FrancophonIA/ELRC3.0 huggingface dataset:
English: Abott GmbH Perfektastraße 84A A-1230 Wien Austria
Danish: Abott GmbH Perfektastraße 84A A-1230 Wien Østrig
English: SI-1000 Ljubljana Slovenia
Danish: SI-1000 Ljubljana Slovenien
English: The CHMP noted that the SCOUT data clearly demonstrates that patients with obesity and known CV disease taking sibutramine are exposed to an increased risk for CV events compared with placebo.
Danish: CHMP noterede sig, at dataene fra SCOUT-undersøgelsen klart viser, at patienter med fedme og en kendt kardiovaskulær lidelse, der tager sibutramin, er udsat for en øget risiko for kardiovaskulære hændelser sammenlignet med patienter, der behandles med placebo.
English: Tietgens Boulevard 40 5220 Odense SØ Denmark
Danish: Tietgens Boulevard 40 5220 Odense SØ Danmark
English: C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Denmark
Danish: C. F. Tietgens Boulevard 40 DK-5220 Odense SØ Danmark
English: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Danish: 1 A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Tyskland
English: Verovškova 57 1000 Ljubljana Slovenia
Danish: Verovškova 57 1000 Ljubljana Slovenien
English: • The Committee further considered that a patient population in which sibutramine-containing medicinal products have a clear positive benefit/risk cannot be identified based on the current data,
Danish: • CHMP fandt desuden, at der ikke på grundlag af de aktuelle data kan identificeres en patientpopulation, hvor lægemidler indeholdende sibutramin vil have et klart positivt benefit/risk-forhold.
English: Teva Pharmaceuticals Europe B.V. European Headquarters Computerweg 10
Danish: European Headquarters Computerweg 10
English: 1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Germany
Danish: 1A Pharma GmbH Keltenring 1 + 3 82041 Oberhaching Tyskland
English: Verovskova 57 1000 Ljubljana Slovenia
Danish: Verovskova 57 1000 Ljubljana Slovenien
English: Czech Republic TEVA Pharmaceuticals ČR,s.r.o.
Danish: TEVA Pharmaceuticals ČR,s.r.o.
English: Teva Pharma B.V. Computerweg 10 3542 Dr Utrecht Netherlands
Danish: Computerweg 10 3542 DR Utrecht Holland
English: 10237 Prague 10 Dolni Mecholupy Czech Republic
Danish: 10237 Prague 10 Dolni Mecholupy Den Tjekkiske republik
English: 15 mg Film-coated tablet oral use
Danish: 15 mg Filmovertruken tablet
English: 10 mg Film-coated tablet oral use
Danish: 10 mg Filmovertruken tablet
English: Capsule, hard oral use
Danish: Kapsel, hård
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Czech Republic
Danish: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy Den Tjekkiske republik
English: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Czech Republic
Danish: U kabelovny 130, 102 37 Praga-10 Dolní Měcholupy, Den Tjekkiske republik
English: The CHMP concluded that the benefit/risk balance of sibutramine-containing medicinal products is affected adversely by the results from the SCOUT study and is considered to be negative.
Danish: • CHMP fandt, at de af indehaverne af markedsføringstilladelserne foreslåede risikominimeringsforanstaltninger ikke vil sikre overensstemmelse med produktresuméet eller i tilstrækkeligt omfang beskytte folkesundheden konkluderede CHMP, at benefit/risk-forholdet for lægemidler indeholdende sibutramin berøres negativt af resultaterne af SCOUT-undersøgelsen og anses for at være negativt.
