FrancophonIA/ELRC3.0 huggingface dataset:
English: frequency cannot be estimated from the available data.
Danish: Hyppigheden kan ikke estimeres ud fra tilgængelige data.
English: • At the request of the European Medicines Agency
Danish: • Efter anmodning fra Det Europæiske Lægemiddelagentur
English: Your doctor or radiologist will consider this with you.
Danish: Din læge eller radiolog vil overveje dette sammen med dig.
English: The contents of the packs are:
Danish: Indholdet af pakningerne er:
English: In addition, an updated RMP should be submitted:
Danish: Derudover bør en ny RMP indsendes:
English: Risk Management Plan
Danish: Plan for risikostyring
English: If any of these apply to you, your doctor will decide whether the intended examination is possible or not.
Danish: Hvis noget af det ovenstående gælder for dig, vil din læge beslutte, om den påtænkte undersøgelse er mulig eller ej.
English: The dose used should also be recorded.
Danish: Den anvendte dosis skal ligeledes noteres.
English: Driving and using machines
Danish: Kørsel og brug af maskiner
English: You must tell your doctor if you think you are or might become pregnant.
Danish: Du skal fortælle det til din læge, hvis du tror du er eller evt. bliver gravid.
English: No dose adjustment is considered necessary.
Danish: Ingen dosisjustering anses for nødvendig.
English: It is for use in adults only.
Danish: Må kun anvendes til voksne.
English: • you had any reactions to previous injections of contrast media
Danish: • Du har haft reaktioner på tidligere injektioner med kontraststof
English: Seeing, feeling or hearing things that is not there Appetite decreased
Danish: Ser, føler eller hører ting, der ikke er der
English: The usual injection site is the back of your hand or just in front of your elbow.
Danish: Injektionsstedet er normalt på bagsiden af hånden eller lige foran albuen.
English: System Organ Class (MedDRA)
Danish: Organklasse (MedDRA)
English: No carcinogenicity studies were performed.
Danish: Der er ikke foretaget carcinogenicitetsundersøgelser.
English: The diagnosis can be made with greater accuracy than without using this medicine.
Danish: Diagnosen kan stilles med større nøjagtighed, end hvis der ikke anvendes dette lægemiddel.
English: The rubber stopper should never be pierced more than once.
Danish: Gummiproppen bør aldrig perforeres mere end en gang.
English: Children or adolescents under 18 years This medicine should not be used in children or adolescents under 18 year of age.
Danish: Børn eller unge under 18 år Dette lægemiddel bør ikke anvendes til børn eller unge under 18 år gamle.
English: Further information regarding the administration and handling of this medicine is given at the end of the leaflet.
Danish: Yderligere information om anvendelsen og håndteringen af dette lægemiddel findes i slutningen af indlægssedlen.
English: More than one dose should not be used during a scan.
Danish: Der må ikke anvendes mere end én dosis under scanningen.
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • Inden for 60 dage efter en vigtig (farmakoovervågning eller risikominimering) milepæl nås
English: It has not been proven that this medicine is safe to use during pregnancy.
Danish: Det er ikke bevist, at dette lægemiddel er sikkert at anvende under graviditet.
English: OUTER PACKAGING - BOX
Danish: YDRE EMBALLAGE - ÆSKE
English: Based on clinical trial experience in more than 1,800 patients, the following adverse reactions have been observed.
Danish: Kliniske forsøgsdata Baseret på erfaringer fra over 1.800 patienter er der set følgende uønskede reaktioner.
English: There are no data from the use of Ablavar in pregnant women.
Danish: Der savnes data fra anvendelse af Ablavar hos gravide kvinder.
English: PSURs The MAH will continue to submit yearly PSURs unless otherwise specified by the CHMP.
Danish: PSUR'er MAH vil fortsætte med at indsende årlige PSUR'er, medmindre andet specificeres af CHMP.
English: No clinical information is available about repeated use of this medicinal product.
Danish: Der er ingen klinisk information om gentagen brug af dette lægemiddel.
English: The dose of this medicine varies depending on your weight.
Danish: Den dosis, du får af dette lægemiddel, afhænger af din vægt.
English: • you have recently had, or soon expect to have, a liver transplant
Danish: • Du for nylig har fået eller står for at skal have foretaget en levertransplantation
English: Steady state imaging can begin after the dynamic scan has been completed.
