FrancophonIA/ELRC3.0 huggingface dataset:
English: Portugal
Danish: European Medicines Agency
English: This medicine is for diagnostic use only.
Danish: TESLASCAN er til diagnostisk brug.
English: Suomi/Finland
Danish: EMEA/H/C/137
English: B. CONDITIONS OF THE MARKETING AUTHORISATION
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for TESLASCAN.
English: What TESLASCAN contains - The active substance is mangafodipir trisodium.
Danish: Det aktive stof i TESLASCAN, mangafodipir, indeholder metallet mangan.
English: Near maximal enhancement of the normal liver and pancreas parenchyma is generally observed 15-20 minutes from the start of administration and lasts for approximately 4 hours.
Danish: Kontrastforstærkningen af billedet begynder 15 til 20 minutter efter start af infusionen og varer i ca. 4 timer.
English: United Kingdom GE Healthcare Limited Amersham Place Little Chalfont HP7 9NA - UK Tel: + 44 (0) 1 494 54 4000
Danish: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Common Uncommon Very rare Common Uncommon Very rare
Danish: Derved træder forskellen mellem normalt og unormalt væv frem.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell the radiologist/radiographer or your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om din sygdomstilstand eller behandling, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This corresponds to a dose of 35 ml for a 70 kg person.
Danish: TESLASCAN gives som en enkelt intravenøs infusion i en dosis på 0,5 ml pr. kg legemsvægt.
English: Those most commonly reported were: feeling of warmth/flushing, headache and nausea.
Danish: De hyppigste bivirkninger for TESLASCAN (som kunne observeres hos mellem 1 og 10 patienter ud af 100) er hovedpine, kvalme, rødme og varmefornemmelse.
English: Contrast medium for diagnostic Magnetic Resonance Imaging (MRI) for the detection of lesions of the liver suspected to be due to metastatic disease or hepatocellular carcinomas.
Danish: TESLASCAN anvendes hos patienter, der får foretaget magnetisk resonans-scanning (MRI) til påvisning af læsioner (skadet væv) i leveren, der kan skyldes leverkræft eller kræft, der har bredt sig til leveren fra andre dele af kroppen.
English: It should be administered as an intravenous infusion at the rate of 2-3 ml/min for liver imaging and at a rate of 4-6 ml/min for imaging of the pancreas.
Danish: ved scanning af leveren og 4 til 6 ml/min.
English: TESLASCAN is a paramagnetic contrast medium used in connection with Magnetic Resonance Imaging (MRI), to improve the diagnostic information.
Danish: Mangan anvendes som kontraststof for at få bedre billeder ved MRI-scanning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22.05.1997
Danish: Denne tilladelse blev fornyet den 22.
English: Care should be exercised in patients with severe cardiac disease and in patients with injuries of the blood brain barrier and severe cerebral disease.
Danish: TESLASCAN bør ikke anvendes hos kvinder, der er gravide eller ammer, patienter med fæokromocytom (en binyresvulst) eller patienter
English: Manganese is preferentially taken up by normal liver parenchyma and also in the pancreas so that contrast enhancement between abnormal and normal tissue can be expected.
Danish: Når medicinen er indsprøjtet, frigives mangan og optages bedre i det normale væv i leveren og bugspytkirtlen end i kræftcellerne.
English: There are limited data available on the use of Teslascan in children.
Danish: Hvilken fordel viser undersøgelserne, at der er ved TESLASCAN?
English: The amount of TESLASCAN in breast milk is not known.
Danish: Den fuldstændige liste over de indberettede bivirkninger for TESLASCAN fremgår af indlægssedlen.
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TESLASCAN
English: Rarely, hypersensitivity reactions (urticaria and other possible allergic phenomena) or anaphylactoid reactions may occur.
Danish: TESLASCAN bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for mangafodipir trinatrium eller andre af indholdsstofferne.
English: MARKETING AUTHORISATION HOLDER GE Healthcare AS
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for TESLASCAN til GE Healthcare AS den 22. maj 1997.
English: For any information about this medicine, please contact the local representative of the Marketing
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CHMP's anbefalinger, kan du læse de faglige
English: HIGIEA d.o.o.
Danish: ved scanning af bugspytkirtlen.
English: SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light.
Danish: Denne vekselvirkning bevirker, at signalet fra vandmolekylerne bliver kraftigere, så billedet bliver klarere.
English: TESLASCAN is for intravenous use and will be infused before the MRI examination.