English: Sibutril 15 mg capsules, hard 15 mg Capsule, hard oral
Danish: Sibutril 15 mg capsules, hard 15 mg Kapsel, hård oral
English: Sibutril 10 mg capsules, hard 10 mg Capsule, hard oral
Danish: Sibutril 10 mg capsules, hard 10 mg Kapsel, hård oral
English: 16929 Solna Sweden
Danish: 16929 Solna Sverige
English: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Danish: Abbott GmbH & Co.KG Max-Planck-Ring 2 65205 Wiesbaden Tyskland
English: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Germany
Danish: Abbott GmbH & Co KG Max-Planck-Ring 2 65205 Wiesbaden Tyskland
English: SE-169 29, Solna Sweden
Danish: SE-169 29, Solna Sverige
English: Sibutramina West Pharma 10 mg Capsule, hard oral use
Danish: Sibutramina West Pharma 10 mg Kapsel, hård
English: Sibutramina West Pharma 15 mg Capsule, hard oral use
Danish: Sibutramina West Pharma 15 mg Kapsel, hård
English: Zelium 10 mg Hartkapseln 10 mg Capsule, hard oral use
Danish: Zelium 10 mg Hartkapseln 10 mg Kapsel, hård
English: Zelium 15 mg Hartkapseln 15 mg Capsule, hard oral use
Danish: Zelium 15 mg Hartkapseln 15 mg Kapsel, hård
English: SE-169 29 Solna Sweden
Danish: SE-169 29 Solna Sverige
English: Sibutramin Sandoz 15 mg 15 mg Capsule, hard oral use
Danish: Sibutramin Sandoz 15 mg 15 mg Kapsel, hård
English: 169 29 Solna Sweden
Danish: 169 29 Solna Sverige
English: Sibutramin Sandoz 10 mg 10 mg Capsule, hard oral use
Danish: Sibutramin Sandoz 10 mg 10 mg Kapsel, hård
English: LINDAXA 15 mg, capsule 15 mg Capsule, hard oral use
Danish: LINDAXA 15 mg, capsule 15 mg Kapsel, hård
English: LINDAXA 10 mg, capsule 10 mg Capsule, hard oral use
Danish: LINDAXA 10 mg, capsule 10 mg Kapsel, hård
English: Sibutramina Argam 10 mg Capsule, hard oral use
Danish: Sibutramina Argam 10 mg Kapsel, hård
English: 1348 Ottignies/LLN Belgium
Danish: Abbott SA rue du Bosquet 2 1348 Ottignies/LLN Belgien
English: SIBUTRAMIN SANDOZ 10 mg Capsule, hard oral use
Danish: SIBUTRAMIN SANDOZ 10 mg Kapsel, hård
English: 15 mg capsule oral use
Danish: 15 mg kapsel
English: SIBUTRAMIN SANDOZ 15 mg Capsule, hard oral use
Danish: SIBUTRAMIN SANDOZ 15 mg Kapsel, hård
English: Abbott Scandinavia AB P.O.
Danish: Abbott Scandinavia AB P.O. Box 509
English: Sitrane 10 mg hard capsules 10 mg Capsule, hard oral use
Danish: Sitrane 10 mg hard capsules 10 mg Kapsel, hård
English: 10 mg capsule oral use
Danish: 10 mg kapsel
English: SILUTON 15 mg, capsule 15 mg Capsule, hard oral use
Danish: SILUTON 15 mg, capsule 15 mg Kapsel, hård
English: Sitrane 15 mg hard capsules 15 mg Capsule, hard oral use
Danish: Sitrane 15 mg hard capsules 15 mg Kapsel, hård
English: Sibutramina Argam 15 mg Capsule, hard oral use
Danish: Sibutramina Argam 15 mg Kapsel, hård
English: Reductil 10 mg hard capsules 10 mg Capsule, hard oral use
Danish: Reductil 10 mg hard capsules 10 mg Kapsel, hård
English: Marketing Authorisation Holder Invented Name
Danish: Indehaver af markedsføringstilladelsen
English: MINIMACIN 15 mg, capsule 15 mg Capsule, hard oral use
Danish: MINIMACIN 15 mg, capsule 15 mg Kapsel, hård
English: Reductil 15 mg hard capsules 15 mg Capsule, hard oral use
Danish: Reductil 15 mg hard capsules 15 mg Kapsel, hård
English: SILUTON 10 mg, capsule 10 mg Capsule, hard oral use
Danish: SILUTON 10 mg, capsule 10 mg Kapsel, hård
English: Reductil 10 mg trde kapsule 10 mg Capsule, hard oral use
Danish: Reductil 10 mg trde kapsule 10 mg Kapsel, hård
English: MINIMACIN 10 mg, capsule 10 mg Capsule, hard oral use
