FrancophonIA/ELRC3.0 huggingface dataset:
English: Local reactions have occurred at the injection site and may lead to local irritation type reactions.
Danish: Lokale reaktioner er forekommet på injektionsstedet, og disse kan medføre reaktioner i form af lokal irritation.
English: Special Populations
Danish: Særlige populationer
English: Administer the lowest dose possible for adequate imaging.
Danish: Den lavest mulige dosis for tilstrækkelig billeddannelse skal administreres.
English: Premedication with antihistamines and/or glucocorticoids may be considered.
Danish: Forudgående medicinering med antihistaminer og/eller glucocorticoider kan overvejes.
English: The use of a contrast agent may therefore reduce the threshold for lesion detection and visualization.
Danish: Anvendelse af et kontrastmiddel kan derfor sænke tærskelen for læsionsdetektion og visualisering.
English: • to any of the other ingredients of Optimark (see section 6), or
Danish: • over for et af de øvrige indholdsstoffer i Optimark (angivet i punkt 6), eller
English: Osmolality (37°C): 1000 - 1200 mOsm/kg
Danish: Osmolalitet (37 °C): 1.000-1.200 mOsm/kg
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstid under anvendelse og betingelser før brug brugerens ansvar.
English: Effect of Gender:
Danish: Indvirkningen af køn:
English: Before the examination, care must be taken that patients are sufficiently hydrated.
Danish: Før undersøgelsen skal det sikres, at patienten er tilstrækkeligt hydreret.
English: If you think you have been injected with too much Optimark, tell the doctor or nurse/technologist immediately.
Danish: Hvis De mener, at De har fået indsprøjtet for meget Optimark, skal De omgående fortælle det til lægen eller sygeplejersken/teknikeren.
English: • you are on a controlled sodium diet
Danish: • De er på en saltfattig diæt
English: There are no data from the use of gadoversetamide in pregnant women.
Danish: Der er ingen data fra anvendelse af gadoversetamid til gravide kvinder.
English: As a result, these agents have been referred to as markers for sites of abnormal BBB breakdown.
Danish: Som følge heraf er der blevet refereret til disse midler som markører af områder med abnorm BBB-nedbrydning.
English: You must tell the doctor or nurse/technologist immediately if you feel pain around the area where the needle is placed.
Danish: De skal omgående fortælle lægen eller sygeplejersken/teknikeren det, hvis De føler smerter omkring det område, hvor kanylen er placeret.
English: Effects of Age:
Danish: Indvirkningen af alder:
English: Most of these reactions occur within half an hour after administering the contrast medium.
Danish: De fleste af disse reaktioner forekommer inden for en halv time efter administration af kontrastmidlet.
English: Interaction with other medicinal products and other forms of interaction No formal interaction studies have been performed.
Danish: Interaktion med andre lægemidler og andre former for interaktion Der er ikke udført formelle interaktionsstudier.
English: Since gadoversetamide is only administered as a single dose this will lead to a longer and higher exposure for a limited duration.
Danish: Da gadoversetamid kun administreres som en enkeltdosis, vil dette medføre en længere og højere eksponering af begrænset varighed.
English: However, these were not evident from clinical trials with Optimark.
Danish: Dette var dog ikke evident ud fra kliniske studier med Optimark.
English: Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Danish: Patienter, som har eller skal have levertransplantation, er særligt udsatte, da incidensen af akut nyresvigt er stor i denne gruppe.
English: Talk to your doctor before Optimark is used, if:
Danish: Kontakt lægen, før De får Optimark, hvis:
English: It is not necessary to adjust your dose if you are 65 years of age or older but you will have a blood test to check how well your kidneys are working.
Danish: Det er ikke nødvendigt at justere Deres dosis, hvis De er 65 år eller derover, men De vil få taget en blodprøve for at kontrollere, hvor godt Deres nyrer fungerer.
English: The usual dose of 0.2 ml/kg body weight is the same in adults and children of 2 years and older.
Danish: Den sædvanlige dosis er 0,2 ml/kg kropsvægt og er den samme til voksne og til børn over 2 år.
English: Optimark should be drawn into the syringe and used immediately.
Danish: Optimark skal trækkes op i sprøjten og bruges med det samme.