Danish: TESLASCAN kan desuden anvendes ved MRI til
English: Pharmacokinetics in the elderly has not been investigated.
Danish: Hvordan blev TESLASCAN undersøgt?
English: Non-clinical studies reveal no special hazard for humans based on conventional studies of genotoxicity, safety pharmacology and validating kinetics and metabolism.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved TESLASCAN er større end risiciene som kontrastmiddel til anvendelse i forbindelse med diagnostisk MRI, til afsløring af leverlæsioner, der mistænkes for at være forårsaget af metastatiske sygdomme eller leverkræft, og som hjælpemiddel til MRI ved undersøgelse af fokale læsioner i bugspytkirtlen.
English: An uncontrolled observational study assessed the use of mangafodipir in the radiological assessment of infant patients with suspected bilary atresia.
Danish: Undersøgelserne af sygdom i bugspytkirtlen omfattede 292 patienter og sammenlignede virkningen af TESLASCAN-forstærket MRI med virkningen af "spiral-CT", en anden diagnostisk metode, der benyttes til at finde forandringer i bugspytkirtlen.
English: In whole human blood in vitro, the protein binding of manganese is approximately 27 % but binding of fodipir to protein is negligible.
Danish: I alle undersøgelser under ét fik 33 % af patienterne påvist flere læsioner efter TESLASCAN, men 20 % af patienterne havde færre læsioner.
English: TESLASCAN should be visually inspected for particulate matter and for the integrity of the container prior to use.
Danish: Virkningen blev hovedsagelig bedømt på forskellen i det antal leverlæsioner, der blev fundet ved den foregående scanning og ved anvendelse af TESLASCAN under MRI.
English: Pre-clinical studies in rats have established teratogenic effects when TESLASCAN was given repeatedly during major organogenesis.
Danish: Til afsløring af læsioner i bugspytkirtlen var TESLASCAN-forstærket MRI lige så effektivt som spiral-CT.
English: TESLASCAN may be infused into a vein, normally an arm vein, via a thin plastic tube.
Danish: TESLASCAN er en opløsning til infusion (dråbetilførsel i en vene), der indeholder det aktive stof
English: Important information about some of the ingredients of Teslascan This medicine contains 5.5 mmol (126 mg) sodium per normal dose of 35 ml.
Danish: Patienterne havde fra en til fem leverlæsioner, der i forvejen var fundet med MRI, ultralyd eller computertomografi (CT).
English: 9 to < 16 16 to 23 > 23 to 34
Danish: 9 til < 16 16 til 23 > 23 til 34
English: These risks are assessed in the corresponding national procedures.
Danish: Disse risici er blevet vurderet i de tilsvarende nationale procedurer.
English: Incomplete development of teeth.
Danish: Ufuldstændig udvikling af tænder.
English: SN: {number}
Danish: SN: {nummer} NN: {nummer}
English: Date of first authorisation: 09 July, 2003 Date of latest renewal: 08 July, 2008
Danish: Dato for første markedsføringstilladelse: 9. juli 2003 Dato for seneste fornyelse: 8. juli 2008
English: The long-term outcomes confirmed that the efficacy was maintained without unexpected effects.
Danish: Langtidsresultaterne bekræftede, at virkningen blev fastholdt uden uventede virkninger.
English: At the recommended dose, this is the desired effect.
Danish: I den anbefalede dosis er det den ønskede virkning.
English: By example:
Danish: For eksempel:
English: Other side effects may include:
Danish: Andre bivirkninger kan indbefatte:
English: No pharmacokinetic explanation justifies this interaction.
Danish: Der er ingen farmakokinetisk forklaring, der berettiger denne interaktion.
English: Occurrence of VOD was not related to overexposure.
Danish: Forekomsten af VOD var ikke forbundet med overeksponering.
English: Dimethylacetamide Macrogol 400.
Danish: Macrogol 400.
English: In adults:
Danish: Til voksne:
English: Paediatric population (0 to 17 years)
Danish: Pædiatrisk population (0 til 17 år)
English: However, caution is recommended (see sections 4.8 and 5.2).
Danish: Det anbefales dog at udvise forsigtighed (se pkt 4.8 og 5.2).
English: VOD observed were neither fatal nor severe and resolved in all cases.
Danish: Den observerede VOD var hverken fatal eller alvorlig og svandt i alle tilfælde.
English: No dose adjustment was deemed necessary.
