andre områder af din krop.
English: Immediately following bolus injection.
Danish: Umiddelbart efter bolusinjektion.
English: Section 4.2 Posology and method of administration The lowest dose that provides sufficient enhancement for diagnostic purposes should be used.
Danish: 4.2 Dosering og administration Der skal anvendes den laveste dosis, som giver en tilstrækkelig forstærkning til diagnostiske formål.
English: • Magnetic Resonance Angiography (MRA) for the assessment of stenoses, occlusions and collaterals in adults and children (above the age of 2 years).
Danish: • Magnetisk resonansangiografi (MRA) til vurdering af stenoser, tillukninger og kollateraler hos voksne og børn (i alderen over 2 år).
English: Section 4.2 Posology and method of administration
Danish: 4.2 Dosering og administration
English: Brain and Spine up to 60 minutes after the administration.
Danish: Hjerne og rygrad Op til 60 minutter efter indgivelsen.
English: The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below.
Danish: Ændringer af relevante punkter i produktinformationen De eksisterende produktoplysninger skal ændres (henholdsvis indsætning, erstatning eller sletning af tekst) så de svarer til nedenstående vedtagne tekst.
English: • Assessment of cardiac masses or myocardial viability
Danish: • Vurdering af myokardiemasser eller myokardieviabilitet
English: Post-contrast imaging acquisition: Liver
Danish: Optagelse af post-kontrast scanning: Lever
English: This medicinal product is for diagnostic use by intravenous administration only.
Danish: Dette lægemiddel er kun til diagnostisk brug ved intravenøs administration.
English: • MRI of the brain and spine in adults and children above the age of 2 years, where it improves the detection of lesions and provides diagnostic information additional to that obtained with unenhanced MRI (see section 5.1).
Danish: • MRI af hjerne og rygrad hos voksne og børn i alderen over 2 år, da det forbedrer påvisning af læsioner og giver diagnostisk information udover den der opnås ved ikke-forstærket MRI (se pkt.
English: If an automatic contrast detection pulse sequence is not used for bolus timing, then a test bolus injection <2 mL of the agent should be used to calculate the appropriate scan delay.
Danish: Hvis der ikke benyttes automatisk kontrastdetektionsimpulssekvens til bolus-timingen, bør en testbolusinjektion <2 ml af midlet bruges til beregning af den korrekte scanningsforsinkelse.
English: As there is a possibility that NSF may occur with <Product name>, it should therefore be avoided in patients with severe renal impairment and in patients in the perioperative liver transplantation period unless the diagnostic information is essential and not available with non-contrast enhanced MRI.
Danish: Da der er risiko for, at der kan opstå NSF ved anvendelse af <Produktnavn>, bør det derfor undlades til patienter med svær nyreinsufficiens og til patienter i den perioperative fase af en levertransplantation, medmindre den diagnostiske information er særdeles vigtig og ikke tilgængelig med ikke-kontrastforstærket MRscanning.
English: Intravenous gadoteric acid, gadobutrol, gadoteridol Summary of product characteristics
Danish: Intravenøs gadoterinsyre, gadobutrol, gadoteridol Produktresumé
English: Magnetic resonance angiography
Danish: Magnetisk resonansangiografi (MRA)
English: MRI of the breast, heart or other body areas: 0.2 ml per kilogram of body weight
Danish: MRI af brystet, hjertet eller andre områder af kroppen: 0.2 ml per kilo legemsvægt
English: Delayed imaging:
Danish: Forsinket scanning:
English: Cardiac MRI
Danish: MRI af hjertet
English: <Product name> is a paramagnetic contrast agent for use in diagnostic magnetic resonance imaging (MRI) indicated for: of the liver in adults and children (above the age of 2 years)
Danish: <Produktnavn> er et paramagnetisk kontrastmiddel til diagnostisk MR-scanning (MRI) indiceret til: af leveren hos voksne og børn (over 2 år)
English: Dynamic imaging:
Danish: Dynamisk scanning:
English: With the linear GdCAs this can cause dose-dependent increases in T1-weighted signal intensity in the brain, particularly in the dentate nucleus, globus pallidus, and thalamus.
Danish: Med lineære GdCA'er kan dette forårsage dosisafhængige stigninger i T1-vægtet signalintensitet i hjernen, især i nucleus dentatus, globus pallidus og thalamus.
English: If use of <Product name> cannot be avoided, the dose should not exceed 0.1 mmol/kg body weight when used for MR of the brain and spine, MR-angiography breast MRI or whole body MRI and should not exceed 0.05 mmol/kg body weight when used for MR of the liver, kidneys, urinary tract or adrenal glands.
Danish: Hvis anvendelse af <Produktnavn> ikke kan undgås, må dosis ikke overstige 0.1 mmol/kg legemsvægt, når det anvendes til MRI-scanning af hjerne og rygmarv, MR-angiografi bryst MRI eller helkrops MRI og bør ikke overstige 0,05 mmol/kg legemsvægt, når det anvendes til MR-scanning af leveren, nyrerne, urinvejene eller binyrerne.