English: NSF may result in debilitating joint immobility, muscle weakness or may affect the normal working of internal organs which may potentially be life-threatening.
Danish: NSF kan medføre nedsat bevægelighed i leddene, muskelsvaghed eller kan påvirke den normale funktion af de indre organer, hvilket kan være livstruende.
English: • you have recently had, or soon expect to have, a liver transplant
Danish: • De for nyligt har fået, eller forventer snart at få, en levertransplantation
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De får dette lægemiddel.
English: However, the administration of gadoversetamide does not cause a true decrease in serum calcium.
Danish: Administration af gadoversetamid medfører dog ikke noget ægte fald i serum-calcium.
English: Optimark should only be administered by physicians experienced in clinical MRI practice.
Danish: Optimark må kun administreres af læger med erfaring inden for klinisk MRI-praksis.
English: Elderly (aged 65 years and above) No dosage adjustment is considered necessary.
Danish: Ældre (i alderen 65 år og derover) Dosisjustering anses ikke for nødvendig.
English: Optimark should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.
Danish: Optimark bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver anvendelse af gadoversetamid.
English: Optimark has no or negligible influence on the ability to drive and use machines.
Danish: Optimark påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: The pharmacokinetics of gadoversetamide conforms to a two compartment open-model.
Danish: Farmakokinetikken for gadoversetamid er i overensstemmelse med en åben to-kammermodel.
English: See the end of section 4 for how to report side effects.
Danish: Se sidst i afsnit 4, hvordan De/du indberetter bivirkninger.
English: Feeling hot
Danish: Følelse af varme
English: Pharmacotherapeutic Group: MRI contrast media, ATC code: V08CA06
Danish: Farmakoterapeutisk klassifikation: MRI-kontrastmiddel, ATC-kode: V08C A06
English: 15, rue des Vanesses 93420 Villepinte France
Danish: 15, rue des Vanesses 93420 Villepinte Frankrig
English: Date of latest renewal: 15 June 2012
Danish: Dato for første markedsføringstilladelse: 23. juli 2007 Dato for seneste fornyelse: 15 juni 2012
English: If you are an ambulant patient and plan to drive or use tools or machines, take into account that dizziness may incidentally occur after you undergo a procedure involving the injection of Optimark.
Danish: Hvis De er ambulant patient og har planlagt at køre bil eller arbejde med værktøj eller maskiner, skal De tage hensyn til, at der kan opstå svimmelhed, efter at De har gennemgået en procedure, der omfattede indsprøjtning af Optimark.
English: Do not use Optimark if you are allergic
Danish: De må ikke få Optimark: hvis De er allergisk
English: The risk of acute kidney injury may increase with an increased dose of the contrast agent.
Danish: Risikoen for akut nyreskade kan stige med en øget dosis kontrastmiddel.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De/du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Before you receive Optimark, you will need to have a blood test to check how well your kidneys are working.
Danish: Før De får Optimark, skal De have taget en blodprøve for at kontrollere, hvor godt Deres nyrer fungerer.
English: Gadoversetamide does not undergo protein binding in vitro.
Danish: Gadoversetamid gennemgår ingen proteinbinding in vitro.
English: As the renal clearance of gadoversetamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Danish: Da clearance af gadoversetamid i nyrerne kan være nedsat hos ældre, er der især vigtigt at screene patienter i alderen 65 år og derover for forstyrrelser af nyrefunktionen.
English: Discard any remaining solution after first use.
Danish: Kassér al ubrugt opløsning efter første anvendelse.
English: The elimination of Optimark in dogs younger than 3 months of age was significantly delayed because of immature renal function and resulted in a high systemic exposure to Optimark.
Danish: Eliminationen af Optimark hos hunde under 3 måneder var betydeligt forsinket på grund af den umodne nyrefunktion, hvilket resulterede i en høj systemisk eksponering for Optimark.
English: Such results (ratio renal clearance/total plasma clearance close to 1) indicate that gadoversetamide is essentially cleared through the kidneys.
Danish: Sådanne resultater (forholdet nyre-clearance/total plasma-clearance tæt på 1) tyder på, at gadoversetamid hovedsageligt udskilles via nyrerne.