Danish: Dosisjustering blev vurderet ikke at være nødvendig.
English: Therefore special care is recommended when combining these two compounds.
Danish: Derfor anbefales det at udvise særlige omhu ved kombination af de to forbindelser.
English: This signal was open based on an isolated case from the literature and no additional cases have been reported.
Danish: Signalet blev åbnet på baggrund af et enkeltstående tilfælde i litteraturen, og der er ikke blevet indberettet yderligere tilfælde.
English: None of the metabolites is thought to contribute significantly to either efficacy or toxicity.
Danish: Ingen af metabolitterne menes at bidrage i væsentlig grad til effekt eller toksicitet.
English: Therefore careful monitoring will be performed.
Danish: Behandlingen vil derfor finde sted under omhyggelig overvågning.
English: if you are currently taking other medicines.
Danish: - om De tager andre lægemidler.
English: Precautions to be taken before handling or administering the medicinal product
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering eller administration af lægemidlet
English: The signal concerning interaction with deferasirox is refuted and it can be closed.
Danish: Signalet om en interaktion med deferasirox afvises og kan lukkes.
English: Other infections were considered severe in 3% of patients.
Danish: Andre infektioner blev anset for alvorlige hos 3 % af patienterne.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/254/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/03/254/002
English: The following information is intended for medical or healthcare professionals only
Danish: Nedenstående oplysninger er til læger og sundhedspersonale.
English: In new-born infants, children and adolescents (0 to 17 years):
Danish: Til spædbørn, børn og unge (0 til 17 år):
English: Reversible binding to plasma proteins was around 7% while irreversible binding, primarily to albumin, was about 32%.
Danish: Reversibel binding til plasmaproteiner var på ca. 7 %, mens irreversibel binding primært til albumin var ca. 32 %.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100) or not known (cannot be estimated from the available data).
Danish: Hyppigheder er defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Nevertheless the risk of liver toxicity may be increased in this population.
Danish: Det antages dog, at risikoen for levertoksicitet kan være øget hos denne population.
English: Headache Nervous system disorders [Not Elsewhere Classified]
Danish: Forstyrrelser i nervesystemet [Ikke klassificeret andetsteds]
English: Small volumes may be administered over 2 hours using electric syringes.
Danish: Små mængder kan administreres i løbet af 2 timer med anvendelse af elektriske sprøjter.
English: There are no cases with oral busulfan.
Danish: Der er ingen tilfælde med oral busulfan.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke anvendes umiddelbart, er brugeren ansvarlig for opbevaringstid og -betingelser før brug, som normalt ikke overstiger de ovenfor angivne betingelser, når fortynding har fundet sted under kontrollerede og validerede aseptiske betingelser.
English: It may no longer be possible for you to achieve a pregnancy (infertility) after treatment with busulfan.
Danish: Det kan være, at det ikke længere er muligt for dig at opnå en graviditet (ufrugtbarhed) efter behandling med busulfan.
English: Fast and complete engraftment rates in 80-100% of patients were reported in the majority of studies.
Danish: Der blev rapporteret om hurtig og komplet engraftment hos 80-100 % af patienterne i størstedelen af studierne.
English: Two of the above four patients with serious serum hepatotoxicity were among patients with diagnosed HVOD.
Danish: To af de ovenfor nævnte fire patienter med alvorlig serum-hepatotoksicitet var blandt patienterne med diagnosticeret HVOD.
English: All patients experienced a profound myelosuppression.
Danish: Alle patienter fik omfattende myelosuppression.
English: The information presented on biotransformation and elimination is based on oral busulfan.
Danish: Informationerne om biotransformation og elimination baserer sig på oral busulfan.
English: A cumulative review of the literature and safety database has been performed.
Danish: Der er foretaget en samlet gennemgang af litteraturen og sikkerhedsdatabasen.
English: During the same period there was no death in autologous recipients.
Danish: Der forekom ingen dødsfald hos autologe recipienter i denne periode.
English: Contribution of long-lasting metabolites is not excluded.
Danish: Langtidsholdbare metabolitter kan heller ikke udelukkes.
English: There was no regimen-related death through the first 100-day post-transplant and up to one year post-transplant.
Danish: Der var ingen regimenrelaterede dødsfald i de første 100 dage efter transplantation og op til 1 år efter transplantation.
English: Vials: 3 years
Danish: Hætteglas: 3 år
English: The benefit risk profile of the product remains favourable in the approved indications.