English: No side effects have been seen due to gadolinium remaining in the brain.
Danish: Der er ikke blevet observeret bivirkninger fra gadolinium, der stadig er tilbage i hjernen.
English: More than one dose should not be used during a scan except for MR cardiac perfusion imaging where two separate doses of 0.05 mmol/kg body weight can be administered in the course of a single examination.
Danish: Der må ikke anvendes mere en én dosis under scanning pånær for MR kardial perfusion scanning, hvor to seperate doser af 0,05 mmol/kg legemsvægt kan administreres under en enkelt undersøgelse.
English: • MR imaging of the whole body in adults and children (above the age of 2 years) including head and neck region, thoracic space (including the heart and female breast), abdomen (pancreas and liver), abdomen (gastrointestinal tract), retroperitoneal space (kidney, adrenal glands), pelvis (prostate, bladder and uterus) and musculoskeletal system where it facilitates identification of abnormal structures or lesions and helps in differentiating normal from pathological tissues (see sections 4.2 and
Danish: • MRI af hele kroppen hos voksne og børn (i alderen over 2 år), herunder hoved- og nakkeregion, thorax (herunder hjertet samt det kvindelige bryst), abdomen (pancreas og lever), abdomen (mave-tarm-kanalen), retroperitoneum (nyrer, binyrer), pelvis (prostata, blære og uterus) og det muskuloskeletale system, hvor det muliggør identifikation af unormale strukturer eller læsioner og hjælper med at skelne normalt fra patologisk væv (se pkt.
English: <Product name> is a special dye (or contrast agent) which contains the rare earth metal gadolinium and improves images of the liver brain/spine, arteries and other body areas during MRI scans.
Danish: <Produktnavn> er et specielt farvestof (eller kontrastmiddel), der indeholder det sjældne jordmetal gadolinium og forbedrer billeder af leveren hjerne, rygsøjle, bryst og arterier ved MR-scanninger.
English: MRI of brain/spine: 0.2 ml per kilogram of body weight MRI of arteries: 0.2 ml per kilogram of body weight MRI of the liver, the kidney, urinary tract or adrenal glands: 0.1 ml per kilogram of body weight
Danish: MRI af hjerne/rygsøjle: 0.2 ml per kilo legemsvægt MRI af arterierne: 0.2 ml per kilo legemsvægt MRI af leveren, nyeren, urinvejene eller binyrerne: 0,1 ml pr. kilo legemsvægt
English: Section 4.1 Therapeutic indications <Product name> is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI).
Danish: 4.1 Terapeutiske indikationer <Produktnavn> er indiceret til detektion af fokale leverlæsioner, og giver information om læsionstyperne ved T1-vægtet MR-scanning (MRI).
English: Head and neck region, thoracic space (including the heart and female breast), abdomen (gastrointestinal tract including pancreas), pelvis (prostate, bladder and uterus) and musculoskeletal system
Danish: Hoved- og nakkeregion, thorax (inklusive hjerte samt det kvindelige bryst), abdomen (mave-tarm-kanalen inklusive pancreas), pelvis (prostata, blære og uterus) og det muskuloskeletale system
English: MRA immediately after the administration, with scan delay calculated on the basis of test bolus or automatic bolus detection technique.
Danish: MRA Umiddelbart efter indgivelsen, med scanningsforsinkelse beregnet på baggrund af en testbolus eller automatisk detektion af bolus.
English: Brain up to 60 minutes after the administration.
Danish: Op til 60 minutter efter indgivelsen.
English: immediately after the administration, with scan delay calculated on the basis of test bolus or automatic bolus detection technique.
Danish: Umiddelbart efter indgivelsen, med scanningsforsinkelse beregnet på baggrund af en testbolus eller automatisk detektion af bolus.
English: The recommended dose of <active substance name (INN)> in adult patients and children is 0.05 mmol/kg body weight (0.1 mL/kg of the 0.5 M solution).
Danish: Den anbefalede dosis af <aktivt stofnavn (INN)> til voksne patienter og børn er 0,05 mmol/kg legemsvægt (0,1 ml/kg af en 0,5 M opløsning).
English: Breast A T1-weighted, gradient-echo sequence with a time resolution of 2 minutes or less should be acquired before contrast injection and repeated several times over a period of
Danish: Der skal udføres en T1-vægtet, gradient ekkosekvens med en tidsopløsning på 2 minutter eller mindre før indsprøjtning af kontrastmiddel.
English: Liver, kidneys, urinary tract , adrenal glands
Danish: Lever, nyrer, urinveje, binyrer
English: Studies have shown that after exposure to GdCAs given intravenously at significantly higher doses than intra-articular products gadolinium is retained in the body.
Danish: Studier har vist, at gadolinium tilbageholdes i kroppen efter eksponering over for GdCA'er, der gives intravenøst, ved signifikant højere doser end for præparater, der gives intraartikulært.