Danish: MINIMACIN 10 mg, capsule 10 mg Kapsel, hård
English: Reductil 10 mg - Hartkapseln 10 mg Capsule, hard oral use
Danish: Reductil 10 mg - Hartkapseln 10 mg Kapsel, hård
English: Reductil 15 mg - Hartkapseln 15 mg Capsule, hard oral use
Danish: Reductil 15 mg - Hartkapseln 15 mg Kapsel, hård
English: Reductil 15 mg trde kapsule 15 mg Capsule, hard oral use
Danish: Reductil 15 mg trde kapsule 15 mg Kapsel, hård
English: 10mg capsule oral use
Danish: 10 mg Kapsel
English: Reduxade 10 mg Hartkapseln 10 mg Capsule, hard oral use
Danish: Reduxade 10 mg Hartkapseln 10 mg Kapsel, hård
English: Reduxade 15 mg Hartkapseln 15 mg Capsule, hard oral use
Danish: Reduxade 15 mg Hartkapseln 15 mg Kapsel, hård
English: SIBUTRAL 10 mg, gélule 10 mg capsule oral use
Danish: SIBUTRAL 10 mg, gélule 10 mg Kapsel, hård
English: Reductil 10 mg Hartkapseln 10 mg Capsule, hard oral use
Danish: Reductil 10 mg Hartkapseln 10 mg Kapsel, hård
English: REDUCTIL 10 mg, capsule 10 mg Capsule, hard oral use
Danish: REDUCTIL 10 mg, capsule 10 mg Kapsel, hård
English: REDUCTIL 15 mg, capsule 15 mg Capsule, hard oral use
Danish: REDUCTIL 15 mg, capsule 15 mg Kapsel, hård
English: Reductil 15 mg Hartkapseln 15 mg Capsule, hard oral use
Danish: Reductil 15 mg Hartkapseln 15 mg Kapsel, hård
English: SIBUTRAMINA TEVA 15 mg Capsule, hard oral use
Danish: SIBUTRAMINA TEVA 15 mg Kapsel, hård
English: SIBUTRAL 15 mg, gélule 15 mg capsule oral use
Danish: SIBUTRAL 15 mg, gélule 15 mg Kapsel, hård
English: 15mg capsules oral use
Danish: 15 mg Kapsel
English: Your doctor will give you Evoltra once every day for 5 days.
Danish: Din læge vil give dig Evoltra en gang daglig i 5 dage.
English: From a microbiological point of view, it should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør lægemidlet anvendes med det samme.
English: Evoltra contains salt
Danish: Evoltra indeholder salt
English: PR = Partial Remission
Danish: PR = Partiel remission
English: Evoltra should not be handled by pregnant women.
Danish: Evoltra må ikke håndteres af gravide kvinder.
English: Estimates based on non-compartmental analysis (n = 14 / n = 14)
Danish: Estimater baseret på nonkompartmental analyse (n = 14 / n = 14)
English: Evoltra may harm both male and female reproductive organs.
Danish: Evoltra kan skade både mandlige og kvindelige kønsorganer.
English: EU/1/06/334/001 3 vials EU/1/06/334/002 4 vials EU/1/06/334/003 10 vials EU/1/06/334/004 20 vials EU/1/06/334/005 1 vial
Danish: EU/1/06/334/001 3 hætteglas EU/1/06/334/002 4 hætteglas EU/1/06/334/003 10 hætteglas EU/1/06/334/004 20 hætteglas EU/1/06/334/005 1 hætteglas
English: This is usually reversible and appears to be dosedependent.
Danish: Denne er normalt reversibel og synes at være dosisafhængig.
English: Therefore, Evoltra should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus).
Danish: Evoltra bør derfor ikke anvendes under graviditet, og især ikke i løbet af det første trimester, med mindre det er klart nødvendigt (dvs. kun hvis den potentielle fordel for moderen opvejer den potentielle risiko for fostret).
English: 2 to 6 weeks depending on toxicity and response.
Danish: - 6. uge afhængigt af toksicitet og respons.
English: It is a clear, almost colourless solution that is prepared and diluted before it is used.
Danish: Det er en klar, næsten farveløs opløsning, der tilberedes og fortyndes før brug.
English: CR = Complete Remission
Danish: CR = Komplet remission
English: Evoltra is for single use only.