Danish: Lægemidlets benefit/risk-profil forbliver fordelagtig ved de godkendte indikationer.
English: In case of overdose, management would include general supportive care.
Danish: I tilfælde af overdosering skal behandlingen omfatte almindelige støttende foranstaltninger.
English: Two prospective, single arm, open-label, uncontrolled phase II studies were conducted in patients with haematological disease, the majority of whom had advanced disease.
Danish: 2 prospektive, single arm, åbne, ukontrollerede fase II-studier blev gennemført hos patienter med hæmatologisk sygdom, hvoraf de fleste havde sygdommen i fremskreden grad.
English: From a microbiological point of view, the product should be used immediately after dilution.
Danish: Ud fra et mikrobiologisk synspunkt bør produktet anvendes umiddelbart efter fortynding.
English: 39% of patients (40/103) experienced one or more episodes of infection, of which 83% (33/40) were rated as mild or moderate.
Danish: 39 % af patienterne (40/103) oplevede en eller flere episoder med infektion, hvoraf 83 % (33/40) blev klassificeret som mild eller moderat.
English: Not relevant
Danish: Ikke relevant.
English: The highest frequency of nausea and vomiting was 59.1% and the highest frequency of stomatitis was
Danish: Den højeste forekomst af kvalme og opkastning var 59,1 %, og den højeste forekomst af stomatitis var
English: Each infusion will last 2 hours
Danish: Hver infusion varer 2 timer
English: Therefore Busilvex should be used with caution in this type of patients.
Danish: Busilvex skal derfor anvendes med forsigtighed til denne type patienter.
English: Mild/moderate fever was reported in 76% of patients.
Danish: Mild/moderat feber blev indberettet for 76 % af patienterne.
English: As with other cytotoxic compounds, caution should be exercised in handling and preparing the Busilvex solution: - The use of gloves and protective clothing is recommended.
Danish: Som for andre cytostatika skal der udvises forsigtighed ved håndtering og tilberedning af Busilvexopløsningen: - Det anbefales at anvende beskyttelseshandsker og -tøj.
English: Infections.
Danish: Infektioner.
English: The warning for TMA after HCT only applies to one pharmaceutical form: the intravenous.
Danish: Advarslen vedrørende TMA efter HCT gælder kun for én lægemiddelform: intravenøs.
English: However, more than 500 patients aged ≥ 55 years were reported in publications with FB conditioning regimens, yielding efficacy outcomes similar to younger patients.
Danish: Der er dog rapporteret om mere end 500 patienter i alderen ≥ 55 år i publikationer vedrørende konditionerende FB-regimer, der gav samme effektresultat som hos yngre patienter.
English: Not known (frequency cannot be estimated from the available data) Sex glands dysfunction.
Danish: Ukendt hyppighed (kan ikke vurderes ud fra tilgængelige data) Nedsat funktion af kønskirtlerne.
English: * veno occlusive liver disease is more frequent in paediatric population.
Danish: *Hepatisk venookklusiv sygdom er hyppigere forekommende i den pædiatriske population.
English: Seven literature reports have been published cumulatively concerning disturbance in dental development.
Danish: Samlet set er der publiceret syv litteraturrapporter vedrørende forstyrrelser i tandudviklingen.
English: Therefore, this interaction should be included in the product information for both pharmaceutical forms.
Danish: Denne interaktion skal derfor føjes til produktinformationen for begge lægemiddelformer.
English: It must be considered that overdose of Busilvex will also increase exposure to DMA.
Danish: Det skal tages i betragtning, at en overdosis af Busilvex også øger eksponeringen for DMA.
English: Patients older than 50 years of age (n=23) have been successfully treated with Busilvex without doseadjustment.
Danish: Patienter over 50 år (n=23) er blevet behandlet med succes med Busilvex uden dosisjustering.
English: OTHER SPECIAL WARNING IF NECESSARY Cytotoxic: handle with caution.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk: Håndter med forsigtighed
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og pakningen efter Exp.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Pierre Fabre Médicament
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Pierre Fabre Médicament
English: Patients should receive adequate anticonvulsant prophylaxis.
Danish: Patienterne skal have passende antikonvulsiv profylakse.
English: • The diluted solution must be mixed thoroughly by inverting several times.
Danish: • Den fortyndede opløsning skal blandes grundigt ved at vende op og ned på posen flere gange.