Danish: Steady state-scanning kan påbegyndes, når den dynamiske scanning er afsluttet.
English: Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet ved gentagne høje doser (se afsnit 5.3).
English: It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check how well your kidneys are working.
Danish: Det er ikke nødvendigt at justere din dosis, hvis du er 65 år gammel eller derover, men det kan være, du skal have taget en blodprøve, for at undersøge, hvor godt dine nyrer fungerer.
English: Your doctor may decide to take a blood test to check how well your kidneys are working before making the decision to use this medicine, especially if you are 65 years of age or older.
Danish: Lægen kan beslutte sig for at tage en blodprøve for at kontrollere, hvor godt dine nyrer fungerer, inden der tages beslutning om at anvende dette lægemiddel, især hvis du er 65 år gammel eller derover.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
Danish: Ifølge CHMP Guideline on Risk Management Systems for lægemidler til human anvendelse skal enhver opdateret RMP indsendes på samme tidspunkt som den følgende Periodic Safety Update Report (PSUR).
English: The doctor will decide how much medicine is needed for your examination.
Danish: Lægen vil beslutte, hvor stor dosis lægemiddel, der er behov for til undersøgelsen.
English: Experience with other contrast media shows that the risk of hypersensitivity reactions is higher in those patients.
Danish: Erfaring med andre kontraststoffer viser, at risikoen for overfølsomhedsreaktioner er højere hos disse patienter.
English: Like all medicines, Ablavar can cause side effects, although not everybody gets them.
Danish: Ablavar kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of potential severe reactions to the contrast agent itself.
Danish: Der skal være relevante faciliteter tilgængelige til håndtering af eventuelle komplikationer ved proceduren samt til akut behandling af eventuelle svære reaktioner på selve kontraststoffet.
English: If you have any of the following symptoms you should tell a doctor immediately:
Danish: Hvis du har nogen af de følgende symptomer, skal du straks underrette lægen.
English: The safety and effectiveness of Ablavar in patients under 18 years of age have not been established.
Danish: Sikkerheden og virkningen af Ablavar hos patienter under 18 år er ikke blevet fastlagt.
English: • you have a cardiac pacemaker or any ferromagnetic implant or a metallic stent in your body
Danish: • Du har pacemaker eller andre ferromagnetiske implantater eller et metalstent i kroppen
English: Ninety-four percent (94%) of the urinary excretion occurred in the first 72 hours.
Danish: 94% af udskillelsen i urinen forekom i de første 72 timer.
English: 0.05 mmol/kg at 20 MHz.
Danish: 0,05 mmol/kg ved 20 MHz.
English: If use of Ablavar cannot be avoided, the dose should not exceed 0.03 mmol/kg body weight.
Danish: Hvis brug af Ablavar ikke kan undgås, må dosis ikke overstige 0,03 mmol/kg kropsvægt.
English: Your doctor will advise you what to do.
Danish: Din læge vil rådgive dig om det.
English: Vascular stents
Danish: Vaskulære stents
English: Laboratory test interactions
Danish: Laboratorietest-interaktioner
English: Do not use Ablavar
Danish: Brug ikke Ablavar:
English: The anticoagulant activity of warfarin was not altered and the efficacy of the medicinal product was not influenced.
Danish: Warfarins antikoagulerende aktivitet blev ikke ændret, og effekten af lægemidlet blev ikke påvirket.
English: This medicine is used together with an imaging technique called magnetic resonance imaging (MRI).
Danish: Dette lægemiddel anvendes sammen med en scanningsteknik som kaldes magnetisk resonansscanning (MRI).
English: After the injection you will be observed in case there might be any initial side effects.
Danish: Efter injektionen bliver du holdt under opsyn, hvis der skulle opstå begyndende bivirkninger.
English: The following is a list of side-effects observed in clinical trials:
Danish: Her følger en oversigt over alle bivirkninger, som er set i kliniske studier:
English: If you think you may have had an overdose talk to your doctor immediately.
Danish: Hvis du mener, at du har fået en overdosis, så tal straks med din læge.
English: It is therefore advisable to use a flexible indwelling cannula for intravenous contrast medium administration.
Danish: Det tilrådes derfor at anvende en fleksibel indlagt kanyle til indgivelse af intravenøst kontraststof.