Danish: Evoltra er kun til engangsbrug.
English: Each box contains 1, 3, 4, 10 or 20 vials, but not all pack sizes may be marketed.
Danish: Hver æske indeholder 1, 3, 4, 10 eller 20 hætteglas, men det er muligt, at ikke alle pakningsstørrelser markedsføres.
English: Date of latest renewal: 14 January 2016
Danish: Dato for første tilladelse: 29. maj 2006 Dato for seneste fornyelse: 14. januar 2016
English: Each box contains 1, 3, 4, 10 or 20 vials.
Danish: Hver æske indeholder 1, 3, 4, 10 eller 20 hætteglas.
English: Adverse reactions are listed by system organ class and frequency (very common ( 1/10); common ( 1/100 to < 1/10), uncommon ( 1/1,000 to < 1/100; rare ( 1/10,000 to < 1/1,000) and very rare (< 1/10,000)) in the table below.
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed (meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100; sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden (< 1/10.000)) i nedenstående tabel.
English: Yearly, simultaneously with submission of Periodic Safety Update reports
Danish: Årlig, samtidigt med indsendelsen af den periodiske sikkerhedsopdateringsrapport.
English: During treatment with Evoltra, your doctor will carry out regular blood tests and other tests to monitor your health.
Danish: Under behandling med Evoltra vil din læge jævnligt tage blodprøver og udføre andre undersøgelser for at checke dit helbred.
English: Where follow-up data are available, the majority of bilirubin elevations returned to  grade 2 within 10 days.
Danish: Hvor opfølgende data er til rådighed, returnerede størstedelen af stigningerne i bilirubin til ≤ grad 2 inden for 10 dage.
English: • Prophylactic administration of allopurinol should be considered if hyperuricemia (tumour lysis) is expected.
Danish: • Profylaktisk administration af allopurinol bør overvejes, hvis hyperurikæmi (tumorlyse) forventes.
English: Responses were seen in different immunophenotypes of ALL, including pre-B cell and T-cell.
Danish: Respons sås hos forskellige immunfænotyper af ALL, inklusive præ-B-celle- og Tcelle-ALL.
English: - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Danish: • (Antal patienter med CR + antal patienter med CRp)antal valgbare patienter, der fik clofarabin
English: If you forget to use Evoltra
Danish: Hvis du har glemt at få Evoltra
English: Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.
Danish: En klar, næsten farveløs opløsning med pH 4,5 - 7,5 og osmolaritet på 270 - 310 mOsm/l.
English: Once prepared and diluted, Evoltra should be used straight away or within 24 hours if stored in a refrigerator (at 2
Danish: Efter tilberedning og fortynding skal Evoltra anvendes med det samme eller i løbet af 24 timer, hvis det er blevet opbevaret i køleskab (2 °C - 8 °C).
English: Accordingly, longer infusion times should be considered in children weighing  20 kg (see section 4.2).
Danish: Længere infusionstid bør derfor overvejes hos børn, der vejer < 20 kg (se pkt.
English: The diluted concentrate should be a clear, colourless solution.
Danish: Det fortyndede koncentrat skal fremstå som en klar, farveløs opløsning.
English: (If the use of a 0.2 micrometre syringe filter is not feasible, the concentrate should be pre-filtered with a 5 micrometre filter, diluted and then administered through a 0.22 micrometre in-line filter.)
Danish: (Hvis det ikke er muligt at anvende et 0,2 µm sprøjtefilter, skal koncentratet forfiltreres gennem et 5 µm filter, fortyndes og dernæst administreres gennem et 0,22 µm in-line filter).
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, ATC code: L01BB06.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, antimetabolitter, ATC-kode: L01BB06
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium.
Danish: Det svarer til 3,08 mmol (eller 70,77 mg) natrium.
English: • An M1 marrow that did not qualify for CR or CRp
Danish: • M1-knoglemarv, der ikke kunne henregnes til CR eller CRp
English: • An M2 bone marrow ( 5% and ≤ 25% blasts) and appearance of normal progenitor cells
Danish: • M2-knoglemarv (≥ 5 % og ≤ 25 % blaster)udseende som for normale progenitorceller
English: Cytotoxic medicinal products should be handled with caution.
Danish: Cytostatika skal håndteres med forsigtighed.