English: Caution should be exercised because transient decreases in serum iron and zinc parameters have been observed in clinical trials.
Danish: Der skal udvises forsigtighed, idet forbigående fald i serum-jern og -zinkparametre er observeret ved kliniske studier.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Danish: • Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme afslutte følgende foranstaltninger/tiltag:
English: Patients with cardiovascular disease
Danish: Patienter med kardiovaskulær sygdom
English: Especially in patients with serious heart diseases (e.g. severe heart failure, coronary artery disease) cardiovascular reactions may deteriorate.
Danish: Specielt hos patienter med alvorlige hjertesygdomme (f.eks. alvorlig hjerteinsufficiens, koronararteriesygdom) kan de kardiovaskulære reaktioner forværres.
English: Optimark is used to obtain a clearer scan in patients who have or are thought to have abnormalities in the brain, spine or liver.
Danish: Optimark anvendes til at få en tydeligere scanning hos patienter, som har eller menes at have abnormiteter i hjerne, rygmarv eller lever.
English: There was no systematic difference in any of the kinetic parameters as a function of dose level (100 to 700 micromol/kg).
Danish: Der var ingen systematisk forskel i nogen af de kinetiske parametre som funktion af dosisniveau (100 til 700 mikromol/kg).
English: When looking at certain abnormalities in the brain, Optimark may need to be used at three times the usual dose in one injection in adults.
Danish: I forbindelse med visse abnormiteter i hjernen kan det være nødvendigt at injicere Optimark i tre gange den normale dosis på en gang hos voksne.
English: If electronic patient records are used, the name of the product, the batch number and the dose should be entered into the patient record.
Danish: Hvis der anvendes elektroniske patientjournaler, skal lægemidlets navn, batchnummer og dosis indtastes i patientens journal.
English: No carcinogenicity studies were performed.
Danish: Der blev ikke udført karcinogenicitetsstudier.
English: As a result of these characteristics, the timing of the image acquisition after contrast administration is critical in liver imaging.
Danish: Som følge af disse egenskaber er tidspunktet for billeddannelsen efter administration af kontrastmidlet kritisk ved billeddannelse af leveren.
English: The required dose should be administered by hand to children of 2 to 11 years to avoid overdosage by mistake.
Danish: Den nødvendige dosis skal administreres manuelt til børn i alderen 2 til 11 år for at undgå utilsigtet overdosering.
English: This volume of distribution (approximately 10-15 l for a body weight of 70 kg) is consistent with a medicinal product which distributes into the extracellular fluid.
Danish: Dette distributionsvolumen (cirka 10-15 l for en legemsvægt på 70 kg) er i overensstemmelse med et lægemiddel, som distribueres til den ekstracellulære væske.
English: The safety of repeat doses has not been established in children and adolescents (2 years and older), in patients with renal impairment, or the elderly.
Danish: Sikkerheden ved gentagne doser kendes ikke hos børn og unge (i alderen 2 år og derover), hos patienter med nedsat nyrefunktion eller hos ældre.
English: It is unknown whether gadoversetamide is excreted in human milk.
Danish: Det er ukendt, om gadoversetamid udskilles i human mælk.
English: Not all package sizes may be marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: The frequencies below and the following symptoms are based on clinical trials, and on the experience in using Optimark after it was on the market:
Danish: Nedenstående hyppigheder og symptomer er baseret på kliniske studier og erfaringen med anvendelse af Optimark, efter at det kom på markedet:
English: This difference in enhancement pattern is useful in formulating a differential diagnosis based on lesion characterization and diagnostic confidence.
Danish: Denne forskel i kontrastoptagelsesmønsteret er nyttig ved formulering af en differential diagnose baseret på læsionskarakteristik og øger diagnostisk sikkerhed.
English: It is used in adult patients and children of two years and older, who are undergoing magnetic resonance imaging (MRI), a type of scan where images of the internal organs are taken.
Danish: Det anvendes til voksne og børn over 2 år, som gennemgår magnetisk resonans (MR) scanning, en form for scanning, hvor der tages billeder af de indre organer.
English: Optimark must not be administered with an autoinjector.
Danish: Optimark må ikke administreres med en autoinjektor.