English: Plasma protein binding was in a range 80% to 87% for up to the first 4 hours after injection.
Danish: Plasmaproteinbindingen lå i intervallet 80% til 87% i op til 4 timer efter injektionen.
English: Disturbed nerve signals in the heart (first degree) Fast heart beat
Danish: Forstyrrede nervesignaler i hjertet (første grad) Hurtig hjerterytme
English: Tell your doctor immediately if you notice itching, a feeling of mild swelling in your throat or tongue, which might be a first sign of some allergy-like reaction.
Danish: Fortæl straks lægen, hvis du bemærker kløe eller en let hævelse i svælget eller på tungen, hvilket kan være det første tegn på en allergi-lignende reaktion.
English: The usual safety precautions for magnetic resonance imaging must be observed, e.g., exclusion of cardiac pacemakers and ferromagnetic implants.
Danish: De sædvanlige sikkerhedskrav for magnetisk resonansscanning skal overholdes, f.eks. udelukkelse af pacemaker og ferromagnetiske implantater.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Detaljerede oplysninger om dette produkt forefindes på hjemmesiden for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu
English: No functional impairment was observed and electron microscopic investigations of the rat kidneys indicated that the observed vacuolation was primarily a storage phenomenon.
Danish: Der blev ikke observeret nogen funktionshæmning, og elektronmikroskopiske undersøgelser af rottenyrerne viste, at den observerede vakuolisering primært var et aflejringsfænomen.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Danish: Indehaveren af MAH forpligter sig til at udføre undersøgelserne og yderligere farmakoovervågningsaktiviteter angivet i Pharmacovigilance Plan som man er enig om i version 2.0 Risk Management Plan (RMP) fremlagt i markedsføringstilladelsens modul 1.8.2 og alle efterfølgende opdateringer af RMP i enighed med CHMP.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Det skal der tages hensyn til for de patienter, som er på en kontrolleret natriumdiæt.
English: Your doctor will treat you should overdose occur.
Danish: Din læge vil behandle dig, hvis der forekommer en overdosering.
English: Because gadofosveset is bound to albumin, an interaction with other plasma protein bound active substances (e.g., ibuprofen and warfarin) is generally possible, i.e., a competition for the protein binding site can occur.
Danish: Da gadofosveset er bundet til albumin, er en interaktion med andre plasma-proteinbundne aktive stoffer (f.eks. ibuprofen og warfarin) generelt mulig, dvs. der kan opstå konkurrence om proteinbindingsstedet.
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg din læge eller apotek til råds, før du tager nogen form for medicin.
English: However, in a series of in vitro drug interaction studies (in 4.5 % human serum albumin and human plasma), gadofosveset demonstrated no adverse interaction with digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac and piroxicam at clinically relevant concentrations.
Danish: I en række in vitro-interaktionsforsøg (i 4,5 % humant serumalbumin og humant plasma), udviste gadofosveset imidlertid ingen uønsket interaktion med digitoxin, propranolol, verapamil, warfarin, phenprocoumon, ibuprofen, diazepam, ketoprofen, naproxen, diclofenac og piroxicam ved klinisk relevante koncentrationer.
English: In an animal study, it was shown that less than 1% of the dose of gadofosveset administered enters breast milk.
Danish: Et dyreforsøg har vist, at mindre end 1% af den dosis af gadofosveset, der indgives, går i modermælken.
English: You will need special medical attention if allergy-like reactions occur.
Danish: Du skal under lægebehandling, hvis der forekommer allergi-lignende reaktioner.
English: In clinical trials, imaging was completed up to approximately one hour following injection.
Danish: I kliniske forsøg blev scanning afsluttet op til cirka en time efter injektionen.
English: Any remaining solution not used in one examination must be discarded.
Danish: Opløsning, som ikke anvendes ved én undersøgelse, skal kasseres.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, local tolerance, contact-sensitising potential, and genotoxicity.
Danish: De prækliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, akut toksicitet, lokal tolerance, kontaktsensibiliseringspotentiale og genotoksicitet.
English: No comparative studies with extracellular gadolinium contrast agents have been conducted.
Danish: Der er ikke udført sammenlignelige studier med ekstracellulære gadolinium-kontraststoffer.