English: These infections may lead to septic shock, respiratory failure, renal failure, and/or multiorgan failure.
Danish: Disse infektioner kan føre til septisk shock, respirationssvigt, nyresvigt, og/eller multiorgansvigt.
English: Adsorption and distribution
Danish: Absorption og fordeling
English: • Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 10
Danish: • Patienter, der overholder alle kriterierne for CR undtagen normalisering af trombocyttal til > 100 x 109/l
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil hvert år vurdere nye oplysninger lægemidlet, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: • DNA polymerase  inhibition resulting in termination of DNA chain elongation and/or DNA synthesis / repair.
Danish: • DNA-polymerase α-hæmning, der afslutter DNA-kædens elongering og/eller DNAsyntese/reparation.
English: Most of the cardiac adverse events were reported in the first 2 cycles.
Danish: De fleste af bivirkninger tilhørende hjerte organklassen blev indberettet inden for de første to cykler.
English: If a patient becomes pregnant during treatment with clofarabine, they should be informed of the possible hazard to the foetus.
Danish: Hvis en patient bliver gravid under behandlingen med clofarabin, skal hun informeres om den mulige risiko for fostret.
English: Patients who underwent transplant while in continued remission*
Danish: Patienter, der gennemgik transplantation under fortsat remission*
English: Histological evidence of hepatic effects was seen in dogs following acute administration of high doses, but was also not accompanied by changes in serum chemistry.
Danish: Histologisk dokumentation af leverpåvirkning sås hos hunde efter akut administration af høje doser, men det var heller ikke ledsaget af forandringer i serum-værdier.
English: Tell your doctor if you are using or have recently used: - medicines for heart disease; - any medicine that changes your blood pressure; - medicines that affect your liver or kidneys; - any other medicines including those obtained without a prescription.
Danish: Fortæl lægen, hvis du bruger anden medicin eller har gjort det for nyligt: - hjertemedicin; - medicin, der påvirker blodtrykket; - medicin, der påvirker lever eller nyrer; - andre lægemidler, også hvis der er tale om ikke-receptpligtige lægemidler.
English: However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Evoltra (see section 4.3).
Danish: På grund af muligheden for alvorlige bivirkninger under amning af spædbørn skal amningen dog indstilles før, under og efter behandling med Evoltra (se pkt.
English: Evoltra is used to treat children (≥ 1 year old), teenagers and young adults up to 21 years old with acute lymphoblastic leukaemia (ALL) when previous treatments have not worked or have stopped working.
Danish: Evoltra anvendes til at behandle børn (≥ 1 år) og unge i alderen op til 21 år med akut lymfoid leukæmi (ALL), når tidligere behandlinger ikke virkede eller er holdt op med at virke.
English: 1 vial 3 vials 4 vials 10 vials 20 vials
Danish: 1 hætteglas 3 hætteglas 4 hætteglas 10 hætteglas 20 hætteglas
English: Pericardial effusion and pericarditis were reported as an adverse event in 9% (10/115) of patients.
Danish: Perikardiel ekssudation og pericarditis optrådte som bivirkning hos 9 % (10/115) af patienterne.
English: CR * Duration of remission censored at the time of transplant ** Patient received a transplant following alternate therapy *** Patient received a transplant following relapse
Danish: CR * Remissionsvarighed vurderet på tidspunktet for transplantation ** Patient gennemgik transplantation efter alternativ behandling *** Patient gennemgik transplantation efter recidiv
English: Genzyme Limited 37 Hollands Road Haverhill Suffolk
Danish: 37 Hollands Road Haverhill Suffolk
English: Evoltra contains the active substance clofarabine.
Danish: Evoltra indeholder det aktive stof clofarabin.
English: The majority of elevations in ALT and AST occurred within 10 days of clofarabine administration and returned to  grade 2 within 15 days.
Danish: De fleste tilfælde af forhøjet ALAT og ASAT forekom inden for 10 dage efter administration af clofarabin og returnerede til ≤ grad 2 inden for 15 dage.
English: Very common: Febrile neutropaenia Common: Neutropaenia
Danish: Meget almindelig: Febril neutropeni Almindelig: Neutropeni
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium and should be taken into consideration for patients on a controlled sodium diet.