English: 6.6 Special precautions for disposal and other handling Optimark is intended for single use only; any unused portions should be discarded.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Optimark er udelukkende beregnet til engangsbrug; eventuelle ikke anvendte portioner skal destrueres.
English: NSF is a disease involving thickening of the skin and connective tissues.
Danish: NSF er en sygdom, som medfører fortykkelse af huden og bindevævet.
English: Repeat dose
Danish: Gentagen dosis
English: It would account for 14 ml for a 70 kg individual, and this volume would be injected over about 7-14 seconds into a vein, usually a vein in an arm.
Danish: Det svarer til 14 ml til en person på 70 kg, og dette volumen vil blive indsprøjtet i løbet af cirka 7-14 sekunder i en blodåre, normalt en blodåre i armen.
English: The high accountability for the dose as intact complex in urine suggests that no significant metabolism of gadoversetamide occurs in humans.
Danish: Den høje udskillelse af dosen som intakt kompleks i urin tyder på, at der ikke forekommer nogen signifikant omsætning af gadoversetamid hos mennesker.
English: • you suffer from epilepsy or brain lesions
Danish: • De lider af epilepsi eller hjernelæsioner
English: Therefore, a rapid imaging sequence should be initiated 20 seconds after bolus injection of the contrast agent when the agent is predominately in the hepatic arteries and then again at 60 seconds after injection during the dominant portal venous phase.
Danish: Derfor bør en hurtig billeddannelsessekvens indledes 20 sekunder efter bolusinjektion af kontrastmidlet, når midlet overvejende befinder sig i de hepatiske arterier, og dernæst igen 60 sekunder efter injektionen under den dominerende portvenefase.
English: Optimark is filled in vials made of colourless highly resistant borosilicate glass (EP Type I).
Danish: Optimark dispenseres i hætteglas fremstillet af farveløst, stærkt resistent borsilikatglas (EP Type I).
English: Diagnostic procedures involving the use of contrast agents should be conducted under supervision of a physician with the prerequisite training and a thorough knowledge of the procedure to be performed.
Danish: Diagnostiske procedurer, som omfatter anvendelse af kontrastmidler, skal gennemføres under overvågning af en læge med den fornødne uddannelse i og et solidt kendskab til den procedure, der skal gennemføres.
English: Treatment should be symptomatic and immediate access to necessary medicinal products and emergency equipment should be available should a serious event occur.
Danish: Behandlingen bør være symptomatisk, og der skal være umiddelbar adgang til nødvendige lægemidler og nødudstyr, hvis der skulle opstå en alvorlig bivirkning.
English: When the BBB is disrupted, the gadoversetamide molecules diffuse into the interstitial compartment thereby producing the characteristic paramagnetic effect of T1 and T2 shortening.
Danish: Når BBB er nedbrudt, diffunderer gadoversetamid-molekylerne ind i det interstitielle rum og skaber derved den karakteristiske paramagnetiske effekt af T1- og T2-forkortelse.
English: No functional impairment was observed.
Danish: Der blev ikke observeret nogen funktionsnedsættelse.
English: When Optimark was used in children aged 2 or older they had similar side effects as in adults.
Danish: Når Optimark blev anvendt til børn på 2 år eller derover, havde børn de samme bivirkninger som voksne.
English: If hypersensitivity reactions occur, the administration of the contrast medium must be discontinued immediately and intravenous treatment initiated, if necessary.
Danish: Hvis der forekommer overfølsomhedsreaktioner, skal administrationen af kontrastmidlet omgående seponeres, og der skal om nødvendigt indledes intravenøs behandling.
English: Headache, Dysgeusia
Danish: Hovedpine, dysgeusi
English: Repeated-dose toxicity studies in rats and dogs revealed vacuolation of the tubular cells of the kidneys, with strong evidence for reversibility of the effect.
Danish: Toksicitetsstudier med gentagen dosering hos rotter og hunde afslørede vakuolisering af nyrernes tubulære celler med stærke tegn på reversibilitet af effekten.
English: If non-disposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.
Danish: Hvis der anvendes udstyr til flergangsbrug, skal der udvises stor omhu for at hindre restkontamination med spor af rengøringsmidler.