English: Relaxivity in plasma was measured to be 33.4 to 45.7 mM-1s-1 over the dose range of up to
Danish: Relaksiviteten i plasma blev målt til 33,4 til 45,7 mM-1s-1 over et dosisinterval på op til
English: It has been shown in published studies that MRA in the presence of metallic stents causes artefacts.
Danish: Det er vist i publicerede studier at MRA medfører artefakter ved tilstedeværelse af metalstents.
English: In clinical trials using Ablavar, no specific trends were observed that would signify a potential interaction of the medicinal product with laboratory test methods.
Danish: I kliniske forsøg med Ablavar sås ingen specifikke tendenser, som kunne tyde på en potentiel interaktion af lægemidlet med laboratorietestmetoder.
English: The usual dose
Danish: Sædvanlig dosis
English: If a patient experiences these effects he/she should not drive or use machines
Danish: Hvis en patient oplever disse virkninger, bør han/hun ikke køre eller betjene maskiner.
English: This medicine is given as a rapid injection into a vein by a medical professional only.
Danish: Dette lægemiddel gives som en hurtig injektion i en vene udelukkende af en sundhedsmedarbejder.
English: Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group.
Danish: Patienter, der får foretaget levertransplantation, er i større risiko, da der er høj incidens af akut nyresvigt hos denne gruppe.
English: However if use is required you should only receive one dose of this medicine during a scan and you should not receive a second injection for at least 7 days.
Danish: Hvis det imidlertid er nødvendigt at bruge præparatet, bør du kun modtage én dosis lægemiddel under scanningen, og der skal gå mindst 7 dage, inden du modtager den næste dosis.
English: Most of the adverse reactions (80%) occurred within 2 hours.
Danish: De fleste uønskede reaktioner (80%) opstod inden for 2 timer efter indgivelse.
English: Use is not recommended in neonates, infants, children and adolescents.
Danish: Anbefales ikke til for tidligt fødte, nyfødte, børn og unge.
English: Thickening of the arteries due to cholesterol deposits Low blood pressure
Danish: Fortykning af arterierne grundet kolesterolaflejringer Lavt blodtryk
English: It is used to help detect changes in the blood vessels which are known or suspected to be abnormal.
Danish: Det anvendes for lettere at kunne påvise ændringer i blodkar, som man ved eller har mistanke om er unormale.
English: Your doctor will discuss whether you should continue breast-feeding or interrupt breast-feeding for a period of 24 hours after you receive this medicine.
Danish: Lægen vil drøfte, om du skal fortsætte med at amme eller afbryde amningen i 24 timer, efter du har modtaget dette lægemiddel.
English: In vitro studies using human liver microsomes did not indicate any potential to inhibit the cytochrome P 450 enzyme system.
Danish: In vitro-forsøg med humane levermikrosomer udviste intet potentiale for hæmning af cytokrom P 450-enzymsystemet.
English: During the dialysis sessions the mean half-life of plasma concentration decline was in the range 5-6 hours.
Danish: Under dialysen lå den gennemsnitlige halveringstid af plasmakoncentrationsfaldet omkring 5-6 timer.
English: In human studies, gadofosveset substantially shortens blood T1 values for up to 4 hours after intravenous bolus injection.
Danish: I humane forsøg forkorter gadofosveset blodets T1-værdier væsentligt i op til 4 timer efter intravenøs bolusinjektion.
English: The use of this medicine is not recommended in patients with severe kidney problems and patients who have recently had, or soon expect to have, a liver transplant.
Danish: Det anbefales ikke at anvende dette lægemiddel hos patienter med svære nyreproblemer samt patienter, der for nylig har fået eller står for at skal have foretaget en levertransplantation.
English: In patients with moderate to severe renal impairment the half-life is markedly prolonged and the AUC increased by 2-3fold.
Danish: Hos patienter med moderat til svært nedsat nyrefunktion er halveringstiden tydeligt forlænget, og AUC øges 2-3 gange.
English: In the situation of elevated levels of gadofosveset or underlying QT prolongation the patient should be carefully observed including cardiac monitoring.
Danish: I situationer med forhøjede niveauer af gadofosveset eller underliggende QT-forlængelse skal patienten observeres nøje herunder ved hjertemonitorering.