English: The administration of FB regimen has not been specifically investigated in elderly patients.
Danish: Der er ikke foretaget specifikke undersøgelser af FB-regimet hos ældre patienter.
English: Elevated bilirubin (n=3) and elevated AST (n=1) were also observed.
Danish: Der blev også set forhøjet bilirubin (n=3) og forhøjet ASAT (n=1).
English: Immediate and complete availability of the dose is obtained after intravenous infusion of busulfan.
Danish: Der opnås omgående og fuldstændig tilgængelighed af dosis efter intravenøs infusion af busulfan.
English: For a microbiological point of view, the diluted solution should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør den fortyndede opløsning anvendes straks.
English: It is possible that use of Busilvex may increase the risk of suffering another malignancy in the future.
Danish: Det er muligt, at anvendelse af Busilvex øger risikoen for at få en anden ondartet sygdom i fremtiden.
English: HPCT is contraindicated in pregnant women; therefore, Busilvex is contraindicated during pregnancy.
Danish: HPCT er kontraindiceret hos gravide kvinder, hvorfor Busilvex er kontraindiceret under graviditet.
English: Therefore, “tooth hypoplasia” should be added to the product information for both pharmaceutical forms.
Danish: ”Hypoplasi af tænder” skal derfor føjes til produktinformationen for begge lægemiddelformer.
English: Therefore all patients experienced profound cytopenia: leucopenia 96%, thrombocytopenia 94%, and anemia 88%.
Danish: Derfor fik alle patienter omfattende cytopeni: leukopeni 96 %, trombocytopeni 94 % og anæmi 88 %.
English: PROCEDURE FOR PROPER DISPOSAL
Danish: 3 PROCEDURE FOR KORREKT BORTSKAFFELSE
English: It has been suggested that conditioning regimens containing fludarabine were associated with higher incidence of opportunistic infections after transplantation because of the immunosuppressive effect of fludarabine.
Danish: Det er blevet antydet, at konditionerende regimer indeholdende fludarabin var forbundet med højere forekomst af opportunistiske infektioner efter transplantation på grund af fludarabins immunsupprimerende virkning.
English: ** reported in post marketing with IV busulfan *** reported in post marketing with oral busulfan
Danish: **rapporteret post-marketing med i.v.-busulfan ***rapporteret post-marketing med oral busulfan
English: It is unknown whether busulfan and DMA are excreted in human milk.
Danish: Det er ukendt, om busulfan og DMA udskilles i human mælk.
English: Concentrate 4 vials of 10ml.
Danish: Koncentrat 4 hætteglas a 10 ml.
English: DMA is teratogenic in rats.
Danish: DMA er teratogent hos rotter.
English: It was considered as deaths that could be attributable to secondary side effects after HPCT and not related to the relapse/progression of the underlying haematological malignancies.
Danish: Det blev betragtet som dødsfald, der kunne tilskrives sekundære bivirkninger efter HPTC, og ikke relateret til recidiv/progression af de underliggende hæmatologiske maligniteter.
English: The treatment-related mortality/non-relapse mortality (TRM/NRM) reported until day+100 posttransplant has also been examined through a review of published data from clinical trials.
Danish: Den behandlingsrelaterede mortalitet/mortalitet uden recidiv (TRM/NRM), der blev indberettet indtil dag +100 efter transplantation, er også blevet undersøgt via en gennemgang af publicerede data fra kliniske forsøg.
English: No specific antidote for DMA overdose is known.
Danish: Der kendes ingen antidot for overdosering af DMA.
English: Blood: decrease of blood circulating cells (red and white) and platelets.
Danish: Blodet: nedsættelse af antallet af cirkulerende blodceller (røde og hvide) og blodplader.
English: Pneumonia was fatal in 1% (1/103) and life-threatening in 3% of patients.
Danish: Pneumoni var dødelig hos 1 % (1/103) og livstruende hos 3 % af patienterne.
English: Late haemorrhagic cystitis occurring 2 weeks post-transplant are likely related to viral infection / reactivation.
Danish: Sen hæmoragisk cystitis, der indtræder 2 uger efter transplantation, er sandsynligvis relateret til virusinfektion/reaktivering.
English: Read this guide prior to the preparation and administration of Busilvex.
Danish: Læs denne vejledning før tilberedning og indgift af Busilvex.
English: There are no or limited amount of data from the use of busulfan or DMA in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af busulfan eller DMA til gravide kvinder.