Danish: Det svarer til 3,08 mmol (eller 70,77 mg) natrium, og der bør tages højde for dette hos patienter på diæt med kontrolleret natriumindhold.
English: Evoltra must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Danish: Evoltra må ikke blandes med eller administreres samtidig med andre lægemidler via det samme intravenøse drop (se pkt.
English: If persistent leukaemia is not evident, it is recommended that the dose for the next cycle be reduced by 25% of the previous dose following recovery of ANC to ≥ 0.75 × 10
Danish: Hvis der ikke er tegn på persisterende leukæmi, anbefales det at reducere dosis til næste cyklus med 25 % i forhold til den forudgående dosis, efter at ANC atter er ≥0,75 x 109/l.
English: The threshold for developmental toxicity was considered to be 6 mg/m 2/day in rats and 1.2 mg/m 2/day in rabbits.
Danish: Grænsen for udviklingstoksicitetsforsøg ansås at være 6 mg/m2/dag hos rotter og 1,2 mg/m2/dag hos kaniner.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt produkt eller affald herfra bortskaffes i overensstemmelse med lokale regler.
English: Paasheuvelweg 251105 BP Amsterdam The Netherlands Manufacturer
Danish: Paasheuvelweg 25 1105 BP Amsterdam Holland
English: Dosing commenced at 11.25 with escalation to 15, 30, 40, 52 and 70 mg/m2/day by intravenous infusion for 5 days every
Danish: Administration begyndte med en dosis på 11,25 og eskalerede til 15, 30, 40, 52 og 70 mg/ m2/dag som intravenøs infusion i 5 dage hver 2.
English: The most frequent haematological laboratory abnormalities observed in patients treated with clofarabine were anaemia (83.3%; 95/114); leucopaenia (87.7%; 100/114); lymphopaenia (82.3%; 93/113), neutropaenia (63.7%; 72/113), and thrombocytopaenia (80.7%; 92/114).The majority of these events were of grade  3.
Danish: De hyppigste hæmatologiske laboratorieanomalier, der blev observeret hos patienter, som blev behandlet med clofarabin, var anæmi (83,3 %; 95/114); leukopeni (87,7 %; 100/114); lymfopeni (82,3 %; 93/113), neutropeni (63,7 %; 72/113) og trombocytopeni (80,7 %; 92/114).
English: Concentrate for solution for infusion 20 mg/20 ml
Danish: Koncentrat til infusionsvæske, opløsning 20 mg/20 ml
English: To date, the highest daily dose administered to human beings is 70 mg/m for 5 consecutive days (2 paediatric ALL patients).
Danish: Hidtil er den højeste døgndosis administreret til mennesker 70 mg/m2 5 dage i træk (2 pædiatriske ALL-patienter).
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER GODKENDT UNDER SÆRLGE OMSTÆNDIGHEDER
English: Patients who did not undergo transplant CR
Danish: Patienter, der ikke gennemgik transplantation
English: Common: Anorexia, decreased appetite, dehydration Frequency not known: hyponatremia
Danish: Almindelig: Anoreksi, nedsat appetit, dehydrering Ikke kendt: hyponatriæmi
English: It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride 9 mg/ml (0.9%) intravenous infusion to produce a total volume according to the examples given in the table below.
Danish: Opløsningen filtreres gennem et sterilt 0,2 µm sprøjtefilter og fortyndes så med 9 mg/ml (0,9 %) natriumchlorid til fortynding af infusionskoncentrat, så der opnås et samlet volumen som angivet i eksemplerne på tabellen nedenfor.
English: The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine at the recommended dose of 52 mg/m daily x 5.
Danish: De foreliggende oplysninger er baseret på data fra kliniske forsøg, hvor 115 patienter (> 1 og ≤ 21 år) enten med ALL eller akut myeloid leukæmi (AML) fik mindst én dosis clofarabin i den anbefalede dosis på 52 mg/m2 dagligt x 5.
English: If you are the parent of a child who is being treated with Evoltra, tell the doctor if any of them apply to your child.
Danish: Hvis du er forælder til et barn, som bliver behandlet med Evoltra, skal du fortælle lægen, hvis et af disse punkter passer på dit barn.