English: Sugar in the urine
Danish: Sukker i urinen
English: As the renal clearance of gadofosveset may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Danish: Da nyreudskillelsen af gadofosveset kan være nedsat hos ældre, er det særligt vigtigt at screene patienter i alderen 65 år og over for renal dysfunktion.
English: Effects were of higher severity in rats than in monkeys, probably because of the higher renal clearance in rats.
Danish: Effekten var kraftigere hos rotter end hos aber, især på grund af den højere udskillelse gennem nyrerne hos rotter.
English: In rabbits, an increased number of early resorptions and a slight but significant increase in the number of foetal anomalies (in particular hydrocephalus and malrotated limbs) were observed at doses at which no or slight maternal toxicity was observed (exposure was 2 and 5 times the expected human exposure, respectively).
Danish: Hos kaniner sås et øget antal tidlige resorptioner og en let, men signifikant, stigning i antallet af fosteranomalier (især hydrocephalus og malrotation af ekstremiteter) ved doser, hvor ingen eller ringe toksicitet sås hos moderen (eksponering var hhv. 2 og 5 gange den forventede humane eksponering).
English: Diagnostic procedures involving the use of MRI contrast agents should be carried out under the 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 MRI-kontraststoffer, skal udføres under overvågning af en læge med den nødvendige kompetence og et indgående kendskab til den procedure, der skal udføres.
English: Gadofosveset binds reversibly to human serum albumin.
Danish: Gadofosveset bindes reversibelt til humant serumalbumin.
English: Medicinal product subject to restricted medicinal prescription (See Annex 1: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé, 4.2)
English: Scanning may start immediately after the Ablavar injection.
Danish: Scanningen kan starte straks efter injektionen med Ablavar.
English: Dose in special patient groups
Danish: Dosis til særlige patientgrupper
English: Ablavar can be associated with allergy-like reactions (anaphylactoid / hypersensitivity reactions) characterised by:
Danish: Ablavar kan være forbundet med allergi-lignende reaktioner (anafylaktoide reaktioner/overfølsomhedsreaktioner) karakteriseret ved:
English: The results from various evaluations of plasma and urine samples indicated that gadofosveset does not undergo measurable metabolism.
Danish: Resultaterne fra forskellige evalueringer af plasma- og urinprøver indikerer, at gadofosveset ikke gennemgår nogen målbar metabolisme.
English: At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.
Danish: Ved kliniske doser forventes ingen virkning på nyfødte på grund af de små mængder, der udskilles i mælken, og dårlig optagelse i tarmen..
English: You must not be given Ablavar if you are allergic (hypersensitive) to gadofosveset or any of the other ingredients of this medicine (see section 6 of this leaflet).
Danish: • Du må ikke få Ablavar hvis du er allergisk (overfølsom) over for gadofosveset eller et af de øvrige indholdstoffer i dette lægemiddel (se pkt.
English: If you get these effects you should not drive or use machines
Danish: Hvis du får disse virkninger, bør du ikke køre eller bruge maskiner.
English: Pharmacotherapeutic group: Contrast media, paramagnetic contrast media, ATC code: V08CA.
Danish: Farmakoterapeutisk klassifikation: Kontraststof, paramagnetisk kontraststof, ATC-kode: V08CA
English: If necessary, this medicine can be removed from the body by haemodialysis using high-flux filters.
Danish: Om nødvendigt kan dette lægemiddel fjernes fra kroppen ved hæmodialyse med anvendelse af high-flux-filtre.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 October 2005
Danish: Dato for første tilladelse: 3 oktober 2005 Dato for seneste fornyelse:
English: Proteins in the urine
Danish: Protein i urinen
English: Delayed reactions (after hours to days) may occur.
Danish: Forsinkede reaktioner (efter timer til dage) kan forekomme.
English: Read all of this leaflet carefully before you are given this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden du begynder at bruge medicinen.
English: The table below reports adverse reactions by MedDRA system organ classes (MedDRA SOCs).
Danish: Bivirkningerne fremgår af nedenstående tabel i henhold til MedDRA-organklasser (MedDRA SOCs).
English: Warm feeling (vasodilatation) including flushing Nausea
Danish: Varm følelse (karudvidelse) inklusive rødmen Kvalme
English: Low calcium levels in the blood Unusual amount of salt in the body.
Danish: Høje sukkerniveauer i blodet Lave kalciumniveauer i blodet Usædvanlig mængde salt i kroppen