English: After administration of <active substance name (INN)> gadolinium can be retained in the brain and in other tissues of the body (bones, liver, kidneys, skin) and can cause dose-dependent increases in T1weighted signal intensity in the brain, particularly in the dentate nucleus, globus pallidus, and thalamus.
Danish: Efter administration af <aktivt stofnavn (INN)> kan gadolinium tilbageholdes i hjernen og andet kropsvæv (knogler, lever, nyrer, hud), og kan medføre dosisafhængige stigninger i T1-vægtet signalintensitet i hjernen, især i nucleus dentatus, globus pallidus og thalamus.
English: Intravenous gadoxetic acid
Danish: Intravenøs gadoxetinsyre
English: A T1-weighted, gradient-echo sequence with a time resolution of 2 minutes or less should be acquired before contrast injection and repeated several times over a period of 5 to 8 min after a rapid intravenous contrast bolus injection.
Danish: Denne sekvens skal gentages flere gange over en periode på 5-8 minutter efter en hurtig intravenøs bolusinjektion med kontrastmiddel.
English: Studies have shown that after exposure to GdCAs gadolinium is retained in the body.
Danish: Studier har vist, at gadolinium tilbageholdes i kroppen efter eksponering over for GdCA'er.
English: 0.05 mmol/kg body weight (0.1 mL/kg of the 0.5 M solution)
Danish: 0,05 mmol/kg legemsvægt (0,1 ml/kg af 0,5 M opløsning)
English: 0.1 mmol/kg body weight (0.2 mL/kg of the 0.5 M solution)
Danish: 0,1 mmol/kg legemsvægt (0,2 ml/kg af 0,5 M opløsning)
English: After intravenous administration of <active substance name (INN)> gadolinium can be retained in the brain and in other tissues of the body (bones, liver, kidneys, skin) and can cause dose-dependent increases in T1-weighted signal intensity in the brain , particularly in the dentate nucleus, globus pallidus, and thalamus.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Efter intravenøs administration af <aktivt stofnavn (INN)> kan gadolinium tilbageholdes i hjernen og andet kropsvæv (knogler, lever, nyrer, hud), og kan medføre dosisafhængige stigninger i T1-vægtet signalintensitet i hjernen, især i nucleus dentatus, globus pallidus og thalamus.
English: Intra-articular gadoteric acid
Danish: Intraartikulær gadoterinsyre
English: Section 4.1 Therapeutic indications <Product name> should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI).
Danish: 4.1 Terapeutiske indikationer <Produktnavn> må kun anvendes, når den diagnostiske information er essentiel og ikke tilgængelig med ikke-kontrastforstærket MR-scanning (MRI).
English: <Product name> should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI) and when delayed phase imaging is required.
Danish: <Produktnavn> må kun anvendes, når den diagnostiske information er essentiel og ikke tilgængelig med ikke-kontrastforstærket MR-scanning (MRI), og når det er nødvendigt med forsinket fasescanning.
English: Section 4.1 Therapeutic indications <Product name> should be used only when diagnostic information is essential and not available with unenhanced magnetic resonance imaging (MRI) and when another authorised product cannot be used.
Danish: 4.1 Terapeutiske indikationer <Produktnavn> må kun anvendes, når den diagnostiske information er essentiel og ikke tilgængelig med ikke-kontrastforstærket MR-scanning, og når et andet godkendt præparat ikke kan anvendes.
English: Two separate injections of 0.05 mmol/kg body weight (each corresponding to 0.1 mL/kg of the 0.5 M solution) during rest and stress imaging.
Danish: 0,1 mmol/kg legemsvægt, indgivet som en enkelt bolusinjektion på 0,2 ml/kg af 0,5 M opløsning Under scanning gives to særskilte injektioner på 0,05 mmol/kg legemsvægt (som hver svarer til 0,1 ml/kg af 0,5 M opløsning) i hviletilstand og under stress.
English: Intra-articular gadopentetic acid
Danish: Intraartikulær gadopentetinsyre
English: • Section 1 What <Product name> is and what it is used for
Danish: • Punkt 1 Virkning og anvendelse
English: QUESTIONS AND ANSWERS ON WITHDRAWAL OF AN APPLICATION FOR AN EXTENSION OF THE MARKETING AUTHORISATION for OPATANOL
Danish: SPØRGSMÅL OG SVAR VEDRØRENDE TILBAGETRÆKNINGEN AF EN ANSØGNING OM UDVIDELSE AF MARKEDSFØRINGSTILLADELSEN for OPATANOL
English: The application was at ‘Day 120' when the Company withdrew.
Danish: Denne ansøgning var på "dag 120", da firmaet trak den tilbage.
English: The company's letter of withdrawal is published on the EMEA website and can be found here.
Danish: Firmaets brev med meddelelsen om tilbagetrækningen er lagt ud på EMEAs hjemmeside og kan findes her.