English: Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Danish: Injektioner med Optimark bør ikke gentages, medmindre intervallet mellem injektionerne er mindst 7 dage.
English: If your kidneys are working normally it is unlikely you will have any problems.
Danish: Hvis Deres nyrer fungerer normalt, får de sandsynligvis ingen problemer.
English: Acute toxicity symptoms are unlikely to occur in patients with normal renal function.
Danish: Det er usandsynligt, at der vil forekomme toksiske symptomer hos patienter med normal nyrefunktion.
English: Optimark should not be used during pregnancy unless strictly necessary.
Danish: Graviditet og amning Optimark må ikke anvendes under graviditet, medmindre det er strengt nødvendigt.
English: Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver.
Danish: Optimark er indiceret til brug ved magnetisk ressonansbilleddannelse (MRI) af centralnervesystemet (CNS) og leveren.
English: Inspect the syringe for signs of leakage.
Danish: Efterse sprøjten for tegn på lækage.
English: There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect also soft tissue and internal organs).
Danish: Der har været rapporter om nefrogen systemisk fibrose (som forårsager forhærdning af huden, og som også kan påvirke bløddele og interne organer).
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, reproductive toxicity, local tolerance, antigenicity, and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, akut toksicitet, reproduktionstoksicitet, lokal tolerance, antigen-virkning og genotoksicitet.
English: In patients with moderate kidney problems, more than one dose of Optimark should not be used during a scan.
Danish: Hos patienter med moderate nyreproblemer, bør mere end én dosis ikke anvendes under en scanning.
English: Please see package leaflet for further information.
Danish: Se indlægssedlen for yderligere oplysninger.
English: Optimark contains the active substance gadoversetamide.
Danish: Optimark indeholder det aktive stof gadoversetamid.
English: Because of the lack of information on repeated administration, Optimark injections should not be repeated unless the interval between injections is at least 7 days.
Danish: Grundet manglende information om gentagne indgivelser bør injektioner med Optimark ikke gentages, medmindre intervallet mellem injektionerne er mindst 7 dage.
English: In the presence of gadoversetamide, the OCP technique produces an erroneous, low value for plasma calcium.
Danish: Ved tilstedeværelse af gadoversetamid skaber OCPteknikken en fejlagtigt lav værdi for plasma-calcium.
English: Clinical consequences of an overdose have not been reported.
Danish: Der er ikke rapporteret om kliniske følger af overdosering.
English: Optimark contains sodium
Danish: Optimark indeholder natrium
English: The MAH shall conduct a study evaluating the potential for long-term accumulation of gadolinium in the bone based on a CHMP agreed protocol.
Danish: Indehaveren af markedsføringstilladelsen skal udføre et studie, der evaluerer potentialet for langvarig akkumulering af gadolinium i knogler, baseret på en protokol godkendt af CHMP.
English: • to the active substance gadoversetamide or
Danish: • over for det aktive stof gadoversetamid eller
English: Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på etiketten på kartonen og på injektionssprøjten efter Exp.
English: Gadoversetamide has been tested in humans in doses up to 700 micromol/kg (seven times the standard dose).
Danish: Gadoversetamid er blevet testet på mennesker i doser på op til 700 mikromol/kg (syv gange standarddosis).
English: • you are taking a special kind of antihypertensive medicine, i.e. a beta-blocker
Danish: • De tager en speciel form for blodtryksmedicin, dvs. et betablokker-præparat
English: Similar results are obtained in normal subjects and patients with various combinations of liver, CNS and renal dysfunctions with renal clearance of gadoversetamide being approximately 95% of the total plasma clearance.
Danish: Der opnås lignende resultater hos normale forsøgspersoner og patienter med forskellige kombinationer af lever-, CNS- og nyrelidelser med nyre-clearance af gadoversetamid på cirka 95% af den totale plasmaclearance.
English: In general, the addition of contrast to MRI, at the standard clinical dose of 100 micromol/kg, has led to a significantly improved lesion detection, sensitivity and diagnostic accuracy.
Danish: Generelt har tilføjelsen af kontrast til MRI i en klinisk standarddosis på 100 mikromol/kg ført til en signifikant forbedret læsionsdetektion, sensitivitet og diagnostisk nøjagtighed.